Comparison of efficacy and safety of two parenteral iron preparations in pregnant women Randomized double-blind safety comparison of intravenous iron dextran versus iron sucrose in an adult non-hemodialysis outpatient population: A feasibility study Safety and Efficacy of Intravenous Ferric Carboxymaltose (750 mg) in the Treatment of Iron Deficiency Anemia: Two Randomized, Controlled Trials Darbepoetin alfa 300 or 500 μg once every 3 weeks with or without intravenous Iron in patients with chemotherapy‐induced anemia A Randomized, Open-Label, Non-Inferiority Study of Intravenous Iron Isomaltoside 1,000 (Monofer) Compared With Oral Iron for Treatment of Anemia in IBD (PROCEED) Safety and Usefulness of Intravenous Iron Sucrose in the Management of Preoperative Anemia in Patients with Menorrhagia: A Phase IV, Open-Label, Prospective, Randomized Study Randomized, multicenter, controlled trial comparing the efficacy and safety of darbepoetin alpha administered every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. The safety of achieved iron stores and their effect on IV iron and ESA use: post-hoc results from a randomized trial of ferric citrate as a phosphate binder in dialysis . Intravenous iron isomaltoside improves hemoglobin concentration and iron stores in female iron‐deficient blood donors: a randomized double‐blind placebo‐controlled clinical trial A prospective randomized, controlled trial of intravenous versus oral iron for moderate iron deficiency anaemia of pregnancy. Efficacy and safety of intravenously administered iron sucrose with and without adjuvant recombinant human erythropoietin for the treatment of resistant iron-deficiency anemia during pregnancy. 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Iron deficiency and its management in patients undergoing lipoprotein apheresis. Comparison of two parenteral iron formulations. Clinical update: intravenous iron for anaemia Intravenous Iron Sucrose in Peritoneal Dialysis Patients with Renal Anemia A 1-year trial of repeated high-dose intravenous iron isomaltoside 1000 to maintain stable hemoglobin levels in inflammatory bowel disease Ferumoxytol as an intravenous iron replacement therapy in hemodialysis patients. Comparative efficacy and safety of intravenous ferric carboxymaltose in the treatment of postpartum iron deficiency anemia. Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial. Intravenous ferric gluconate significantly improves response to epoetin alfa versus oral iron or no iron in anemic patients with cancer receiving chemotherapy. Safety and efficacy of iron sucrose in patients sensitive to iron dextran: North American clinical trial. FDA report: Ferumoxytol for intravenous iron therapy in adult patients with chronic kidney disease A randomized open-label study of darbepoetin alfa administered every 3 weeks with or without parenteral iron in anemic subjects with nonmyeloid malignancies receiving chemotherapy. Efficacy of Intravenous Iron Sucrose in Hemodialysis Patients with Restless Legs Syndrome (RLS): A Randomized, Placebo-Controlled Study Ferric Citrate Reduces Intravenous Iron and Erythropoiesis-Stimulating Agent Use in ESRD. Intravenous Iron Sucrose in Chinese Hemodialysis Patients with Renal Anemia Intravenous iron or placebo for anaemia in intensive care: the IRONMAN multicentre randomized blinded trial Efficacy of IV iron compared to oral iron for increment of haemoglobin level in anemic chronic kidney disease patients on erythropoietin therapy. Comparative assessment of the bioavailability, efficacy and safety of a modified-release (MR) carbonyl iron tablet and oral conventional iron preparation in adult Indian patients with nutritional iron deficiency anaemia. Safety and efficacy of total dose infusion of 1,020 mg of ferumoxytol administered over 15 min Oral valganciclovir leads to higher exposure to ganciclovir than intravenous ganciclovir in patients following allogeneic stem cell transplantation. Iron prophylaxis in pregnancy: intravenous route versus oral route. Evaluating the effectiveness of IV iron dosing for anemia management in common clinical practice: results from the Dialysis Outcomes and Practice Patterns Study (DOPPS) Intravenous Iron Sucrose versus Oral Iron Supplementation for the Treatment of Iron Deficiency Anemia in Patients with Inflammatory Bowel Disease—A Randomized, Controlled, Open-Label, Multicenter Study Comparative study--efficacy, safety and compliance of intravenous iron sucrose and intramuscular iron sorbitol in iron deficiency anemia of pregnancy. Oral versus Intravenous Iron Supplementation in Peritoneal Dialysis Patients Intravenous iron for the treatment of fatigue in nonanemic, premenopausal women with low serum ferritin concentration. A comparison of oral and intravenous iron supplementation in preterm infants receiving recombinant erythropoietin. Randomized trial of intravenous iron supplementation in patients with chemotherapy-related anemia without iron deficiency treated with darbepoetin alpha. Direct Comparison of the Safety and Efficacy of Ferric Carboxymaltose versus Iron Dextran in Patients with Iron Deficiency Anemia Ferric pyrophosphate citrate (Triferic™) administration via the dialysate maintains hemoglobin and iron balance in chronic hemodialysis patients Intravenous iron sucrose versus oral iron in treatment of iron deficiency anemia in pregnancy: a randomized clinical trial. A comparison between intravenous iron polymaltose complex (Ferrum Hausmann®) and oral ferrous fumarate in the treatment of iron deficiency anaemia in pregnancy A Blinded, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of Ferric Carboxymaltose in Iron-Deficient Patients with Fibromyalgia Sodium ferric gluconate complex in hemodialysis patients. II. Adverse reactions in iron dextran-sensitive and dextran-tolerant patients. Functional iron deficiency in hemodialysis patients with high ferritin Effect of intravenous iron supplementation on erythropoiesis in erythropoietin-treated premature infants. The Important Role for Intravenous Iron in Perioperative Patient Blood Management in Major Abdominal Surgery Safety and efficacy of rapidly administered (one hour) one gram of low molecular weight iron dextran (INFeD) for the treatment of iron deficient anemia A Novel Intravenous Iron Formulation for Treatment of Anemia in Inflammatory Bowel Disease: The Ferric Carboxymaltose (FERINJECT®) Randomized Controlled Trial Safety of ferumoxytol in patients with anemia and CKD. Colonoscopy preparation in children: safety, efficacy, and tolerance of high- versus low-volume cleansing methods. A phase 3 study of deferasirox (ICL670), a once-daily oral iron chelator, in patients with beta-thalassemia. Intravenous iron sucrose complex in the treatment of iron deficiency anemia during pregnancy. Efficacy and safety of oral versus intravenous ascorbic acid for anaemia in haemodialysis patients. High-dose intravenous treatment in iron deficiency anaemia in inflammatory bowel disease: early efficacy and impact on quality of life. Iron protein succinylate in the treatment of iron deficiency: controlled, double-blind, multicenter clinical trial on over 1,000 patients. Intravenous Versus Oral Iron for Treatment of Anemia in Pregnancy: A Randomized Trial Iron therapy in iron deficiency anemia in pregnancy: intravenous route versus oral route. [Intravenous iron sucrose in maintenance dialysis patients with renal anemia: a clinical study]. Safety and Efficacy of Total-Dose Infusion of Low Molecular Weight Iron Dextran for Iron Deficiency Anemia in Patients with Inflammatory Bowel Disease Ferric Maltol Is Effective in Correcting Iron Deficiency Anemia in Patients with Inflammatory Bowel Disease: Results from a Phase-3 Clinical Trial Program Effect of intravenous injection speed on responses to cocaine and hydromorphone in humans Ferric carboxymaltose injection in the treatment of postpartum iron deficiency anemia: a randomized controlled clinical trial. Intravenous ferric carboxymaltose in iron-deficient chronic heart failure patients with and without anaemia: a subanalysis of the FAIR-HF trial Sodium ferric gluconate complex in hemodialysis patients: adverse reactions compared to placebo and iron dextran. The safety of intravenous iron dextran in hemodialysis patients. Ferric gluconate is highly efficacious in anemic hemodialysis patients with high serum ferritin and low transferrin saturation: results of the Dialysis Patients' Response to IV Iron with Elevated Ferritin (DRIVE) Study. Intravenous versus oral iron therapy for postpartum anaemia. Rationale and design of the IRON-HF study: a randomized trial to assess the effects of iron supplementation in heart failure patients with anemia. Controlled, double-blind, multicenter clinical trial of iron protein succinylate in the treatment of iron deficiency in children. Comparison of efficacy, tolerability, and cost of iron polymaltose complex with ferrous sulphate in the treatment of iron deficiency anemia in pregnant women. Intravenous Ferric Carboxymaltose Compared With Oral Iron in the Treatment of Postpartum Anemia: A Randomized Controlled Trial FERGIcor, a randomized controlled trial on ferric carboxymaltose for iron deficiency anemia in inflammatory bowel disease. Venous Thromboembolism Is Rare with a Multimodal Prophylaxis Protocol after Total Hip Arthroplasty Comparison of a Combination Ferrous Fumarate Product and a Polysaccharide Iron complex as Oral Treatments of Iron Deficiency Anemia: A Taiwanese Study Intravenous branched chain amino acid trial in marrow transplant recipients. Effect of intravenous iron sucrose in peritoneal dialysis patients who receive erythropoiesis-stimulating agents for anemia: a randomized, controlled trial. Intravenous iron isomaltoside 1000 (Monofer®) reduces postoperative anaemia in preoperatively non-anaemic patients undergoing elective or subacute coronary artery bypass graft, valve replacement or a combination thereof: a randomized double-blind placebo-controlled clinical trial (the PROTECT trial) Factors affecting response and tolerability to ferumoxytol in nondialysis chronic kidney disease patients. Ferric pyrophosphate citrate administered via dialysate reduces erythropoiesis-stimulating agent use and maintains hemoglobin in hemodialysis patients Intravenous iron exposure and mortality in patients on hemodialysis. Oral ciprofloxacin vs. intravenous ceftazidime plus tobramycin in pediatric cystic fibrosis patients: comparison of antipseudomonas efficacy and assessment of safety with ultrasonography and magnetic resonance imaging. Cystic Fibrosis Study Group. WHO sponsored collaborative studies on nutritional anaemia in India. The effect of parenteral iron administration in the control of anaemia of pregnancy. Ferumoxytol versus placebo in iron deficiency anemia: efficacy, safety, and quality of life in patients with gastrointestinal disorders
Objective : To compare the efficacy and safety with a fixed dose of two parenteral iron preparations , iron sucrose complex and iron sorbitol citric acid as per the current practice . Material s and Methods : A prospect i ve r and omized open label study was conducted . In this study , 60 pregnant women with hemoglobin less than 8.5 g/dl received a fixed dose of either IV iron sucrose or IM iron sorbitol citric acid therapy . The efficacy of the therapy was assessed by laboratory parameters such as hemoglobin , hematocrit , MCV , MCH , and serum ferritin level after 14 and 28 days . To assess the safety , adverse drug reactions with both the therapies were recorded . Results : Hemoglobin concentration increased significantly ( P < 0.001 ) with respect to time in both the groups . The rise in the hemoglobin level in third and fourth weeks was significantly higher in iron sucrose ( 0.92 g/dl ) than iron sorbitol citric acid therapy ( 0.56 g/dl ) . There was no significant change in the rise of the serum ferritin level after both the therapies . Adverse events were common with iron sorbitol citric acid therapy . However , no serious adverse drug reactions were observed . Conclusions : No significant difference in the efficacy of both of the therapy . However , adverse events and dropout rates were much more common in the group of pregnant women who received iron sorbitol citric acid Background Intravenous iron therapy is a treatment option for iron deficient patients who are intolerant to oral iron or where oral iron is ineffective , but with possible adverse effects . Currently , prospect i ve studies comparing different intravenous iron formulations are needed to determine safety and efficacy of these agents . Methods We conducted a prospect i ve , double-blind , r and omized controlled trial ( RCT ) to assess the feasibility of a trial comparing the safety of high molecular weight intravenous iron dextran , Infufer ® , with intravenous iron sucrose , Venofer ® , in non-hemodialysis adult out patients . Primary outcome was the occurrence of immediate severe drug reactions . Results We enrolled 143 patients in a one-year period . Overall , 45/143 ( 31.5 % ) patients ( 20 iron dextran , 25 iron sucrose ) developed 48 infusion reactions ( 14 immediate , 28 delayed , and 3 both ) . The risk of an immediate reaction was similar in both groups , 9/73 ( 12.3 % ) iron dextran versus 8/70 ( 11.4 % ) iron sucrose , RR = 0.93 ( 95 % CI ; 0.38 to 2.27 ) . The risk of a delayed reaction was significantly higher in the iron sucrose group 22/70 ( 31.4 % ) versus the iron dextran group 9/73 ( 12.3 % ) , RR = 2.55 ( 95 % CI ; 1.26 to 5.15 ; p = 0.0078 ) . Conclusion In this limited feasibility study , no major differences in immediate reactions were seen , but a significantly higher number of delayed reactions were seen in the iron sucrose group . Further , under our assumptions and design a full RCT to evaluate the safety of different intravenous iron preparations is not feasible . Future studies should consider modifying the clinical outcomes , utilize multiple centers , and consider other emerging parenteral iron formulations . ( Clinical Trials.gov NCT005936197 January 3 , 2008 ) Background . Iron deficiency anemia ( IDA ) is a common hematological complication with potentially serious clinical consequences that may require intravenous iron therapy . Ferric carboxymaltose ( FCM ) is a stable , nondextran iron formulation administered intravenously in large single doses to treat IDA . Objective . Two open-label , r and omized , placebo-controlled trials evaluated safety of multiple or single 750 mg FCM doses compared to st and ard medical care ( SMC ) in IDA patients . Secondary endpoints were improvements in hemoglobin and iron indices . Design and Patients . Adults with hemoglobin ≤12 g/dL , ferritin ≤100 or ≤300 ng/mL with transferrin saturation ≤30 % were r and omized to receive single ( n = 366 ) or weekly ( n = 343 ) FCM or SMC ( n = 360 and n = 366 ) . Results . Significantly greater ( P ≤ 0.001 ) increases in hemoglobin and iron indices occurred in FCM groups versus SMC . In the multidose study , up to two infusions of FCM were needed to reach target iron levels versus 3–5 of intravenous iron comparators . FCM and SMC groups had similar incidences and types of adverse events and serious adverse events . Transient hypophosphatemia not associated with adverse events or clinical sequelae occurred in the FCM groups . Conclusion . Intravenous FCM is safe , well tolerated , and associated with improvements in hemoglobin and iron indices comparable to SMC when administered in single doses of up to 750 mg at a rate of 100 mg/min . Fewer FCM infusions were required to reach target iron levels compared to other intravenous iron preparations This study evaluated efficacy and safety of darbepoetin alfa administered every 3 weeks ( Q3W ) at fixed doses of 300 or 500 μg with or without intravenous ( IV ) iron in treating anemia in patients receiving multicycle chemotherapy . This Phase 2 , double‐blind , 2 × 2 factorial study r and omized patients to one of four treatment arms ; darbepoetin alfa 300 μg  ( n = 62 ) , darbepoetin alfa 300 μg plus IV iron ( n = 60 ) , darbepoetin alfa 500 μg ( n = 60 ) , or darbepoetin alfa 500 μg plus IV iron ( n = 60 ) . Patients had nonmyeloid malignancies , hemoglobin levels ≤10 g dL−1 , and no iron deficiency . Primary endpoint was achievement of target hemoglobin ( ≥11 g dL−1 ) . Secondary endpoints included incidence of transfusions and change in Functional Assessment of Cancer Therapy Fatigue ( FACT‐F ) score from baseline to end of study . Safety was evaluated by incidence of adverse events . No evidence of a statistically significant interaction between darbepoetin alfa dose received and IV iron usage was observed , therefore , results are provided separately comparing darbepoetin alfa doses and comparing IV iron usage groups . Similar proportions of patients receiving darbepoetin alfa 300 or 500 μg achieved target hemoglobin ( 75 and 78 % , respectively ) ; Kaplan – Meier median time to target hemoglobin was 10 and 8 weeks , respectively . More patients receiving IV iron ( 82 % ) than not receiving IV iron ( 72 % ) achieved hemoglobin target . Adverse events profiles were similar for darbepoetin alfa treatment groups . Transient anaphylactoid reactions were reported in two patients receiving IV iron . Darbepoetin alfa at 300 μg Q3W and 500 μg Q3W showed similar benefit , while added IV iron  improved treatment response in these patients . Am . J. Hematol . , 2010 . © 2010 Wiley‐Liss , OBJECTIVES : In the largest head-to-head comparison between an oral and an intravenous ( IV ) iron compound in patients with inflammatory bowel disease ( IBD ) so far , we strived to determine whether IV iron isomaltoside 1,000 is non-inferior to oral iron sulfate in the treatment of iron deficiency anemia ( IDA ) . METHODS : This prospect i ve , r and omized , comparative , open-label , non-inferiority study was conducted at 36 sites in Europe and India . Patients with known intolerance to oral iron were excluded . A total of 338 IBD patients in clinical remission or with mild disease , a hemoglobin ( Hb ) < 12 g/dl , and a transferrin saturation ( TSAT ) < 20 % were r and omized 2:1 to receive either IV iron isomaltoside 1,000 according to the Ganzoni formula ( 225 patients ) or oral iron sulfate 200 mg daily ( equivalent to 200 mg elemental iron ; 113 patients ) . An interactive web response system method was used to r and omize the eligible patient to the treatment groups . The primary end point was change in Hb from baseline to week 8 . Iron isomaltoside 1,000 and iron sulfate was compared by a non-inferiority assessment with a margin of −0.5 g/dl . The secondary end points , which tested for superiority , included change in Hb from baseline to weeks 2 and 4 , change in s-ferritin , and TSAT to week 8 , number of patients who discontinued study because of lack of response or intolerance of investigational drugs , change in total quality of life ( QoL ) score to weeks 4 and 8 , and safety . Exploratory analyses included a responder analysis ( proportion of patients with an increase in Hb ≥2 g/dl after 8 weeks ) , the effect of regional differences and total iron dose level , and other potential predictors of the treatment response . RESULTS : Non-inferiority in change of Hb to week 8 could not be demonstrated . There was a trend for oral iron sulfate being more effective in increasing Hb  than iron isomaltoside 1,000 . The estimated treatment effect was −0.37 ( 95 % confidence interval ( CI ) : −0.80 , 0.06 ) with P=0.09 in the full analysis set ( N=327 ) and −0.45 ( 95 % CI : −0.88 , −0.03 ) with P=0.04 in the per protocol analysis set ( N=299 ) . In patients treated with IV iron isomaltoside 1,000 , the mean change in s-ferritin concentration was higher with an estimated treatment effect of 48.7 ( 95 % CI : 18.6 , 78.8 ) with P=0.002 , whereas the mean change in TSAT was lower with an estimated treatment effect of −4.4 ( 95 % CI : −7.4 , −1.4 ) with P=0.005 , compared with patients treated with oral iron . No differences in changes of QoL were observed . The safety profile was similar between the groups . The proportion of responders with Hb ≥2 g/dl ( IV group : 67 % ; oral group : 61 % ) were comparable between the groups ( P=0.32 ) . Iron isomaltoside 1,000 was more efficacious with higher cumulative doses of > 1,000 mg IV . Significant predictors of Hb response to IV iron treatment were baseline Hb and C-reactive protein ( CRP ) . CONCLUSIONS : We could not demonstrate non-inferiority of IV iron isomaltoside 1,000 compared with oral iron in this study . Based on the dose – response relationship observed with the IV iron compound , we suggest that the true iron dem and of IV iron was underestimated by the Ganzoni formula in our study . Alternative calculations including Hb and CRP should be explored to gauge iron stores in patients with IBD Background : The aim of this study was to compare the efficacy , safety and achievement of the target hemoglobin level ( Hb ≥10 g/dl ) in patients with preoperative anemia due to menorrhagia who received intravenous iron sucrose compared with oral iron protein succinylate for anemia management . Methods : Seventy-six patients with Hb levels < 9.0 g/dl who were scheduled to undergo surgical treatment were r and omized to receive either intravenous iron sucrose ( based on the calculated total iron deficit divided into 2 ampoule infusions intravenously 3 times a week , beginning 3 weeks before surgery ) or oral iron ( 80 mg/day of oral iron protein succinylate daily ) . Results : The intravenous iron group had higher increases in Hb ( 3.0 vs. 0.8 g/dl ; p < 0.0001 ) and ferritin levels ( 170.1 vs. 4.1 μg/l ; p < 0.0001 ) than the oral iron group . Achieving the target Hb was also higher in the intravenous iron group than in the oral iron group ( 76.7 vs. 11.5 % ; p < 0.0001 ) . There were tolerable adverse events in both groups . Conclusion : Preoperative intravenous iron sucrose administration is more effective  than oral iron and is as safe as oral iron therapy in the correction of preoperative anemia due to menorrhagia PURPOSE The concomitant use of intravenous ( IV ) iron as a supplement to erythropoiesis-stimulating agents in patients with chemotherapy-induced anemia is controversial . This study was design ed to evaluate the efficacy and safety of darbepoetin alpha given with IV iron versus with local st and ard practice ( oral iron or no iron ) . PATIENTS AND METHODS In this multicenter , r and omized , open-label , phase III study , 396 patients with nonmyeloid malignancies and hemoglobin ( Hb ) less than 11 g/dL received darbepoetin alpha 500 microg with ( n = 200 ) or without ( n = 196 ) IV iron once every 3 weeks ( Q3W ) for 16 weeks . RESULTS The hematopoietic response rate ( proportion of patients achieving Hb > or= 12 g/dL or Hb increase of > or= 2 g/dL from baseline ) was significantly higher in the IV iron group : 86 % versus 73 % in the st and ard practice group ( difference of 13 % [ 95 % CI , 3 % to 23 % ] ; P = .011 ) . Fewer RBC transfusions ( week 5 to the end of the treatment period ) occurred in the IV iron group : 9 % versus 20 % in the st and ard practice group ( difference of -11 % [ 95 % CI , -18 % to -3 % ] ; P = .005 ) . Both treatments were well tolerated with no notable differences in adverse events . Serious adverse events related to iron occurred in 3 % of patients in the IV iron group and were mostly gastrointestinal in nature . CONCLUSION Addition of IV iron to darbepoetin alpha Q3W in patients with chemotherapy-induced anemia was well tolerated , result ing in an improved hematopoietic response rate and lower incidence of transfusions compared with darbepoetin alpha alone Iron stores assuring optimal efficacy/safety for erythropoiesis are unknown in the dialysis population . Using multicenter trial data , we related safety profiles , erythropoiesis-stimulating agent ( ESA ) , and intravenous iron dosing to achieved iron stores in 441 subjects r and omized 2 : 1 to ferric citrate or active control as their phosphate binder over 52 weeks .  Intravenous iron was given at each site 's discretion if ferritin ≤ 1,000 ng/mL and transferrin saturation ≤ 30 % . Multivariable time-dependent Cox regression jointly related the primary safety outcome ( composite of cardiac , infection , gastrointestinal , and hepatobiliary serious adverse events ) to moving averages of ferritin and transferrin saturation over the preceding 90 days with covariate adjustment . Multivariable generalized estimating equations related elevated ESA and intravenous iron doses to trailing 90-day averages of ferritin and transferrin saturation with covariate adjustment . The adjusted hazard ratio for the safety composite per 10 % increase in transferrin saturation was 0.84 ( 95 % confidence interval 0.68 - 1.02 , p = 0.08 ) and 1.09 ( 0.86 - 1.35 , p = 0.48 ) per 400 ng/mL increase in ferritin . The adjusted hazard ratio for the safety composite was 0.50 ( 0.29 - 0.88 , p = 0.016 ) for the highest transferrin saturation tertile vs. the lowest . Adjusted odds ratios for higher intravenous iron dose were lower in the highest ( 0.23 [ 0.16 - 0.35 ] , p < 0.001 ) and middle transferrin saturation tertile ( 0.42 [ 0.31 - 0.57 ] , p < 0.001 ) vs. lowest . Incidence of elevated ESA dose was lower in the highest transferrin saturation tertile ( p = 0.01 ) . Ferritin did not predict clinical events or ESA dose . Transferrin saturation may be a better marker than serum ferritin to judge optimal iron stores in dialysis patients . Transferrin saturations > 34 % are safe and provide maximal efficacy . BACKGROUND This trial evaluated the efficacy and safety of intravenous ( IV ) iron isomaltoside ( Monofer ) in comparison with placebo in first-time female blood donors . STUDY DESIGN AND METHODS The trial was a prospect i ve , double blind , placebo-controlled , r and omized , comparative , single-center trial of 85 first-time female blood donors . The subjects were r and omly assigned 1:1 to either 1000 mg IV iron isomaltoside infusion or placebo . The primary endpoint of the trial was change in hemoglobin ( Hb ) from baseline to right before the third blood donation . RESULTS The increase in Hb was significantly higher for iron isomaltoside compared with placebo right before both the second blood donation ( p = 0.0327 ) and the third blood donation ( primary endpoint , p < 0.0001 ) . Improvements in other iron-related variables ( plasma iron , plasma ferritin , transferrin saturation , and reticulocyte count ) in favor of iron isomaltoside were also observed . The trial was not powered on patient-reported outcomes . However , improvements in iron stores and Hb levels after iron isomaltoside administration were supported by the fact that several of the fatigue symptoms scores showed numerical differences in favor of iron isomaltoside . There were no differences in side effects between the groups . CONCLUSION In iron-deficient female blood donors a single IV iron isomaltoside administration result ed in an improvement in Hb concentration and iron stores and demonstrated a favorable safety profile comparable to placebo BACKGROUND Iron deficiency anaemia is the most common deficiency disorder in the world , affecting more than one billion people , with pregnant women at particular risk . OBJECTIVES AND DESIGN We conducted a single site , prospect i ve , nonblinded r and omized-controlled trial to compare the efficacy , safety , tolerability and compliance of st and ard oral daily iron versus intravenous iron . SUBJECTS We prospect ively screened 2654 pregnant women between March 2007 and January 2009 with a full blood count and iron studies , of which 461 ( 18 % ) had moderate IDA . Two hundred women matched for haemoglobin concentration and serum ferritin level were recruited . INTERVENTIONS Patients were r and omized to daily oral ferrous sulphate 250 mg ( elemental iron 80 mg ) with or without a single intravenous iron polymaltose infusion . RESULTS Prior to delivery , the intravenous plus oral iron arm was superior to the oral iron only arm as measured by the increase in haemoglobin level ( mean of 19.5 g/L vs. 12 g/L ; P < 0.001 ) ; the increase in mean serum ferritin level ( 222 microg/L vs. 18 ug/L ; P < 0.001 ) ; and the percentage of mothers with ferritin levels below 30 microg/L ( 4.5 % vs. 79 % ; P < 0.001 ) . A single dose of intravenous iron polymaltose was well tolerated without significant side effects . CONCLUSIONS Our data indicate that intravenous iron polymaltose is safe and leads to improved efficacy and iron stores compared to oral iron alone in pregnancy-related IDA OBJECTIVE This study was undertaken to determine the efficacy and safety of intravenously administered iron sucrose with versus without adjuvant recombinant human erythropoietin in the treatment of gestational iron-deficiency anemia resistant to therapy with orally administered iron alone . STUDY DESIGN Forty patients with gestational iron-deficiency anemia were r and omly assigned to receive intravenously iron sucrose plus recombinant human erythropoietin or iron sucrose alone twice weekly . Target hemoglobin value was 11.0 g/dL. Efficacy measures were reticulocyte count , increase in hematocrit , and time to target hemoglobin level ( treatment duration in weeks and need for continued therapy after 4 weeks ) . RESULTS Both regimens were effective , but with adjuvant recombinant human erythropoietin the reticulocyte counts were higher from day 4 ( P<.01 ) , increases in hematocrit were greater from day 11 ( P < .01 ) , and the median duration of therapy was shorter ( 18 vs 25 days ) , with more patients reaching the target hemoglobin level by 4 weeks of treatment ( n = 19 vs. n = 15 ) . The groups did not differ with respect to maternal-fetal safety parameters . CONCLUSION Adjuvant recombinant human erythropoietin safely enhanced the efficacy of iron sucrose in the treatment of gestational iron-deficiency anemia resistant to orally administered iron alone Study Objective A safe alternative to erythropoiesis‐stimulating agents to treat anemia is warranted in patients with cancer and anemia ; thus the objective of this trial was to compare the efficacy and safety of intravenous ( IV ) iron isomaltoside with oral iron in patients with cancer and anemia by testing the noninferiority of IV versus oral iron . Design Phase III , prospect i ve , open‐label , comparative , r and omized , noninferiority , multicenter trial . Setting Forty‐seven hospitals or private cancer clinics in Asia , the United States , and Europe . Patients A total of 350 patients with cancer and anemia . Intervention Patients were r and omized in a 2:1 ratio to either intravenous iron isomaltoside or oral iron sulfate . Patients in the iron isomaltoside group were then r and omized into an infusion subgroup ( single intravenous infusions of a maximum dose of 1000 mg over 15 min ) or a bolus injection subgroup ( bolus injections of 500 mg over 2 min ) . Measurements and Main Results The primary efficacy outcome was change in hemoglobin concentration from baseline to week 4 . Changes in other relevant hematology variables , effect on quality of life , and safety outcomes were also assessed . The primary efficacy outcome was tested for noninferiority , whereas the remaining outcomes were tested for superiority . Iron isomaltoside was noninferior to oral iron in change in hemoglobin concentration from baseline to week 4 ( difference estimate 0.016 , 95 % confidence interval –0.26 to 0.29 , p<0.001 ) . A faster onset of the hemoglobin response was observed with infusion of iron isomaltoside ( superiority test : p=0.03 at week 1 ) , and a sustained effect on hemoglobin level was shown in both the iron isomaltoside and oral iron treatment groups until week 24 . A significant mean decrease in fatigue score was observed from baseline to week 12 in the iron isomaltoside group ( p<0.001 ) but not in the oral iron group ( p=0.057 ) . A higher proportion of patients treated with oral iron  experienced adverse drug reactions ( 18.8 % vs 6.6 % , p<0.001 ) and discontinued the trial due to intolerance ( 8.0 % vs 0.9 % , p=0.001 ) . Transient hypophosphatemia ( phosphate level less than 2 mg/dl ) was reported at similar low frequencies among the groups : 7.1 % in the iron isomaltoside infusion subgroup versus 8.5 % in the iron isomaltoside bolus injection subgroup versus 5.4 % in the oral iron group . Conclusion This trial demonstrated comparable sustained increases in hemoglobin concentration over time with both iron isomaltoside and oral iron . Iron isomaltoside was better tolerated than oral iron , and fatigue was significantly decreased with iron isomaltoside . Low rates of clinical ly insignificant hypophosphatemia were reported in patients receiving both treatments There is limited safety information about ferric carboxymaltose ( FCM ) , a new intravenous iron preparation . This r and omized , crossover study compared the safety and tolerability of double‐blinded intravenous doses of FCM or placebo in patients with iron deficiency anemia . Subjects ( 559 ) with iron deficiency anemia received a dose of either FCM ( 15 mg/kg , maximum 1000 mg ) over 15 minutes or placebo on day 0 . On day 7 , subjects received the other agent . Safety evaluations were performed on days 7 and 14 . The primary endpoint was the incidence of treatment‐emergent adverse events during each 7‐day study period . During the first 24 hours and during the 7‐day treatment period , at least one treatment‐emergent adverse event was experienced by 15.0 % and 29.3 % of subjects after FCM and 11.4 % and 19.7 % after placebo , respectively . Most were classified as Grade 1 or 2 . Six subjects had Grade 3 treatment‐emergent adverse events  after FCM and 9 subjects after placebo . One subject had a Grade 4 , and 1 subject had a Grade 5 treatment‐emergent adverse event , but neither was considered study drug‐related . During the first 24 hours of the treatment period , drug‐related adverse events were reported in 9.3 % of subjects receiving FCM and 4.8 % receiving placebo . Of drug‐related Grade 3 events , 4 subjects received FCM and 5 subjects received placebo . Administration of FCM ( 15 mg/kg , maximum of 1000 mg ) over 15 minutes was well tolerated and associated with minimal risk of adverse reactions in patients with iron deficiency anemia BACKGROUND Currently available intravenous ( IV ) iron agents vary in indication , dosing regimens and safety profiles . Ferric carboxymaltose ( FCM ) is a stable , non-dextran-containing iron formulation developed for rapid IV administration in high doses with controlled delivery of iron into target tissues . The objective of the present study was to evaluate the safety of FCM compared with st and ard medical care ( SMC ) in dialysis ( HD ) and non-dialysis-dependent ( NDD ) chronic kidney disease ( CKD ) patients . METHODS Adults 18 - 85 years of age with CKD were enrolled . NDD-CKD ( n = 204 ) patients received an undiluted IV dose of FCM ( 15 mg/kg to a maximum of 1000 mg IV ) and HD-CKD ( n = 50 ) patients received an undiluted IV push of 200 mg ~30 - 60 min into the dialysis session . Subjects r and omized to the SMC group ( n = 259 ) received treatment determined by the investigator that could include oral iron , IV iron or no iron . RESULTS Single doses of FCM of 200 mg in HD-CKD patients and up to 1000 mg in NDD-CKD patients were well tolerated . Incidences of treatment-emergent adverse events were similar between the groups : 30.3 % ( 77 of 254 ) in the FCM group and 32.8 % ( 85 of 259 ) in the SMC group . Incidences of serious adverse events were higher in the SMC group overall and in patients receiving iron sucrose or sodium ferric gluconate . There were no clinical ly significant differences in laboratory or clinical chemistry values or vital signs between the groups . There were no statistically significant differences between the FCM and SMC groups in indices of hemoglobin ( Hb ) improvement , including proportions of patients achieving a ≥ 1 g/dL increase in Hb and proportions of patients achieving Hb level of > 12 g/dL. CONCLUSION FCM in doses of 200 mg for HD-CKD patients and up to 1000 mg in NDD-CKD patients were well tolerated and displayed comparable efficacy to other IV iron formulations Iron deficiency anemia ( IDA ) is the most common form of anemia worldwide . Although oral iron is used as first‐line treatment , many patients are unresponsive to or can not take oral iron . This Phase III , open‐label , non‐inferiority study compared the efficacy and safety of ferumoxytol , a rapid , injectable intravenous ( IV ) iron product with low immunological reactivity and minimal detectable free iron , with IV iron sucrose in adults with IDA of any cause . Patients ( N = 605 ) were r and omized 2:1 to receive ferumoxytol ( n = 406 , two doses of 510 mg 5 ± 3 days apart ) or iron sucrose ( n = 199 , five doses of 200 mg on five nonconsecutive days over 14 days ) and followed for 5 weeks . Ferumoxytol demonstrated noninferiority to iron sucrose at the primary endpoint , the proportion of patients achieving a hemoglobin increase of ≥2 g dL−1 at any time from Baseline to Week 5 ( ferumoxytol , 84.0 % [ n = 406 ] vs. iron sucrose , 81.4 % [ n = 199 ] ) , with a noninferiority margin of 15 % . Ferumoxytol was superior to iron sucrose ( 2.7 g dL−1 vs. 2.4 g dL−1 ) in the mean change in hemoglobin from Baseline to Week 5 ( the alternative preplanned primary endpoint ) with P = 0.0124 . Transferrin saturation , quality ‐of‐life measures , and safety outcomes were similar between the two treatment groups . Overall , ferumoxytol  demonstrated comparable safety and efficacy to iron sucrose , suggesting that ferumoxytol may be a useful treatment option for patients with IDA in whom oral iron was unsatisfactory or could not be used . Am . J. Hematol . 89:646–650 , 2014 . © 2014 Wiley Periodicals , Although oral iron is the initial treatment approach for iron deficiency anemia ( IDA ) , some patients fail to respond to or can not tolerate oral iron . This double‐blind safety and efficacy study of the intravenous ( IV ) iron , ferumoxytol , r and omized patients with a history of unsatisfactory oral iron therapy , or in whom oral iron could not be used ,  to ferumoxytol ( n = 609 ) or placebo ( n = 203 ) . The proportion of patients achieving the primary endpoint ( hemoglobin increase ≥2.0 g/dL at Week 5 ) was 81.1 % with ferumoxytol versus 5.5 % with placebo ( P < 0.0001 ) . The mean increase in hemoglobin from Baseline to Week 5 , a secondary endpoint ( also the alternative preplanned primary efficacy endpoint for other health authorities ) , was 2.7 versus 0.1 g/dL ( P < 0.0001 ) . Achievement of a hemoglobin ≥12 g/dL , time to a hemoglobin increase ≥2.0 g/dL , and improvement in the Functional Assessment of Chronic Illness Therapy Fatigue score also significantly favored ferumoxytol over placebo at Week 5 (  P < 0.0001 ) . Ferumoxytol treatment‐emergent adverse events were mainly mild to moderate . Ferumoxytol was effective and well tolerated in patients with IDA of any underlying cause in whom oral iron was ineffective or could not be used . This trial was registered at www . clinical trials.gov as # NCT01114139 . Am . J. Hematol . 89:7–12 , 2014 . © 2013 Wiley Periodicals , OBJECTIVE Intravenous ( IV ) iron has been used as a treatment to reduce Restless Legs Syndrome ( RLS ) symptoms , but two double-blinded trials of a frequently prescribed IV iron formulation , iron sucrose , failed to show lasting efficacy . This study evaluates efficacy and safety of a new IV iron formulation ( ferric carboxymaltose , FCM ) with molecular properties that may make iron more available for uptake to the brain than iron sucrose does . METHODS In this 28-day , multi-centre , r and omised , placebo-controlled trial 46 RLS patients were discontinued from all RLS treatment . Twenty-four received 500 mg FCM in two doses 5 days apart and 22 received a matching placebo . At day 28 , those on placebo were given a single 1000 mg IV FCM and those not responding to initial treatment were given a third dose of 500 mg FCM . Patients were followed up for 24 weeks or until needing added RLS treatment . RESULTS FCM significantly improved primary and secondary outcomes compared to placebo :  International Restless Legs Syndrome study group severity scale ( IRLS ) average ( SD ) decrease of 8.9 ( 8.52 ) versus 4.0 ( 6.11 ) , p=0.040 ; Clinical Global Inventory of Change ( CGI-1 ) very much or much improved 48.3 % versus 14.3 % , p=0.004 . Quality of life was also significantly improved . Of the 24 with initial iron treatment 45 % responded and 29 % remitted ( IRLS ≤ 10 ) at day 28 , and 25 % continued free of other RLS medications at 24 weeks after treatment . The single 1000 mg dose on day 28 produced the same degree of treatment response as the divided dose , but the added 500 mg dose for those not responding to the initial treatment showed little benefit . There were no significant adverse events . CONCLUSIONS IV FCM  provided a safe and effective treatment for RLS that lasted for at least 24 weeks for some patients . Larger studies are needed to confirm these results OBJECTIVES There is evidence of iron deficiency ( ID ) in patients treated with lipoprotein apheresis .  Aim of this study was to assess ID in apheresis patients and to study its management comparing safety and efficacy of two approved intravenous ( i.v . ) iron formulations . METHODS Inclusion criteria were defined as a ) serum ferritin < 300 μg/l and transferrin saturation < 20 % , b ) ferritin < 100 μg/l . Both iron deficient alone and ID anemic ( IDA ) patients were included . Other causes for anemia were ruled out by thorough history-taking and examination/blood tests . Patients were treated with six different lipoprotein apheresis methods : DALI , Liposorber D , TheraSorb LDL , HELP , MONET and Lipidfiltration .  50 patients were r and omized to either ferric carboxymaltose ( FCM , 500 - 1000 mg as single shot infusion over 20 min ) or ferric gluconate ( FG , 62.5 mg once weekly ) . RESULTS 50 of 67 patients of our Lipoprotein Apheresis Center showed iron deficiency . Both i.v . iron formulations studied were equally safe ( no serious adverse events ( SAEs ) , 6 patients /group showed adverse events ( AEs ) ) and both effective ( clinical ly and with respect to laboratory data ) in lipoprotein apheresis patients , however FCM led to a more rapid and steeper rise of iron parameters . CONCLUSIONS ID and IDA are common findings in lipoprotein apheresis patients . The pathogenesis remains yet poorly understood and is probably multifactorial . Differential diagnosis of ID/IDA is as essential as differential therapy . H and led with care , older i.v . iron preparations like FG appear to be safe and effective in lipoprotein apheresis patients . However , novel formulations like FCM can be administered rapidly at higher doses due to high complex stability , allowing faster filling of iron stores . Newer laboratory parameters ( Reticulocyte-He , low/medium/high fluorescence reticulocytes ( LFR/MFR/HFR ) ) assessing iron status may be helpful in early detection of ID and in monitoring iron replacement therapy For nearly half a century , parenteral iron has been considered dangerous and for use only in extreme situations and when oral iron was not tolerated . This proscription was based largely on poorly characterised and infrequent anaphylactoid reactions to the high-molecular-weight dextran preparation ( Imferon ) that for most of this time was the only product available . Moreover , when parenteral iron was necessary , the recommended approach was small intramuscular doses ( ≤100 mg ) , even after intravenous administration of the total iron defi cit as a single dose or as repetitive boluses was shown to be as safe and eff ective as the intramuscular route . This mindset persists despite the subsequent introduction of low-molecular-weight iron dextran and two iron salt preparations , ferric gluconate and iron saccharate ( the latter is also known as iron sucrose ) , all of which are associated with fewer serious adverse events than the high-molecular-weight dextran . The introduction of recombinant erythropoietin for dialysis patients was associated with the development , in some individuals , of functional iron defi ciency that limited effi cacy . Intravenous iron , unlike oral iron , improves erythropoietic response in dialysis patients , and is now routinely used . The discovery of the iron regulatory peptide , hepcidin , has improved our underst and ing of the anaemia of chronic infl ammatory states , including cancer . Hepcidin is upregulated in these conditions , result ing in increased synthesis by the liver . Hepcidin inhibits iron transport across cell membranes , which decreases the accessibility of storage iron and gastrointestinal absorption of dietary iron , leading to an increased frequency of iron-restricted erythropoiesis , especially during therapy with recombinant erythropoietin . The most frequent laboratory fi ndings during the anaemia of chronic infl ammation are hypoferraemia and a low percent transferrin saturation , although these fi ndings are not always present . The increasing use of recombinant erythropoietin to treat anaemia in patients with chronic diseases has exp and ed the population of patients with functional iron defi ciency and increased interest in safe rational approaches to parenteral iron therapy . There is mounting evidence that anaemic patients with cancer undergoing chemotherapy and receiving  recombinant erythropoietin respond better when parenteral iron is administered . This benefi t is independent of baseline iron variables , such as ferritin , low percentage transferrin saturation , and stainable marrow haemosiderin , leaving the clinician in need of laboratory variables to reliably detect iron-restricted erythropoiesis in patients with infl ammatory illnesses and to predict improvement of erythropoietic response to parenteral iron in the setting of infl ammatory illness . Two new laboratory measures look promising : percent hypochromic red blood cells and reticulocyte haemoglobin content . These tests are reliable and accurate correlates of functional iron defi ciency . Although these investigations are not yet widely available , their use will probably exp and and guide identifi cation of functional iron defi ciency and rational intervention with parenteral iron . Currently , four parenteral iron preparations are available ( table ) . No r and omised trials have compared the safety and effi cacy of any of these agents . The largest retrospective review of dialysis experience suggests that most serious adverse events have been associated with the high-molecular-weight iron dextrans ( Imferon , which is no longer available and the current preparation , Dexferrum ) and are rare ( < 1:200 000 ) with the low-molecular-weight iron dextran or the two iron salts ( fi gure ) . Adverse event rates might be somewhat higher in patients with infl ammatory diseases in which immune-mediated drug reactions  may be observed more commonly than in dialysis patients . Some of the adverse clinical experience with parenteral iron is due to inappropriate supportive care . Myalgias , when they include chest and back discomfort , are mistakenly described as anaphylaxis , prompting Low – molecular – weight iron dextran Iron saccharate Ferric gluconate High – molecular – weight iron Objective To explore the safety and efficacy of intravenous ( IV ) iron sucrose in maintenance peritoneal dialysis ( PD ) . Design R and omized , controlled , parallel-group single-center trial . Setting Blood Purification Center of Chaoyang , Beijing Capital University of Medical Science , China . Methods 46 patients on PD were involved in this trial . 26 patients received IV iron sucrose ( 200 mg iron ) once per week for 4 weeks then once every other week for a further 4 weeks . The other 20 patients received oral ferrous succinate , 200 mg three times per day , for 8 weeks . Hemoglobin , hematocrit , serum ferritin ( SF ) level , and transferrin saturation ( TSAT ) were assessed at baseline and then again after 2 , 4 , and 8 weeks of treatment . Results There were no differences between the IV and oral groups in terms of sex , age , duration of PD , mean dialysate dosage per day , erythropoietin dosage per week , or hematological parameters at baseline . After 4 and 8 weeks of treatment , mean Hb and Hct were significantly increased in the IV group and were also significantly higher than those in the oral group . Levels of SF and TSAT were also significantly increased in the IV group , and significantly higher than in the oral group . After 8 weeks , the response rate in the IV group was 94.8 % , which was significantly higher than that in the oral group . The mean erythropoietin dose was significantly lower in the IV group than in the oral group . Hb , Hct , SF , and TSAT levels were maintained between 4 and 8 weeks in the IV group despite the decrease in dose frequency . There were no adverse events with IV iron . Eight patients in the oral group had adverse gastrointestinal effects . Conclusion IV iron sucrose is safe in PD patients . It increases Hb levels and serum iron parameters more effectively than oral iron ; it is well tolerated and can permit reductions in the required dose of erythropoietin Abstract Objective . Iron isomaltoside 1000 ( Monofer ® ) is a high-dose intravenous ( IV ) iron , which in a recent 8 weeks trial in inflammatory bowel disease ( IBD ) subjects with iron deficiency anemia ( IDA ) demonstrated good tolerability and efficacy . The present trial is an extension to this trial , which evaluates the need for additional high IV iron doses to maintain a stable hemoglobin ( Hb ) ≥12.0 g/dl . Material and methods . This was a prospect i ve , open-label , 12 months trial of European IBD subjects willing to participate after completing the lead-in trial . Subjects were allowed re-dosing with 500–2000 mg single doses of iron isomaltoside 1000 infused over ∼15 min at 3 months intervals depending on a predefined algorithm . Outcome measures included Hb , safety parameters and need for additional iron dosing . Results . A total of 39 subjects were enrolled of which 34 subjects required re-dosing with a median cumulative 1-year dose of 1.8 g ( mean cumulative dose 2.2 g ) . The mean ( SD ) Hb was 12.3 ( 1.5 ) g/dl at baseline , 12.8 ( 1.6 ) g/dl at 3 months , 12.8 ( 1.6 ) g/dl at 6 months , 12.9 ( 1.4 ) g/dl at 9 months and 12.9 ( 1.6 ) g/dl at 12 months . Seventy-four percent of subjects who had an Hb ≥12.0 g/dl at baseline were able to maintain Hb ≥12.0 g/dl till the end of the trial at 12 months . Nonserious probably related hypersensitivity reactions without significant hypotension were reported at the beginning of the infusion in two subjects , who recovered without sequelae . Conclusion . Repeated treatment of iron deficiency with iron isomaltoside 1000 could avoid episodes of IDA without major safety issues . Trial registration : Clinical Trial.gov identifier : NCT01410435 BACKGROUND AND OBJECTIVES Intravenous iron is a key component of anemia management for chronic kidney disease ( CKD ) .  Ferumoxytol is a unique intravenous iron product that can be administered as a rapid injection in doses up to 510 mg . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS This was a r and omized , open-label , controlled , multicenter Phase 3 trial to evaluate the safety and efficacy of intravenous ferumoxytol compared with oral iron .  Anemic patients with CKD stage 5D on hemodialysis and on a stable erythropoiesis-stimulating agent regimen received either two injections of 510 mg of ferumoxytol within 7 d ( n = 114 ) or 200 mg elemental oral iron daily for 21 d ( n = 116 ) . The primary efficacy endpoint was the change in hemoglobin from baseline to day 35 . Safety was closely monitored . RESULTS Ferumoxytol result ed in a mean increase in hemoglobin of 1.02 + /- 1.13 g/dl at day 35 compared with 0.46 + /- 1.06 g/dl with oral iron ( P = 0.0002 ) . Twice as many ferumoxytol-treated patients than oral iron-treated patients achieved a > or = 1 g/dl hemoglobin increase at day 35 ( P = 0.0002 ) . There was a greater mean increase in transferrin saturation ( TSAT ) with ferumoxytol compared with oral iron at day 35 ( P < 0.0001 ) . The larger hemoglobin increase after ferumoxytol compared with oral iron at day 35 persisted after adjustment for baseline hemoglobin , TSAT , and serum ferritin . Overall adverse event rates were comparable between groups . CONCLUSIONS In patients on hemodialysis , rapid intravenous injection of 510 mg of ferumoxytol led to significantly greater hemoglobin increases compared with oral iron , with comparable tolerability OBJECTIVES To compare the safety and efficacy of iron carboxymaltose with ferrous sulfate to treat iron deficiency anemia in the post partum . METHODS Patients were r and omized ( 2:1 ratio ) to receive iron carboxymaltose  ( up to 3 weekly doses of 1000 mg maximum , applied in 15 min ; n=227 ) or ferrous sulfate ( 100 mg twice daily , 12 weeks ; n=117 ) . Changes in hemoglobin and iron stores up to week 12 were analyzed . RESULTS Iron carboxymaltose was as effective as oral iron sulfate in changing hemoglobin , despite the much shorter treatment period ( 2 weeks vs 12 weeks ) . Ferritin levels were significantly higher . Except for injection site burning , iron carboxymaltose was better tolerated than ferrous sulfate , mainly concerning gastrointestinal side effects . There were no safety concerns identified in breast-fed infants . CONCLUSION Parenteral iron carboxymaltose is a safe and effective treatment option for postpartum anemia , with advantages of a shorter treatment period , better compliance , rapid normalization of iron storages , and lower incidence of gastrointestinal side effects BACKGROUND The objective was to evaluate efficacy and safety of rapid , large-dose intravenous ( IV ) administration of ferric carboxymaltose compared to oral iron in correcting iron deficiency anemia due to heavy uterine bleeding . STUDY DESIGN AND METHODS In a r and omized , controlled trial , 477 women with anemia , iron deficiency , and heavy uterine bleeding were assigned to receive either IV ferric carboxymaltose ( < or=1000 mg over 15 min , repeated weekly to achieve a total calculated replacement dose ) or 325 mg of ferrous sulfate ( 65 mg elemental iron ) prescribed orally thrice daily for 6 weeks . RESULTS Compared to those assigned to ferrous sulfate , more patients assigned to ferric carboxymaltose responded with a hemoglobin ( Hb ) increase of 2.0 g/dL or more ( 82 % vs. 62 % , 95 % confidence interval for treatment difference 12.2 - 28.3 , p < 0.001 ) , more achieved a 3.0 g/dL or more increase ( 53 % vs. 36 % , p < 0.001 ) , and more achieved correction ( Hb > or= 12 g/dL ) of anemia ( 73 % vs. 50 % , p < 0.001 ) . Patients treated with ferric carboxymaltose compared to those prescribed ferrous sulfate reported greater gains in vitality and physical function and experienced greater improvement in symptoms of fatigue ( p < 0.05 ) . There were no serious adverse drug events . CONCLUSIONS In patients with iron deficiency anemia due to heavy uterine bleeding , rapid IV administration of large doses of a new iron agent , ferric carboxymaltose , is more effective than oral iron therapy in correcting anemia , replenishing iron stores , and improving quality of life PURPOSE To evaluate the safety and efficacy of intravenous ( IV ) sodium ferric gluconate complex ( FG ) , oral ferrous sulfate , or no iron to increase hemoglobin ( Hb ) in anemic cancer patients receiving chemotherapy and epoetin alfa .  PATIENTS AND METHODS In this open-label , multicenter trial , 187 patients with chemotherapy-related anemia ( Hb < 11 g/dl ; serum ferritin > or = 100 ng/ml or transferrin saturation > or = 15 % ) scheduled to receive chemotherapy and epoetin alfa ( 40,000 U subcutaneously weekly ) were r and omized to 8 weeks of 125 mg of IV FG weekly , 325 mg of oral ferrous sulfate three times daily , or no iron . The primary outcome was a change in Hb from baseline to endpoint , first whole-blood or red blood cell transfusion , or study withdrawal . RESULTS One hundred twenty-nine patients were evaluable for efficacy ( FG , n = 41 ; oral iron , n = 44 ; no iron , n = 44 ) . Mean increase in Hb was 2.4 g/dl ( 95 % confidence interval [ CI ] , 2.1 - 2.7 ) for FG ( p = .0092 vs. oral iron ; p = .0044 vs. no iron ) , 1.6 g/dl ( 95 % CI , 1.1 - 2.1 ) for oral iron ( p = .7695 vs. no iron ) , and 1.5 g/dl ( 95 % CI , 1.1 - 1.9 ) for no iron . Hb response ( increase > or = 2 g/dl ) was 73 % for FG ( p = .0099 vs. oral iron ; p = .0029 vs. no iron ) , 46 % for oral iron ( p = .6687 vs. no iron ) , and 41 % for no iron . FG was well tolerated . CONCLUSION For cancer patients with chemotherapy-related anemia receiving epoetin alfa , FG produces a significantly greater increase in Hb and Hb response compared with oral iron or no iron , supporting more aggressive treatment with IV iron supplementation for these patients Sensitivity to iron dextran is a potent obstacle to maintaining optimum iron status in patients with dialysis-associated anemia . As part of the North American clinical trials for iron sucrose injection , we examined the effect of intravenous ( IV ) iron sucrose in 23 hemodialysis patients with documented sensitivity to iron dextran , ongoing epoetin alfa therapy , and below-target-range hemoglobin ( Hgb ) levels ( < 11.0 g/dL ) . We assigned patients to treatment groups according to whether reactions they had experienced to iron dextran were judged to be mild ( n = 16 ; group A ) or severe ( n = 7 ; group B ) . We prospect ively examined adverse events and vital signs after administering 100 mg of IV iron sucrose in each of 10 consecutive dialysis treatment sessions and compared results with those recorded in each of three consecutive dialysis sessions without iron treatment . We administered iron sucrose by IV push over 5 minutes to group A patients and by IV push over 5 minutes or IV infusion over 15 to 30 minutes to group B patients . We did not administer a test dose . Results showed no serious adverse drug reactions after a total of 223 doses of iron sucrose ( 184 doses by IV push , 39 doses by IV infusion ) . Intradialytic blood pressure changes after IV iron sucrose injection did not differ from those recorded during dialysis sessions without treatment . An increase in values for Hgb , hematocrit , transferrin saturation , and ferritin , coupled with no significant change in  epoetin dose and a decrease in total iron-binding capacity , confirmed the efficacy of iron sucrose injection in managing anemia . We conclude that iron sucrose injection is safe and effective in the management of anemia in patients sensitive to iron dextran and can be administered without a test dose by IV push or infusion On June 30 , 2009 , the United States Food and Drug Administration ( FDA ) approved ferumoxytol ( Feraheme ™ injection , AMAG Pharmaceuticals ) , an iron‐containing product for intravenous ( IV ) administration , for the treatment of iron deficiency anemia in adult patients with chronic kidney disease ( CKD ) . The safety and efficacy of ferumoxytol were assessed in three r and omized , open‐label , controlled clinical trials . Two trials evaluated patients with nondialysis dependent CKD and a third trial assessed patients undergoing hemodialysis . R and omization was either to ferumoxytol or oral iron . Ferumoxytol was administered as two 510 mg IV injections , separated by 3–8 days . Oral iron , Ferro‐Sequels ® , was administered at a dose of 100 mg twice daily for 21 days . In all three clinical trials , ferumoxytol administration increased the mean blood hemoglobin ( Hgb ) concentrations by ∼1.0 g/dL over the 35 day period , a mean increase that was greater than what was observed in patients receiving oral iron . Patients receiving ferumoxytol also had increases in blood transferrin saturation ( TSAT ) and ferritin values . For the proposed ferumoxytol dosing regimen , 4.9 % of patients had serum ferritin ≥800 ng/mL and TSAT ≥50 % post‐treatment . The most important ferumoxytol safety concerns were hypersensitivity reactions and /or hypotension . Anaphylaxis or anaphylactoid reactions were reported in 0.2 % of subjects , and other adverse reactions potentially associated with hypersensitivity ( e.g. , pruritus , rash , urticaria , or wheezing ) were reported in 3.7 % . Hypotension was observed in 1.9 % , including three patients with serious hypotensive reactions . Ferumoxytol administration may transiently affect the diagnostic ability of magnetic resonance imaging and the drug label provides further information regarding this effect . Am . J. Hematol . 2010 . Published 2010 Wiley‐Liss , 8612 Background : Patients ( pts ) with cancer receiving chemotherapy often have chemotherapy-induced anemia ( CIA ) and reduced quality of life .  Darbepoetin alfa ( DA ) is an erythropoiesis-stimulating agent ( ESA ) that can effectively treat CIA when administered once every 3 weeks ( Q3W ) . In patients with CIA , limited data in the literature suggest that administration of intravenous ( IV ) iron with ESA therapy may increase clinical response . METHODS This r and omized , multicenter , open-label , 16-week study evaluated the safety and efficacy of DA 500 mcg administered Q3W using the SureClick injection device in pts with CIA ( Hb < 11 g/dL ) who received either IV iron or st and ard practice for iron administration ( oral iron or no iron ) . The dose of IV iron was 200 mcg administered either Q3W with DA Q3W or , if required , as 2 doses ( 200 mcg total ) within a 3-week period . Pts who received ≥ 1 dose of DA and who completed the 16-week study period by October 19 , 2005 are included in this interim analysis ( planned sample size = 400 pts ) . Accrual will have finished by conference time . R and omization was stratified by tumor type and baseline ( BL ) Hb ( < 10 or ≥ 10 g/dL ) . The incidence of adverse events and serious adverse events , in particular embolic/thrombotic events , was summarized . Efficacy endpoints were estimated using the crude % of pts ( 95 % CI ) . Hb values within 28 days of a transfusion were not included in any efficacy analysis . RESULTS Of the 114 pts included in this interim analysis , 65 % were women , 99 % were Caucasian , the mean ( SD ) age was 60 years ( 12 ) , and 26 % had lung or gynecological tumors ; study endpoints are shown in the table . CONCLUSIONS Based on the interim results , the safety profile for pts receiving DA 500 mcg Q3W with IV iron appears to be comparable to pts receiving DA 500 mcg Q3W with oral iron or no iron . The % pts who achieved the target Hb ( ≥ 11 g/dL ) appeared higher , and the % pts who required transfusions appeared lower , in the group receiving IV iron . [ Table : see text ] [ Table : see text ] Background Restless legs syndrome ( RLS ) is a common disorder in hemodialysis ( HD ) patients that causes sleep disturbances and diminished quality of life . Because iron deficiency has been implicated in the pathogenesis of RLS , we sought to investigate the effects of intravenous ( IV ) iron sucrose on symptoms of RLS in HD patients . Material / Methods The study was a r and omized , placebo-controlled study of 1000 mg iron sucrose versus normal saline as placebo . Patients were evaluated at baseline and 2 weeks after the last injection . The severity of RLS was assessed using the International RLS Study Group rating scale ( IRLS ) . Blood sample s were taken to measure iron parameters reflecting the iron status , including serum ferritin ( SF ) concentration , percentage transferrin saturation ( TSAT% ) and hemoglobin ( Hb ) , and other biochemical parameters as safety assessment s , including creatinine ( Cr ) , urea , intact parathyroid hormone ( iPTH ) , and the index of urea clearance ( Kt/V ) . Adverse events were monitored in all subjects during the period of infusion . Results After 2 weeks , IRLS scores decreased more in the IV-iron group ( −7.38±2.03 ) than in the placebo group ( −0.81±2.61 ) ( P=0.000 ) . Serum ferritin , TSAT , and hemoglobin increased more in the IV-iron group ( 227.63±77.64 μg/L ; 26.06±7.77 % ; 13.98±3.62g/L , respectively ) than in the placebo group ( SF , p=0.000 ; TSAT , p=0.000 ; Hb , p=0.000 , respectively ) . There were no significant differences between IV-iron and placebo groups in Cr , urea , iPTH , and Kt/V. No adverse effects were observed in the study . Conclusions IV iron sucrose is a safe and effective treatment for reducing RLS symptoms in HD patients over the short-term Ferric citrate ( FC ) is a phosphate binder with shown efficacy and additional effects on iron stores and use of intravenous ( iv ) iron and erythropoiesis-stimulating agents ( ESAs ) . We provide detailed analyses of changes in iron/hematologic parameters and  iv iron/ESA  use at time points throughout the active control period of a phase 3 international r and omized clinical trial . In all , 441 subjects were r and omized ( 292 to FC and 149 to sevelamer carbonate and /or calcium acetate [ active control ( AC ) ] ) and followed for 52 weeks . Subjects on FC had increased ferritin and transferrin saturation ( TSAT ) levels compared with subjects on AC by week 12 ( change in ferritin , 114.1±29.35 ng/ml ; P<0.001 ; change in TSAT , 8.62%±1.57 % ; P<0.001 ) . Change in TSAT plateaued at this point , whereas change in ferritin increased through week 24 , remaining relatively stable thereafter . Subjects on FC needed less iv iron compared with subjects on AC over 52 weeks ( median [ interquartile range ] dose=12.9 [ 1.0 - 28.9 ] versus 26.8 [ 13.4 - 47.6 ] mg/wk ; P<0.001 ) , and the percentage of subjects not requiring iv iron was higher with FC ( P<0.001 ) . Cumulative ESA over 52 weeks was lower with FC than AC ( median [ interquartile range ] dose=5303 [ 2023 - 9695 ] versus 6954 [ 2664 - 12,375 ] units/wk ; P=0.04 ) . Overall , 90.3 % of subjects on FC and 89.3 % of subjects on AC experienced adverse events . In conclusion , treatment with FC as a phosphate binder results in increased iron parameters apparent after 12 weeks and reduces iv iron and ESA use while maintaining hemoglobin over 52 weeks , with a safety profile similar to that of available binders Background / Aims : Renal anemia is one of the commonest complications of chronic renal failure . Iron deficiency is the most common factor which affects the efficacy of recombinant human erythropoietin ( EPO ) therapy . Intravenous ( i.v . ) iron preparations are commonly used in Western countries , but iron sucrose is seldom used in Chinese patients on maintenance hemodialysis . The aim of the present study was to explore the safety and efficacy of i.v . iron sucrose in Chinese patients on maintenance hemodialysis and to explore the optimal administration frequency . Methods : One hundred and thirty-six patients on maintenance hemodialysis were involved in this r and omized , controlled , parallel-group , single-center trial . Seventy patients received i.v . iron sucrose ( Venofer ® , delivering 100 mg iron ) twice a week for 8 weeks , then once a week for another 4 weeks . The other 66 patients received oral ( p.o . ) ferrous succinate 200 mg t.i.d . for 12 weeks . Levels of serum ferritin ( SF ) , transferrin saturation ( TSAT ) , hemoglobin ( Hb ) and hematocrit ( Hct ) were assessed at baseline and then again after 4 , 8 and 12 weeks of treatment . Results : There were no differences between i.v . and p.o . groups in terms of sex , age , duration of hemodialysis , dialysis frequency per week , EPO dosage per week , the level of intact parathyroid hormone , serum creatinine , blood urea nitrogen , or hematological parameters at baseline . After 8 and 12 weeks of treatment , mean Hb concentration and Hct were significantly increased in the i.v . group , and were also significantly higher than those in the p.o . group . Levels of SF and TSAT were also significantly increased in the i.v . group , and significantly higher than in the p.o . group . After 8 weeks , the response rate in the i.v . group was 88.6 % , which was significantly higher than that in the p.o . group . The mean EPO dose was significantly lower in the i.v . group than the p.o . group . Hb , Hct , SF and TSAT levels were maintained between 8 and 12 weeks in the i.v . group despite the decrease in dose frequency . There were no adverse events related to i.v . iron administration . Twenty-two patients in the p.o . group had adverse gastrointestinal effects . After 12 weeks , the cost of EPO + i.v . iron was significantly higher than the cost of EPO + p.o . iron . Conclusion : Intravenous iron sucrose can effectively increase serum iron parameters and Hb levels in Chinese patients on maintenance hemodialysis and is well tolerated . Infusion of i.v . iron sucrose 100 mg per week can maintain serum iron parameters and Hb levels in Chinese patients on maintenance hemodialysis and can permit reductions in the required dose of EPO . However , the total cost of i.v . iron is relatively high Purpose Both anaemia and allogenic red blood cell transfusion are common and potentially harmful in patients admitted to the intensive care unit . Whilst intravenous iron may decrease anaemia and RBC transfusion requirement , the safety and efficacy of administering iron intravenously to critically ill patients is uncertain . Methods The multicentre , r and omized , placebo-controlled , blinded Intravenous Iron or Placebo for Anaemia in Intensive Care ( IRONMAN ) study was design ed to test the hypothesis that , in anaemic critically ill patients admitted to the intensive care unit , early administration of intravenous iron , compared with placebo , reduces allogeneic red blood cell transfusion during hospital stay and increases the haemoglobin level at the time of hospital discharge . Results Of 140 patients enrolled , 70 were assigned to intravenous iron and 70 to placebo . The iron group received 97 red blood cell units versus 136 red blood cell units in the placebo group , yielding an incidence rate ratio of 0.71 [ 95 % confidence interval ( 0.43–1.18 ) , P = 0.19 ] . Overall , median haemoglobin at hospital discharge was significantly higher in the intravenous iron group than in the placebo group [ 107 ( interquartile ratio IQR 97–115 ) vs. 100 g/L ( IQR 89–111 ) , P = 0.02 ] . There was no significant difference between the groups in any safety outcome . Conclusions In patients admitted to the intensive care unit who were anaemic , intravenous iron , compared with placebo , did not result in a significant lowering of red blood cell transfusion requirement during hospital stay . Patients who received intravenous iron had a significantly higher haemoglobin concentration at hospital discharge . The trial was registered at http://www.anzctr.org.au as # ACTRN12612001249842 INTRODUCTION Anemia is the most common finding in chronic kidney disease patients .  Iron supplements are commonly prescribed for these patients with or without erythropoietin therapy by means of oral and intravenous iron . Both oral and intravenous irons have their own advantage and disadvantage , and the efficacy is also different . The objective of the study is to analyze the efficacy of oral and intravenous iron in chronic kidney disease patients on erythropoietin therapy , an erythropoiesis stimulating agents for increment of haemoglobin . METHODS This is a prospect i ve study comparing intravenous iron to oral iron in chronic kidney disease patients who underwent maintenance hemodialysis at different centers and visited Kathm and u Medical College Teaching Hospital from April 2010 to April 2011 . Patients having a haemoglobin level of < 11 g/dl , transferrin saturation ( TSAT ) < 25 % , ferritin < 300ng/ml and who were on erythropoietin therapy were allocated alternately into two groups to receive oral iron ( iron fumarate ) or IV iron ( iv sucrose ) .  Haemoglobin was measured after 30 days of therapy . RESULTS A significant increase in haemoglobin levels was observed in both groups . But the mean haemoglobin increment was more in the IV iron group than in the oral iron group . Sixty percent 60 % of patients in the IV iron group had an increase in the haemoglobin level of more than 1gm/dl while only 20 % of the oral iron group had this increase . CONCLUSIONS Intravenous iron therapy is more effective in raising the hemoglobin level in hemodialysis dependent chronic kidney disease patients The objective of the study is to evaluate the bioavailability , efficacy and safety of a new modified-release ( MR ) formulation of carbonyl iron ( 45 mg ) relative to a commercially available conventional formulation of ferrous fumarate ( 300 mg ) in adult Indian patients with clinical and laboratory diagnosis of nutritional iron deficiency anaemia . This prospect i ve , comparative , r and omised , double-blind study was carried out among 60 patients received a single daily dose of either MR carbonyl iron or ferrous fumarate for 12 weeks . The effect of therapy on haematological parameters and iron status and estimation of bioavailability were the main efficacy outcomes . There was a significant ( p<0.05 ) increase in mean haemoglobin levels , reticulocyte counts , haematocrit and mean corpuscular volume in MR carbonyl iron group compared to ferrous fumarate group . There was also an increase in mean serum iron and ferritin levels and a corresponding decrease in total iron binding capacity in MR carbonyl iron group compared to ferrous fumarate group at the end of 12 weeks therapy . The estimated overall bioavailability of MR carbonyl iron was about 147 % that of ferrous fumarate . Both the formulations were equally well-tolerated and adverse events were mainly gastrointestinal in nature . The prevalence of adverse events was slightly more in the ferrous fumarate group . It can be concluded that the MR formulation of carbonyl iron was more efficacious than ferrous fumarate in correcting haematologic abnormalities and improving iron status in patients with nutritional iron deficiency anaemia . In conditions where efficacy is an important consideration , the higher bioavailability of MR carbonyl iron may make it the treatment of choice for nutritional iron deficiency anaemia For the majority of patients with iron deficiency anemia ( IDA ) , a full course of intravenous ( IV ) iron is 1 g. Most IV irons require 5–10 administrations of 100–300 mg . We have successfully employed 1 g low molecular weight iron dextran over 1 hr . For further convenience for patients and physicians , we explored the administration of 1.02 g of ferumoxytol over 15 min instead of the approved 2 × 510 mg injections . Sixty patients with IDA , ( hemoglobin < 11 g/dL , transferrin saturation [ TSAT ] ≤20 % , and ferritin < 100 ng/mL ) with an inadequate response or intolerance to oral iron , received 1020 mg ferumoxytol over 15 min . Vital signs were measured for 1 hr . Adverse events ( AEs ) were collected via telephone at 1 , 2 , and 7 days . Follow‐up visits occurred at 4 and 8 weeks for efficacy assessment s. The primary endpoint was safety and tolerability . Secondary efficacy endpoints included mean change in hemoglobin , TSAT , and red cell distribution width . No serious adverse events ( SAEs ) occurred . Fifty‐eight patients received the planned dose . Twenty‐six out of sixty ( 43.3 % ) patients reported AEs of which 13 were mild and transient during infusion . All resolved within minutes . Fourteen patients reported self‐limited arthralgias , myalgias , and /or headache within 24–48 hr . At Baseline , the mean hemoglobin was 9.4 g/dL. The mean increments at Week 4 and 8 were 2.1 and 2.6 g/dL , respectively . Ferumoxytol , administered as 1.02 g infusion over 15 min was well tolerated with no SAEs and demonstrated excellent efficacy . If corroborated in future studies this represents an improved method of treating IDA . Am . J. Heamtol . 88:944–947 , 2013 . © 2013 Wiley Periodicals , Cytomegalovirus ( CMV ) infection is a major complication after allogeneic stem cell transplantation ( SCT ) .  Valganciclovir ( V-GCV ) is an oral prodrug hydrolyzed to the anti-CMV drug ganciclovir ( GCV ) . A r and omized , multicenter , crossover , open-label clinical trial compared exposure to GCV after V-GCV and intravenous GCV ( IV-GCV ) as preemptive therapy for CMV disease in SCT . The primary objective was to compare exposure to GCV in patients with CMV infection stratified for intestinal graft-versus-host disease ( I-GVHD ) . Secondary objectives were the assessment of safety and efficacy .  Patients without I-GVHD had a higher exposure to GCV after V-GCV when compared with IV-GCV ( area under the concentration-time curve from drug administration to last observed concentration after 12 hours [ AUC(0 - 12 ) ] 53.8 + /- 17.97 microg/mL . h [ mean + /- SD ] vs 39.5 + /- 13.91 ; P < .001 ; ratio of V-GCV/IV-GCV was 1.4 ; 90 % confidence interval [ CI ] , 1.2 - 1.5 ) . This was also true in patients with I-GVHD grade s I-II ( AUC(0 - 12 ) 52.9 + /- 21.75 vs 33.1 + /- 12.97 mug/mL . h ; P = .018 ; ratio 1.6 ; 90 % CI , 1.3 - 2.0 ) . Absolute bioavailability of GCV  after V-GCV was approximately 75 % in individuals with or without I-GVHD grade s I-II . No severe GCV-related toxicity was observed and efficacy and safety was comparable ( 84-day follow-up ) . This supports the use of V-GCV in SCT , even in patients with I-GVHD grade s I-II . Due to higher exposure after V-GCV compared with IV-GCV , patients should be monitored carefully for safety reasons OBJECTIVE To assess and compare the efficacy and safety of two and three doses of intravenous iron sucrose with daily oral ferrous sulphate in the prophylaxis of iron deficiency anaemia in pregnant women . STUDY DESIGN 260 women with singleton pregnancy who met inclusion criteria and who gave informed consent were r and omised between the 21st and 24th week into either the intravenous iron group or the oral iron group . Of 130 women in the intravenous iron group , 75 women received two doses of 200 mg iron sucrose and 55 three doses of 200 mg iron sucrose . The first dose was administered between the 21st and 24th gestational weeks , the second between the 28th and 32nd and the third between the 35th and 37th . The women of the oral group were given oral tablets of 80 mg ferrous sulphate daily , beginning on the day of study enrolment and stopping on the day of delivery . RESULTS There was a non-significant trend to a higher frequency of responders ( haemoglobin > or = 11 g/dl ) in the intravenous iron group ( 75 vs. 80 % ) . There was a significant difference of repleted iron stores before delivery ( ferritin>50 microg/l ) in the group with three intravenous iron doses in comparison to the oral iron group ( 49 vs. 14 % ; p<0.001 ) . No differences were observed in regard to maternal and perinatal outcomes . CONCLUSIONS There was no clinical ly significant difference in the haematological , maternal and foetal outcomes in the parenteral route of iron prophylaxis in pregnant women Background Anemia management protocol s in hemodialysis ( HD ) units differ conspicuously regarding optimal intravenous ( IV ) iron dosing ; consequently , patients receive markedly different cumulative exposures to IV iron and erythropoiesis-stimulating agents ( ESAs ) . Complementary to IV iron safety studies , our goal was to gain insight into optimal IV iron dosing by estimating the effects of IV iron doses on Hgb , TSAT , ferritin , and ESA dose in common clinical practice . Methods 9,471 HD patients ( 11 countries , 2009 - 2011 ) in the DOPPS , a prospect i ve cohort study , were analyzed . Associations of IV iron dose ( 3-month average , categorized as 0 , < 300 , ≥300 mg/month ) with 3-month change in Hgb , TSAT , ferritin , and ESA dose were evaluated using adjusted GEE models . Results Relative change : Monotonically positive associations between IV iron dose and Hgb , TSAT , and ferritin change , and inverse associations with ESA dose change , were observed across multiple strata of prior Hgb , TSAT , and ferritin levels . Absolute change : TSAT , ferritin , and ESA dose changes were nearest zero with IV iron < 300 mg/month , rather than 0 mg/month or ≥300 mg/month by maintenance or replacement dosing . Findings were robust to numerous sensitivity analyses . Conclusions Though residual confounding can not be ruled out in this observational study , findings suggest that IV iron dosing < 300 mg/month , as commonly seen with maintenance dosing of 100 - 200 mg/month , may be a more effective approach to support Hgb than the higher IV iron doses ( 300 - 400 mg/month ) often given in many European and North American hemodialysis clinics . Alongside studies supporting the safety of IV iron in 100 - 200 mg/month dose range , these findings help guide the rational dosing of IV iron in anemia management protocol s for everyday hemodialysis practice OBJECTIVES : Anemia is a frequent complication in patients with inflammatory bowel disease ( IBD ) . The optimal route for iron supplementation to replenish iron stores has not been determined so far . We therefore evaluated the efficacy and safety of intravenous iron sucrose as compared with oral iron sulfate for the treatment of iron deficiency anemia ( IDA ) in patients with IBD . METHODS : A r and omized , prospect i ve , open-label , multicenter study was performed in 46 patients with anemia and transferrin saturation ≤20 % and /or serum ferritin concentrations ≤20 μg/L. The intravenous group received a single dose of iron sucrose of 7 mg iron/kg body weight , followed by five 200 mg infusions for the following 5 wks . The oral group received iron sulfate 100–200 mg per day for 6 wks . RESULTS : While a comparable increase in hemoglobin was observed for both administration routes ( median increase 0.25 g/L in the intravenous group vs 0.21 g/L in the oral group ) , only iron sucrose led to a rise in serum ferritin concentrations . Intractable gastrointestinal adverse events caused permanent study drug discontinuation in five patients ( 20.8 % ) receiving iron sulfate , whereas only one patient ( 4.5 % ) had to be withdrawn because of side effects due to iron sucrose . CONCLUSIONS : Although being equal in short-term efficacy and overall tolerability our results suggest a better gastrointestinal tolerability for iron sucrose . Larger trials are m and atory to prove a possible advantage of iron sucrose in short- and long-term efficacy as well as in tolerability over iron sulfate in the management of IDA in IBD OBJECTIVE ( 1 ) To determine an alternative iron supplementation with better efficacy , compliance & safety in treatment of iron deficiency anemia during pregnancy , ( 2 ) to reduce blood transfusion during pregnancy , labor and puerperium . MATERIAL AND METHOD A prospect i ve comparative study . A total number of 60 pregnant women with the gestational age of 12 - 34 weeks were included in the study who were suffering from iron deficiency anemia . They were divided in 3 groups ( A , B and C ) . Group A ( n = 15 ) received intravenous iron sucrose according to recommended dose containing 500 mg of iron sucrose for storage , in group B ( n = 20 ) iron sucrose was administered according to deficit calculated as per formula but 200 mg of iron was given for storage instead of 500 mg , to reduce cost . While group C received intra muscular iron Sorbitol in the dose used as practice . RESULTS Mean hemoglobin in group A and B was 8.0 + /- 1.1 g/dl and 8.9 + /- 0.7 respectively , in group C , it was 8.8 + /- 0.9 g/dl . In group A & B initial hemoglobin was assessed 3 weeks post therapy which showed an average rise of 2.8 g/dl ( group A ) and 1.9 g/dl ( group B ) and second assessment of Hemoglobin was done prior to delivery ( ave : 6.6 weeks ) showed a total rise of 3.8 g/dl ( group A ) and 2.4 g/dl ( group B ) . Pre delivery mean Hemoglobin in group A and B was 11.8 g/dl and 11.3 g/dl respectively . In group C , the Hemoglobin was assessed only prior to delivery ( average : 8.4 weeks from the start of therapy ) , and a rise of 1.4 g/dl was observed with pre delivery mean Hemoglobin of 10.2 g/dl . Target hemoglobin levels i.e. 11 g/dl was achieved by 80 % in Group A , 70 % in Group B and 28 % in Group C by the time of delivery . Blood transfusion was not required in any group . In group A and B one patient had moderate abdominal pain , 2 had weakness and shivering and 3 had phlebitis at the site where intravenous canula was retained . None of patient discontinued the therapy due to any adverse effect . In group C majority complained of pain at injection site while 5 patients dropped out from the study due to intolerance . CONCLUSION Intravenous iron therapy is safe , convenient and more effective then intramuscular iron therapy in treatment of iron deficiency anemia during pregnancy . The intravenous iron therapy can replace blood transfusion in antenatal period The vast majority of erythropoietin (EPO)–treated peritoneal dialysis ( PD ) patients require iron supplementation . Most authors and clinical practice guidelines recommend primary oral iron supplementation in PD patients because it is more practical and less expensive . However , numerous studies have clearly demonstrated that oral iron therapy is unable to maintain EPO-treated PD patients in positive iron balance . Once patients become iron-deficient , intravenous iron administration has been found to more effectively augment iron stores and hematologic response than does oral therapy . We recently performed a prospect i ve , cross-over trial in 28 iron-replete PD patients and showed that twice-monthly outpatient iron polymaltose infusions ( 200 mg ) were a practical and safe alternative to oral iron . That treatment produced significant increases in hemoglobin concentration and body iron stores . The additional expense of intravenous iron therapy was completely offset by reductions in EPO dosage . Careful monitoring of iron stores is important in patients receiving intravenous  iron supplementation in view of epidemiologic links with infection and cardiovascular disease . Nevertheless , a growing body of evidence suggests that , as has been found for hemodialysis patients , intravenous iron therapy is superior to oral iron supplementation in EPO-treated PD patients This is the first study to investigate the efficacy of intravenous iron in treating fatigue in nonanemic patients with low serum ferritin concentration . In a r and omized , double-blinded , placebo-controlled study , 90 premenopausal women presenting with fatigue , serum ferritin ≤ 50 ng/mL , and hemoglobin ≥ 120 g/L were r and omized to receive either 800 mg of intravenous iron (III)-hydroxide sucrose or intravenous placebo . Fatigue and serum iron status were assessed at baseline and after 6 and 12 weeks . Median fatigue at baseline was 4.5 ( on a 0 - 10 scale ) . Fatigue decreased during the initial 6 weeks by 1.1 in the iron group compared with 0.7 in the placebo group ( P = .07 ) . Efficacy of iron was bound to depleted iron stores : In patients with baseline serum ferritin ≤ 15 ng/mL  , fatigue decreased by 1.8 in the iron group compared with 0.4 in the placebo group ( P = .005 ) , and 82 % of iron-treated compared with 47 % of placebo-treated patients reported improved fatigue ( P = .03 ) . Drug-associated adverse events were observed in 21 % of iron-treated patients and in 7 % of placebo-treated patients ( P = .05 ) ; none of these events was serious . Intravenous administration of  iron improved fatigue in iron-deficient , nonanemic women with a good safety and tolerability profile . The efficacy of intravenous iron was bound to a serum ferritin concentration ≤ 15 ng/mL. This study was registered at the International St and ard R and omized Controlled Trial Number Register ( www.is rct n.org ) as IS RCT N78430425 OBJECTIVE To determine whether intravenously administered iron supplements would improve the hematologic response to recombinant erythropoietin  in stable preterm infants . METHODS Forty-two preterm infants ( <33 weeks ' gestation , birth weight < 1500 gm , hematocrit < 38 % ) were treated with recombinant human erythropoietin ( Eprex ) , 600 U/kg per week , and r and omly assigned to receive either an oral preparation of ferrous lactate ( elemental iron , 12 mg/kg per day ) or an intravenous preparation of iron sucrose ( 6 mg/kg per week ) . RESULTS Hematocrits , reticulocyte counts , and transfusions were similar in the oral group ( OG ) and the intravenous group ( IVG ) . However , markedly higher serum ferritin concentrations were noted in the IVG ( p < 0.001 ) , and by completion of the study the arithmetic mean values were 265 + /- 127 microg/L versus 137 + /- 65 microg/L in the IVG and the OG , respectively . The numbers of hypochromic erythrocytes increased in both groups during the study but were significantly higher in the OG ( p = 0.04 ) . Mean daily weight gain in the IVG ( 27 + /- 6.4 gm/day ) was greater than in the OG ( 22.9 + /- 4.78 gm/day ; p = 0.04 ) . CONCLUSIONS High doses of both orally administered iron and intravenously administered iron sucrose appear to supply sufficient iron for erythropoiesis in stable infants . Storage iron may become depleted after oral supplementation . The intravenous preparation appears to be safe and maintains serum ferritin concentrations , and it may be indicated for patients with low ferritin levels and for those not established on enteral feedings PURPOSE Unresponsiveness to erythropoiesis-stimulating agents , occurring in 30 % to 50 % of patients , is a major limitation to the treatment of chemotherapy-related anemia . We have prospect ively evaluated whether intravenous iron can increase the proportion of patients with chemotherapy-related anemia who respond to darbepoetin .  PATIENTS AND METHODS Between December 2004 and February 2006 , 149 patients with lung , gynecologic , breast , and colorectal cancers and > or= 12 weeks of planned chemotherapy were enrolled from 33 institutions . Patients were required to have hemoglobin < or= 11 g/L and no absolute or functional iron deficiency . All patients received darbepoetin 150 microg subcutaneously once weekly for 12 weeks and were r and omly assigned to sodium ferric gluconate 125 mg intravenously ( IV ) weekly for the first 6 weeks ( n = 73 ) or no iron ( n = 76 ) . Primary end point of the study was the percentage of patients achieving hematopoietic response ( hemoglobin > or= 12 g/dL or > or= 2 g/dL increase ) . RESULTS Hematopoietic response by intention-to-treat analysis was 76.7 % ( 95%CI , 65.4 % to 85.8 % ) in the darbepoetin/iron group and 61.8 % ( 95%CI , 50.0 % to 72.7 % ) in the darbepoetin group ( P = .0495 ) . Among patients fulfilling eligibility criteria and having received at least four darbepoetin administrations , hematopoietic responses in the darbepoetin/iron group ( n = 53 ) and in the darbepoetin-only group ( n = 50 ) were 92.5 % ( 95 % CI , 81.8 % to 97.9 % ) and 70 % ( 95 % CI , 55.4 % to 82.1 % ) , respectively ( P = .0033 ) . Increase of hemoglobin during treatment period showed a time profile favoring darbepoetin/iron with statistically significant effect from week 5 on . The safety profile was comparable in the two arms . CONCLUSION In patients with chemotherapy-related anemia and no iron deficiency , IV iron supplementation significantly reduces treatment failures to darbepoetin without additional toxicity Several intravenous iron complexes are available for the treatment of iron deficiency anemia ( IDA ) .  Iron dextran ( DEX ) is associated with an elevated risk of potentially serious anaphylactic reactions , whereas others must be administered in several small infusions to avoid labile iron reactions . Ferric carboxymaltose ( FCM ) is a nondextran intravenous iron which can be administered in high single doses . A r and omized , open label , and multicenter comparison of FCM to DEX in adults with IDA and baseline hemoglobin of ≤11.0 g/dL was conducted . A total of 160 patients were in the safety population  ( FCM n = 82 ; DEX n = 78 ) . Adverse events , including immune system disorders ( 0 % in FCM versus 10.3 % in DEX , P = 0.003 ) and skin disorders ( 7.3 % in FCM versus 24.4 % in DEX , P = 0.004 ) , were less frequently observed in the FCM group . A greater portion of patients in the FCM group experienced a transient , asymptomatic decrease in phosphate compared to patients in the DEX group ( 8.5 % in FCM versus 0 % in DEX , P = 0.014 ) . In the FCM arm , the change in hemoglobin from baseline to the highest observed level was 2.8 g/dL , whereas the DEX arm displayed a change of 2.4 g/dL ( P = 0.20 ) . Treatment of IDA with FCM result ed in fewer hypersensitivity-related reactions  than DEX Background Administration of ferric pyrophosphate citrate ( FPC , Triferic ™ ) via hemodialysate may allow replacement of ongoing uremic and hemodialysis-related iron losses . FPC donates iron directly to transferrin , bypassing the reticuloendothelial system and avoiding iron sequestration . Methods Two identical Phase 3 , r and omized , placebo-controlled trials ( CRUISE 1 and 2 ) were conducted in 599 iron-replete chronic hemodialysis patients . Patients were dialyzed with dialysate containing 2 µM FPC-iron or st and ard dialysate ( placebo ) for up to 48 weeks . Oral or intravenous iron supplementation was prohibited , and doses of erythropoiesis-stimulating agents were held constant . The primary efficacy end point was the change in hemoglobin ( Hgb ) concentration from baseline to end of treatment ( EoT ) . Secondary end points included reticulocyte hemoglobin content ( CHr ) and serum ferritin . Results In both trials , Hgb concentration was maintained from baseline to EoT in the FPC group but decreased by 0.4 g/dL in the placebo group ( P < 0.001 , combined results ; 95 % confidence interval [ CI ] 0.2–0.6 ) . Placebo treatment result ed in significantly larger mean decreases from baseline in CHr ( −0.9 pg versus −0.4 pg , P < 0.001 ) and serum ferritin ( −133.1 µg/L versus −69.7 µg/L , P < 0.001 ) than FPC treatment . The proportions of patients with adverse and serious adverse events were similar in both treatment groups . Conclusions FPC delivered via dialysate during hemodialysis replaces iron losses , maintains Hgb concentrations , does not increase iron stores and exhibits a safety profile similar to placebo . FPC administered by hemodialysis via dialysate represents a paradigm shift in delivering maintenance iron therapy to hemodialysis patients AIM Iron deficiency is a leading cause of anemia in pregnancy . The present study aim ed to compare the efficacy of oral and intravenous iron therapy in improving iron deficiency anemia in pregnancy and restoring iron stores , compare the obstetric outcome in the two groups and evaluate the safety of intravenous iron sucrose . MATERIAL AND METHODS This was a prospect i ve study , where 100 anemic antenatal women with hemoglobin 7 - 9 g/dL , mean corpuscular volume < 85 fL and serum ferritin < 15 ng/mL , were r and omized into two groups . In group A ( n=50 ) , the women received 200 mg tablets of ferrous sulphate , each containing 60 mg elemental iron , three times a day for 4 weeks . In group B ( n=50 ) , iron sucrose was given in divided doses of 200 mg each on alternate days by slow intravenous infusion . Primary outcome measure was treatment efficacy , assessed by measurement of hemoglobin , red blood cell indices and reticulocytes on days 7 , 14 , 21 , and 30 and at delivery , and of ferritin on day 30 and at delivery . Any side-effects of treatment and the neonatal outcome were studied as secondary outcome measures . RESULTS There was a statistically significant difference in increase of hemoglobin levels ( 3.1g/dL in group A vs 5.1 g/dL in group B ; P=0.002 ) and ferritin levels between the two groups on day 30 ( P=0.005 ) . The adverse effects from iron treatment were mild but more prominent in group A. Neonatal outcome was comparable in the two groups . CONCLUSION Intravenous administration of iron sucrose is a safe treatment for correction of anemia in pregnancy , without serious side-effects Abstract : Anaemia is the most common medical disorder in pregnancy with iron deficiency anaemia accounting for the majority of cases . Over 90 % of the iron deficiency anaemia is due to red cell iron deficiency associated with depleted iron stores and deficient intake . The two main modalities of treating iron deficiency anaemia are oral or parenteral iron . Ferrous Hausmann ® ( iron dextrin ) is the latest iron preparation which can be used for intravenous parenteral administration as a total dose infusion . This study compares the efficacy of Ferrum Hausmann ® with oral ferrous fumarate therapy in the treatment of iron deficiency anaemia in pregnancy . Our study shows that treatment with intravenous Ferrum Hausmann ® ( iron dextrin ) result ed in a significantly better level and rate of increase of haemoglobin ( p<0.001 ) . Serum ferritin , which is the best indicator of iron stores , was significantly higher ( p<0.001 ) in the intravenous group . Other indices of iron status such as serum iron , serum transferrin and zinc protoporphyrin also showed a significant improvement in the intravenous group compared to those given oral iron . The results suggest that intravenous iron as a total dose infusion is able to replenish iron stores more efficiently , completely and at a faster rate than oral iron therapy , thus providing the fuel for stimulation of full erythopoiesis compared to oral iron . There were also no reports of any adverse reactions with intravenous iron dextrin , whereas there were a considerable proportion of women on oral iron therapy who reported side effects . In conclusion , intravenous iron therapy with Ferrous Hausmann ® ( iron dextrin ) is a suitable , effective and safe alternative to oral iron therapy in the treatment of iron deficiency anaemia in pregnancy Introduction This study sought to compare efficacy and safety of ferric carboxymaltose vs. placebo in iron-deficient patients with fibromyalgia . Methods This blinded , placebo-controlled , phase 2 study r and omized adults with fibromyalgia and Revised Fibromyalgia Impact Question naire ( FIQR ) scores ≥ 60 , ferritin levels < 0.05 µg/ml , and transferrin saturation < 20 % ( 1:1 ) to receive ferric carboxymaltose [ 15 mg/kg ( up to 750 mg ) ] , or placebo ( 15 cc  normal saline ) intravenously on study days 0 and 5 . Patients visited the clinic on days 14 , 28 , and 42 for efficacy and safety assessment s. The primary efficacy endpoint was proportion of patients with a ≥ 13-point improvement from baseline to day 42 in FIQR scale score . Secondary endpoints included changes from baseline in FIQR scale , Brief Pain Inventory ( BPI ) total score , Medical Outcomes Study ( MOS ) Sleep scale , Fatigue Visual Numeric Scale ( VNS ) , iron indices ( transferrin saturation and ferritin ) , and safety . Results The efficacy analysis group comprised 80 patients , and the safety analysis group comprised 81 .  More ferric carboxymaltose patients ( 77 % ) vs. placebo patients ( 67 % ) achieved the primary endpoint , but the difference was not significant . Greater improvements from baseline to day 42 were observed for ferric carboxymaltose vs. placebo in FIQR total score , BPI total score , Fatigue VNS score , and iron indices . Mean changes in MOS Sleep scale scores were similar between groups . Ferric carboxymaltose was safe and well tolerated . Conclusions Compared with placebo , ferric carboxymaltose improved measures of fibromyalgia severity and was well tolerated . The current results suggest that ferric carboxymaltose shows benefit in iron-deficient patients with concurrent fibromyalgia . Funding Luitpold Pharmaceuticals , Inc . Trial Registration Clinical Trials.gov identifier , NCT02409459 BACKGROUND Iron dextran administration is associated with a high incidence of adverse reactions including anaphylaxis and death . Although dextran , rather than iron , is believed to be the cause of these reactions , it is not known whether iron dextran-sensitive patients can be safely administered another form of parenteral iron , sodium ferric gluconate in sucrose ( SFGC ) . METHODS In a 69 center , prospect i ve , double-blind , controlled trial of safety and tolerability of SFGC , the rate of reactions to SFGC and placebo in 144 iron dextran-sensitive patients was compared with 2194 patients who were previously tolerant to iron dextran preparations .  Serum tryptase levels , a marker of mast cell degranulation , also were measured . RESULTS Among 143 iron dextran-sensitive patients exposed to  SFGC  , three ( 2.1 % ) were intolerant . All three had suspected allergic events to SFGC  , including one patient with a serious reaction ( 0.7 % ) . One dextran-sensitive patient ( 0.7 % ) had a suspected allergic reaction after placebo . In contrast , among 2194 iron dextran-tolerant patients , reactions to  SFGC  were significantly less common , with  SFGC intolerance seen in seven patients ( 0.3 % ; P = 0.020 ) , including five ( 0.2 % ) who had suspected allergic events ( P = 0.010 ) , but none who had serious events ( 0.0 % ; P = 0.061 ) . Two iron dextran-tolerant patients ( 0.09 % ) had allergic-like reactions following placebo injections . Two of the three suspected allergic events in the iron dextran-sensitive group were confirmed as mast cell dependent by a 100 % increase in serum tryptase , while there were no confirmed allergic events in the iron dextran-tolerant group . Long-term exposure to SFGC in iron dextran-sensitive patients result ed in intolerance in only one additional patient and no serious adverse events . CONCLUSIONS Patients with a history of iron dextran sensitivity had approximately sevenfold higher rates of reaction to both placebo and SFGC compared to iron dextran tolerant patients . However , logistic regression analysis , performed to account for the higher reaction rate to placebo , suggests that this increased reactivity was not drug-specific nor immunologically mediated , but represented host idiosyncrasy . These results support the conclusions that reactions to SFGC can be attributed to pseudoallergy , and that SFGC is not a true allergen Although functional iron deficiency ( FID ) may be present in hemodialysis ( HD ) patients with high serum ferritin levels ( > 800 ng/mL ) , current protocol s often preclude the use of intravenous ( IV ) iron in these patients . However , it has not been demonstrated that iron supplementation during erythropoietin therapy is ineffective or unsafe in increasing hemoglobin ( Hb ) levels in patients with high serum ferritin . This report describes the hematologic efficacy and safety of ferric gluconate ( FG ) therapy in patients with serum ferritin > 800 ng/mL. A retrospective analysis was performed on HD patients at a single California dialysis center from January 1 to December 31 , 2003 . Patients classified as having high ferritin levels ( serum ferritin > 800 ng/mL on at least 66 % of routine monthly measurements and transferrin saturation [ TSAT ] < 25 % on at least 1 occasion ) were stratified as follows : patients in Group I were suspected of having FID and received FG ≥250 mg IV over a 3‐month period when Hb was < 11 g/dL , and patients in Group II were thought not to have FID and received < 250 mg FG over a 3‐month period . Both groups received st and ard recombinant human erythropoietin therapy as per the unit 's protocol . Of 496 patients , 95 exhibited high ferritin and of these , 39 patients had sufficient data for analysis . Group I patients ( n=14 ) showed a significant increase in Hb levels compared with Group II ( n=25 ) . There was no increase in ferritin levels in response to iron administration . No significant differences in hospitalizations or infections were observed between groups . Hemodialysis patients with high ferritin levels may have FID , and IV iron therapy safely improves FID in some patients . A larger r and omized trial examining the optimal management of iron administration in HD patients with high ferritin levels is warranted OBJECTIVE To test the efficacy and safety of combining intravenous iron in amounts approximating the in utero iron accretion rate and the postnatal iron loss with erythropoietin ( EPO ) in very low birth weight ( VLBW ) infants . METHODS A prospect i ve , controlled , r and omized , unmasked trial lasting 21 days was performed in 29 clinical ly stable VLBW infants < 31 weeks ' gestation and < 1300 g birth weight not treated with red blood cell transfusions during the study period . Mean ( + /- st and ard error of the mean ) age at study entry was 23 + /- 2.9 days . After a 3-day run-in baseline period in which all participants received oral supplements of 9 mg/kg/day of iron polymaltose complex ( IPC ) , participants were r and omized to receive 18 days of treatment with : 1 ) oral IPC alone ( oral iron group ) ; 2 ) 300 U of recombinant human EPO ( r-HuEPO ) kg/day and daily oral IPC ( EPO + oral iron group ) ; 3 ) 2 mg/kg/day of intravenous iron sucrose , r-HuEPO , and oral iron ( intravenous iron + EPO group ) . To assess efficacy of the 3 treatments , serial blood sample s were analyzed for hemoglobin ( Hb ) , hematocrit ( Hct ) , reticulocyte count , red blood cell indices and plasma levels of transferrin , transferrin receptor ( TfR ) , ferritin , and iron . Oxidant injury was assessed before and after treatment by plasma and urine levels of malondialdehyde ( MDA ) and o-tyrosine . RESULTS At the end of treatment , Hb , Hct , reticulocyte count , and plasma TfR were markedly higher in both of the EPO-treated groups , compared with the oral iron group . At study exit a trend toward increasing Hb and Hct levels and significantly higher reticulocyte counts were observed in the intravenous iron + EPO group , compared with the EPO + oral iron group . During treatment , plasma ferritin levels increased significantly in the intravenous iron + EPO group and decreased significantly in the other 2 groups . By the end of treatment , ferritin levels were significantly higher in the intravenous iron + EPO group compared with the other 2 groups . Although plasma and urine MDA or o-tyrosine did not differ among the 3 groups , plasma MDA was significantly greater in the subgroup of intravenous iron + EPO participants sample d at the end of the 2-hour parenteral iron infusion , compared with values observed immediately before and after parenteral iron-dosing . CONCLUSIONS In stable VLBW infants receiving EPO treatment , parenteral supplementation with 2 mg/kg/day of iron sucrose results in a small , but significant , augmentation of erythropoiesis beyond that of r-HuEPO and enteral iron alone . However , to reduce the potential adverse effects of parenteral iron/kg/day on increasing plasma ferritin levels and on causing oxidative injury , we suggest that the parenteral iron dose used should be reduced and /or the time of infusion extended to maintain a serum iron concentration below the total iron-binding capacity Objective : To determine if preoperative intravenous ( IV ) iron improves outcomes in abdominal surgery patients . Summary Background Data : Preoperative iron deficiency anemia ( IDA ) occurs frequently ; however if left untreated , increases the risk of blood transfusion allogeneic blood transfusion ( ABT ) . Limited evidence supports IDA treatment with preoperative IV iron . This r and omized controlled trial aim ed to determine whether perioperative IV iron reduced the need for ABT . Methods : Between August 2011 and November 2014 , 72 patients with IDA were assigned to receive either IV iron or usual care . The primary endpoint was incidence of ABT . Secondary endpoints were various hemoglobin ( Hb ) levels , change in Hb between time points , length of stay , iron status , morbidity , mortality , and quality of life 4 weeks postsurgery . Results : A 60 % reduction in ABT was observed in the IV iron group compared with the usual care group ( 31.25 % vs 12.5 % ) . Hb values , although similar at r and omization , improved by 0.8 g/dL with IV iron compared with 0.1 g/dL with usual care ( P = 0.01 ) by the day of admission . The IV iron group had higher Hb 4 weeks after discharge compared with the usual care group ( 1.9 vs 0.9 g/dL , P = 0.01 ) , and a shorter length of stay ( 7.0 vs 9.7 d , P = 0.026 ) . There was no difference in discharge Hb levels , morbidity , mortality , or quality of life . Conclusions : Administration of perioperative IV iron reduces the need for blood transfusion , and is associated with a shorter hospital stay , enhanced restoration of iron stores , and a higher mean Hb concentration 4 weeks after surgery Oral iron is a st and ard treatment of iron deficient anemia despite high rates of intolerance and nonadherence and may not replenish iron stores rapidly enough to meet ongoing losses [ 1 ] . Intravenous ( IV ) iron has advantages but remains underutilized . Whereas most formulations of IV iron require multiple doses for replacement , low molecular weight iron dextran ( LMW ID ) may be administered as a total dose infusion , typically over a 4to 6-hr period [ 2,3 ] . A 4-hr infusion for doses up to 4 g was st and ard in our practice until 2 years ago . However , clinical studies suggest that 1 g of IV iron is an adequate dose for many patients [ 3–5 ] , and it became apparent that we were frequently infusing doses of at least 1 g in 1 hr without evidence of significant adverse events [ 3 ] . Now , our clinical practice routinely infuses 1 g of LMW ID in 250 mL normal saline over 1 hr without premedication as our st and ard practice . We summarize our experience with the safety and efficacy of this method of administering IV iron in unselected patients with iron deficiency . From July 11 , 2008 to February 25 , 2010 , a total of 396 consecutive iron deficient patients received 1 g LMW ID infusions . The mean age was 50.7 years ( range 14 to 90 ) , 84.1 % were women , 75.1 % were white , and 14.4 % had multiple documented drug allergies at baseline . The most common diagnoses were  heavy uterine bleeding among women ( 43.5 % ) and gastrointestinal bleeding among men ( 33.3 % ) . The majority ( 78.9 % ) included in this study had baseline transferrin saturation ( TSAT ) 20 % ( mean : 11.5 ± 8.7 % ) and serum ferritin 100 ng/mL ( median : 11.0 ng/mL , range : 2 ) drug allergies and an increased likelihood of an AE [ odds ratio ( OR ) 5 3.40 ; 95 % CI : 1.09–10.63 ; P 5 0.036 ] when controlling for race , gender , and relative dose [ estimated body surface area ( BSA ) ] ( Figure 2 ; Supplemental Table II , available online ) . However , this finding should be interpreted with caution due to the very low absolute incidence rate . Other variables , including baseline iron status and age , were not associated with the incidence of observed AEs . Premedication with 125 mg of IV methylprednisolone was administered to only 10 patients with a history of multiple drug allergies ( 4 ) , asthma , active inflammatory bowel disease , and /or a previous reaction to IV iron .  Three received granisetron premedication due to anticipatory nausea ( n 5 2 ) or nausea with prior IV iron therapy ( n 5 1 ) . All premedicated patients subsequently received the infusion without AEs . No patient received premedication with antihistamines . Clinical ly significant hypophosphatemia , defined as a serum phosphate level 20 % and /or serum ferritin > 100 ng/mL. There was no significant difference in magnitude of Hb response between these two subsets ( mean difference in Hb increase between patients with TSAT 20 % and serum ferritin 100 ng/mL and the others was 0.3 g/dL ; 95 % CI:20.0 to 0.5 g/dL ; P 5 0.08 ) . When baseline TSAT 20 % and serum ferritin 100 ng/mL , 54 % of infusions led to an increase in Hb of at least 1 g/dL , while 37 % of infusions when TSAT > 20 % or serum ferritin > 100 ng/mL achieved an increase in Hb of at least 1 g/dL ( Supplemental Table IV , available online ) . A total of 31 infusions in 43 women with pregnancy-related anemia ( second and third trimester , or postpartum ) , for whom follow-up data were available , were included in the efficacy analysis . In this subgroup , the mean change in Hb from baseline was 1.2 g/dL ( 95 % CI : 0.79–1.65 g/dL ; P 2 g/dL. Four of the patients with pregnancy-related anemia reported AEs . One resolved with a decreased rate and temporary interruption of the infusion and three received treatment with IV methylprednisolone . Although oral iron is a convenient and inexpensive therapy for iron deficient anemia , it has several important limitations . Even in patients who are not inflamed , and therefore have no problems with absorption , effective treatment requires a long course to correct anemia and completely replenish stores . Significant nonadherence and intolerance abound . While any of the available IV irons can infrequently cause acute reactions , the incidence and severity of these reactions are far less than perceived [ 6 ] . Whereas LMW ID , iron sucrose , ferric gluconate , and ferumoxytol can be administered safely and effectively , only LMW ID can be used to provide total dose repletion in a single setting ( a method of administration approved in Europe but not the United States ) . This method of administration has typically been 2–6 hr in published reports . In some studies , doses of 3 g ( and up to 4.5 g ) were infused . Numerous clinical studies suggest that 1 g is an adequate dose for the majority of patients , and several support the use of 1 g/hr , providing a rationale for administering 1 g over 1 hr in this study [ 3,7–11 ] . No prospect i ve study has shown benefit of premedication with antihistamines , yet they are often administered empirically . A study of 135 iron deficient patients who received antihistamines before the administration of IV iron  reported that the most frequent AE observed was sedation due to the antihistamine [ 1 ] . Antihistamines have been associated with flushing , hypotension , supraventricular tachycardia and somnolence , all of which may be misinterpreted as iron-related reactions . In contradistinction to the AEs just described , there is a syndrome occurring in 1:200 patients described by Fishbane , consisting of arthralgia and myalgia of the chest or flank , usually BACKGROUND AIMS : Anemia is a common complication of inflammatory bowel diseases ( IBD ) This multicenter study tested the noninferiority and safety of a new intravenous iron preparation , ferric carboxymaltose ( FeCarb ) , in comparison with oral ferrous sulfate ( FeSulf ) in reducing iron deficiency anemia ( IDA ) in IBD . METHODS : Two hundred patients were r and omized in a 2:1 ratio ( 137 FeCarb:63 FeSulf ) to receive FeCarb ( maximum 1,000 mg iron per infusion ) at 1-wk intervals until the patients ' calculated total iron deficit was reached or FeSulf ( 100 mg b.i.d . ) for 12 wk . The primary end point was change in hemoglobin ( Hb ) from baseline to week 12 . RESULTS : The median Hb improved from 8.7 to 12.3 g/dL in the FeCarb group and from 9.1 to 12.1 g/dL in the FeSulf group , demonstrating noninferiority ( P = 0.6967 ) . Response ( defined as Hb increase of > 2.0 g/dL ) was higher for FeCarb at week 2 ( P = 0.0051 ) and week 4 ( P = 0.0346 ) . Median ferritin increased from 5.0 to 323.5 μg/L at week 2 , followed by a continuous decrease in the FeCarb group ( 43.5 μg/L at week 12 ) . In the FeSulf group , a moderate increase from 6.5 to 28.5 μg/L at week 12 was observed . Treatment-related adverse events ( AEs ) occurred in 28.5 % of the FeCarb and 22.2 % of the FeSulf groups , with discontinuation of study medication due to AEs in 1.5 % and 7.9 % , respectively . CONCLUSIONS : FeCarb is effective and safe in  IBD-associated anemia  . It is noninferior to FeSulf in terms of Hb change over 12 wk , and provides a fast Hb increase and a sufficient refill of iron stores BACKGROUND Iron deficiency anemia is a common complication in patients with chronic kidney disease ( CKD ) . Currently available intravenous ( IV ) iron replacement therapies have either inconvenient regimens of administration or adverse event profiles that limit their utility in the outpatient setting .  Ferumoxytol is a novel , semisynthetic , carbohydrate-coated , superparamagnetic iron oxide nanoparticle that is administered IV as an injection . The main objective of this study was to assess the safety of ferumoxytol for the treatment of patients with CKD stages 1 to 5 and 5D . STUDY DESIGN Phase 3 , r and omized , double-blind , placebo-controlled , crossover , multicenter study of a single 510-mg dose of ferumoxytol versus saline as placebo . SETTING & PARTICIPANTS 750 patients with CKD stages 1 to 5 and 5D . INTERVENTION An IV injection of either 17 mL of ferumoxytol or saline placebo over 17 seconds on day 0 and the alternate agent on day 7 . OUTCOMES & MEASUREMENTS Descriptive comparison of adverse events , laboratory tests , and vital signs . RESULTS Of 750 r and omly assigned patients with CKD , 60 % were not on dialysis therapy . 713 patients received ferumoxytol , and 711 received placebo .  There were 420 adverse events reported ; 242 in 152 patients ( 21.3 % ) with ferumoxytol and 178 in 119 patients ( 16.7 % ) with placebo .  The incidence of related adverse events was 5.2 % with ferumoxytol and 4.5 % with placebo . The most common related adverse events after each treatment included symptoms related to the injection/infusion site , dizziness , pruritus , headache , fatigue , and nausea . Serious adverse events occurred in 21 patients ( 2.9 % ) after ferumoxytol and 13 patients ( 1.8 % ) after placebo .  Serious related adverse events were observed in 1 patient ( 0.1 % ) after each treatment . There was no meaningful decrease in blood pressure after administration of ferumoxytol or placebo . LIMITATIONS Follow-up was 7 days after each study treatment . CONCLUSIONS Ferumoxytol is well tolerated and has a safety profile similar to placebo in anemic patients with CKD stages 1 to 5 and 5D BACKGROUND The use of large-volume electrolyte balanced solutions as preparation for colonoscopy often results in poor patient compliance and acceptance . The tolerance , safety , and efficacy of high-versus low-volume colon-cleansing methods as preparation for colonoscopy in children were compared by r and omized operator-blinded trial . METHODS Twenty-nine children ages 3.6 - 14.6 years had either high-volume nasogastric balanced polyethylene glycol electrolyte lavage ( 20 ml/kg/ h ) until the effluent was clear ( n = 15 ) , or two oral doses of sodium phosphate solution ( 22.5 - 45 ml ) separated by oral fluid intake ( n = 14 ) . RESULTS Both preparations were equally effective . The low-volume preparation was better tolerated and caused less discomfort that the high-volume preparation , judging by serial nurse observations . The incidence of abdominal symptoms , diarrhea , sleep disturbance , and vomiting was not significantly different between the two groups . Both groups had a small reduction in mean hematocrit and serum calcium levels . The sodium phosphate preparation caused increases in mean serum sodium concentrations from 140 to 145 mmol/L and serum phosphate concentrations from 1.41 to 2.53 mmol/L. Ten hours after the commencement of the preanesthetic fast , these concentrations had returned to normal . CONCLUSIONS There are advantages in terms of tolerance , discomfort , and case of administration with acceptable colonic cleansing with the use of the less-invasive oral sodium phosphate low-volume colon-cleansing preparation in children . Safe use requires ensuring an adequate oral fluid intake during the preparation time and avoidance of use in patients with renal insufficiency Deferasirox ( ICL670 ) is a once-daily oral iron chelator developed for the treatment of chronic iron overload from blood transfusions . A comparative phase 3 trial was conducted to demonstrate the efficacy of deferasirox in regularly transfused patients with beta-thalassemia aged 2 years or older . Patients were r and omized and received treatment with deferasirox ( n = 296 ) or deferoxamine ( n = 290 ) , with dosing of each according to baseline liver iron concentration ( LIC ) . The primary endpoint was maintenance or reduction of LIC ; secondary endpoints included safety and tolerability , change in serum ferritin level , and net body iron balance . In both arms , patients with LIC values of 7 mg Fe/g dry weight ( dw ) or higher had significant and similar dose-dependent reductions in LIC and serum ferritin , and effects on net body iron balance . However , the primary endpoint was not met in the overall population , possibly due to the fact that proportionally lower doses of deferasirox relative to deferoxamine were administered to patients with LIC values less than 7 mg Fe/g dw . The most common adverse events included rash , gastrointestinal disturbances , and mild nonprogressive increases in serum creatinine . No agranulocytosis , arthropathy , or growth failure was associated with deferasirox administration . Deferasirox is a promising once-daily oral therapy for the treatment of transfusional iron overload OBJECTIVE To evaluate the safety and efficacy of intravenous iron sucrose complex ( ISC ) as compared with oral ferrous sulfate in the treatment of iron deficiency anemia during pregnancy . STUDY DESIGN prospect i ve , open , controlled study in which pregnant women with iron deficiency anemia were sequentially selected from the antenatal clinic and assigned either to ISC ( study group ) or to ferrous sulfate ( control group ) . METHODS Each study patient was given the total calculated amount of ICS ( Hb deficit ( g/l ) x body weight ( kg ) x 0.3 ) in divided doses ( 200 mg ( elemental iron ) in 100 ml normal saline intravenously over 1 h daily ) followed by 10 mg/kg to replenish iron stores . Each patient of the control group was given ferrous sulfate 300 mg ( 60 mg elemental iron ) orally three times a day . All patients were monitored for adverse effects , clinical and laboratory response . RESULTS There were 52 patients and 59 controls . ISC group achieved a significantly higher Hb level ( 128.5 + /- 6.6 g/l vs. 111.4 + /- 12.4 g/l in the control group P < or = 0.001 ) in a shorter period ( 6.9 + /- 1.8 weeks vs. 14.9 + /- 3.1 weeks in the control group , P < or = 0.001 ) . ISC complex group showed no major side effects while 4 ( 6 % ) of the control group could not tolerate ferrous sulfate , 18 ( 30 % ) complained of disturbing gastrointestinal symptoms and 18 ( 30 % ) had poor compliance . CONCLUSION We conclude that ISC is safe and effective in the treatment of iron deficiency anemia during pregnancy BACKGROUND Intravenous ( i.v . ) ascorbic acid ( AA ) improves anaemia in iron-overloaded , erythropoietin ( rEPO ) hyporesponsive haemodialysis patients . While oral AA is readily attainable , the efficacy and safety of oral versus i.v . AA has not been examined . METHODS We conducted an open-label r and omised parallel study on the effects of 8 weeks of 250 mg oral AA ( n=10 ) compared with 250 mg i.v . AA ( n=11 ) 3x/week on haemoglobin ( Hb ) , ferritin and rEPO dose in 21 iron-overloaded haemodialysis patients . We also examined the effect of 3 months of 500 mg oral AA 3x/week ( n=70 ) compared with no treatment ( n=83 ) on Hb , ferritin and rEPO dose in 153 haemodialysis patients . RESULTS Patients had severe AA deficiency ( mean 2.2+/-SE 0.4 mg/L ; normal range , 4.0 - 14.0 ) . Following treatment , the plasma AA level increased ( P<0.001 ) , but was not significantly different between the groups . There was no change in Hb , iron availability and rEPO dose with oral or i.v . AA . There was a significant increase in serum oxalate but no significant changes in left ventricular function or renal calculi formation . In the second study , oral AA had no effect on Hb , rEPO dose and ferritin in the whole group and a subgroup of 30 with anaemia . CONCLUSION Haemoglobin and iron availability did not improve following oral or i.v . AA in this select small group of iron-overloaded haemodialysis patients or in a larger population of haemodialysis patients given oral AA at a higher dose and for a longer duration . AA supplementation may still be warranted in view of severe AA deficiency in haemodialysis patients BACKGROUND Anaemia and iron deficiency are very common in inflammatory bowel disease . Clinical trials have shown intravenous iron to be effective and well tolerated . However , published experience in clinical practice with specific evaluation of the effect on quality of life is limited . MATERIAL AND METHODS We carried out a prospect i ve , multicentre , observational study on the effects of ferric carboxymaltose in the treatment of iron deficiency anaemia in inflammatory bowel disease . Anaemia and iron deficiency were defined according to World Health Organization criteria . Efficacy and safety were evaluated at infusion , at 2 weeks and at 12 weeks . Quality of life was evaluated according to the SIBDQ-9 index . Complete response was defined as anaemia correction or more tan 2 g/dL increase in haemoglobin . RESULTS A total of 88 courses of ferric carboxymaltose in 72 patients were evaluated . Complete response was observed in 46 % of patients at week 2 , and 81.2 % at week 12 . Quality of life improved significatively at week 2 in both complete responders and partial responders ( p<0.0005 ) ; complete responders showed siginficantly better response ( p=0.016 ) . No predictive factor was identified . Only one transient adverse effect was observed ; however , this was severe . DISCUSSION Ferric carboxymaltose showed comparable efficacy to that demonstrated in clinical trials . After only two weeks of treatment , there was a significant improvement in quality of life , with a greater effect observed in those patients with a complete haematologic response . Intravenous iron can very quickly improve quality of life in inflammatory bowel disease A prospect i ve , controlled , double-blind , double-dummy , multicenter clinical trial was made to assess the efficacy and tolerability of iron-protein-succinylate ( ITF 282 ) in comparison with a well known iron preparation in the treatment of iron deficiency or iron deficient anemia . One thous and and ninety-five patients affected with iron deficiency or overt iron deficient anemia were r and omized to receive either two ITF 282 tablets/day ( 60 mg iron each ) or a commercially available ferrous sulphate controlled release tablet ( one tablet containing 105 mg iron/day ) . Five hundred and forty-nine patients received ITF 282 ; 546 patients were treated with ferrous sulphate . Both treatments lasted 60 days . The treatment outcome was checked by evaluating special hematology , symptomatology , safety hematology and hematochemistry . After two months of treatment , the normalization of the main hematologic parameters in both groups was detected . Although in the first month the reference treatment appears to provide somewhat faster results , at the end of the observation , the values of hematocrit , hemoglobin and ferritin were greater in the ITF 282 group , indicating a more progressive and steady therapeutic effect . The overall clinical rating was significantly in favor of ITF 282 , with 78.9 % of favorable results vs 67.6 % . By dividing the patient population according to pathological conditions ( iron deficiency or overt anemia ) , or according to the etiopathogenesis of the iron deficiency ( increased requirement , or increased loss in adults and in the elderly ) , separate analyses on the treatment outcome were made ( and have been included ) . The general tolerability , although favorable with both treatments , was significantly more favorable with ITF 282 . With this medication , 63 patients ( 11.5 % ) complained of 69 adverse reactions ( 25 heartburn , 19 constipation , 25 abdominal pain ) vs 141 events reported by 127 patients ( 26.3 % ) with the reference medication ( 33 heartburn , 31 epigastric pain , 23 constipation , 32 abdominal pain , 8 skin rash , 14 nausea ) . These observations confirm that , although the most modern preparations of ferrous sulphate exhibit a relatively low frequency of adverse events of limited clinical concern , it is nevertheless possible to decrease both the prevalence and the duration of such events without prejudice for the clinical efficacy , with the use of more " physiological " preparations in which the iron is reversibly bound to a protein carrier , thus effectively removing one of the main obstacles to the correct compliance with treatments that must be administered for prolonged periods of time OBJECTIVE : The aim of this study was to compare the efficacy of intravenous iron to oral iron in the treatment of anemia in pregnancy . METHODS : In this r and omized open-label study , 90 women with hemoglobin levels between 8 and 10.5 g/dL and ferritin values less than 13 & mgr;g/L received either oral iron polymaltose complex ( 300 mg elemental iron per day ) or intravenous iron sucrose . The iron sucrose dose was calculated from the following formula : weight before pregnancy ( kg ) × ( 110 g/L – actual hemoglobin [ g/L ] ) × 0.24 + 500 mg . Treatment efficacy was assessed by measuring hemoglobin and ferritin on the 14th and 28th days and at delivery , and the hemoglobin on the first postpartum day . Adverse drug reactions , fetal weight , hospitalization time , and blood transfusions were also recorded . RESULTS : Hemoglobin values varied significantly with time between groups ( interaction effect , P < .001 ) . The change in hemoglobin from baseline was significantly higher in the intravenous group than the oral group at each measurement ; the changes with respect to subsequent hemoglobin were significantly higher on the 14th ( P = .004 ) and 28th ( P = .031 ) days . Ferritin values were higher in patients receiving intravenous iron throughout pregnancy . No serious adverse drug reactions were observed . Fetal weight and hospitalization time were similar in the 2 groups . Blood transfusion was required for only one patient in the oral group . CONCLUSION : Intravenous iron treated iron-deficiency anemia of pregnancy and restored iron stores faster and more effectively than oral iron , with no serious adverse reactions . LEVEL OF EVIDENCE : OBJECTIVE The aim of this study was to compare intravenous iron sucrose versus oral iron sulfate in anemia at 6 months of pregnancy . STUDY DESIGN A r and om , prospect i ve , open study with individual benefit was performed involving 50 patients with hemoglobin levels between 8 and 10 g/dL and a ferritin value of < 50 microg/L. In the intravenous group ( IV group ) , the iron dose was calculated from the following formula : Weight before pregnancy ( kg ) x ( 120 g/L - Actual hemoglobin [ g/L ] ) x 0.24 + 500 mg . The oral group ( PO group ) received 240 mg of iron sulfate per day for 4 weeks . Treatment efficacy was assessed by measurement of hemoglobin and reticulocytes on days 8 , 15 , 21 , and 30 and at delivery and of ferritin on day 30 and at delivery . The baby 's birth weight and iron stores were noted . Results were expressed as median + /- interquartile range . Mann-Whitney and Wilcoxon tests were used for the analysis , with P < .05 considered significant . RESULTS An increase in hemoglobin was observed , rising from 9.6 + /- 0.79 g/dL to 11.11 + /- 1.3 g/dL on day 30 in the IV group and from 9.7 + /- 0.5 g/dL to 11 + /- 1.25 g/dL on day 30 in the PO group ( not significant ) . On day 30 ( P < .0001 ) and at delivery ( P = .01 ) ferritin was higher in the IV group . A mean higher birth weight of 250 g was noted in the IV group ( not significant ) . CONCLUSION Iron sucrose appears to be a treatment without serious side effects indicated in correction of pregnancy anemia or iron stores depletion OBJECTIVE To explore the safety and efficacy of intravenous iron sucrose in maintenance dialysis and to establish the optimal administration frequency and dose . METHODS One hundred and ninety-four patients on maintenance dialysis with the hemoglobin ( Hb ) level of 60 - 100 g/L and hematocrit ( Hct ) of 18 % - 30 % were r and omly divided into 2 sex , age , duration of dialysis , weekly erythropoietin dosage , and hematological parameters-matched groups : intravenous iron sucrose group ( n = 102 ) and oral medication group ( n = 92 ) . The intravenous iron sucrose group were sub-divided into 2 subgroups : ( 1 )  hemodialysis  ( HD ) subgroup receiving intravenous iron sucrose 200 mg once a week for 4 weeks and then 100 mg once a week for a further 8 weeks , and ( 2 )  peritoneal dialysis ( PD ) subgroup receiving intravenous iron sucrose 200 mg once a week for 4 weeks and then 200 mg once every other week for a further 8 weeks . The oral medication group received ferrous succinate 200 mg tid for 12 weeks . The levels of serum ferritin ( SF ) , transferrin saturation ( TSAT ) , Hb , and Hct were examined before treatment and 4 , 8 , and 12 weeks after treatment . RESULTS ( 1 ) Compared with baseline levels , the levels of Hb , Hct , SF , and TSAT significantly increased 2 weeks after treatment in the intravenous iron sucrose group , and 4 weeks after treatment in the oral medication group ( all P < 0.05 ) . ( 2 ) The Hb , Hct , SF , and TSAT levels 4 , 6 , 8 , and 12 weeks after treatment of the 2 intravenous iron sucrose subgroups were all significantly higher than those of the oral medication group ( all P < 0.05 ) . ( 3 ) The Hb , Hct , SF , and TSAT levels 12 weeks after treatment 6 , 8 , and 12 weeks after treatment were not significantly different from those 4 weeks after treatment in the intravenous iron sucrose group ( all P > 0.05 ) . ( 4 ) The response rate of the intravenous iron sucrose group was 95.09 % , significantly higher than that of the oral medication group ( 55.44 % , P < 0.05 ) . ( 5 ) The mean EPO doses 6 , 8 and 12 weeks after treatment of the intravenous iron sucrose group were significantly lower than that before treatment and those of the oral medication group ( all P < 0.05 ) . ( 6 ) The Hb , Hct , SF , and TSAT levels maintained stable during the period 6 , 8 , and 12 weeks after treatment in the intravenous iron sucrose group despite the decrease in dose and frequency . ( 7 ) The Hb , Hct , SF , and TSAT levels were significantly higher in the intravenous PD subgroup than in the intravenous HD subgroup . ( 8) No adverse event was found in the intravenous iron sucrose group , and adverse gastrointestinal effects occurred in 12 patients of the oral medication group . ( 9 ) After 12 weeks , the cost of EPO + intravenous iron sucrose was significantly higher than that of EPO + ferrous succinate . CONCLUSION Intravenous iron sucrose effectively increases the serum iron parameters and hemoglobin levels during maintenance peritoneal dialysis and is well tolerated . Infusing intravenous iron sucrose 200 mg every two weeks can maintain the serum iron parameters and hemoglobin level in maintenance peritoneal dialysis patients and n permits reduction of the required dose of EPO . However , the total cost of intravenous iron treatment is relatively high Background Intravenous iron has been suggested as a safe and effective treatment of anemia complicating inflammatory bowel disease ( IBD ) .  Low molecular weight ( LMW ) iron dextran has the ability to administer the patient ’s total iron requirement in a single infusion . Aims The aim of this study was to assess the safety and efficacy of the total dose of LMW iron dextran infusion for the treatment of iron deficiency in IBD . Methods Fifty IBD patients ( 27 female , 35 Crohn ’s disease , 15 ulcerative colitis ) were included in the study . Mean ± st and ard deviation ( SD ) hemoglobin and ferritin levels before the infusion were 9.88 ± 1.42 g/dl and 13.9 ± 10.9 ng/ml , respectively . A 25-mg test dose was followed by infusion of the total dose of LMW iron dextran based on the iron deficit . Several clinical and laboratory parameters were measured before and on week 4 after infusion . Results Four patients ( 8 % ) developed adverse reactions during the test infusion and did not receive the total-dose infusion . Only one patient developed an allergic reaction during the total-dose infusion . In the remaining 45 patients , the mean ± SD iron dose that was given was 1,075 ± 269 mg . The mean ± SD elevation of hematocrit and hemoglobin on week 4 was 4.9 ± 1.9 % and 1.7 ± 0.8 g/dl , respectively . Hematopoietic response was observed in 23 of 45 patients ( 51.1 % ) . Conclusion Total parenteral iron replacement with LMW iron dextran is an easy , safe , and effective alternative method for treating iron deficiency anemia in IBD . Harmless adverse reactions may develop in a minority of patients Background : Iron deficiency anemia ( IDA ) is frequently seen in inflammatory bowel disease . Traditionally , oral iron supplementation is linked to extensive gastrointestinal side effects and possible disease exacerbation . This multicenter phase-3 study tested the efficacy and safety of ferric maltol , a complex of ferric ( Fe3 + ) iron with maltol ( 3-hydroxy-2-methyl-4-pyrone ) , as a novel oral iron therapy for IDA . Methods : Adult patients with quiescent or mild-to-moderate ulcerative colitis or Crohn 's disease , mild-to-moderate IDA ( 9.5–12.0 g/dL and 9.5–13.0 g/dL in females and males , respectively ) , and documented failure on previous oral ferrous products received oral ferric maltol capsules ( 30 mg twice a day ) or identical placebo for 12 weeks according to a r and omized , double-blind , placebo-controlled study design . The primary efficacy endpoint was change in hemoglobin ( Hb ) from baseline to week 12 . Safety and tolerability were assessed . Results : Of 329 patients screened , 128 received r and omized therapy ( 64 ferric maltol-treated and 64 placebo-treated patients ) and comprised the intent-to-treat efficacy analysis : 55  ferric maltol patients ( 86 % ) and 53 placebo patients ( 83 % ) completed the trial . Significant improvements in Hb were observed with ferric maltol versus placebo at weeks 4 , 8 , and 12 : mean ( SE ) 1.04 ( 0.11 ) g/dL , 1.76 ( 0.15 ) g/dL , and 2.25 ( 0.19 ) g/dL , respectively ( P < 0.0001 at all time-points ; analysis of covariance ) . Hb was normalized in two-thirds of patients by week 12 . The safety profile of ferric maltol was comparable with placebo , with no impact on inflammatory bowel disease severity . Conclusions : Ferric maltol provided rapid clinical ly meaningful improvements in Hb and showed a favorable safety profile , suggesting its possible use as an alternative to intravenous iron in IDA inflammatory bowel disease Abstract . Rationale : It is commonly accepted that the relative abuse liability of drugs is positively related to the rate of delivery to the central nervous system ; however , few controlled studies have tested this hypothesis in humans . Objectives : The aims of this study were to evaluate systematic ally the effects of modifying intravenous infusion speed on the pharmacodynamic responses related to abuse liability and toxicity of intravenous cocaine and hydromorphone . Methods : Twelve experienced opiate and cocaine users completed this 3-week inpatient study . After completing a safety session , participants were tested on 9 separate test days with intravenous cocaine ( 30 mg/70 kg ) , hydromorphone ( 3 mg/70 kg ) , and placebo , each administered under double-blind and r and omized conditions at infusion rates of 2 , 15 , and 60 s. Dependent outcome measures included a range of physiological , subjective , and observer-rated measures , and continuous electrocardiographic monitoring was conducted for safety monitoring . Results : Subjective responses to cocaine ( for example , " high , " " liking " ) were significantly greater when cocaine was infused more rapidly . Physiological responses to cocaine were largely unaltered with no evidence of increased toxicity with faster infusion speeds . None of the effects of hydromorphone were altered by varying the speed of infusion . Conclusions : This study provides empirical evidence for the commonly accepted belief that the abuse liability of cocaine can be enhanced by increasing the rate of the intravenous infusion ; this principal may not hold true for opioids but further work would be required to rule this out . The data also indicate that moderate doses of cocaine can be administered over a range of infusion speeds commonly used in experimental setting s without appreciably altering the apparent medical risks OBJECTIVE The objective of the study was to evaluate the efficacy , safety , and tolerability of intravenous ferric carboxymaltose , compared with oral ferrous sulfate in women with postpartum anemia . STUDY DESIGN In a multicenter , r and omized , controlled study , 291 women less than 10 days after delivery with hemoglobin 10 g/dL or less were r and omized to receive ferric carboxymaltose ( n = 143 ) 1000 mg or less intravenously over 15 minutes or less , repeated weekly to a calculated replacement dose ( maximum 2500 mg ) or ferrous sulfate ( n = 148 ) 325 mg orally thrice daily for 6 weeks . RESULTS Ferric carboxymaltose-treated subjects were significantly more likely to : ( 1 ) achieve a hemoglobin greater than 12 g/dL in a shorter time period with a sustained hemoglobin greater than 12 g/dL at day 42 , ( 2 ) achieve hemoglobin rise 3 g/dL or greater more quickly , and ( 3 ) attain higher serum transferrin saturation and ferritin levels . Drug-related adverse events occurred less frequently with ferric carboxymaltose . CONCLUSION Intravenous ferric carboxymaltose was safe and well tolerated with an efficacy superior to oral ferrous sulfate in the treatment of postpartum iron deficiency anemia Aims Therapy with i.v . iron in patients with chronic heart failure ( CHF ) and iron deficiency ( ID ) improves symptoms , functional capacity , and quality of life . We sought to investigate whether these beneficial outcomes are independent of anaemia . Methods and results FAIR-HF r and omized 459 patients with CHF [ NYHA class II or III , LVEF ≤40 % ( NYHA II ) or ≤45 % ( NYHA III ) ] and ID to i.v . iron as ferric carboxymaltose ( FCM ) or placebo in a 2:1 ratio . We analysed the efficacy and safety according to the presence or absence of anaemia ( haemoglobin ≤120 g/L ) at baseline . Of 459 patients , 232 had anaemia at baseline ( 51 % ) . The effect of FCM on the primary endpoints of self-reported Patient Global Assessment ( PGA ) and NYHA class at week 24 was similar in patients with and without anaemia [ odds ratio ( OR ) for improvement , 2.48 vs. 2.60 , P = 0.97 for PGA and 1.90 vs. 3.39 , P = 0.51 for NYHA ) . Results were also similar for the secondary endpoints , including PGA and NYHA at weeks 4 and 12 , 6 min walk test distance , Kansas City Cardiomyopathy Question naire overall score , and European Quality of Life-5 Dimensions Visual Analogue Scale at most time points . Regarding safety , no differences were noticed in the rates of death or first hospitalization  between FCM and placebo both in anaemic and in non-anaemic patients . Conclusions Treatment of ID with FCM in patients with CHF is equally efficacious and shows a similar favourable safety profile irrespective of anaemia . Iron status should be assessed in symptomatic CHF patients both with and without anaemia and treatment of ID should be considered BACKGROUND Parenteral iron is often required by hemodialysis patients to maintain adequate iron stores . Until recently , the only available form of intravenous iron was iron dextran , which is associated with significant adverse reactions , including anaphylaxis and death . Sodium ferric gluconate complex ( SFGC ) was recently approved for use in the U.S. under FDA 's priority drug review . This Phase IV study was design ed to evaluate the safety of a single dose of intravenous SFGC as compared to placebo and a historical iron dextran control . METHODS This multicenter , crossover , r and omized , double blind , placebo-controlled prospect i ve comparative study was performed in hemodialysis patients requiring at least 125 mg of elemental iron . The historical control was obtained from a meta- analysis of four publications examining outcomes in patients exposed to iron dextran . SFGC naïve patients were administered SFGC without a test dose , undiluted , at a rate of 125 mg over 10 minutes , and compared to placebo comprising bacteriostatic saline . RESULTS A total of 2534 patients were enrolled . The incidence of drug intolerance ( an adverse event precluding re-exposure ) was significantly less [ 0.44 % , confidence interval ( CI ) 0.21 to 0.71 % ] after SFGC as compared to the iron dextran control ( 2.47 % , CI 1.87 to 3.07 % , P < 0.0001 ) , but higher than after placebo ( 0.1 % , P = 0.02 ) . There was no difference found between SFGC and placebo in serious adverse events . A single life-threatening event occurred after SFGC ( 0.04 % , CI 0.00 to 0.22 % ) , which was significantly less than following iron dextran ( 0.61 % , CI 0.36 to 0.86 % ) , P = 0.0001 . CONCLUSION SFGC is well tolerated when given by intravenous push without a test dose . SFGC has a significantly lower incidence of drug intolerance and life-threatening events as compared to previous studies using iron dextran . The routine use of iron dextran in hemodialysis patients should be discontinued The treatment of anemia in hemodialysis patients is frequently hindered by the presence of suboptimal iron stores . Intravenous iron dextran is in common use to maintain iron stores in this population , but there are little published data regarding the incidence and type of adverse events . The purpose of this study was to evaluate the safety of this medication . Charts from four hemodialysis centers of all 573 patients treated with intravenous iron dextran ( INFeD ; Schein Pharmaceutical , Inc , Florham Park , NJ ) between July 1 , 1993 , and June 30 , 1995 , were studied . Twenty-seven patients ( 4.7 % ) had adverse reactions that were related to iron dextran . Four patients ( 0.7 % ) had reactions classified as serious ( one cardiac arrest ; three others required hospitalization ) . Ten patients ( 1.7 % ) had reactions classified as anaphylactoid . No patients died or developed permanent disability as a result of reactions . The most common adverse reactions included itching ( 1.5 % of patients ) and dyspnea or wheezing ( 1.5 % ) ; others included chest pain ( 1.0 % ) , nausea ( 0.5 % ) , hypotension ( 0.5 % ) , swelling ( 0.5 % ) , dyspepsia ( 0.5 % ) , diarrhea ( 0.5 % ) , skin flushing ( 0.3 % ) , headache ( 0.3 % ) , cardiac arrest ( 0.2 % ) , and myalgias ( 0.2 % ) . Five of all the reactions occurred during a test dose ; four of these were anaphylactoid . Several factors were studied as possible predictors of adverse reactions . A positive history of drug allergy ( odds ratio , 2.4 ; P = 0.03 ) and history of multiple drug allergy ( odds ratio , 5.5 ; P = 0.0004 ) were significant predictors of reactions . In summary , we found serious adverse reactions to be uncommon in hemodialysis patients treated with intravenous iron dextran .  Future prospect i ve studies will help confirm this finding Few data exist to guide treatment of anemic hemodialysis patients with high ferritin and low transferrin saturation ( TSAT ) . The Dialysis Patients ' Response to IV Iron with Elevated Ferritin ( DRIVE ) trial was design ed to evaluate the efficacy of intravenous ferric gluconate in such patients . Inclusion criteria were hemoglobin < or=11 g/dl , ferritin 500 to 1200 ng/ml , TSAT < or=25 % , and epoetin dosage > or=225 IU/kg per wk or > or=22,500 IU/wk . Patients with known infections or recent significant blood loss were excluded . Participants ( n=134 ) were r and omly assigned to no iron ( control ) or to ferric gluconate 125 mg intravenously with eight consecutive hemodialysis sessions ( intravenous iron ) . At r and omization , epoetin was increased 25 % in both groups ; further dosage changes were prohibited . At 6 wk , hemoglobin increased significantly more ( P=0.028 ) in the intravenous iron group ( 1.6 + /- 1.3 g/dl ) than in the control group ( 1.1 + /- 1.4 g/dl ) . Hemoglobin response occurred faster ( P=0.035 ) and more patients responded after intravenous iron than in the control group ( P=0.041 ) . Ferritin < or=800 or > 800 ng/ml had no relationship to the magnitude or likelihood of responsiveness to intravenous iron relative to the control group . Similarly , the superiority of intravenous iron compared with no iron was similar whether baseline TSAT was above or below the study median of 19 % . Ferritin decreased in control subjects ( -174 + /- 225 ng/ml ) and increased after intravenous iron ( 173 + /- 272 ng/ml ; P<0.001 ) . Intravenous iron result ed in a greater increase in TSAT than in control subjects ( 7.5 + /- 7.4 versus 1.8 + /- 5.2 % ; P<0.001 ) . Reticulocyte hemoglobin content fell only in control subjects , suggesting worsening iron deficiency . Administration of ferric gluconate ( 125 mg for eight treatments ) is superior to no iron therapy in anemic dialysis patients receiving adequate epoetin dosages and have a ferritin 500 to 1200 ng/ml and TSAT < or=25 % OBJECTIVE Postpartum iron deficiency anaemia ( IDA ) is common in women . Most women are treated with either oral iron supplementation or blood transfusion . Hence , the aim of our study was to compare the effect of treatment with either oral ferrous sulphate or intravenous ferrous sucrose on postpartum IDA . DESIGN A single centre , prospect i ve r and omised controlled trial . SETTING Women 's Centre , John Radcliffe Hospital , Oxford , UK . POPULATION Forty-four women with haemoglobin ( Hb ) of < 9 g/dl and ferritin of < 15 microgram/l at 24 - 48 hours postdelivery . METHODS Women were r and omised to receive either oral ferrous sulphate 200 mg twice daily for 6 weeks ( group O ) or intravenous ferrous sucrose 200 mg ( Venofer ; Vifor International Ltd , St Gallen , Switzerl and ) , two doses given on days 2 and 4 following recruitment ( group I ) . RESULTS were analysed by the Students t-test , chi-square test and analysis of variance . MAIN OUTCOME MEASURES Hb , haematocrit , red cell indices , ferritin and serum iron levels were measured on days 0 , 5 , 14 and 40 . Results By day 5 , the Hb level in women treated with intravenous iron had risen from 7.3 + /- 0.9 to 9.9 + /- 0.7 g/dl , while there was no change in those treated with oral iron . Women treated with intravenous iron had significantly higher Hb levels on days 5 and 14 ( P < 0.01 ) than those treated with oral iron ; although by day 40 , there was no significant difference between the two groups . Throughout the study , ferritin levels rose rapidly in those treated with intravenous iron and remained significantly higher than in those treated with oral iron ( P < 0.01 ) . CONCLUSIONS Intravenous iron sucrose increases the Hb level more rapidly than oral ferrous sulphate in women with postpartum IDA . It also appears to replenish iron stores more rapidly . However , this study was not large enough to address the safety of this strategy BACKGROUND Anemia is a common finding in heart failure ( HF ) patients and has been associated with increased morbidity and mortality . It is generally denominated as anemia of chronic disease ( ACD ) , but the association with true ferropenic anemia is common . Many studies have investigated the effects of treating anemia in HF patients with either erythropoietin alone or combination of erythropoietin and intravenous iron . However , the effect of iron supplementation alone in HF patients with ACD , ferropenic anemia , or both is unknown . METHODS AND RESULTS IRON-HF study is a multicenter , investigator initiated , r and omized , double-blind , placebo controlled trial that will enroll anemic HF patients with relatively preserved renal function , low transferrin saturation , low iron levels , and low to moderately elevated ferritin levels . Interventions are iron sucrose intravenously 200 mg once per week for 5 weeks , ferrous sulfate 200 mg by mouth 3 times per day for 8 weeks , or placebo . The primary objective is to assess the impact of iron supplementation  ( intravenously or by mouth ) compared with placebo in HF patients with anemia from deficient iron availability . The primary end point is variation of peak oxygen consumption assessed by ergospirometry over 3-month follow-up . Secondary end points include functional class , brain natriuretic peptide levels , quality of life scores , left ventricular ejection fraction , adverse events , HF hospitalization , and death . CONCLUSIONS The results of IRON-HF should help to clarify the potential clinical impact of mild to moderate anemia correction in HF patients A total of 502 children up to the age of 14 years were treated for iron deficiency or overt anemia .  ITF 282 was prescribed to 256 children , and a commercially available ferrous polystyrene sulphonate preparation to 246 , in a r and omized double-blind , double-dummy , ten-center trial . One oral vial of ITF 282 ( 60 mg iron ) was administered once a day to children weighing up to 40 kg ; and twice a day to children with body weight equal or superior to 40 kg . In the reference group , oral vials of polystyrene sulphonate ( 52.5 mg iron ) were administered once a day to children weighing up to 40 kg , and twice a day to children weighing 40 kg or more . Treatments lasted 60 days . The treatments ' efficacy and tolerability were evaluated taking into consideration : special hematology , symptomatology , safety hematology and hematochemistry , urinalysis . At the end of treatment , the trend was detected to the normalization of the main hematologic parameters in both groups ( hemoglobin , hematocrit , ferritin , blood iron , transferrin saturation , MCHC ) . Although in the first month the reference treatment appears to provide somewhat faster results , significantly greater values of blood iron are observed at the end of the observation in the ITF 282 group , indicating a more progressive and steady therapeutic effect . The overall clinical rating was , although not significant , in favor of ITF 282 , with a failure rate of 18.0 vs 24.0 % . The general tolerance , although favorable with both treatments , was significantly more favorable with ITF 282 . With this medication , 13 patients complained of 13 events ( 1 heartburn , 6 constipation , 6 abdominal pain ) vs 48 events reported by 43 patients with the reference medication ( 1 heartburn , 2 epigastric pain , 14 constipation , 14 abdominal pain , 3 skin rash , 14 vomiting ) . These observations confirm that , although the most modern preparations of ferrous ions exhibit a relatively low frequency of adverse events of limited clinical concern , it is nevertheless possible to decrease ( with the use of more " physiologic " preparations in which the iron is reversibly bound to a protein carrier ) the prevalence and , tendentially , duration and intensity of such events without prejudice for the clinical efficacy . Therefore , the good clinical tolerability of ITF 282 effectively removed one of the main obstacles to the correct compliance with iron treatments ( necessarily to be taken long-term ) , as reduced the risks of undesired events in a particularly susceptible population subgroup , such as children BACKGROUND The efficacy of iron polymaltose complex ( IPC ) in the treatment of iron deficiency anemia ( IDA ) during pregnancy has not been well established , and the evidence is inconclusive . AIMS The aim of the study was to compare efficacy , safety , compliance , and cost-effectiveness of IPC with ferrous sulphate ( FS ) in pregnant patients . SETTING S AND DESIGN S The r and omized , double-blind , parallel-group study was conducted in the Department of Pharmacology in collaboration with the Department of Obstetrics and Gynaecology Postgraduate Institute of Medical Education and Research , Ch and igarh , India . METHODS One hundred pregnant women aged 20 - 40 years at 14 to 27 weeks ' gestation , with hemoglobin ( Hb ) < 9 g/dL , and serum ferritin < 12 mcg/L , were classified into 2 groups . One group received IPC ( 100 mg elemental iron ) , and the other group received FS ( 120 mg elemental iron ) daily for 8 weeks . At Week 0 and Week 8 , Hb , packed cell volume ( PCV ) , mean corpuscular volume ( MCV ) , mean corpuscular hemoglobin ( MCH ) , mean corpuscular hemoglobin concentration ( MCHC ) , serum iron , and serum ferritin were measured . Compliance with study medication was determined by pill counting at each visit . Cost minimization analysis was done to compare the costs of the 2 treatments . STATISTICAL ANALYSIS Data are expressed as mean -/+ SD . Paired and unpaired ' t ' test were used to analyze differences within groups and between groups . Chi-square ( x2 ) test was used to analyze primary efficacy parameters and adverse drug reactions ( ADR ) . RESULTS Statistically significant increases in Hb , PCV , MCV , MCH , MCHC , serum iron , and serum ferritin levels were seen at the end of 8 weeks of treatment in both groups . The overall adverse effects were more common in the FS group compared with the IPC group [ 41 ( 78 % ) vs 15 ( 31 % ) , P < .001 ] . The compliance rate was significantly ( P < .05 ) higher for the IPC ( 91 % ) group than for the FS ( 87 % ) group . The average total cost ( direct + indirect ) of treatment of anemia was comparable between the 2 groups . CONCLUSION The results of the present study suggest that IPC can be considered as a useful alternative formulation for the treatment of IDA during pregnancy for those patients who can not tolerate other iron preparations ( ferrous form ) ; this is an important finding , as compliance is a significant concern during pregnancy OBJECTIVE : To estimate efficacy of rapid , large-dose intravenous ( IV ) administration of ferric carboxymaltose compared with oral iron therapy in anemic postpartum women . METHODS : In a r and omized , controlled trial , we assigned anemic women ( hemoglobin [ Hb ] less than or equal to 10 g/dL ) within 10 days postpartum to receive either IV ferric carboxymaltose ( less than or equal to1,000 mg over 15 minutes , repeated weekly to achieve a total calculated replacement dose ) or ferrous sulfate ( FeSO4 ) 325 mg orally thrice daily for 6 weeks . RESULTS : One hundred seventy-four patients received 350 IV doses of ferric carboxymaltose ( mean total dose 1,403.1 mg ) in 3 , 2 , or 1 injection ( 10.9 % , 79.3 % , or 9.8 % of patients , respectively ) ; 178 received FeSO4 . Patients assigned to IV ferric carboxymaltose compared with those assigned to oral iron achieved a Hb rise greater than or equal to 2.0 g/dL earlier ( 7.0 compared with 14.0 days , P<.001 ) , were more likely to achieve a Hb rise greater than or equal to 3.0 g/dL at any time ( 86.3 % compared with 60.4 % , P<.001 ) , and were more likely to achieve a Hb greater than 12.0 g/dL ( 90.5 % compared with 68.6 % , P<.001 ) . A similar proportion of patients achieved a Hb rise greater than or equal to 2.0 g/dL ( 96.4 % compared with 94.1 % , IV compared with oral , P=.443 ) . There were no serious adverse drug reactions . CONCLUSION : Large-dose IV ferric carboxymaltose administration is a new iron agent that is effective for the treatment of postpartum anemia . When compared with oral ferrous sulfate , IV ferric carboxymaltose is better tolerated , prompts a more rapid Hb response , and corrects anemia more reliably . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00396292 LEVEL OF EVIDENCE : BACKGROUND & AIMS Iron deficiency anemia ( IDA ) is common in chronic diseases and intravenous iron is an effective and recommended treatment . However , dose calculations and inconvenient administration may affect compliance and efficacy . We compared the efficacy and safety of a novel fixed-dose ferric carboxymaltose regimen ( FCM ) with individually calculated iron sucrose ( IS ) doses in patients with inflammatory bowel disease ( IBD ) and IDA . METHODS This r and omized , controlled , open-label , multicenter study included 485 patients with IDA ( ferritin < 100 μg/L , hemoglobin [ Hb ] 7 - 12 g/dL [ female ] or 7 - 13 g/dL [ male ] ) and mild-to-moderate or quiescent IBD at 88 hospitals and clinics in 14 countries . Patients received either FCM in a maximum of 3 infusions of 1000 or 500 mg iron , or Ganzoni-calculated IS dosages in up to 11 infusions of 200 mg iron . Primary end point was Hb response ( Hb increase ≥ 2 g/dL ) ; secondary end points included anemia resolution and iron status normalization by week 12 . RESULTS The results of 240  FCM-treated and 235 IS-treated patients were analyzed . More patients with FCM than IS achieved Hb response ( 150 [ 65.8 % ] vs 118 [ 53.6 % ] ; 12.2 % difference , P = .004 ) or Hb normalization ( 166 [ 72.8 % ] vs 136 [ 61.8 % ] ; 11.0 % difference , P = .015 ) . Both treatments improved quality of life scores by week 12 . Study drugs were well tolerated and drug-related adverse events were in line with drug-specific clinical experience . Deviations from scheduled total iron dosages were more frequent in the IS group . CONCLUSIONS The simpler FCM-based dosing regimen showed better efficacy and compliance , as well as a good safety profile , compared with the Ganzoni-calculated IS dose regimen We evaluated the safety and efficacy of a multimodal approach for prophylaxis of thromboembolism after total hip arthroplasty , which includes preoperative discontinuation of procoagulant medication ; autologous blood donation ; hypotensive epidural anesthesia ; intravenous administration of heparin during surgery and before femoral preparation ; aspiration of intramedullary contents ; pneumatic compression ; knee-high elastic stockings ; and early mobilization and chemoprophylaxis for 4 to 6 weeks ( aspirin 83 % ; warfarin 17 % ) . One thous and nine hundred forty-seven consecutive , nonselected patients ( 2032 total hip arthroplasties ) who received this multimodal prophylaxis were observed prospect ively for 3 months . The incidence of asymptomatic deep vein thrombosis assessed by ultrasound in the first 171 patients was 6.4 % . The incidence of clinical deep vein thrombosis in the subsequent 1776 patients was 2.5 % . Symptomatic pulmonary embolism occurred in 0.6 % ( 12 of 1947 ; nine in patients receiving aspirin and three in patients receiving Coumadin ) , none of them fatal . One patient died of a myocardial infa rct . This multimodal approach is safe and efficacious and compares favorably with those reported in the literature and with our historic controls . If these preventive measures are strictly observed during the perioperative period , postoperative chemoprophylaxis does not need to be aggressive in the patient without predisposing factors . Our low rate of deep vein thrombosis and pulmonary embolism do not support routine anticoagulation prophylaxis with drugs that increase risk of bleeding . Level of Evidence : Therapeutic study , Level IV ( case series ) . See the Guidelines for Authors for a complete description of levels of evidence Despite efforts to improve iron supplements for iron deficiency anemia , there is no consensus on products that balance efficacy , safety and tolerability , and cost . Ferrous products are effective , but they are associated with more gastrointestinal side effects than ferric products . Ferric products tend to have lower absorption . We present results from a 12-week study that ran domized 72 people with uncomplicated iron deficiency anemia to receive a ferrous iron supplement ( Ferall , a combination of ferrous fumarate with ascorbic acid , folic acid , and cyanocobalamin ) or a ferric iron polysaccharide complex ( Niferex , ferro-glycine sulfate ) plus ascorbic acid . The ferrous product was significantly more effective , the primary and secondary endpoints including changes in levels of hemoglobin and serum ferritin . There was a slightly higher frequency of gastrointestinal side effects in patients taking the ferrous product , but both supplements were well tolerated . No participant withdrew from the study because of side effects . We concluded that the ferrous product is safe and effective for use in uncomplicated iron deficiency anemia . The lack of direct comparison between single-agent ferrous fumarate and the combination ferrous product limited interpretation of results in terms of possible effects due to other components , such as ascorbic acid Branched chain amino acids ( BCAA ) improve nitrogen balance and end-organ function in surgical patients , but are untested in marrow transplant recipients . We compared nitrogen balance , urinary 3-methylhistidine-to-creatinine ratio , upper arm anthropometry , serum prealbumin , and day to peripheral engraftment in a r and omized , double-blinded trial between  45 % ( high-leucine ) and 23 % BCAA intravenous solutions in 40 adult leukemia patients for 1 month following allogeneic marrow transplantation .  Nutritional support , provided at approximately 30 nonprotein calories/kg and 0.21 g nitrogen/kg ideal weight , did not differ between groups . Despite greater nitrogen loss and muscle breakdown evidence d by increased 3-methylhistidine-to-creatinine ratio and loss of arm muscle area by study end in the 45 % BCAA , no statistical differences were observed when nitrogen balance was compared by week and within stress level as defined by organ and infectious complications . It is likely the patients in the 45 % BCAA experienced greater metabolic stress by study end . Serum prealbumin and day posttransplant to peripheral engraftment also did not differ between groups . The chances ( power ) of this study exceeded 85 % in detecting a difference in nitrogen balance of 2.5 g during study week 1 and 4.0 g during week 2 . The power during week 3 was 77 % for detecting a difference of 4.0 g , and it is unlikely that the true difference exceeds this magnitude . Thus , we did not find any evidence that intravenous BCAA-enriched solutions improved nitrogen balance during the first month after marrow transplantation Although iron therapy is essential to optimize use of erythropoiesis-stimulating agents ( ESA ) , r and omized , controlled trials have heretofore been unavailable to evaluate reliably the efficacy of intravenous iron as an adjuvant to ESA treatment in peritoneal dialysis ( PD ) patients . In a multicenter trial , patients who had anemia , PD-dependent chronic kidney disease , stable ESA therapy , and a broad range of iron status ( ferritin < or = 500 ng/ml , transferrin saturation < or = 25 % ) were r and omly assigned to receive either 1 g of iron sucrose intravenously in three divided doses ( 300 mg over 1.5 h on days 1 and 15 , 400 mg over 2.5 h on day 29 ) or no supplemental iron . No serious adverse drug events occurred after intravenous iron administration . The primary end point , peak hemoglobin increase , was higher ( 1.3 + /- 1.1 versus 0.7 + /- 1.1 , mean + /- SD ; P = 0.0028 ) , and anemia intervention ( transfusion , increase in ESA dose , or intravenous iron therapy not called for in protocol ) occurred later ( P = 0.0137 ) and less often in intravenous iron-treated patients compared with untreated control subjects ( one of 66 [ 1.3 % ] versus five of 30 [ 16.7 % ] ) . Among patients who did not require intervention , iron-treated patients showed a calculated net ESA dose decrease compared with untreated control subjects . Baseline iron status did not predict responsiveness to intravenous iron therapy . Intravenous iron sucrose is an effective adjunct to ESA therapy in anemic patients with PD-dependent chronic kidney disease and is administered safely as 300 mg over 1.5 h or 400 mg over 2.5 h. Evidence of iron deficiency at baseline is not required to demonstrate intravenous iron efficacy Background and Objectives This trial explores whether intravenous iron isomaltoside 1000 ( Monofer ® ) results in a better regeneration of haemoglobin levels and prevents anaemia compared to placebo in preoperative non-anaemic patients undergoing cardiac surgery . Study Design and Methods The trial is a prospect i ve , double-blind , comparative , placebo-controlled trial of 60 non-anaemic patients undergoing cardiac surgery . The patients were r and omized 1:1 to either 1000 mg intravenous iron isomaltoside 1000 administered perioperatively by infusion or placebo . Results Mean preoperative haemoglobin in the active treatment group was 14·3 g/dl vs. 14·0 g/dl in the placebo group . At discharge 5 days after surgery , haemoglobin levels were reduced to 10·7 and 10·5 g/dl , respectively . One month after surgery , haemoglobin concentration had increased to an average of 12·6 g/dl vs. 11·8 g/dl ( p = 0·012 ) and significantly more patients were non-anaemic in the intravenous iron isomaltoside 1000-treated group compared to the placebo group ( 38·5 % vs. 8·0 % ; p = 0·019 ) . There were no differences in side-effects between the groups . Conclusion A single perioperative 1000 mg dose of intravenous iron isomaltoside 1000 significantly increased the haemoglobin level and prevented anaemia 4 weeks after surgery , with a short-term safety profile similar to placebo . Future trials on potential clinical benefits of preoperative treatment with intravenous iron in non-anaemic patients are needed BACKGROUND Ferumoxytol is a unique intravenous ( i.v . ) iron therapy . This report examines factors affecting hemoglobin response to i.v . ferumoxytol , and the relationship between hematologic parameters , concomitant erythropoiesis-stimulating agents ( ESA ) , and adverse events ( AEs ) in nondialysis CKD patients . METHODS A series of post-hoc efficacy and safety analyses were performed using pooled data from two identically design ed Phase III studies in 608 nondialysis CKD patients r and omized to receive two 510 mg i.v . injections of ferumoxytol within 5 ± 3 days versus oral iron . RESULTS Ferumoxytol result ed in a significant increase in hemoglobin in the presence and absence of ESA , and across a range of baseline hemoglobin , transferrin saturation , ferritin , and reticulocyte hemoglobin content levels . Adverse event rates  with ferumoxytol were similar across quartiles of change in hemoglobin ; there were no trends suggesting an increased rate of cardiovascular AEs with higher maximum achieved hemoglobin or faster rate of hemoglobin rise . There was no meaningful difference in the rate of AEs , serious AEs , and cardiovascular AEs between patients receiving or not receiving ESA . CONCLUSIONS These analyses add to the knowledge of predictors of response and safety outcomes associated with i.v . iron therapy in nondialysis CKD patients Ferric pyrophosphate citrate ( FPC ) is a water-soluble iron salt administered via dialysate to supply iron directly to transferrin . The PRIME study tested whether treatment with FPC could reduce prescribed erythropoiesis-stimulating agent ( ESA ) use and maintain hemoglobin in hemodialysis patients . This 9-month , r and omized , placebo-controlled , double-blind , multicenter clinical study included 103 patients undergoing hemodialysis 3–4 times weekly . The FPC group received dialysate containing 2 μmol/l of iron . The placebo group received st and ard dialysate . A blinded central anemia management group facilitated ESA dose adjustments . Intravenous iron was administered according to the approved indication when ferritin levels fell below 200 μg/l . The primary end point was the percentage change from baseline in prescribed ESA dose at end of treatment . Secondary end points included intravenous iron use and safety . At the end of treatment , there was a significant 35 % reduction in prescribed ESA dose in FPC-treated patients compared with placebo . The FPC patients used 51 % less intravenous iron  than  placebo . Adverse and serious adverse events were similar in both groups . Thus , FPC delivered via dialysate significantly reduces the prescribed ESA dose and the amount of intravenous iron needed to maintain hemoglobin in chronic hemodialysis patients BACKGROUND AND OBJECTIVES Clinical trials assessing effects of larger cumulative iron exposure with outcomes are lacking , and observational studies have been limited by assessment of short-term exposure only and /or failure to assess cause-specific mortality . The associations between short- and long-term iron exposure on all-cause and cause-specific mortality were examined . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS The study included 14,078 United States patients on dialysis initiating dialysis between 2003 and 2008 .  Intravenous iron dose accumulations over 1- , 3- , and 6-month rolling windows were related to all-cause , cardiovascular , and infection-related mortality in Cox proportional hazards models that used marginal structural modeling to control for time-dependent confounding . RESULTS Patients in the 1-month model cohort ( n=14,078 ) were followed a median of 19 months , during which there were 27.6 % all-cause deaths , 13.5 % cardiovascular deaths , and 3 % infection-related deaths . A reduced risk of all-cause mortality with receipt of > 150 - 350 ( hazard ratio , 0.78 ; 95 % confidence interval , 0.64 to 0.95 ) or > 350 mg ( hazard ratio , 0.79 ; 95 % confidence interval , 0.62 to 0.99 ) intravenous iron compared with > 0 - 150 mg over 1 month was observed . There was no relation of 1-month intravenous iron dose with cardiovascular or infection-related mortality and no relation of 3- or 6-month cumulative intravenous iron dose with all-cause or cardiovascular mortality . There was a nonstatistically significant increase in infection-related mortality with receipt of > 1050 mg intravenous iron in 3 months ( hazard ratio , 1.69 ; 95 % confidence interval , 0.87 to 3.28 ) and > 2100 mg in 6 months ( hazard ratio , 1.59 ; 95 % confidence interval , 0.73 to 3.46 ) . CONCLUSIONS Among patients on incident dialysis , receipt of ≤ 1050 mg intravenous iron in 3 months or 2100 mg in 6 months was not associated with all-cause , cardiovascular , or infection-related mortality . However , nonstatistically significant findings suggested the possibility of infection-related mortality with receipt of > 1050 mg in 3 months or > 2100 mg in 6 months . R and omized clinical trials are needed to assess the safety of exposure to greater cumulative intravenous iron doses BACKGROUND More data on the efficacy and safety of ciprofloxacin in pediatric cystic fibrosis patients are needed . METHODS One hundred eight pediatric cystic fibrosis patients ( ages 5 to 17 years ) with acute bronchopulmonary exacerbations entered a r and omized multicenter trial design ed to compare the safety and efficacy of antipseudomonas therapy with oral ciprofloxacin ( 15 mg/kg twice daily ; maximum dosage 750 mg twice daily ) or intravenous ceftazidime plus tobramycin ( CAZ/TM ) for 14 days . RESULTS Clinical improvement was observed in 93 % of patients treated with oral ciprofloxacin and in 96 % of those receiving parenteral therapy . Transient suppression of Pseudomonas aeruginosa was achieved in 63 % of patients at the end of the course of iv CAZ/TM therapy and in 24 % receiving ciprofloxacin . Ultrasound examination and nuclear magnetic resonance imaging scans showed no evidence of cartilage toxicity in any of the ciprofloxacin-treated patients . Musculoskeletal adverse events were reported with similar frequency in the two groups of patients ( 7 % in the group receiving ciprofloxacin therapy and 11 % in the IV CAZ/TM group ) . The only sustained musculoskeletal symptom was a case of synovitis in a patient receiving parenteral CAZ/TM . CONCLUSION Ciprofloxacin thus appears to be safe and effective for use in young patients with bronchopulmonary exacerbation of cystic fibrosis 1 . The relative efficacy of oral and parenteral iron administration in the prophylaxis and treatment of Fe-deficiency anaemia of pregnancy has been studied . 2 . Intravenous administration of Fe by total dose infusion of Fe dextran was not superior to oral Fe 120 mg/d , 6 d/week for 10 - 12 weeks . 3 . Intramuscular Fe dextran , 100 mg twice per week for 10 - 12 weeks , produced a significantly greater rise in mean haemoglobin concentration than oral Fe therapy . 4 . The superiority of intramuscular Fe as compared with intravenous Fe is probably related to the different h and ling of the Fe dextran by the reticulo-endothelial system . 5 . In spite of the better response to intramuscular Fe dextran , it is not recommended for public health practice because of the risks associated with its use and the much higher cost of the preparation and its delivery Introduction Iron deficiency anemia ( IDA ) is common in patients with gastrointestinal ( GI ) disorders and can adversely affect quality of life .  Oral iron is poorly tolerated in many patients with GI disorders . Ferumoxytol is approved for the intravenous treatment of IDA in patients with chronic kidney disease . This study aim ed to evaluate the efficacy and safety of ferumoxytol in patients with IDA and concomitant GI disorders . Patients and methods This analysis included 231 patients with IDA and GI disorders from a Phase III , r and omized , double-blind , placebo-controlled trial evaluating ferumoxytol ( 510 mg ×2 )  versus placebo in patients who had failed or were intolerant of oral iron therapy . The primary study end point was the proportion of patients achieving a ≥20 g/L increase in hemoglobin ( Hgb ) from baseline to Week 5 . Other end points included mean change in Hgb , proportion of patients achieving Hgb ≥120 g/L , mean change in transferrin saturation , and patient-reported outcomes ( PROs ) . Results Significantly more patients with IDA  receiving ferumoxytol achieved a ≥20 g/L increase in Hgb  versus placebo ( 82.1 % vs 1.7 % , respectively ; P<0.001 ) . Mean increase in Hgb ( 28.0 g/L vs −1.0 g/L , respectively ; P<0.001 ) significantly favored ferumoxytol treatment . Ferumoxytol-treated patients demonstrated significantly greater improvements than placebo-treated patients relative to their very poor baseline PRO scores posttreatment , including improvements in the Functional Assessment of Chronic Illness Therapy – Fatigue question naire and various domains of the 36-Item Short-Form Health Survey . Ferumoxytol-treated patients had a low rate of adverse events . Conclusion In this study , ferumoxytol was shown to be an efficacious and generally well-tolerated treatment option for patients with IDA and underlying GI disorders who were unable to use or had a history of unsatisfactory oral iron therapy
There was no increased risk of infections with IV iron .
Gastrointestinal AEs were reduced with IV iron .
CONCLUSION Intravenous iron therapy is not associated with an increased risk of SAEs or infections .
Infusion reactions are more pronounced with IV iron
OBJECTIVE To amass all available evidence regarding the safety of intravenous ( IV ) iron preparations to provide a true balance of efficacy and safety .