Orlistat, a gastrointestinal lipase inhibitor, in therapy of obesity with concomitant hyperlipidemia. Weight loss, weight maintenance, and improved cardiovascular risk factors after 2 years treatment with orlistat for obesity. European Orlistat Obesity Study Group. Orlistat maintains biliary lipid composition and hepatobiliary function in obese subjects undergoing moderate weight loss Role of Orlistat in the Treatment of Obese Patients With Type 2 Diabetes: A 1-year randomized double-blind study The effect of the gastrointestinal lipase inhibitor, orlistat, on serum lipids and lipoproteins in patients with primary hyperlipidaemia Weight control and risk factor reduction in obese subjects treated for 2 years with orlistat: a randomized controlled trial. Orlistat, a lipase inhibitor, for weight maintenance after conventional dieting: a 1-y study. A one-year trial to assess the value of orlistat in the management of obesity. One-year treatment of obesity: a randomized, double-blind, placebo-controlled, multicentre study of orlistat, a gastrointestinal lipase inhibitor Orlistat in the long-term treatment of obesity in primary care settings. Gastrointestinal side effects of orlistat may be prevented by concomitant prescription of natural fibers (psyllium mucilloid) Efficacy and tolerability of orlistat in the treatment of obesity: a 6-month dose-ranging study. Orlistat Dose-Ranging Study Group. Clinical efficacy of orlistat therapy in overweight and obese patients with insulin-treated type 2 diabetes: A 1-year randomized controlled trial. Effect of orlistat in overweight and obese patients with type 2 diabetes treated with metformin. The effects of orlistat on weight and on serum lipids in obese patients with hypercholesterolemia: a randomized, double-blind, placebo-controlled, multicentre study Randomised placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients Randomised placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients. European Multicentre Orlistat Study Group. Orlistat (Ro 18-0647), a lipase inhibitor, in the treatment of human obesity: a multiple dose study. Effects of a weight-reduction program with orlistat on serum leptin levels in obese women: A 12-week, randomized, placebo-controlled study. The effects of metformin or orlistat on obese women with polycystic ovary syndrome: a prospective randomized open-label study Lipase inhibition and hormonal status, body composition and gastrointestinal processing of a liquid high-fat mixed meal in moderately obese subjects. The effect of orlistat on body weight and coronary heart disease risk profile in obese patients: the Swedish Multimorbidity Study. Effects of 1-year orlistat treatment compared to placebo on insulin resistance parameters in patients with type 2 diabetes. Comparison of orlistat treatment and placebo in obese type 2 diabetic patients A randomized double-blind study comparing the efficacy and safety of orlistat versus placebo in obese patients with mild to moderate hypercholesterolemia. Orlistat for obesity: benefits beyond weight loss. Effects of weight loss with orlistat on glucose tolerance and progression to type 2 diabetes in obese adults. Comparison of the effects of sibutramine and orlistat on obese, poorly-controlled type 2 diabetic patients. Influences of fat restriction and lipase inhibition on gastric emptying in obesity Latin-American trial of orlistat for weight loss and improvement in glycaemic profile in obese diabetic patients. A randomized study of orlistat in combination with a weight management programme in obese patients with Type 2 diabetes treated with metformin. Effects of moderate weight loss and orlistat on insulin resistance, regional adiposity, and fatty acids in type 2 diabetes. Orlistat improves blood pressure control in obese subjects with treated but inadequately controlled hypertension Orlistat in the treatment of overweight or obese Chinese patients with newly diagnosed Type 2 diabetes. Effect of orlistat on fecal fat, fecal biliary acids, and colonic cell proliferation in obese subjects. Effect of weight loss with or without orlistat treatment on adipocytokines, inflammation, and oxidative markers in obese women. Weight reduction and long-term maintenance after 18 months treatment with orlistat for obesity Insulin and leptin concentrations in obese humans during long-term weight loss. Orlistat inhibits dietary cholesterol absorption.
Orlistat , a gastrointestinal lipase inhibitor , decreases fat absorption and thus it reduces caloric intake . The objectives of this placebo-controlled , double-blind , multicentre trial were to evaluate the efficacy of orlistat in terms of weight reduction , the effects on serum lipid levels and its tolerability profile .  119 obese patients ( body mass index , BMI > or = 30 kg/m2 ) with hyperlipidemia ( LDL-cholesterol > or = 4 , 2 mmol/l ) were r and omized to receive either orlistat capsules 120 mg ( n = 60 ) or placebo capsules ( n = 59 ) , three times daily , during 24 weeks . All patients were also on a mild hypocaloric diet .  Mean weight reduction was 10.75 kg ( 10.7 % ) in orlistat group and 7.34 kg ( 7.5 % ) in placebo group . All serum lipid parameters improved in the orlistat group . The only adverse event more frequently noted with orlistat was stool fat .  Orlistat in combination with diet provides increased weight loss than diet alone , improvements of serum lipids in subjects with hyperlipidemia and it has a good tolerability profile without systemic effects OBJECTIVE To determine the effect of orlistat , a new lipase inhibitor , on long-term weight loss , to determine the extent to which orlistat treatment minimizes weight regain in a second year of treatment , and to assess the effects of orlistat on obesity-related risk factors . RESEARCH METHODS AND PROCEDURES This was a 2-year , multicenter , r and omized , double-blind , placebo-controlled study . Obese patients ( body mass index 28 to 43 kg/m2 ) were r and omized to placebo or orlistat ( 60 or 120 mg ) three times a day , combined with a hypocaloric diet during the first year and a weight maintenance diet in the second year of treatment to prevent weight regain . Changes in body weight , lipid profile , glycemic control , blood pressure , quality of life , safety , and tolerability were measured . RESULTS  Orlistat-treated patients  lost significantly more weight ( p<0.001 ) than placebo-treated patients after Year 1 ( 6.6 % , 8.6 % , and 9.7 % for the placebo , and orlistat 60 mg and 120 mg groups , respectively ) . During the second year , orlistat therapy produced less weight regain than placebo ( p = 0.005 for orlistat 60 mg ; p<0.001 for orlistat 120 mg ) . Several obesity-related risk factors improved significantly more with orlistat treatment than with placebo . Orlistat was generally well tolerated and only 6 % of  orlistat-treated patients withdrew because of adverse events . Orlistat leads to predictable gastrointestinal effects related to its mode of action , which were generally mild , transient , and self-limiting and usually occurred early during treatment . DISCUSSION Orlistat administered for 2 years promotes weight loss and minimizes weight regain . Additionally , orlistat therapy improves lipid profile , blood pressure , and quality of life OBJECTIVES : Orlistat , an intestinal lipase inhibitor , has recently been approved by the US Food and Drug Administration for treatment of obesity . The effects of orlistat on hepatobiliary function have not been previously defined . A 4 wk study was performed involving modest weight loss in obese subjects to observe any short-term hepatobiliary responses that occur after initiating treatment with orlistat and a hypocaloric diet . METHODS : A total of 23 obese ( BMI 30–41 kg/m2 ) subjects were r and omized to a double blind t.i.d . treatment with 120 mg of orlistat or a placebo in conjunction with a hypocaloric diet ( 1200–1500 kcal/day ) . The study was design ed to achieve similar modest weight loss in both groups in order to be able to directly assess the effects of orlistat .  Cholesterol saturation , bile composition , and gallbladder motility were measured . RESULTS : At the end of the treatment period , mean weight loss of 3.8 kg was achieved in the orlistat group ( vs 2.3 kg with placebo , p = NS ) . Total bile acid concentration decreased significantly with placebo ( –18.57 ± 6.99 mmol/L ; 95 % CI = –32.26 to –4.87 ) , but not with orlistat . Biliary phospholipid concentration decreased significantly with placebo ( −4.38 ± 1.91 mmol/L ; 95 % CI = –8.13 to –0.64 ) but not with orlistat . Mean changes from the baseline in cholesterol saturation index and gallbladder motility were similar in both groups . Microscopy of bile failed to reveal cholesterol microcrystals before or after treatment in either group . CONCLUSIONS : Our findings indicate a primary initial effect of weight loss is a reduction in biliary bile acids and phospholipids . Orlistat blocks these adverse changes in biliary lipid composition and maintains hepatobiliary function . We speculate that the risk of formation of gallstones during weight loss may actually be lowered with orlistat OBJECTIVE Obesity is an important risk factor for type 2 diabetes . Weight loss in patients with type 2 diabetes is associated with improved glycemic control and reduced cardiovascular disease risk factors , but weight loss is notably difficult to achieve and sustain with caloric restriction and exercise . The purpose of this study was to assess the impact of treatment with orlistat , a pancreatic lipase inhibitor , on weight loss , glycemic control , and serum lipid levels in obese patients with type 2 diabetes on sulfonylurea medications . RESEARCH DESIGN AND METHODS In a multicenter 57-week r and omized double-blind placebo-controlled study , 120 mg orlistat or placebo was administered orally three times a day with a mildly hypocaloric diet to 391 obese men and women with type 2 diabetes who were aged > 18 years , had a BMI of 28–40 kg/m2 , and were clinical ly stable on oral sulfonylureas .  Changes in body weight , glycemic control , lipid levels , and drug tolerability were measured . RESULTS After 1 year of treatment , the orlistat group lost 6.2 ± 0.45 % ( mean ± SEM ) of initial body weight vs. 4.3 ± 0.49 % in the placebo group ( P < 0.001 ) . Twice as many patients receiving orlistat ( 49 vs. 23 % ) lost ≥ 5 % of initial body weight ( P < 0.001 ) . Orlistat treatment plus diet compared with placebo plus diet was associated with significant improvement in glycemic control , as reflected in decreases in HbA1c ( P < 0.001 ) and fasting plasma glucose ( P < 0.001 ) and in dosage reductions of oral sulfonylurea medication ( P < 0.01 ) . Orlistat therapy also result ed in significantly greater improvements than placebo in several lipid parameters , namely , greater reductions in total cholesterol , ( P < 0.001 ) , LDL cholesterol ( P < 0.001 ) , triglycerides ( P < 0.05 ) , apolipoprotein B ( P < 0.001 ) , and the LDL-to-HDL cholesterol ratio ( P < 0.001 ) . Mild to moderate and transient gastrointestinal events were reported with orlistat therapy , although their association with study withdrawal was low . Fat-soluble vitamin levels generally remained within the reference range , and vitamin supplementation was required in only a few patients . CONCLUSIONS Orlistat is an effective treatment modality in obese patients with type 2 diabetes with respect to clinical ly meaningful weight loss and maintenance of weight loss , improved glycemic control , and improved lipid profile The effect of orlistat , a nonabsorbed inhibitor of gastric and pancreatic lipases , was examined in patients with primary hyperlipidaemia ( serum cholesterol ≥6.2 mmol·l−1 and triglycerides ≤5.0 mmol·l−1 ) not responsive to dietary change alone . In a multicentre , r and omised , double-blind study , 103 men and 70 women received 30 , 90 , 180 , or 360 mg of orlistat or placebo for 8 weeks . Total and low-density lipoprotein cholesterol levels were reduced by 4 % and 5 % with 30 mg orlistat , by 7 % and 8 % with 90 mg orlistat , by 7 % and 7 % with 180 mg orlistat and by 11 % and 10 % with 360 mg orlistat  compared to placebo . High density lipoprotein cholesterol levels significantly decreased in the 360 mg  orlistat group . Triglyceride levels significantly increased in the placebo group but not in the drug groups . Body weight decreased by 1.2 kg with 360 mg orlistat , despite a weight maintenance diet . Decreases in vitamin E and D levels occurred , although both vitamins remained within the normal range . Adverse effects from the gastrointestinal tract were frequent , but led to discontinuation of therapy in only seven patients . Orlistat is a new therapeutic drug for the treatment of hyperlipidaemia that may be particularly useful among overweight patients . Its potential place in therapy will await long-term studies . Vitamin supplementation should be considered during treatment CONTEXT Orlistat , a gastrointestinal lipase inhibitor that reduces dietary fat absorption by approximately 30 % , may promote weight loss and reduce cardiovascular risk factors . OBJECTIVE To test the hypothesis that orlistat combined with dietary intervention is more effective than placebo plus diet for weight loss and maintenance over 2 years . DESIGN R and omized , double-blind , placebo-controlled study conducted from October 1992 to October 1995 . SETTING AND PARTICIPANTS Obese adults ( body mass index [ weight in kilograms divided by the square of height in meters ] , 30 - 43 kg/m2 ) evaluated at 18 US research centers . INTERVENTION Subjects received placebo plus a controlled-energy diet during a 4-week lead-in . On study day 1 , the diet was continued and subjects were r and omized to receive placebo 3 times a day or orlistat , 120 mg 3 times a day , for 52 weeks . After 52 weeks , subjects began a weight-maintenance diet , and the placebo group ( n = 133 ) continued to receive placebo and orlistat-treated subjects were rer and omized to receive placebo 3 times a day ( n = 138 ) , orlistat , 60 mg ( n = 152 ) or 120 mg ( n = 153 ) 3 times a day , for an additional 52 weeks . MAIN OUTCOME MEASURES Body weight change and changes in blood pressure and serum lipid , glucose , and insulin levels . RESULTS A total of 1187 subjects entered the protocol , and 892 were r and omly assigned on day 1 to double-blind treatment . For intent-to-treat analysis , 223 placebo-treated subjects and 657  orlistat-treated  subjects were evaluated . During the first year orlistat-treated subjects lost more weight ( mean + /- SEM , 8.76+/-0.37 kg ) than placebo-treated subjects ( 5.81+/-0.67 kg ) ( P<.001 ) . Subjects treated with orlistat , 120 mg 3 times a day , during year 1 and year 2 regained less weight during year 2 ( 3.2+/-0.45 kg ; 35.2 % regain ) than those who received orlistat , 60 mg ( 4.26+/-0.57 kg ; 51.3 % regain ) , or placebo ( 5.63+/-0.42 kg ; 63.4 % regain ) in year 2 ( P<.001 ) . Treatment with orlistat , 120 mg 3 times a day , was associated with improvements in fasting low-density lipoprotein cholesterol and insulin levels . CONCLUSIONS Two-year treatment with orlistat plus diet significantly promotes weight loss , lessens weight regain , and improves some obesity-related disease risk factors BACKGROUND Long-term maintenance of weight loss remains a therapeutic challenge in obesity treatment . OBJECTIVE This multicenter , double-blind , placebo-controlled study was design ed to test the hypothesis that orlistat , a gastrointestinal lipase inhibitor , is significantly more effective than a placebo in preventing weight regain . DESIGN Obese subjects who lost > or = 8 % of their initial body weight during a 6-mo lead-in of a prescribed hypoenergetic diet ( 4180-kJ/d deficit ) with no adjunctive pharmacotherapy  were r and omly assigned to receive placebo , 30 mg orlistat , 60 mg orlistat , or 120 mg orlistat 3 times daily for 1 y in combination with a maintenance diet to help prevent weight regain . Of 1313 recruited subjects [ body mass index ( in kg/m2 ) : 28 - 43 ] , 729 subjects lost > or = 8 % of their initial body weight during the 6-mo weight-loss lead-in period and were enrolled in the double-blind phase . RESULTS After 1 y , subjects treated with 120 mg orlistat 3 times daily regained less weight than did placebo-treated subjects ( 32.8 + /- 4.5 % compared with 58.7 + /- 5.8 % regain of lost weight ; P < 0.001 ) . Moreover , more subjects in the 120-mg orlistat group than in the placebo group regained < or = 25 % of lost weight ( 47.5 % of subjects compared with 29.9 % ) . In addition , orlistat treatment ( 120 mg 3 times daily ) was associated with significantly greater reductions in total and LDL-cholesterol concentrations than was placebo ( P < 0.001 ) . CONCLUSION The use of orlistat during periods of attempted weight maintenance minimizes weight readjustment and facilitates long-term improvement in obesity-related disease risk factors OBJECTIVES This paper describes the methodology of a multicentre study design ed to assess the efficacy and tolerability of orlistat 120 mg tid as therapy for inducing weight loss in excess of that achieved with a moderately calorie-restricted diet alone . The results from a single centre are presented to illustrate the nature of the response . DESIGN This was a double-blind , r and omized , parallel-group , placebo-controlled multicentre study . A four-week , single-blind , placebo run-in period preceded a 52 week double-blind treatment period during which patients received either orlistat or placebo three times a day . At the start of the run-in period , all patients were placed on a diet containing approximately 30 % of calories as fat and design ed to cause an energy deficit of approximately 600 kcal/d . SUBJECTS Patients of either sex , more than 18 y of age , with a body mass index ( BMI ) between 30 and 43 kg/m2 were eligible for enrolment . MEASUREMENTS Efficacy assessment s included : measurements of body weight ; anthropometry ; quality of life ; blood pressure ; serum lipids ; fasting serum glucose and insulin . Safety assessment s included : adverse events ; vital signs ; ECG ; renal and gallbladder ultrasound ; haematology ; serum biochemistry . OUTCOME In the single centre there was a reduction in body weight of 5.5 + /- 4.5 ( s.d . ) kg ( 5.7 % reduction ) in the placebo group and 8.6 + /- 5.4 kg in the orlistat-treated group ( 8.4 % reduction ) by six months . Thereafter , the placebo group tended to relapse whereas the orlistat group maintained their loss ( 2.6 % vs 8.4 % reduction from initial value at 52 weeks ) . Total and LDL cholesterol fell by 0.05 mmol/l ( 1.6 % ) and 0.14 mmol/l ( 4.2 % ) , respectively , in orlistat treated patients . The drop-out rate was 48 % in the  placebo  group and 39 % in the orlistat group . Intestinal symptoms related to orlistat were significantly increased compared to placebo but were well tolerated . Fat soluble vitamin levels remained within the normal range in the treatment group ; the reduction seen in alpha-tocopherol levels in patients receiving orlistat was normalized by the decrease in plasma cholesterol concentrations . Beta-carotene and vitamin D concentrations also decreased in orlistat-treated patients . CONCLUSIONS This preliminary analysis suggests that orlistat , when used with a health-promoting low-fat and moderately energy-restricted diet , confers advantages in the long-term management of obesity OBJECTIVE : To assess the efficacy and tolerability of orlistat ( Xenical ® ) in producing and maintaining weight loss over a 12-month period . DESIGN : Patients were r and omized to double-blind treatment with either orlistat 120 mg or placebo three times daily , in conjunction with a low-energy diet , for 12 months . SETTING : Five centres in the UK.SUBJECTS : 228 obese adult patients with body mass index between 30 and 43 kg/m2 and mean weight 97 kg ( range 74–144 kg ) . INTERVENTIONS : All patients were prescribed a low-energy diet , providing 30 % of energy from fat , design ed to produce an individually tailored energy deficit of approximately 600 kcal/day , for a run-in period of 4 weeks and then 12 months , plus orlistat 120 mg or placebo three times daily . MAIN OUTCOME MEASURES : Change in body weight ( the primary efficacy parameter ) , waist circumference and adverse events were review ed regularly , together with serum lipids , insulin , glucose and plasma levels of fat-soluble vitamins and β carotene . RESULTS : Based on an intent-to-treat analysis , after 1 y of treatment patients receiving orlistat had lost an average of 8.5 % of their initial body weight compared with 5.4 % for placebo-treated patients ; 35 % of the orlistat group lost at least 5 % of body weight compared with 21 % of the placebo group ( P<0.05 ) , and 28 % and 17 % , respectively ( P=0.04 ) lost at least  10 %  of body weight . Orlistat-treated patients showed significant decreases ( P<0.05 ) in serum levels of total cholesterol , low density lipoprotein cholesterol , and in the low density lipoprotein : high density lipoprotein ratio in comparison with placebo . Both groups had similar adverse-event profiles , except for gastrointestinal events , which were 26 % more frequent in the orlistat group but were mostly mild and transient . To maintain normal plasma levels of fat-soluble vitamins , supplements of vitamins A , D and E were given to 1.8 % , 8.0 % and 3.6 % , respectively , of orlistat-treated patients , compared with 0.9 % of placebo-treated patients for each vitamin type . After 1 y , the decrease in vitamin E and β carotene was significantly greater in orlistat-treated patients compared with those receiving placebo ( P<0.001 ) . No significant change was found in the mean vitamin E : total cholesterol ratio in either group after 52 weeks . Conclusions : Orlistat , in conjunction with a low-energy diet , produced greater and more frequent significant weight loss  than placebo during 1 y of treatment . One-third of orlistat-treated patients achieved clinical ly relevant weight loss ( ≥5 % initial body weight ) . There was also an improvement in relevant serum lipid parameters . Fat-soluble vitamin supplements may be required during chronic therapy . Orlistat was well tolerated and offers a promising new approach to the long-term management of obesity OBJECTIVE To evaluate the long-term efficacy and tolerability within primary care setting s of orlistat , a gastrointestinal lipase inhibitor , for the treatment of obesity . DESIGN R and omized , double-blind , placebo-controlled , multicenter study . PARTICIPANTS A group of 796 obese patients ( body mass index , 30 - 44 kg/m2 ) , treated with placebo 3 times a day ( TID ) , 60 mg of orlistat TID , or 120 mg of orlistat TID , in conjunction with a reduced-energy diet for the first year and a weight-maintenance diet during the second year . SETTING Seventeen primary care centers in the United States . MAIN OUTCOME MEASURES Changes in body weight and obesity-related disease risk factors . RESULTS Patients treated with orlistat lost significantly more weight ( 7.08 + /- 0.54 and 7.94 + /- 0.57 kg for the 60-mg and 120-mg orlistat groups , respectively ) than those treated with placebo ( 4.14 + /- 0.56 kg ) in year 1 ( P<.001 ) and sustained more of this weight loss during year 2 ( P<.001 ) . More patients treated with orlistat lost 5 % or more of their initial weight in year 1 ( 48.8 % and 50.5 % of patients in the 60-mg and 120-mg groups , respectively ) compared with placebo ( 30.7 % ; P<.001 ) , and approximately 34 % of patients in the orlistat groups sustained weight loss of 5 % or greater over 2 years compared with 24 % in the placebo group ( P<.001 ) . Orlistat produced greater improvements than placebo in serum lipid levels and blood pressure and was well tolerated , although treatment result ed in a higher incidence of gastrointestinal events . CONCLUSIONS This long-term study indicates that orlistat is an effective adjunct to dietary intervention in the treatment of obesity in primary care setting OBJECTIVES : This placebo-controlled open study was design ed to test the hypothesis that most of the gastrointestinal ( GI ) side events induced by treatment of obese patients with orlistat ( a gastrointestinal lipase inhibitor ) could be prevented or ameliorated by concomitant use of natural fibers ( psyllium mucilloid ) . DESIGN : Two groups of obese women ( BMI > 27 kg/m2 ) were treated with orlistat 120 mg three times a day . One group ( A , n=30 ) was r and omized to receive orlistat and , approximately 6.0 g of orange-flavored psyllium mucilloid dissolved in water and the other group ( B , n=30 ) received orlistat and orange-flavored placebo . At the end of 30 days and 2 weeks of washout , group A switched to placebo and group B received psyllium while continuing orlistat three times a day . SUBJECTS : Sixty professional women , more than 21-y-old with a body mass index ( BMI ) between 27.3 and 48.0 kg/m2 , who were not receiving any other medication . MEASUREMENTS : Assessment s included weekly visits to attending physician , filling a form in which GI events were recorded , monthly measurements of body weight , blood pressure and serum lipids . The frequency and severity of GI events were evaluated by a score system , based on information provided by the patients . RESULTS : Both groups A and B significantly lost ( P<0.01 ) weight after 60 days of orlistat ( A=96.8 to 94.9 kg and B=98.7 to 96.5 kg ) . Similarly , BMI values declined significantly in both groups . While in the psyllium plus orlistat group ( group A ) the mean ±s.e.m . of the scores reflecting GI events was 13.0±1.8 , the placebo plus orlistat group ( B ) had a value of 35.9±2.7 ( P<0.01 ) . When the reverse situation was instituted the placebo and orlistat group presented a mean score of 36.1±3.6 and the psyllium plus orlistat a mean score of 8.9±1.5 ( P<0.01 ) . CONCLUSIONS : Psyllium hydrophilic mucilloid concomitantly prescribed to obese patients receiving 120 mg of orlistat three times a day is an effective and safe adjunct therapy that is helpful in controlling the GI side effects of this pancreatic lipase inhibitor OBJECTIVE To determine the weight-reducing efficacy of orlistat , a novel gastrointestinal lipase inhibitor , and to define the optimal dosage regimen and establish the tolerability of the drug when used for a 6-month treatment period . METHODS The study was a multicentre r and omised , double-blind , parallel group in design and involved 676 obese male and female subjects aged at least 18 years with a body mass index between 28 and 43 kg x m(-2 ) Following a 5-week placebo run-in period , subjects were r and omised to receive orlistat 30 mg , 60 mg , 120 mg , 240 mg or matching placebo three times a day ( tid ) for 24 weeks during meals . Patients were maintained on a mildly hypocaloric diet throughout the study period . The primary efficacy parameter was body weight change over time . RESULTS Orlistat result ed in a significantly greater mean loss of body weight than observed in the placebo group . In absolute terms , mean weight loss was greatest in the 120 mg group ( 9.8 % ) . More orlistat- than placebo-treated patients lost > 10 % of initial body weight ( 37 % of the 120 mg group vs 19 % of the placebo group ) . Orlistat was well tolerated . Predictably , in view of its known pharmacological effects , more orlistat-treated patients experienced gastrointestinal events . Mean levels of vitamins A , D and E , and beta-carotene remained within the clinical reference ranges in all treatment groups and rarely required supplementation . After 24 weeks , plasma concentrations of orlistat  were either non-measurable or detected at the assay 's limit of quantitation . CONCLUSION Orlistat treatment results in a dose-dependent reduction in body weight in obese subjects and is well tolerated . Orlistat 120 mg tid represents the optimal dosage regimen UNLABELLED OBJECTIVE ; Weight loss improves glycemic control , lipid profiles , and blood pressure in patients with type 2 diabetes . However , successful long-term weight loss is difficult for these patients , particularly those treated with insulin . The aim of this study was to assess the effect of orlistat , a gastrointestinal lipase inhibitor , on weight loss , glycemic control , and cardiovascular risk factors in overweight or obese insulin-treated type 2 diabetic patients . RESEARCH DESIGN AND METHODS This study was a 1-year multicenter , r and omized , double-blind , placebo-controlled trial of orlistat ( 120 mg three times a day ) or placebo combined with a reduced-calorie diet in overweight or obese adults ( BMI 28 - 40 kg/m(2 ) ) with type 2 diabetes treated with insulin alone or combined with oral agents , but with suboptimal metabolic control ( HbA(1c ) 7.5 - 12.0 % ) . Outcome measurements included changes in body weight , glycemic control , blood pressure , and serum lipids . RESULTS ; After 1 year , the orlistat group lost significantly more weight ( -3.89 + /- 0.3 % of baseline body weight , means + /- SE ) than the placebo group ( -1.27 + /- 0.3 % , P < 0.001 ) . Orlistat treatment , compared with placebo , produced greater decreases in HbA(1c ) ( -0.62 + /- 0.08 vs. -0.27 + /- 0.08 % , P = 0.002 ) , fasting serum glucose ( -1.63 + /- 0.3 vs. -1.08 + /- 0.3 mmol/l , P = 0.02 ) , and the required doses of insulin and other diabetic medications . Orlistat also produced greater improvements than placebo in serum total cholesterol ( P = 0.0002 ) and LDL cholesterol concentrations ( P = 0.001 ) and LDL/HDL ratio ( P = 0.01 ) . CONCLUSIONS ; Orlistat therapy produces clinical ly significant weight loss , with improvements in glycemic control and cardiovascular disease risk factors , in overweight or obese patients with type 2 diabetes who have suboptimal metabolic control with insulin therapy OBJECTIVE The purpose of this study was to assess the effect of orlistat , a gastrointestinal lipase inhibitor , on body weight , glycemic control , and cardiovascular risk factors in metformin-treated type 2 diabetic patients . RESEARCH DESIGN AND METHODS A 1-year multicenter , r and omized , double-blind , placebo-controlled trial of 120 mg  orlistat t.i.d . ( n = 249 ) or placebo ( n = 254 )  combined with a reduced-calorie diet was conducted in overweight and obese patients with suboptimal control of type 2 diabetes . RESULTS After 1 year of treatment , mean ( + /-SE ) weight loss was greater in the orlistat than in the placebo group ( -4.6 + /- 0.3 % vs. -1.7 + /- 0.3 % of baseline wt , P < 0.001 ) . Orlistat treatment caused a greater improvement in glycemic control than placebo , as evidence d by a greater reduction in serum HbA(1c ) , adjusted for changes in metformin and sulfonylurea therapy ( -0.90 + /- 0.08 vs. -0.61 + /- 0.08 , P = 0.014 ) ; a greater proportion of patients achieving decreases in HbA(1c ) of > or = 0.5 and > or = 1.0 % ( both P < 0.01 ) ; and a greater reduction in fasting serum glucose ( -2.0 + /- 0.2 vs. -0.7 + /- 0.2 mmol/l , P = 0.001 ) . Compared with the placebo group , patients treated with orlistat also had greater decreases in total cholesterol , LDL cholesterol , and systolic blood pressure ( all P < 0.05 ) . Although more subjects treated with orlistat experienced gastrointestinal side effects than placebo ( 83 vs. 62 % , P < 0.05 ) , more subjects in the placebo group withdrew prematurely from the study than in the orlistat group ( 44 vs. 35 % , P < 0.05 ) . CONCLUSIONS Orlistat is a useful adjunctive treatment for producing weight loss and improving glycemic control , serum lipid levels , and blood pressure in obese patients with type 2 diabetes who are being treated with metformin OBJECTIVE : Assessment of the effects of orlistat 120 mg three times daily vs placebo on weight loss and serum lipids in obese hypercholesterolemic patients . DESIGN : A 24 week multicentre , double-blind , r and omized , placebo-controlled trial . After a 2-week single-blind run-in period ( placebo+diet ( −600 kcal/day ; ≤30 % of calories as fat ) ) , 294 patients were su bmi tted to the hypocaloric diet and r and omly assigned to either orlistat 120 mg or placebo three times daily . Patients who completed the double-blind study ( n=255 ) were eligible for participation in a subsequent 24 week open-label orlistat extension phase . SUBJECTS : Patients with body mass index ( BMI ) 27–40 kg/m2 and hypercholesterolemia ( low-density-lipoprotein cholesterol , LDL-C , 4.1–6.7 mmol/l ) . MEASUREMENTS : Efficacy assessment s included weight loss , lipid levels , other cardiovascular risk factors and anthropometric parameters . Safety assessment s. RESULTS : Weight loss during run-in was similar in both groups . After r and omization , orlistat-treated patients lost significantly more weight  than placebo recipients : mean percentage weight loss from start of run-in to week 24 was−6.8 % in the orlistat group and −3.8 % in the placebo group ( P<0.001 ) . Moreover , more patients in the orlistat group than in the placebo group achieved clinical ly meaningful weight loss of ≥5 % ( 64 vs 39 % ) or ≥10 % ( 23 vs 13 % ) at week 24 . Treatment with orlistat was associated with significantly greater changes in total cholesterol ( −11.9 % vs −4.0 % ; P<0.001 ) and LDL-C ( −17.6 vs −7.6 % ; P<0.001 ) . For any category of weight loss during the double-blind treatment period , change in LDL-C was more pronounced in orlistat-treated patients than in placebo recipients , indicating that orlistat had a direct cholesterol-lowering effect that was independent of weight reduction ( P<0.001 ) . Adjunction of orlistat during the extension phase in patients who initially received placebo  induced a further decrease in weight , total cholesterol and LDL-C. Orlistat was generally well tolerated with a safety profile comparable to placebo , with the exception of a higher incidence of gastrointestinal events ( ≥1 event in 64 vs 38 % of patients ) . CONCLUSION : Orlistat as an adjunct to dietary intervention promotes weight loss and reduces LDL-C beyond the effect of weight loss in overweight or obese patients with concomitant hypercholesterolemia BACKGROUND We undertook a r and omised controlled trial to assess the efficacy and tolerance of orlistat , a gastrointestinal lipase inhibitor , in promoting weight loss and preventing weight regain in obese patients over a 2-year period . METHODS 743 patients ( body-mass index 28 - 47 kg/m2 ) , recruited at 15 European centres , entered a 4-week , single-blind , placebo lead-in period on a slightly hypocaloric diet ( 600 kcal/day deficit ) . 688 patients who completed the lead-in were assigned double-blind treatment with orlistat 120 mg ( three times a day ) or placebo for 1 year in conjunction with the hypocaloric diet . In a second 52-week double-blind period patients were reassigned orlistat or placebo with a weight maintenance ( eucaloric ) diet . FINDINGS From the start of lead-in to the end of year 1 , the  orlistat  group lost , on average , more bodyweight than the placebo group ( 10.2 % [ 10.3 kg ] vs 6.1 % [ 6.1 kg ] ; LSM difference 3.9 kg [ p < 0.001 ] from r and omisation to the end of year 1 ) . During year 2 , patients who continued with orlistat  regained , on average , half as much weight as those patients switched to placebo ( p < 0.001 ) . Patients switched from placebo to orlistat lost an additional 0.9 kg during year 2 , compared with a mean regain of 2.5 kg in patients who continued on placebo ( p < 0.001 ) . Total cholesterol , low-density lipoprotein ( LDL ) cholesterol , LDL/high-density lipoprotein ratio , and concentrations of glucose and insulin decreased more in the orlistat group than in the placebo group . Gastrointestinal adverse events were more common in the orlistat group . Other adverse symptoms occurred at a similar frequency during both treatments . INTERPRETATION Orlistat taken with an appropriate diet promotes clinical ly significant weight loss and reduces weight regain in obese patients over a 2-year period . The use of orlistat beyond 2 years needs careful monitoring with respect to efficacy and adverse events BACKGROUND We undertook a r and omised controlled trial to assess the efficacy and tolerability of orlistat , a gastrointestinal lipase inhibitor , in promoting weight loss and preventing weight regain in obese patients over a 2-year period . METHODS 743 patients ( body-mass index 28 - 47 kg/m2 ) , recruited at 15 European centres , entered a 4-week , single-blind , placebo lead-in period on a slightly hypocaloric diet ( 600 kcal/day deficit ) . 688 patients who completed the lead-in were assigned double-blind treatment with orlistat 120 mg ( three times a day ) or placebo for 1 year in conjunction with the hypocaloric diet . In a second 52-week double-blind period patients were reassigned orlistat or placebo with a weight maintenance ( eucaloric ) diet . FINDINGS From the start of lead-in to the end of year 1 , the  orlistat  group lost , on average , more bodyweight than the placebo group ( 10.2 % [ 10.3 kg ] vs 6.1 % [ 6.1 kg ] ; LSM difference 3.9 kg [ p<0.001 ] from r and omisation to the end of year 1 ) . During year 2 , patients who continued with orlistat  regained , on average , half as much weight as those patients switched to placebo ( p<0.001 ) . Patients switched from placebo to orlistat lost an additional 0.9 kg during year 2 , compared with a mean regain of 2.5 kg in patients who continued on placebo ( p<0.001 ) . Total cholesterol , low-density lipoprotein ( LDL ) cholesterol , LDL/high-density lipoprotein ratio , and concentrations of glucose and insulin decreased more in the orlistat group than in the placebo group . Gastrointestinal adverse events were more common in the orlistat group . Other adverse symptoms occurred at a similar frequency during both treatments . INTERPRETATION Orlistat taken with an appropriate diet promotes clinical ly significant weight loss and reduces weight regain in obese patients over a 2-year period . The use of orlistat beyond 2 years needs careful monitoring with respect to efficacy and adverse events OBJECTIVE To evaluate efficacy and tolerability of the lipase inhibitor Orlistat ( Ro 18 - 0647 ) in doses of 10 , 60 and 120 mg three times a day in addition to a mild hypocaloric diet containing 30 % of calories as fat . DESIGN 4 week single-blind placebo run-in period of diet alone followed by a 12 week double-blind , placebo-controlled , r and omized treatment period . SETTING S Five European outpatient clinics specializing in endocrinology and /or the treatment of obesity , one central laboratory . SUBJECTS Of 237 healthy obese subjects meeting the inclusion criteria , 188 showed compliance to the diet during the run-in period and were r and omized for the treatment period . MAIN OUTCOME MEASURES Primary efficacy criterion was the difference in weight loss after 12 weeks of treatment between the Orlistat treated groups and the diet alone group . Secondary efficacy criteria were changes in serum total , HDL- and LDL-cholesterol . RESULTS Compared to placebo a mean ( + /- s.e . ) additional weight loss of 0.63 + /- 0.54 kg with 30 mg a day ( P = 0.246 ) , 0.71 + /- 0.55 kg with 180 mg a day ( P = 0.190 ) and 1.75 + /- 0.54 kg with 360 mg a day was seen ( P = 0.001 ) or Orlistat was observed . Overall data indicated dose-dependency . Small decreases were seen in total and LDL-cholesterol ( significant in the 180 and 360 mg a day groups ) and LDL- to HDL-cholesterol ratio ( significant in the 360 mg a day group only ) . Mild , mostly gastrointestinal side effects were observed more frequently in the Orlistat groups and caused premature withdrawal from the study in only four patients . No marked laboratory abnormalities were shown , including the lipid-soluble vitamins A , D and E. CONCLUSION Orlistat , in an apparently dose-dependent manner , leads to additional weight loss compared to diet alone and overall , is well tolerated BACKGROUND Leptin , which has been identified as an antiobesity hormone , regulates body weight by controlling food intake and energy expenditure via the hypothalamic-pituitary-gonadal axis . It appears that leptin may be an important factor in obesity management . Orlistat , a pancreatic lipase inhibitor , could reduce fat absorption and promote weight loss due to leptin metabolism . OBJECTIVE The purpose of this study was to investigate the effects of orlistat therapy on serum leptin levels . METHODS Obese women ( body mass index [ BMI ] , 30 kg/m(2 ) ) aged 18 to 50 years were r and omly assigned to receive 12 weeks of oral treatment with diet-orlistat ( 120 mg TID ) ( DO group ) or diet-placebo ( DP group ) . During the treatment period , patients were asked to eat a balanced diet of -1200 to 1600 kcal/d . Body composition was determined by bioelectrical impedance . Serum leptin levels were measured using radioimmunoassay at baseline and at study end . RESULTS A total of 24 patients entered the study ; 14 patients ( mean [ SE ] BMI , 37.7 [ 1.1 ] kg/m(2 ) ) received orlistat and 10 patients ( mean [ SE ] BMI , 39.4 [ 1.3 ] kg/m(2 ) ) received placebo . Compared with baseline , mean percentages of loss of body weight and fat mass after 12 weeks of treatment were significant in the DO group ( 9.1 % and 14.8 % , respectively ; both P = 0.001 ) and in the DP group ( 9.5 % and 17.6 % ; both P = 0.005 ) . The between-group differences were not statistically significant . Mean ( SE ) serum leptin levels also decreased significantly after treatment in the DO group ( 16.2 [ 1.2 ] vs 9.0 [ 1.0 ] ng/mL ; P = 0.001 ) and in the DP group ( 19.3 [ 2.1 ] vs 9.7 [ 1.4 ] ng/mL ; P = 0.005 ) . The between-group difference was not statistically significant . CONCLUSIONS In this study of obese women , orlistat treatment was associated with a similar decrease in body weight , fat mass , and serum leptin levels as placebo over a 12-week period . In this regard , short-term orlistat therapy may not provide an additional effect on serum leptin levels , and reduction in leptin levels were closely related to the decrease in fat mass Purpose Comparing the effects of metformin or orlistat on hormone , lipid profile and ovulation status in obese women with polycystic ovary syndrome . Methods A total of 80 women were prospect ively recruited to receive either metformin ( n = 40 ) or orlistat ( n = 40 ) . Weight , BMI , waist , serum LH , total serum testosterone and lipid profile were assessed at baseline and after 3 months . The subjects ’ ovulatory status was assessed after 3 months . Results There was no significant difference in ovulation between the two treatment groups ( 30 % vs 15 % ) . Treatment with either drug showed a significant decline in body weight , BMI ( Body Mass Index ) , and waist circumference , but the degree of decline in both groups was the same . Patients who were treated with orlistat , showed a significant reduction in total testosterone and serum lipid . Women in metformin group showed a significant reduction in serum LH . Conclusions Both metformin and orlistat showed a similar effect on weight loss and ovulation rates The effect of Orlistat , a lipase inhibitor used in the treatment of obesity was studied on gastrointestinal transit time , on body composition and on hormones known to be influenced by the degree of hydrolysis of nutritional triglycerides or by reduced nutrient intake and absorption . After a placebo run-in period 14 patients were r and omized to a 12-week treatment period on Orlistat 360 mg per day ( mean body weight 93.1 + /- 9.8 kg ) or placebo ( mean body weight 90.7 + /- 10.5 kg ) . At r and omization and after 12 weeks body weight , body composition , thyroid hormones , catecholamines , insulin-like growth factor I ( IGF-I ) and IGF-binding protein 3 were measured . During 4 hours after consumption of a liquid fat-rich mixed meal containing study medication , 15 g lactulose and 25 g xylose , blood levels of glucose , insulin , c-peptide , glucagon , triglycerides , free fatty acids , cholecystokinin , pancreatic polypeptide and xylose and expiration air levels of hydrogen were measured . Weight loss was 4.2 + /- 3.5 kg in the Orlistat group versus 3.0 + /- 1.9 kg in the placebo group . Fat mass decreased to an equal degree , whereas lean body mass remained stable . No differences were found for thyroid hormones , catecholamines , IGF-I and IGFBP-3 levels . By comparing the areas under the curve ( AUC ) and the peak levels at r and omization ( acute effects ) of insulin and c-peptide a tendency was found to be increased in the Orlistat group , whereas those of xylose were increased significantly , suggesting faster gastric emptying after Orlistat . No differences were found in the other parameters . By comparing the changes in responses ( longer term effects ) no significant differences were found . In conclusion , the presence in the gut of undigested and unabsorbed fat does not seem to have a relevant influence on hormonal status and body composition in a small group of moderately obese patients OBJECTIVE To assess the effect of orlistat on body weight and cardiovascular risk amongst obese patients at high coronary risk . DESIGN After screening , patients entered a two-week single-blind placebo lead-in period , during which they followed a mildly hypocaloric diet , before being r and omized to double-blind treatment with either orlistat 120 mg or placebo three times daily , in conjunction with dietary intervention for 1 years . SETTING The study was conducted at 33 primary care centres in Sweden . SUBJECTS A total of 382 obese adults ( body mass index 28 - 38 kg m-2 ) with type 2 diabetes , hypercholesterolaemia and /or hypertension were recruited , of whom 376 were r and omized to orlistat ( n = 190 ) or placebo ( n = 186 ) . MAIN OUTCOME MEASURES Change in body weight , waist and hip circumferences , blood pressure , serum lipid profile , fasting glucose and HbA1c . RESULTS After 1 years , mean weight loss was significantly greater with orlistat compared with placebo ( 5.9 % vs. 4.6 % ; P < 0.05 ) . Moreover , significantly more orlistat-treated patients than placebo recipients maintained weight loss of > or = 5 % ( 54.2 % vs. 40.9 % ; P < 0.001 ) . Orlistat was also associated with significantly greater improvements than placebo in total serum cholesterol ( - 3.3 % vs. -0.5 % ; P < 0.05 ) , LDL-cholesterol ( - 7.0 % vs. -1.1 % ; P < 0.05 ) , fasting glucose ( 5.1 % vs. -0.1 % ; P < 0.01 ) and HbA1c ( - 2.7 % vs. -0.5 % ; P < 0.05 ) . Similar results were reported for the subgroup of patients with type 2 diabetes . Orlistat was well tolerated . CONCLUSIONS Treatment with orlistat in conjunction with diet promotes significantly greater weight loss and cardiovascular risk factor reduction than diet alone amongst obese patients at high risk of future coronary events WHAT IS KNOWN AND OBJECTIVE The behavioural approach is usually slow and not always sufficient to achieve optimal targets in weight and metabolic control in obese diabetic patients , and a pharmacological treatment is often necessary . The aim of this study was to compare the effects of orlistat and placebo on body weight , glycaemic and lipid profile and insulin resistance in patients with type 2 diabetes . METHODS Two hundred and fifty-four obese , diabetic patients were enrolled in this study and r and omized to take orlistat 360 mg or placebo for 1year . We evaluated at baseline and after 3 , 6 , 9 and 12months body weight , waist circumference ( WC ) , body mass index ( BMI ) , glycated haemoglobin ( HbA(1c ) ) , fasting plasma glucose ( FPG ) , post-pr and ial plasma glucose ( PPG ) , fasting plasma insulin ( FPI ) , homeostasis model assessment insulin resistance index ( HOMA-IR ) , lipid profile , retinol-binding protein-4 ( RBP-4 ) , resistin , visfatin and high-sensitivity C-reactive protein ( Hs-CRP ) . RESULTS AND DISCUSSION We observed a significant reduction in body weight , WC , BMI , lipid profile , RBP-4 and visfatin in the orlistat group but not in control group . Faster improvements in HbA(1c ) , PPG , FPI , HOMA-IR , resistin and Hs-CRP were recorded with orlistat than with placebo . A similar decrease in FPG was seen in the two groups . Significant predictors of change in insulin resistance ( HOMA-IR ) were RBP-4 and resistin concentration in the orlistat group ( r=-0·53 , P<0·05 , and r=-0·59 , P<0·01 , respectively ) . WHAT IS NEW AND CONCLUSION To the best of our knowledge , this is the first study investigating the effect of orlistat on insulin resistance and markers of inflammation . Orlistat improved lipid profile and led to faster glycaemic control and insulin resistance parameters than the control , without any serious adverse event . Orlistat also improved RBP-4 and visfatin , effects not observed with placebo Aim : To evaluate the effects of 1-year treatment with orlistat compared with placebo on different inflammatory parameters in type 2 obese diabetic patients . Material s and methods : Two hundred and fifty-four type 2 diabetic patients were r and omized to take orlistat 120 mg three times a day or placebo for 12 months . We evaluated at baseline and after 3 , 6 , 9 and 12 months : leptin , tumor necrosis factor (TNF)-α , adiponectin ( ADN ) , vaspin and high-sensitivity C-reactive protein ( HS-CRP ) , body weight , waist circumference , body mass index ( BMI ) , lipid profile , glycemic profile , fasting plasma insulin ( FPI ) and homeostasis model assessment insulin resistance index ( HOMA-IR ) . Results : Regarding inflammatory parameters , there was a significant improvement of ADN and TNF-α , and a faster decrease of leptin and HS-CRP in the orlistat group compared with the control group . We also recorded a significant reduction of body weight and BMI with orlistat , but not with placebo . A faster improvement of glycemic profile and FPI was obtained with orlistat compared with the controls . Also , there was a significant reduction of lipid profile  with orlistat , not reached with placebo . Conclusions : Orlistat was more effective than placebo in ameliorating inflammatory parameters such as ADN and TNF-α , and anthropometric parameters INTRODUCTION Obesity is a chronic disease and a serious health problem that leads to increased prevalence of diabetes , hypertension , dyslipidemia and gallbladder disease . OBJECTIVE To evaluate the efficacy of orlistat for weight loss and improved lipid profile compared to placebo in obese patients with hypercholesterolemia , treated over a period of 6 months . METHODOLOGY In a 6-month , multicenter ( 10 centers in Portugal ) , double-blind , parallel , placebo-controlled study , 166 patients , aged 18 - 65 years , body mass index ( BMI ) > or = 27 kg/m2 , LDL cholesterol > 155 mg/dl , were r and omized to a reduced calorie diet ( 600 kcal/day  deficit ) plus orlistat three times a day or placebo .  Exclusion criteria included triglycerides > 400 mg/dl , severe cardiovascular disease , uncontrolled hypertension , type 1 or 2 diabetes under pharmacological treatment , and gastrointestinal or pancreatic disease . RESULTS The mean difference in weight from baseline was 5.9 % ( 5.6 kg ) in the orlistat group vs. 2.3 % ( 2.2 kg ) in the placebo group . In the orlistat group 49 % of patients achieved 5 - 10 % weight loss and 8.8 % achieved > 10 % . The orlistat group showed a significant reduction in total and LDL cholesterol , with similar changes for HDL in both treatment groups . The frequency of gastrointestinal adverse events was slightly higher in the orlistat group than in the placebo group , leading to discontinuation in 7 patients . CONCLUSION Treatment with orlistat plus a reduced calorie diet for 6 months achieved significant reductions in weight , BMI and lipid parameters Orlistat lowers lipids and improves insulin sensitivity , but its effect on other metabolic syndrome related parameters is not known . To assess its influence on adiponectin , high sensitive C-reactive protein ( hs-CRP ) and other metabolic syndrome related parameters , this study enrolled 106 participants in a weight-reduction program and categorized them into a group of 51 who had been treated with orlistat 360 mg/day for one year and a group of 55 age and sex and body mass index ( BMI ) matched controls . The orlistat group had greater changes in BMI , % body fat ( % BF ) , waist circumference , and insulin resistance , hs-CRP , leptin and adiponectin levels after one year on the program than the controls . After adjusting for % BF and waist circumference , change of serum leptin and adiponectin levels remained significantly different . It was found that orlistat could effectively manage obesity related co-morbidities , especially insulin resistance and atherosclerosis risk . It decreases leptin and increases adiponectin independent of % BF and waist circumference . Therefore , orlistat appears to have anti-diabetic and anti-atherogenic properties and may help prevent metabolic syndrome in the overweight people BACKGROUND Orlistat is a gastrointestinal lipase inhibitor that reduces dietary fat absorption by approximately 30 % , promotes weight loss , and may reduce the risk of developing impaired glucose tolerance and type 2 diabetes  in obese subjects . OBJECTIVE To test the hypothesis that orlistat combined with dietary intervention improves glucose tolerance status and prevents worsening of diabetes status more effectively than placebo . METHODS We pooled data from 675 obese ( body mass index , 30 - 43 kg/m2 ) adults at 39 US and European research centers in 3 r and omized , double-blind , placebo-controlled multicenter clinical trials . Subjects received placebo plus a low-energy diet during a 4-week lead-in period . On study day 1 , the diet was continued , and subjects were r and omized to receive placebo 3 times a day ( n=316 ) or treatment with orlistat , 120 mg 3 times a day ( n=359 ) , for 104 weeks . A st and ard 3-hour oral glucose tolerance test was performed on day 1 and at the end of treatment . MAIN OUTCOME MEASURES The categorical assessment of glucose tolerance status ( normal , impaired , diabetic ) and changes in status from r and omization to end of treatment were the primary efficacy measures . The secondary measures were fasting and postchallenge glucose and insulin levels . RESULTS The mean length of follow-up was 582 days . Subjects who were treated with orlistat  lost more weight ( mean + /- SEM , 6.72 + /- 0.41 kg from initial weight ) than subjects who received placebo ( 3.79+/-0.38 kg ; P<.001 ) . A smaller percentage of subjects with impaired glucose tolerance at baseline progressed to diabetic status in the orlistat ( 3.0 % ) vs placebo ( 7.6 % ) group . Conversely , among subjects with impaired glucose tolerance at baseline , glucose levels normalized in more subjects after orlistat treatment ( 71.6 % ) vs placebo ( 49.1 % ; P=.04 ) . CONCLUSIONS The addition of orlistat to a conventional weight loss regimen significantly improved oral glucose tolerance and diminished the rate of progression to the development of impaired glucose tolerance and type 2 diabetes BACKGROUND We assessed and directly compared weight loss effects of sibutramine and orlistat treatment in a group of obese , poorly-controlled type 2 diabetic patients . METHODS This study recruited 34 diabetic subjects [ glycohemoglobin ( HbA1c ) > 8 % ] with a body mass index of at least 27 kg/m2 . A 36-week , three-phase , prospect i ve , r and omized , cross-over comparative study was conducted . In phase 1 , 34 patients were r and omly divided into two groups . One group received sibutramine for 3 months , then completed a 3 month wash-out period and , finally , shifted to orlistat for another 3 months . The second group followed the same procedure but received orlistat first and then sibutramine . The efficacy measures were rate of weight reduction , glycemic control , insulin sensitivity and cardiovascular risk factors , including waist circumference , lipid profiles and blood pressure . RESULTS The sibutramine-treated group achieved 2.0 kg ( 2.5 % ) weight loss with observable but not statistically significant changes in insulin sensitivity , glycemic control , and cardiovascular risk factors . There were no significant changes in systolic or diastolic blood pressure . The weight reduction in the orlistat-treated group was only 0.8 kg ( 0.9 % ) , which was significantly less than that of the sibutramine group . There were significant differences in total cholesterol , low density lipoprotein cholesterol and HbA1C . Direct comparative analysis revealed no significant differences between these two groups . CONCLUSION This study indicates that sibutramine treatment produced greater reduction in weight than orlistat in obese , poorly-controlled type 2 diabetic patients . However , no significant differences in waist circumference , and lipid or glucose levels were found between the two groups Objective : Accelerated gastric emptying of solids may play a role in the pathogenesis of obesity .  Orlistat , a potent lipase inhibitor , induces fat malabsorption and body weight loss but might accelerate gastric emptying as a result of suppressed CCK release . The aim was to investigate the role of fat restriction and lipase inhibition in CCK release and gastric emptying . Subjects : A total of 28 patients ( three male (M)/25 female ( F ) ; mean ( s.d . ) BMI 37.4(3.9 ) kg/m2 ) entering a r and omized , double-blind , placebo-controlled study . Measurements : CCK release and gastric emptying by scintigraphy at the start ( T0 ) , after 1 month of an energy- and fat-restricted diet and placebo ( T1 ) , and after 1 month ( T2 ) and 1 year ( T3 ) of r and omization to placebo or 120 mg orlistat three times a day . Results : One month of dieting and a weight loss of 2.3 kg ( 2.1 % of initial weight ) did not affect gastric emptying of liquids and solids . Basal and meal-stimulated CCK levels remained unaltered . Placebo-treated subjects who continued the diet for 1 month demonstrated a borderline significant suppressed CCK secretion and a weight loss of 1.2 kg ( 1.0 % ) without an effect on gastric emptying . After 1 year , the CCK secretion recovered to or beyond values at the start . A significantly slower emptying of solids ( 17.6 ( T3 ) versus 25.9 (T1)%/h ) and a weight loss of 10.4 kg ( 9.9 % ) was observed . Subjects on 120 mg orlistat lost 2.5 kg ( 2.5 % ) after 1 month , and 9.8 kg ( 9.9 % ) after 1 year . Basal and postpr and ial CCK release decreased significantly after the first month of orlistat treatment but normalized after 1 year . Diet and lipase inhibition did not have any influence on gastric emptying . Conclusion : Energy and fat restriction of 1 month did not alter gastric emptying in the whole group . Continuation of the diet for 1 year result ed in a delayed gastric emptying of solids . Lipase inhibition did not result in a sustained depressed CCK release and the anticipated acceleration of gastric emptying did not occur AIM To determine if obese non-insulin-dependent diabetic patients lose more weight when treated for 24 weeks ( 6 months ) with orlistat ( 120 mg t.i.d . ) , in conjunction with a hypocaloric diet plus behavioural counselling , than when treated by placebo ( t.i.d . ) plus similar instructions . The secondary objectives were to evaluate the effects on glucose profile and to determine the tolerability and safety of  orlistat . DESIGN Double-blind , parallel , r and omized , placebo-controlled , multicentre study . SUBJECTS Obese , non-insulin-dependent diabetic patients , aged 18 - 70 years old , with BMI > 27 kg/m2 , evaluated at 10 Latin-American centres , in five countries .  EFFICACY AND TOLERABILITY MEASUREMENTS : After screened , eligible patients passed by a 2-week placebo run-in period receiving a hypocaloric diet . On day 0 , patients were r and omized to orlistat or placebo for 24 weeks . At each visit , body weight , blood pressure and waist circumference were measured . At the screening visit , baseline visit ( week 0 ) , and at weeks 8 , 16 and 24 , a central laboratory was in charge of measuring fasting glucose and insulin , HbA1c , postpr and ial glucose and insulin , fasting total cholesterol , HDL-cholesterol , LDL-cholesterol , triglycerides , and postpr and ial triglycerides . Other safety laboratory assessment s were measured locally at the screening visit , baseline visit and at the end of the study . Adverse events were assessed at each visit from baseline . RESULTS After 24 weeks of treatment , the orlistat group lost an average of 4.7 % of initial body weight vs. 3.0 % in the placebo group ( p = 0.0003 ) . A greater weight loss was achieved in the orlistat compared with the placebo group ( 4.24 + /- 0.23 vs. 2.58 + /- 1.46 kg , p = 0.0003 ) . Almost twice as many patients receiving orlistat ( 30 % vs. 17 % ) lost > or = 5 % of initial body weight ( p = 0.003 ) . Orlistat treatment plus diet compared to placebo plus diet was associated with significant improvement in glycaemic control , as reflected in decreases in HbA1c ( p = 0.04 ) , fasting plasma glucose ( p = 0.036 ) and postpr and ial glucose ( p = 0.05 ) . Orlistat-treated patients had a mean decrease in glucose levels of 1.00 + /- 0.34 mmol/l [ 3.7 % ] vs. 0.01 + /- 0.30 mmol/l for placebo group , at week 24 and an absolute decrease of HbA1c of 0.61 + /- 0.15 vs. a decrease of 0.22 + /- 0.14 % in the placebo group . Orlistat therapy also result ed in significantly greater improvements than placebo in lipid profile , with reductions in total cholesterol ( p = 0.0001 ) and LDL-cholesterol ( p = 0.002 ) . Mild to moderate transient gastrointestinal events were reported , mainly with orlistat treatment , but their association with withdrawal from the study was low . CONCLUSION Orlistat is a useful and an effective therapy in obese diabetic patients , promoting clinical ly significant weight loss and improved glycaemic control and lipid profile AIMS To assess the effects of orlistat vs. placebo , in combination with a weight management programme , on weight loss and metabolic control in obese patients with Type 2 diabetes . METHODS Patients treated with either metformin alone or metformin in combination with sulphonylurea were r and omized to double-blind treatment with orlistat or placebo ( 120 mg ) three times daily , combined with a mildly reduced calorie diet and a weight management programme for 52 weeks . Changes in body weight , anthropometry , glycaemic control and lipid profile were assessed . RESULTS After 52 weeks , orlistat-treated patients achieved an almost threefold greater reduction in weight compared with placebo recipients ( -5.0 % vs. -1.8 % ; P<0.0001 ) . The decrease in waist circumference was significantly greater with orlistat than placebo ( -4.8 cm vs. -2.8 cm ; P=0.0022 ) . Orlistat treatment was also associated with significantly greater reductions in haemoglobin A(1c ) ( -1.1 % vs. -0.2 % ; P<0.0001 ) , fasting plasma glucose ( -1.9 mmol/l vs. -0.3 mmol/l ; P<0.0001 ) , total cholesterol ( -0.2 mmol/l vs. 0.1 mmol/l ; P=0.03 ) and apolipoprotein B ( -0.08 g/l vs. 0.01 g/l ; P=0.0085 ) and greater improvements in beta-cell function ( P=0.031 ) and insulin resistance ( P=0.001 ) assessed using the homeostasis model assessment ( HOMA ) . Similar results were obtained for subgroups of patients treated with metformin alone or metformin in combination with sulphonylurea . Orlistat treatment reduced the requirement for anti-diabetic medication more than placebo . CONCLUSIONS Orlistat , in combination with a reduced calorie diet and a weight management programme , promotes weight loss and clinical ly relevant improvements in glycaemic control and other cardiovascular risk factors in obese patients with Type 2 diabetes OBJECTIVE Moderate weight loss is recommended for overweight and obese patients with type 2 diabetes , and conjunctive use of weight loss medication has been advocated . The current study examined weight loss-dependent and -independent effects of the intestinal lipase inhibitor orlistat at 6 months of treatment , using behavioral intervention ( Int ) combined with r and omized , double-blinded , placebo (P)-controlled treatment with orlistat ( O ) . RESEARCH DESIGN AND METHODS Metabolic control , insulin sensitivity ( IS ) , regional fat distribution , and fat content in liver and muscle were measured in 39 volunteers with type 2 diabetes in whom all antidiabetic medication was withdrawn 1 month preceding r and omization .  Weight loss was equivalent in the Int+O and Int+P groups , respectively ( -10.3 + /- 1.3 vs. -8.9 + /- 1.1 % ) , and there were identical decreases in visceral adipose tissue ( VAT ) , fat mass ( FM ) , thigh adiposity , and hepatic steatosis . RESULTS Weight loss result ed in substantial improvement ( P < 0.001 ) in HbA(1c ) ( -1.6 + /- 0.3 vs. -1.0 + /- 0.4 % ; NS between groups ) . IS improved significantly more with orlistat ( Delta2.2 + /- 0.4 vs. Delta1.2 + /- 0.4 mg . min(-1 ) . kg(-1 ) fat-free mass [ FFM ] ; P < 0.05 ) , and plasma free fatty acid ( FFA ) levels were strongly correlated with IS ( r = 0.56 ; P < 0.001 ) . Orlistat caused greater reductions in fasting plasma FFA ( Delta-154 + /- 22 vs. Delta-51 + /- 33 micro mol/l ; P < 0.05 ) , insulin-suppressed FFA ( Delta-119 + /- 23 vs. Delta-87 + /- 34 micro mol/l ; P < 0.05 ) , and fasting plasma glucose ( FPG ; -62 + /- 9 vs. -32 + /- 8 mg/dl ; P = 0.02 ) . Changes in HbA(1c ) were correlated with DeltaIS ( r = -0.41 ; P < 0.01 ) but not with weight loss per se . CONCLUSIONS At equivalent weight loss , conjunctive use of orlistat result ed in greater improvement in FFA levels and IS Objective To investigate the hypothesis that weight reduction with orlistat plus mild caloric restriction leads to better blood pressure control than diet alone in obese individuals with inadequately controlled hypertension . Design This was a 1-year , prospect i ve , r and omized , double-blind , placebo-controlled , multicenter trial of orlistat plus diet versus placebo plus diet in obese hypertensives . Interventions Participants were r and omized to receive either orlistat or placebo ;  all received a 600 kcal deficient diet with no more than 30 % of calories from fat  . Weight and blood pressure , lipid levels and fasting glucose and insulin levels were followed . Main outcome measures Patients on orlistat  experienced greater weight loss ( −5.4 ± 6.4 versus −2.7 ± 6.4 kg , P < 0.001 ) and greater reduction in body mass index ( −1.9 ± 2.3 versus −0.9 ± 2.2 kg/m2 , P < 0.001 ) . Target weight loss , defined as ⩾ 5 % body weight ( BW ) , was obtained in more orlistat-treated patients than in the placebo group ( 46 versus 23 % , P < 0.001 ) . Diastolic BP decreased more in orlistat-treated patients than in the placebo group ( −11.4 ± 8.3 versus −9.2 ± 8.4 mmHg , P = 0.002 ) . A greater percentage of orlistat-treated patients reached goal diastolic blood pressure ( BP ) , defined as final diastolic BP < 90 mmHg or a reduction of at least 10 mmHg ( 67 versus 53 % , P < 0.001 ) . The orlistat-treated group had significantly greater reductions in total cholesterol ( P < 0.001 ) , low-density lipoprotein cholesterol ( P = 0.001 ) and non-high-density lipoprotein cholesterol ( P < 0.005 ) and target 30 % cardiovascular risk reduction was obtained in more orlistat-treated patients ( 36.1 versus 24.0 % , P < 0.04 ) . Conclusion A weight-loss program with orlistat is more effective than diet alone to lower blood pressure and results in greater cardiovascular risk reduction AIMS Orlistat promotes weight loss in overweight and obese patients with Type 2 diabetes receiving hypoglycaemic treatment , but has not been investigated in patients with newly diagnosed and previously untreated Type 2 diabetes . We evaluated the efficacy of 24 weeks ' treatment with orlistat , combined with a mildly reduced-calorie diet , on weight loss and glycaemic control in overweight and obese patients with newly diagnosed and previously untreated Type 2 diabetes . METHODS A total of 249 Chinese patients ( body mass index 25 - 40 kg/m2 ) with recently diagnosed Type 2 diabetes were r and omized to placebo ( n=124 ) or orlistat 120 mg ( n=125 ) three times daily ; all patients followed a mildly reduced-calorie diet .  Patients had HbA1c 6.5 - 8.5 % ( mean 7.3 % ) and had never received any glucose-lowering medication . RESULTS Orlistat-treated patients achieved significantly greater weight loss at the study end than placebo-treated patients ( -5.4 vs. -2.4 kg ; P<0.0001 ) . More orlistat than placebo patients lost > or=5 % ( 60.5 vs. 26.8 % ; P<0.0001 ) and > or=10 % of their body weight ( 20.2 vs. 4.9 % ; P=0.0002 ) . A significantly greater decrease in HbA(1c ) from baseline was obtained with orlistat than placebo ( -1.0 vs. -0.6 % ; P=0.0008 ) . Orlistat-treated patients achieved a significantly greater decrease in fasting plasma glucose ( -1.3 vs. -0.5 mmol/l ; P=0.0003 ) and in the 2-h oral glucose tolerance test ( -4.1 vs. -1.4 mmol/l ; P<0.0001 ) than placebo recipients . Also , more orlistat- than placebo-treated patients improved from diabetic status to normal or impaired glucose tolerance ( 44.3 vs. 32.5 % ; P=0.0763 ) after 24 weeks . Orlistat also produced improvements in lipid profiles and waist circumference . CONCLUSIONS In combination with a mildly reduced-calorie diet , orlistat significantly reduces body weight , and improves glycaemic control and several cardiovascular risk factors in overweight and obese Chinese patients with newly diagnosed Type 2 diabetes BACKGROUND & AIMS Orlistat is a weight management agent that selectively inhibits gastrointestinal lipase activity . Because of orlistat 's mode of action , increased fecal fat is presented to the colonic mucosa , and fecal bile acid and free fatty acid composition may be altered during treatment . Our aim was to assess the effect of treatment of obese subjects with orlistat 120 mg 3 times a day for 6 weeks on fecal lipid and bile acid parameters and colonic mucosal cell proliferation . METHODS Twenty-four obese ( body mass index , 30 - 40 kg/m2 ) but otherwise healthy male and female subjects were enrolled in a single-center , r and omized , double-blind , placebo-controlled  , parallel-group study . Participants were hospitalized during days 1 - 3 and 33 - 42 of treatment and were treated as out patients for the remaining days . RESULTS Treatment with orlistat for 6 weeks result ed in significantly greater increases in fecal weight , total fecal fat , and fecal free fatty acids than placebo .  Total fecal bile acid amounts decreased slightly with orlistat , and increased significantly with placebo treatment ( P < .05 between-group difference ) . Orlistat did not alter colonic cell proliferation as assessed by the 3 proliferative indices ( 5-bromo-2-deoxyuridine , whole crypt mitotic count , and proliferating cell nuclear antigen ) . CONCLUSIONS Biochemical changes in fecal composition related to the pharmacodynamic mode of action of orlistat are not accompanied by altered colonic cell proliferation , a putative biomarker of colon cancer risk OBJECTIVE The aim of this study was to evaluate the levels of adipose tissue related hormones , cytokines , and antioxidative substances in obese women before and after intervention with diet alone or with diet plus an inhibitor of gastrointestinental lipase-orlistat .  DESIGN Seventy-one obese women of childbearing age were included in the study and were r and omly assigned into two groups according to the type of intervention : group A1 ( n=35 ) included women who received  orlistat as well as a hypocaloric diet , and group A2 ( n=36 ) included women who were only on hypocaloric diet . The intervention period lasted 6 months . Anthropometric parameters , such as Body Weight ( BW ) , Body Mass Index ( BMI ) , Waist Circumference ( WC ) , and % Body fat ( BF ) were recorded . Insulin , leptin , resistin , interleukin-6 ( IL-6 ) , insulin like growth factor 1 ( IGF-1 ) , tumor necrosis factor alpha ( TNFalpha ) , adiponectin , hsC-reactive protein ( CRP ) , glutathione peroxidase , and isoprostane were determined by appropriate methodology prior to and following the 6-month intervention period . Insulin resistance was measured using the homeostasis model assessment index ( HOMA-IR ) . All participants had normal glucose tolerance . RESULTS In both groups B MI values were lower after intervention and all measured parameters were ameliorated . A statistically significant difference was found between group A1 ( orlistat plus diet ) and group A2 ( diet only ) with regard to the levels of triglycerides , CRP , TNF-alpha , IGF-1 , and isoprostane , even after correcting for weight loss . CONCLUSION Hypocaloric diet plus orlistat in obese women is superior to diet alone with regard to the changes observed in adipokines , CRP , TNFalpha , triglycerides , IGF-1 , and oxidative stress following intervention OBJECTIVE : To determine the effect of orlistat on weight reduction and the long-term maintenance of this weight loss when associated with a continuous mildly reduced energy diet . DESIGN : A multicenter , 18-month , double-blind study conducted in 81 hospital centers . Patients were r and omized to orlistat 120 mg or placebo three times daily in conjunction with a mildly reduced-energy diet maintained throughout the study .SUBJECTS : In total , 696 otherwise healthy , overweight patients aged 18–65 y ( BMI ≥28 kg/m2 ) were r and omized to treatment with orlistat ( n=346 ) or placebo ( n=350 ) . MEASUREMENTS : Body weight , anthropometry , lipid and glycemic control parameters and blood pressure . RESULTS : After 18 months , patients treated with orlistat lost significantly more body weight compared with placebo ( −6.5±0.8 vs −3.0±0.8 % ; P=0.0005 ) . After 12 months , 32.9 % of orlistat vs 24.5 % of placebo patients lost ≥10 % of their initial weight ( P=0.04 ) . A significantly greater number of patients receiving orlistat treatment maintained this ≥10 % weight loss compared to those receiving placebo ( 28.1 vs 13.8 % ; P<0.0001 ) . Compared with placebo , orlistat was associated with a greater decrease in fasting blood glucose ( −0.86±0.12 vs −0.29±0.18 mmol/l ; P<0.05 ) and LDL-cholesterol ( −13.0±1.3 vs −7.0±1.3 % ; P<0.001 ) . CONCLUSION : A clinical ly meaningful reduction in body weight and the maintenance of this weight loss is achievable with orlistat treatment and dietary restriction over a period of 18 months . This weight loss result ed in an improvement in risk factors for coronary heart disease BACKGROUND Leptin is likely to be involved in the homeostasis of body weight . Insulin is suggested to regulate both short-term and long-term circulating leptin levels . The present study aims to assess the relation between insulin and leptin levels in obese humans . METHODS Some 53 obese subjects ( body mass index 35.1 + /- 3.9 kg m-2 ( mean + /- SD ) ) were prescribed a hypocaloric diet and r and omized to either a placebo or the intestinal lipase inhibitor orlistat for 2 years .  Serum leptin and insulin levels were determined repeatedly during these 2 years ( 5 times in the fasting condition and twice after an oral glucose load ) . RESULTS Leptin concentrations appeared to be regulated at a specific level for each individual throughout the weight-loss period . The BMI explained 39.7 % of the total variance in leptin levels , the body-fat distribution 17.2 % , individual characteristics 30.3 % ; and the fasting serum insulin concentration 1.0 % . After a mean weight loss of 7.7 + /- 4.9 kg , the time-integrated insulin response to an oral glucose load was significantly lower but the leptin response remained unchanged . CONCLUSIONS The BMI is the main determinant of the circulating leptin concentration in obese humans . Individual characteristics seem to determine the leptin level , given the BMI . In a short-term observational study in obese humans , changes of insulin levels do not appear to be correlated to changes in leptin levels OBJECTIVE Orlistat decreases the absorption of dietary triglycerides by inhibiting intestinal lipases . Orlistat therapy is associated with a greater decline in plasma low-density lipoprotein-cholesterol concentrations than that expected from weight loss alone . Therefore , we evaluated the effect of orlistat treatment on dietary cholesterol absorption as a possible mechanism for the independent effect of orlistat on plasma cholesterol concentration . RESEARCH METHODS AND PROCEDURES Cholesterol absorption from a st and ardized meal , containing 72 mg of cholesterol , was determined in 18 subjects with class II abdominal obesity ( BMI , 35.0 to 39.9 kg/m(2 ) ) by simultaneous administration of intravenous ( [ (2)H(6 ) ] cholesterol ) and oral ( [ (2)H(5 ) ] cholesterol ) cholesterol tracers . In protocol 1 ( n = 9 ) , cholesterol absorption was determined on two different occasions , 10 to 20 days apart , to assess the reproducibility of the tracer method . In protocol 2 ( n = 9 ) , cholesterol absorption was determined with and without orlistat therapy in a prospect i ve , r and omized , crossover design to assess the effect of orlistat on cholesterol absorption . RESULTS In protocol 1 , cholesterol absorption from the test meal was the same on both occasions ( 53 + /- 5 % and 51 + /- 5 % ) . In protocol 2 , orlistat treatment caused a 25 % reduction in cholesterol absorption , from 59 + /- 6 % to 44 + /- 5 % ( p < 0.01 ) . DISCUSSION These data demonstrate that orlistat inhibits dietary cholesterol absorption , which may have beneficial effects on lipoprotein metabolism in obese subjects that are independent of weight loss itself
Orlistat  reduced body weight ( weighted mean difference : −2.12 , p < 0.001 ) , total‐cholesterol ( weighted mean difference : −0.30 mmol/L , p < 0.001 ) , low‐density lipoprotein cholesterol ( weighted mean difference : −0.27 mmol/L , p < 0.001 ) , high‐density lipoprotein cholesterol ( weighted mean difference : −0.034 mmol/L , p < 0.001 ) and triglyceride ( weighted mean difference : −0.09 mmol/L , p < 0.001 ) concentrations , while no effect on lipoprotein(a ) was observed .
Total‐ and low‐density lipoprotein cholesterol‐lowering were associated negatively with duration of orlistat treatment and positively with body weight changes .
In conclusion , Orlistat treatment slightly reduces cholesterol and triglyceride levels , but not lipoprotein(a ) levels .
Total‐ and low‐density lipoprotein cholesterol levels reductions are more consistent in patients with greater body weight reduction and shorter duration of orlistat treatment .
We investigated the efficacy of orlistat on plasma lipids and body weight in a meta‐ analysis of 33 studies including 9732  participants .Orlistat  was associated with a slight but significant decrease in body weight , plasma cholesterol and triglyceride concentrations , whereas plasma Lp(a ) levels were not affected by orlistat treatment .
Greater body weight reduction and lower duration of orlistat treatment promoted more consistent plasma total‐ and LDL‐cholesterol lowering
& NA ; Orlistat , an inhibitor of intestinal lipase , promotes body weight reduction .
The lipid‐lowering efficacy of orlistat is controversial and the effect of orlistat‐induced body weight reduction on lipid changes has not been explored in meta‐regression analyses .
HighlightsOrlistat is an inhibitor of intestinal lipase promoting body weight reduction , but whose lipid‐lowering efficacy is controversial .