[Efficacy and safety of vardenafil for kidney transplant recipients with erectile dysfunction]. Efficacy and safety of vardenafil in renal transplant recipients with erectile dysfunction. Reversal of uraemic impotence by zinc. Effect of vitamin E therapy on sexual functions of uremic patients in hemodialysis. Efficacy of oral sildenafil in hemodialysis patients with erectile dysfunction. The efficacy of sildenafil for the treatment of erectile dysfunction in male peritoneal dialysis patients. Influence of 1,25 dihydroxycholecalciferol on sexual dysfunction and related endocrine parameters in patiens on maintenance hemodialysis. Effects of sildenafil and vardenafil on erectile dysfunction and health-related quality of life in haemodialysis patients: a prospective randomized crossover study. Effect of oral zinc therapy on gonadal function in hemodialysis patients. A double-blind study. Bromocriptine improves reduced libido and potency in men receiving maintenance hemodialysis. Treatment of erectile dysfunction with sildenafil citrate in renal allograft recipients: a randomized, double-blind, placebo-controlled, crossover trial. Absence of a therapeutic effect of zinc in the sexual dysfunction of haemodialysed patients. Improved sexual function in male haemodialysis patients on bromocriptine.
To evaluate the efficacy and safety of vardenafil in kidney transplant recipients with erectile dysfunction.
                Thirty-nine kidney transplant recipients with erectile dysfunction (ED) and serum creatinine values <2 mg/dl were enrolled in a 4-week randomized, double blind, placebo-controlled study, 19 treated with placebo and 20 with vardenafil. Vardenafil efficacy was assessed with the IIEF questionnaire after 4 weeks of treatment, and its safety appraised by measuring serum creatinine levels, creatinine clearances and cyclosporine concentrations before and after the treatment.
                IIEF scores improved from 12.6 +/- 3.4 to 26.5 +/- 2.8 (P < 0.01), but renal function and cyclosporine concentrations remained unchanged in the vardenafil-treated patients. Adverse effects were observed in 4 patients: headache in 2, palpitation and flush in 1, and dyspepsia in the other.
                Oral vardenafil therapy has a high efficacy and a low incidence of adverse events for kidney transplant recipients with ED. Erectile dysfunction (ED) profoundly affects the quality of life. The prevalence of ED in renal transplant recipients is reported by high as 50% to 60%. We evaluated the efficacy and safety of vardenafil in these patients with ED as well as its effects on graft function and on cylosporine or tacrolimus concentrations. Thirty-nine recipients with ED and serum creatinine values<2 mg/dL were treated with vardenafil. ED was assessed using the self-administered International Index of Erectile Function (IIEF). ED was diagnosed by using penile color-Doppler ultrasonography and intracavernosal injection. Vardenafil efficacy was assessed by readministering the IIEF questionnaire after 4 weeks of therapy. Serum creatinine levels, creatinine clearances, and cyclosporine/tacrolimus concentrations were measured before and after vardenafil therapy. Twenty-one recipients with ED served as placebo controls and 15 without ED as another control group. The IIEF scores improved from 12.80+/-3.5 to 26.46+/-2.4 in vardenafil-treated patients with ED (P<.001). Renal function and cyclosporine/tacrolimus concentrations did not change with vardenafil therapy. Side effects were observed in 7 (18%) patients: headache in three, palpitations in one, flushing in two, and dyspepsia in one. This study demonstrated that ED improved with vardenafil in renal transplant recipients with ED. For 4 weeks vardenafil therapy was free of side effects. Renal function tests did not change. Also, no dose change in immunosuppressive drugs was required during 4 weeks of verdanafil therapy. In eight impotent haemodialysed men with low plasma-zinc levels sexual function, including potency, frequency of intercourse, libido, and plasma testosterone, follicle-stimulating hormone, and luteinising hormone levels, was determined before and after therapy with zinc (four patients) or placebo (four patients). Dialytic administration of zinc strikingly improved potency in all patients and raised the plasma-testosterone to normal in the two with low pretreatment plasma-testosterone levels. Placebo did not improve sexual function in any patient. Zinc deficiency is a reversible cause of gonadal dysfunction in uraemia. Twenty-four uremic patients on hemodialysis who had never been treated with vitamin E or related drugs and 12 control patients with normal renal function were studied. Hemodialysis patients were randomly divided into two groups; 12 were treated with oral vitamin E (300 mg/day) for eight weeks and 12 uremic patients and 12 controls were given placebo. Serum vitamin E, prolactin, FSH, LH, and free testosterone levels were measured in all patients before and after treatment. After the vitamin E treatment serum prolactin levels were significantly decreased (50.8 vs 15.4 ng/ml, p < 0.01). Vitamin E levels were significantly increased (1.11 vs 1.22 mg/dl, p < 0.05). Serum FSH, LH and free testosterone were not affected. In the other two groups there were no significant changes. These results show that vitamin E treatment lowers prolactin levels in uremic hemodialysis patients. This might be due to inhibition of central prolactin secretion. Vitamin E inhibits pituitary gland hypertrophy in vitamin E-deficient rats. The aim of this study was to evaluate the efficacy and safety of oral sildenafil to treat erectile dysfunction (ED) in chronic renal failure in patients on hemodialysis (HD). A double-blind, randomized, placebo-controlled study of oral sildenafil (50 mg) administered as required in HD patients with ED was designed. Patients on HD for at least 6 mo and who had a stable relationship with a female sexual partner were included. Patients older than 70 yr with penile anatomic abnormalities, cirrhosis, diabetes, angina, severe anemia, and those who were on nitrate treatment or with a recent history of stroke or myocardial infarction were not included. The International Index of Erectile Dysfunction (IIEF) was employed to evaluate ED and treatment response. Forty-one patients were evaluated (21 received placebo, and 20 sildenafil). Baseline clinical and demographic parameters were similar in both groups. Sildenafil was associated with improvement in the score of all questions and domains of the IIEF, except those related to sexual desire. Using the erectile function domain to evaluate primary efficacy, improvement was observed in 85% of the sildenafil patients compared with 9.5% of placebo patients. Sildenafil use resulted in normal EF scores in 35% of sildenafil patients. Sildenafil was well tolerated. Headaches and flushing occurred in both groups. Dyspepsia was reported by two patients in the sildenafil group. In conclusion, oral sildenafil seems to be an effective and safe treatment for ED in selected patients with chronic renal failure on hemodialysis. The aim of this study was to evaluate the safety and effectiveness of sildenafil in male peritoneal dialysis patients with erectile dysfunction.
                Sixteen peritoneal dialysis patients were recruited to this prospective, randomized, double-blind, placebo-controlled, crossover study of sildenafil during a period of 8 weeks. Efficacy was assessed by using the International Index of Erectile Function and a Global Assessment Question. Penile arterial supply was assessed by means of Doppler ultrasound in all patients, and adverse events were recorded.
                Three patients failed to complete the study (1 patient received a renal transplant, 1 patient died unrelated to the study, and 1 patient withdrew for personal reasons). In the remainder, there was a significant improvement in erectile function with sildenafil compared with placebo (P = 0.01) and the baseline assessment (P = 0.002). There were also significant improvements in intercourse satisfaction (P = 0.002) and overall satisfaction (P = 0.005) compared with baseline. In response to the Global Assessment Question, 75% of patients reported improvement in erections. Only 1 adverse event was reported: a headache, which resolved after the third dose of sildenafil.
                Sildenafil caused a significant improvement in erectile function in peritoneal dialysis patients, with a success rate at least as high as that reported in other patient groups. The drug was well tolerated, with few adverse events. It has been postulated that hyperparahyroidism is in part responsible for sexual dysfunction in dialyzed patients and that this could improved by 1,25(Oh)2D3. In a single blind study patients on maintenance hemodialysis were treated after a control period with 1,25 (OH)2D3 and with placebo in random order. Sexual performance was assessed with a detailed semistructured psychiatric interview protocol in 14 and several endocrine parameters were analyzed in 15 patients. Under control conditions sexual function was disturbed in 11/14 patients. Plasma testosterone was moderately decreased in men, PRL and PTH levels were distinctly elevated in both sexes. 1,25(OH)2D3 raised serum calcium levels significantly from 9.6 to10.6 mg/100 ml ( P < 0.01) and lowered PTh from 1.39 to 0.82 ng/ml ( P < 0.01). However, no improvement in sexual function (such as libido, frequency of intercourse or masturbation) was found, and apart from a slight rise of testosterone in men and moderate fall of PRl in men and women endocrine parameters remained unchanged. It is concluded that in spite of an improvement of secondary hyperparathyroidism, treatment with 1,25(OH)2D3 for 2 to 4 months was of no value in improving sexual dysfunction in these hemodialysis patients. Erectile dysfunction (ED) is prevalent in end-stage renal disease (ESRD) and has been associated with impaired health-related quality of life (HRQoL). HRQoL, in turn, is related to morbidity and mortality in ESRD patients. Previous studies have shown improved HRQoL with ED treatment using sildenafil and vardenafil. However, no study has examined the effects of sildenafil or vardenafil on HRQoL in impotent ESRD patients. Furthermore, vardenafil has never been tested and its safety profile has not been determined in ESRD patients. The aim of this randomized crossover study was to compare the effects of sildenafil and vardenafil on measures of HRQoL and on ED scores as well as to determine the safety profile of vardenafil in ESRD patients.
                In 32 haemodialysis patients with impotence, ED and HRQoL were evaluated by the International Index of Erectile Function (IIEF-5) and the 36-item Short-Form Health (SF-36) surveys, respectively. Patients were randomized into sildenafil and vardenafil groups. After a 4-week treatment and 2-week washout periods, crossover was performed and an additional 4-week treatment was administered. IIEF-5 and SF-36 surveys were given before and after each treatment period. Adverse effects were evaluated by interview. Friedman tests and Bonferroni-adjusted Wilcoxon signed-rank tests were used to compare groups and for post hoc analysis, respectively.
                IIEF-5 and SF-36 scores were significantly improved by both sildenafil and vardenafil compared to pretreatment values. There were no differences between sildenafil and vardenafil with respect to the studied parameters. Adverse effect profiles were also similar. No patient dropped out because of side effects.
                Sildenafil and vardenafil caused similar improvements in ED and HRQoL in haemodialysis patients. Vardenafil was well tolerated in our patient population. Zinc deficiency may account for the persistence of gonadal dysfunction in a majority of uremic men despite adequate dialysis. Twenty stable patients having hemodialysis three times a week completed a double-blind trial using either 50 mg of elemental zinc as zinc acetate (10 patients) or placebo (10 patients), orally. At the end of the 6-month study period, a significant increase in the mean (+/- SE) plasma zinc (75 +/- 2 micrograms/dL to 100 +/- 2 micrograms/dL, p less than 0.001), serum testosterone (2.8 +/- 0.3 ng/dL to 5.2 +/- 0.5 ng/mL, p less than 0.001), and sperm count (30 +/- 3 million/mL to 63 +/- 5 million/mL, p less than 0.001) occurred in the zinc-treated group, but not in those receiving the placebo. The zinc-treated group also had a significant fall in serum luteinizing hormone (92 +2- 10 mIU/mL to 49 +/- 26 mIU/mL, p less than 0.005) and follicle stimulating hormone (45 +/- 9 mIU/mL to 25 +/- 7 mIU/mL, p less than 0.05), not seen in the placebo group. Patients receiving zinc had an improvement in potency, libido, and frequency of intercourse not found in the placebo group. These results suggest that zinc deficiency is a reversible cause of gonadal dysfunction in patients having regular hemodialysis. Twenty-five men on maintenance hemodialysis commenced a placebo-controlled, double-blind, crossover trial of bromocriptine for erectile impotence. Eight patients on bromocriptine and one on placebo failed to complete the trial due to side-effects and 2 were withdrawn following renal transplantation. Libido or the frequency and/or quality of erections or both improved in 11 of the remaining 14 patients during bromocriptine treatment. A significant (P less than 0.01) improvement in patients' perception of sexual performance occurred on bromocriptine compared with placebo. The 3 patients in whom potency failed to improve had the lowest serum testosterone concentrations. Bromocriptine is usually effective in the management of impotence in males receiving maintenance hemodialysis provided pretreatment serum testosterone is above the lower end of the normal range, but side-effects are relatively common. Erectile dysfunction (ED) is observed frequently in patients with end-stage renal disease, hemodialysis patients, and renal allograft recipients. There are few studies of sildenafil use in renal allograft recipients.
                The study is designed as a randomized, double-blind, placebo-controlled, crossover trial. Efficacy was assessed by using the self-administered International Index of Erectile Function (IIEF), a 15-question validated measure of ED, and a global efficacy question (Did the treatment improve your erection?).
                Thirty-two eligible renal transplant recipients were included in this study. After treatment with sildenafil citrate, patients had significantly better scores in 13 of 15 questions, except for questions 11 (desire frequency; P = 0.39) and 12 (desire level; P = 0.61). Treatment efficacy assessed through questions 3 (penetration ability; P < 0.001) and 4 (maintenance frequency; P < 0.001) was significantly better after sildenafil therapy. There were no significant differences between baseline and post-placebo treatment scores, except for question 13 (relationship satisfaction). Patients treated with sildenafil had significantly better scores in 4 domains compared with baseline, but a difference was not observed in the sexual desire domain (P = 0.32). There were no significant differences in scores between placebo and baseline in any domain. On the global efficacy question, 81.3% of patients showed improvement compared with 18.7% with placebo. There were no differences in areas under the curve and maximum cyclosporine concentrations before and after sildenafil therapy. No patient discontinued the drug because of side effects except for 1 patient with visual hallucination.
                Treatment with sildenafil in renal transplant recipients is a valid option with an effective response. The effect of zinc therapy and placebo on sexual function and endocrine status was investigated in a double-blind study of 14 male patients with chronic renal failure on regular haemodialysis. Zinc chloride was added to the dialysate of 7 patients for 6 weeks, raising the serum zinc concentration by 17% and placebo was added to the dialysate of the other patients. At the start of the trial 9 patients said they had decreased sexual function. Records of penile erectile activity during sleep confirmed the organic nature of the sexual dysfunction. Plasma testosterone concentrations were low or in the low normal range, basal serum luteinising-hormone levels were raised, and the early luteinising-hormone response to luteinising-hormone-releasing hormone was exaggerated, suggesting primary testicular failure. Zinc administration had no significant effect on any aspect of sexual function assessed by questionnaire or nocturnal penile tumescence monitoring. Plasma testosterone and basal and stimulated gonadotrophin levels were also unaltered by zinc administration. The effect of bromocriptine on sexual activity was studied in male haemodialysis patients in a single-blind placebo controlled trial with random cross-over. At a dose of 2.5 mg bromocriptine twice day, plasma-prolactin concentrations were consistently reduced, while sexual function as assessed by a questionnaire was markedly improved. At the doses used, side-effects, particularly hypotension, were common, but bromocriptine helped to restore sexual function in dialysed patients.
PDE5i and zinc are promising interventions for treating sexual dysfunction in men with CKD. Evidence supporting their routine use in CKD patients is limited. There is an unmet need for studying interventions for both male and female sexual dysfunction in CKD, considering the significant disease burden.