Efficacy and safety of oral sildenafil citrate (Viagra) in the treatment of male erectile dysfunction in Colombia,Ecuador, and Venezuela: a double-blind,multicenter, placebo-controlled study

The objective of this work was to assess the efficacy and safety of sildenafil in patients with erectile dysfunction (ED) from Colombia, Ecuador, and Venezuela. One hundred and fifty-eight outpatients with ED participated in a double-blind, flexible-dose, randomized-controlled trial. Efficacy measures included question 3 (achieving an erection) and question 4 (maintaining an erection) from the International Index of Erectile Function (IIEF), the five functional domains of the IIEF, a global efficacy question, and patient event log. Sildenafil increased patients' ability to achieve/maintain erections (P<0.01). Seventy-seven per cent of sildenafil- vs 46% of placebo-treated patients reported improved erections (P<0.001). Sixty-five percent and 35% of intercourse attempts were successful among sildenafil and placebo patients, respectively (P<0.05). Sildenafil patients showed significant improvements in three of the five IIEF functional domains (P<0.05). Adverse events were reported for 51% and 33% of sildenafil and placebo patients, respectively. It can be concluded that sildenafil is an effective, well-tolerated treatment for ED in patients from Latin America.     

Efficacy and safety of fixed-dose oral sildenafil in the treatment of sexual dysfunction in depressed patients with idiopathic Parkinson's disease

OBJECTIVE AND METHODS: The efficacy and safety of oral Sildenafil, a potent inhibitor of phosphodiesterase type 5, were evaluated in depressed men with idiopathic Parkinson's disease and erectile dysfunction. Thirty-three men were enrolled in a 4-month prospective, open-label, fixed-dose study, and received 50mg of Sildenafil in the home setting approximately 1 hour before sexual activity, not more than once daily. Efficacy was determined by responses to question 3 (ability to achieve an erection) and question 4 (ability to maintain an erection) of the 15-item International Index of Erectile Function (IIEF). Other measures of efficacy included the five sexual function domains of IIEF, a global efficacy question, the Beck Depression Inventory (BDI) and the Hamilton Depression Rating Scale-21 (HDRS-21). RESULTS: At the end of the study, improved erections were reported by 84.8% of patients. Sildenafil significantly increased patients' ability to achieve and maintain erections. Significant improvements were also observed in the IIEF domains for erectile function, orgasmic function, intercourse satisfaction and overall sexual satisfaction. BDI and HDRS scores improved from baseline to the end of the study. A clear improvement of depressive symptoms was observed in 75% of patients. Sildenafil was well tolerated in all the patients. CONCLUSIONS: Treatment with oral Sildenafil improves erectile function and, indirectly, depressive symptoms in patients with idiopathic Parkinson's disease stages 1-3, and is well tolerated.     

A dose-escalation study to assess the efficacy and safety of sildenafil citrate in men with erectile dysfunction

OBJECTIVE: To assess the efficacy and safety of sildenafil citrate (Viagra, Pfizer Inc., USA) in a double-blind, placebo-controlled, dose-escalation study over a period of 26 weeks in men with erectile dysfunction of a broad spectrum of aetiology. PATIENTS AND METHODS: In all, 315 patients from five countries were randomized to receive treatment with placebo (156 men) or sildenafil (159 men). Significant concomitant medical conditions were hypertension (20%), a history of pelvic surgery (19%), diabetes mellitus (15%), and ischaemic heart disease (10%). Patients randomized to treatment received a starting dose of 25 mg of sildenafil or matching placebo, which could be increased to 50 mg and then to 100 mg of sildenafil, based on efficacy and tolerability. Assessments of efficacy comprised the 15-item International Index of Erectile Function (IIEF), including question three (ability to achieve an erection) and question four (ability to maintain an erection), a partner questionnaire, an overall efficacy question, and event-log data. RESULTS: After 12 weeks of treatment, 26%, 32% and 42% of patients were taking 25, 50 and 100 mg of sildenafil, respectively. A similar distribution of doses was reported after 26 weeks of treatment. Treatment with sildenafil significantly improved the patients' abilities to achieve and maintain an erection compared with treatment with placebo (P < 0.001). Scores for four of the five sexual function domains of the IIEF (erectile function, orgasmic function, intercourse satisfaction and overall satisfaction) also improved significantly (P < 0.001). There was a significant improvement in the mean score for the erectile function domain, regardless of the aetiology of erectile dysfunction (P < 0.001). After 12 weeks and 26 weeks of treatment, 82% and 79% of patients receiving sildenafil reported improved erections, compared with 24% and 23% of patients receiving placebo, respectively (P < 0.001). Treatment-related adverse events were mild to moderate and occurred in 27% of patients receiving sildenafil, compared with 8% of patients receiving placebo. CONCLUSION: Sildenafil is an effective and well-tolerated treatment for men with erectile dysfunction of a broad spectrum of aetiology.     

Long-term efficacy and safety of oral Viagra (sildenafil citrate) in men with erectile dysfunction and the effect of randomised treatment withdrawal

The long-term efficacy and safety of oral Viagra (sildenafil citrate), a selective phosphodiesterase 5 inhibitor, and the effect of withdrawing treatment were evaluated in men with erectile dysfunction (ED). In 233 men with ED of psychogenic or mixed organic/psychogenic aetiology, 16 weeks of open-label, flexible-dose sildenafil treatment (10-100 mg) was followed by eight weeks of double-blind, fixed-dose, randomised withdrawal to placebo or continued treatment with sildenafil. Sildenafil was taken as needed (not more than once daily) approximately 1 h prior to sexual activity. The main outcome measures were a global efficacy question, a sexual function questionnaire, an event log of erections, and adverse event recording. In the open-label phase, 200 of 216 patients (93%) reported improved erections with sildenafil; 28 patients (12%) discontinued treatment. In the double-blind phase, the significant improvements in the frequency and duration of erections were maintained in the sildenafil group but returned to pre-treatment values in patients on placebo (P values < 0.0001 versus placebo). The most frequent adverse events in the sildenafil group during the double-blind phase were flushing (7%), headache (6%), and dyspepsia (5%). Of the 192 patients enrolled in the 1-y extension, 90% completed the study; only two patients (1%) were withdrawn due to lack of efficacy. In men with ED of psychogenic or mixed aetiology, oral sildenafil is effective and well-tolerated both at the initiation of therapy and during long-term treatment. For most patients, sildenafil treatment must be continued for improvements in erectile function to be maintained.     

Sildenafil citrate (Viagra) for the treatment of erectile dysfunction in Nigerian men

Fifty-eight Nigerian outpatients with documented erectile dysfunction (ED) received open-label sildenafil citrate (Viagra) for 8 weeks. The 50-mg starting dose could be adjusted to 100 or 25 mg based on response and tolerability. The International Index of Erectile Function (IIEF) Questionnaire, a global efficacy question, and intercourse data recorded in a patient event log were used to assess efficacy. Frequency of penetration and maintained erection were both significantly enhanced (P<0.0001); 95% of patients reported improved erections and 81% of all attempts at intercourse were successful. Orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction also improved significantly (P&<0.0001). The most frequent adverse events (all-cause) were headache (17%) and myalgia (3%); only one patient discontinued treatment because of headache, which was considered unrelated to sildenafil. Oral sildenafil significantly improved erectile function and was well tolerated in this trial of Nigerian men suffering from ED. Our results are consistent with reports from other countries.     

Efficacy and safety of flexible-dose oral sildenafil citrate (Viagra) in the treatment of erectile dysfunction in Brazilian and Mexican men

A 12-week, double-blind, placebo-controlled, multicenter study evaluated the efficacy and safety of flexible-dose sildenafil citrate (Viagra) treatment (25, 50 or 100 mg) in Brazilian and Mexican men with erectile dysfunction (ED) of broad-spectrum etiology. Efficacy was assessed on the basis of responses to the 15-item International Index of Erectile Function (IIEF) questionnaire, completed at baseline and after 12 weeks of treatment. At end point, mean scores for all IIEF domains of sexual function (erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction) were significantly (P<0.0001) higher in the sildenafil group (n=109) than in the placebo group (n=105). These findings confirm the significant increases in frequency of penetration and frequency of maintained erections reported previously. Sildenafil treatment was well tolerated. The most common adverse events were headache and flushing. In conclusion, sildenafil is a well-tolerated and effective treatment for ED of broad-spectrum etiology in Latin American men.     

Sildenafil does not improve sexual function in men without erectile dysfunction but does reduce the postorgasmic refractory time

Sildenafil is one of two oral drugs approved for first-line treatment of erectile dysfunction (ED). Anecdotally, some young healthy men who wish to enhance their sexual performance are requesting or abusing sildenafil. In this randomized double-blind, placebo-controlled clinical study, we investigated the effect of sildenafil in young men without ED. A total of 60 young healthy men age 20-40 y with no reported ED were enrolled for this single-dose home-use study. Subjects had used no medication in the 6 months prior to the study. All had been engaged in a stable relationship for at least 3 months. After completing the IIEF-5 questionnaire, patients were randomized in a double-blind fashion to receive either one 25 mg tablet of sildenafil (group 1) taken prior to intercourse, or an identical placebo tablet (group 2). All subjects completed a questionnaire relating to their erectile quality. There were no differences between the two groups in the reported improvement of erection quality, 12/30 sildenafil vs 10/30 placebo (Fisher's test, P=0.79). Sildenafil caused a significant reduction of the postejaculatory refractory time (12/30 vs 4/30) (chi(2) test, P=0.04). Sildenafil does not improve erections in young healthy men. Sildenafil should not be given to young healthy men to improve their erections and patients should be advised against recreational abuse of the drug. In this limited single-dose home study, sildenafil appears to reduce the postorgasmic refractory time. Although controlled studies are needed to evaluate the efficacy of erection-enhancing drugs in premature ejaculation, it is possible that sildenafil might be useful for this indication.     

万艾可治疗勃起功能障碍的疗效和安全性

目的 :评估万艾可 (Viagra○R)治疗男性勃起功能障碍 (ED)的有效性和安全性。　方法 :本试验为双盲、随机(安慰剂 :西地那非 ,1:3)、安慰剂对照、剂量可调整 (2 5、5 0和 10 0mg)、持续 12周的临床研究。共有 84名受试者参与本研究。　结果 :对主要疗效指标 (IIEF问题 3、4)的分析结果显示 ,万艾可对ED病人达到和维持勃起能力的改善作用显著优于安慰剂 (P <0 .0 0 0 1) ,万艾可的临床总有效率为 86 % ,显著高于安慰剂 (37% ) ;对心理性、器质性和混合性ED的有效率分别为 83%、79%和 81% (安慰剂组分别为 5 0 %、33%和 30 % )。同时 ,对次要疗效指标评估 (IIEF其余 13个问题、记事表和总评题 )亦显示 ,万艾可改善性生活的作用明显优于安慰剂 ;万艾可组性交成功率平均为71.8% ,显著高于安慰剂组 (17.0 % ) ;有 87.3%的万艾可组受试者认为研究药物改善了其勃起功能 ,显著高于安慰剂组 (36 .8% )。无 1名受试者因不良事件而中断研究 ,万艾可组的不良事件发生率 (33.3% )较安慰剂组高(19.0 % ) ,但绝大多数为轻度、一过性的。　结论 :口服万艾可是一种可治疗各种病因导致的勃起功能障碍安全有效的药物 ,按需服用时能很好耐受。     

Comparison of the efficacy and safety of sildenafil citrate (Viagra) and oral phentolamine for the treatment of erectile dysfunction

This open-label, multi-center study from Mexico compared the efficacy and safety of oral sildenafil and phentolamine in men with erectile dysfunction. Patients received sildenafil (25-100 mg; n=123) or phentolamine (40 mg; n=119) for 8 weeks, and efficacy was assessed using the International Index of Erectile Function (IIEF) as well as two global efficacy questions. Mean scores for the erectile function domain of the IIEF were significantly higher for sildenafil (27.23 +/- 0.62; P=0.0001) than for phentolamine (19.35 +/- 0.66). Approximately twice as many men receiving sildenafil had successful attempts at sexual intercourse (88% vs 42%), improved erections (95% vs 51.1%), and improved ability to have sexual intercourse (94.4% vs 46.4%) compared with phentolamine. The most common adverse events included rhinitis, headache, tachycardia, and nausea, with a higher frequency reported in patients receiving phentolamine than sildenafil (41% vs 33%), with the exception of headache, which was reported more frequently in sildenafil users. Overall, sildenafil was more effective and appeared to be better tolerated than phentolamine for the treatment of erectile dysfunction.     

口服伐地那非治疗勃起功能障碍疗效和安全性的临床研究

目的 :评价伐地那非对男性勃起功能障碍 (ED)患者的疗效和安全性。　方法 :应用随机、双盲、安慰剂平行对照、剂量固定 (5、1 0和 2 0mg)方法 ,对 88例ED患者进行 1 2周的临床研究。　结果 :5、1 0和 2 0mg伐地那非使ED患者达到和维持勃起的临床主要和次要指标均明显高于安慰剂 (P <0 .0 1 ) ;伐地那非各剂量组不良事件发生率高于安慰剂组 ,均为轻至中度 ,呈一过性。　结论 :伐地那非是治疗各种病因导致ED的安全、有效的药物。     

Sildenafil in the treatment of sexual dysfunction in spinal cord-injured male patients

OBJECTIVES: The aim of this study was to evaluate the efficacy and safety of sildenafil in the treatment of erectile dysfunction (ED) in spinal cord-injury (SCI) patients. Moreover, we looked for neurological conditions permitting therapeutic success and for the ideal dose needed to achieve sufficient erections. METHODS: 41 SCI patients were prospectively examined. Sexual dysfunction was assessed by means of anamnesis, the International Index of Erectile Function (IIEF) questionnaire, and neurological examination. Psychogenic erection capacity was tested by audiovisual stimulation and reflexive erection using a vibrator device. Neurophysiological recordings and cystomanometry were performed in parallel to clinical examinations. Neurophysiological recordings included sympathetic skin responses (SSR), pudendus somatosensory evoked potentials (pSSEP), and bulbocavernous reflex (BCR). Urodynamics aimed at classifying the neurogenic bladder dysfunction (upper motoneuron lesion versus lower motoneuron lesion). Intracavernous injection tests with PGE1 were performed in all patients to exclude major organic disease. 50 mg sildenafil was first given 3 times. Thereafter, the doses were adapted according to patients' reports. RESULTS: Clinically, 28 subjects preserved either reflexive erections (24) or psychogenic erections (4), 11 had both types and only 2 presented with a complete loss of erection. 38 patients (93%) had a positive response to sildenafil and reached a penile rigidity sufficient to permit sexual intercourse. 3 patients dropped out because of non-response despite having increased the dosis up to 100 mg. 22 patients (58%) showed functional erections 1 h after 50 mg sildenafil, whereas 14 (37%) required higher doses of 75-100 mg. By comparing the IIEF questionnaire scores before and after therapy, there was a significant improvement in erectile function and intercourse satisfaction from 9.2+/-4.4 SD) and 4.5 (+/-2.5 SD) to 25.5 (+/-4.2 SD) and 10.5 (+/-2.1 SD) points, respectively (p<0.05). Nearly 10% (4/41) suffered from side effects such as headache or dizziness. Two of them stopped therapy because of the side effects. At least 36 patients (88%) continue treatment with sildenafil. Absence of both psychogenic (nonsomesthetic supraspinally elicited) and reflexive (somesthetic spinally elicited) erections, confirmed by urodynamical and electrophysiological findings (SSR perineum, BCR and pSSEP), seems to exclude a successful treatment. In contrast, SCI male patients with preserved function of at least one component of the erection phenomenon (psychogenic/reflexive) responded well to sildenafil and the dose required to achieve erections sufficient for sexual intercourse did not differ between the two groups. CONCLUSIONS: Sildenafil proves to be a valuable and safe therapeutic management in ED of SCI patients. Therefore, patient acceptance and satisfaction are high. The most common dose required to achieve a satisfying erection is 50 mg. The efficacy of sildenafil depends on sparing of either sacral (S2-S4) or thoracolumbar (T10-L2) spinal segments which, in this study, have been shown to be of relevance in mediating psychogenic erections in male SCI patients. Complete disturbance of any neurogenic impulses excludes successful treatment.     

Cross-Study Review of the Clinical Efficacy of Apomorphine SL 2 and 3 mg:: Pooled Data from Three Placebo-Controlled,Fixed-Dose Crossover Studies

Background: Sublingual (SL) apomorphine is a nonopioid, centrally acting dopamine agonist developed to treat erectile dysfunction (ED). Clinical trials of the drug, using the most stringent and clinically relevant endpoints of “erections firm enough for intercourse”, have demonstrated its benefit in a wide variety of ED patients.Methods: Data were pooled and analyzed from three fixed-dose, placebo-controlled, double-blind, two-period crossover studies in which apomorphine SL 2 or 3 mg was evaluated against placebo for efficacy. Of the 415 patients who received both apomorphine SL (2 or 3 mg) and placebo, 252 received 2 mg and 163 received 3 mg. The clinical endpoints included erections firm enough for intercourse, per attempt intercourse rates and the International Index of Erectile Function (IIEF) criteria including the erectile function domain scores.Results: Apomorphine SL produced statistically significant improvements in a panel of erectile function measures, including erections firm enough for intercourse, total IIEF score, and IIEF domain scores. The proportion of patients achieving erections firm enough for intercourse was statistically significantly greater than placebo for both doses across all studies (p=0.001) and the ability to achieve an erection and have successful intercourse increased with sequential attempts. The percentage of attempts resulting in erections firm enough for intercourse was greatest in patients with mild or moderate ED; 89% of these patients who received at least eight doses of apomorphine SL 3 mg achieved adequate erections during treatment.Conclusions: Apomorphine SL 2 and 3 mg has significant benefit for men with ED as measured by all currently acceptable erectile function endpoints. An erection results as early as 10 minutes after dosing, and nearly 90% of erections occur within 30 minutes. Apomorphine SL is an appropriate first-line therapy for the management of ED, particularly in men presenting with mild to moderate dysfunction.     

Efficacy and safety of sildenafil citrate (Viagra) for the treatment of erectile dysfunction in men in Egypt and South Africa

The efficacy of sildenafil citrate (Viagra), an oral agent for the treatment of erectile dysfunction (ED), has been demonstrated in global studies. This 12-week randomized, double-blind, placebo-controlled, parallel-group, flexible-dose study assessed the efficacy and safety of sildenafil to treat ED in men in Egypt and South Africa. Men with ED of varied etiology were randomized to receive sildenafil 50 mg (n=128) or placebo (n=126); doses could be adjusted to 100 or 25 mg. Questions from the International Index of Erectile Function (IIEF) assessing the ability to achieve (Q3) and maintain (Q4) erections demonstrated a significant improvement with sildenafil compared with placebo (P<0.0001). Improved erections were reported by 74% of patients receiving sildenafil and 27% of those receiving placebo (P<0.0001). Headache, dyspepsia, and flushing were the most common adverse events in sildenafil-treated patients. These results are consistent with clinical trials in other countries. We conclude that sildenafil is an efficacious and well-tolerated treatment for men with ED in Egypt and South Africa.     

A two-part pilot study of sildenafil (VIAGRA) in men with erectile dysfunction caused by spinal cord injury

STUDY DESIGN: This was a two-part pilot study in men with erectile dysfunction (ED) due to spinal cord injury (SCI: cord level range T6-L5). Part I was a randomised, double-blind, two-way cross-over study comparing a single dose of sildenafil 50 mg or placebo. Part II was a randomised, double-blind, parallel-group evaluation of sildenafil 50 mg or placebo, taken as required (not more than once daily) approximately 1 h prior to sexual activity, over a period of 28 days. OBJECTIVES: To assay the efficacy and safety of sildenafil 50 mg and placebo. SETTING: Clinic- and home-based assessments in the United Kingdom. METHODS: A total of 27 subjects who were able to achieve at least a grade 2 erection (hard, but not hard enough for penetration) in response to penile vibratory stimulation (PVS) were recruited. In Part I, the reflexogenic response of the penis to PVS was evaluated in the clinic while in Part II, the response to treatment was assessed in the home (global efficacy. questionniare, diary). RESULTS: In Part I, 17/26 (65%) subjects had erections of >60% rigidity at the penile base (median duration 3.5 min) after sildenafil compared with 2/26 (8%) (median duration 0 min) alter placebo (P=0.0003). In Part II, 9/12 (75%) subjects on sildenafil and 1/14 (7%) subjects on placebo reported that the treatment had improved their erections (P<0.005), and 8/12 (67%) and 2/13 (15%) men, respectively, indicated that they wished to continue treatment (P<0.02). An analysis of diary data showed no difference between the groups with respect to the mean number of erections hard enough for penetration (P = 0.08). The mean proportion of attempts at sexual intercourse that were successful was 30 and 15%, respectively (P=0.21). Similarly, responses to the end-of-treatment questionnaire indicated that there were no significant differences between the groups with respect to the frequency of erections hard enough for sexual intercourse (P=0.47) or that lasted as long as the subject would have liked (P=0.11). No subject discontinued sildenafil due to adverse events. CONCLUSION: Sildenafil is an effective, well-tolerated oral treatment for ED in SCI subjects.     

ASSESS-3: a randomised, double-blind, flexible-dose clinical trial of the efficacy and safety of oral sildenafil in the treatment of men with erectile dysfunction in Taiwan

The efficacy and safety of sildenafil were evaluated in a randomised, double-blind, placebo-controlled, flexible-dose study in Taiwanese men aged 26 to 80 y with erectile dysfunction (ED) of broad-spectrum aetiology and more than 6 months' duration. A total of 236 patients were randomised at six medical centres in Taiwan to receive either sildenafil (50 mg initially increased if necessary to 100 mg or decreased to 25 mg depending on efficacy and toleration) (n=119) or matching placebo (n=117) taken on an 'as needed' basis 1 h prior to anticipated sexual activity for a period of 12 weeks. At the end of 12 weeks, the primary efficacy variables relating to the achievement and maintenance of erections sufficient for sexual intercourse, and the secondary efficacy variables, which included: (1) the five separate domains of sexual functioning of the IIEF (International Index of Erectile Function) scale, (2) the percentage of successful intercourse attempts; and (3) a global assessment of erections, were all statistically significantly improved by sildenafil in comparison with placebo (P<0.0001). Treatment-related adverse events occurred in 43.7% of patients receiving sildenafil and 18.8% receiving placebo. The most common adverse events with sildenafil were flushing, dizziness and headache (25.2, 6.7 and 5.9% of patients, respectively), and most were mild in nature. The efficacy and safety of sildenafil in the population of Taiwanese men appears similar to that reported in other studies in western populations.     

Correlations between increased erection hardness and improvements in emotional well-being and satisfaction outcomes in men treated with sildenafil citrate for erectile dysfunction

To explore relationships between erection hardness and other outcomes in men with erectile dysfunction (ED). Pooled analyses were conducted on 27 randomized, double-blind, placebo-controlled trials and six open-label trials from the worldwide sildenafil database. Outcomes included erection hardness graded subjectively, hardness and sexual satisfaction questions from the International Index of Erectile Function, general and sexually-specific emotional well-being from the self-esteem and relationship questionnaire, and the erectile dysfunction inventory of treatment satisfaction. Hardness outcomes improved (with a possible dose-response relationship for the achievement of fully hard and rigid erections) and correlated positively with the other outcomes. Sildenafil 100 mg produced optimal erection hardness (fully hard and rigid erections) in a substantial proportion of men with ED. Because optimal erection hardness correlated positively with some emotional well-being and satisfaction outcomes, sildenafil 100 mg may be the most appropriate dosage for treatment of ED for most men.     

前列腺素E1与西地那非治疗ED的比较

目的 :比较口服西地那非与阴茎海绵体内注射前列腺素E1(PGE1)治疗勃起功能障碍 (ED)的疗效。　方法 :5 4例ED病人随机分为两组 ,A组口服西地那非 ,B组行海绵体内注射PGE1,均治疗 4～ 9个月 ,平均 6个月。结果 :A、B两组的有效率分别为 80 0 %和 83 3% ,两者差异无显著性 (P >0 0 5 )。A组 6例无效病人经海绵体内注射PGE1治疗 ,2例获得满意勃起 ;而B组 4例无效病人经口服西地那非治疗 ,无 1例勃起。　结论 :口服西地那非与海绵体内注射PGE1对各种病因所致的ED均有良好的治疗作用 ,对西地那非治疗无效者 ,可试用海绵体内注射PGE1,有时也能获得满意的效果     

Efficacy of oral sildenafil in hemodialysis patients with erectile dysfunction

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.     

Early experience with sildenafil for the treatment of erectile dysfunction in renal transplant recipients.

BACKGROUND: Erectile dysfunction (ED) is common in men with renal failure, but is not always alleviated following kidney transplant. The objective of the present study was to assess the feasibility in renal transplant patients of sildenafil citrate treatment, an agent with proven efficacy in the management of ED. METHODS: This was a phase IV, open, multicentre, 3 month, dose-escalation study. All patients meeting the inclusion criteria were prescribed a dose of 50 mg sildenafil at the first visit. Thereafter the dose could be increased to 100 mg or reduced to 25 mg based on efficacy or tolerability. The primary efficacy parameter assessed the ability of patients to achieve erections sufficient for intercourse and to maintain erections after penetration. Secondary endpoints assessed patient satisfaction with sildenafil and the effect of sildenafil on their quality of life. Patients were carefully monitored throughout the study for adverse events, interactions with immunosuppressive therapy and effect on graft function. RESULTS: The study included 50 patients in the intent-to-treat population. Sildenafil significantly improved patient's erection ability and the frequency of their erection maintenance. Analysis of the secondary efficacy parameters revealed that 66% of patients believed treatment had improved their erections. Patients reported improvements in their sexual life and partner relationships and a high level of satisfaction with treatment. There were no interactions between sildenafil and the immunosuppressive drugs and there was no significant adverse effect of sildenafil on graft function. CONCLUSIONS: Sildenafil is an effective and well-tolerated agent for the treatment of ED in renal transplant recipients.     

Efficacy and safety of sildenafil for treating erectile dysfunction in patients on dialysis

OBJECTIVE: To assess the efficacy of sildenafil for erectile dysfunction (ED) in patients on haemodialysis (HD) or peritoneal dialysis (PD), as men with end-stage renal disease (ESRD) often have sexual dysfunction (up to 82% among those on chronic dialysis). PATIENTS AND METHODS: Forty-one patients with ED and in ESRD participated in an open-label prospective study. Thirty patients on HD and 11 on PD were asked to complete the International Index of Erectile Function (IIEF) and Fugl-Meyer life-satisfaction scale before and after sildenafil treatment. A total score in the erectile function domain of < or = 25 was accepted as indicating ED. All patients were started on a 25-mg dose, which was increased to 50 mg if there was no response after two trials. In addition, the overall efficacy question was used to evaluate satisfaction, and patients reported any side-effects during treatment. RESULTS: The erectile function and intercourse satisfaction domains improved significantly in both groups (P < 0.01). After sildenafil treatment, two-thirds of those on HD (20/30) and nine of the 11 on PD recovered their erectile function. The pretreatment scores on the IIEF and four domains (except sexual desire) of those responding were significantly higher than in those not responding (P < 0.05). The satisfaction rate on the overall efficacy question was 80% and 82% for the HD and PD groups, respectively. At least one side-effect was seen in 17 patients (43%); one had severe hypotension in the PD group. Overall, mild headache (seven patients, 18%) and flushing (12, 30%) were reported most often. CONCLUSIONS: Sildenafil is a safe and satisfactory drug for improving erectile function in patients with ESRD. Patients were satisfied whether treated by HD or PD. Pretreatment scores on the IIEF may be useful for predicting the success of treatment.