title: A dose‐escalation study to assess the efficacy and safety of sildenafil citrate in men with erectile dysfunction Effects of tadalafil on erectile dysfunction in men with diabetes. Size is everything – large amounts of information are needed to overcome random effects in estimating direction and magnitude of treatment effects The efficacy and safety of flexible-dose vardenafil (levitra) in a broad population of European men. Erectile dysfunction in patients with spina bifida is a treatable condition. Empirical evidence of bias in infertility research: overestimation of treatment effect in crossover trials using pregnancy as the outcome measure. Efficacy, safety, and treatment satisfaction of tadalafil versus placebo in patients with erectile dysfunction evaluated at tertiary-care academic centers. Sildenafil citrate for treatment of erectile dysfunction in men with type 1 diabetes: results of a randomized controlled trial. Efficacy and safety of tadalafil in a Western European population of men with erectile dysfunction Long-term efficacy and safety of oral Viagra® (sildenafil citrate) in men with erectile dysfunction and the effect of randomised treatment withdrawal Sildenafil citrate (Viagra®) in the treatment of men with erectile dysfunction in southern Latin America: a double-blind, randomized, placebo-controlled, parallel-group, multicenter, flexible-dose escalation study Vardenafil, a new phosphodiesterase type 5 inhibitor, in the treatment of erectile dysfunction in men with diabetes: a multicenter double-blind placebo-controlled fixed-dose study. The efficacy of sildenafil for the treatment of erectile dysfunction in male peritoneal dialysis patients. Efficacy of sildenafil citrate (Viagra®) for the treatment of erectile dysfunction in men in remission from depression Safety and efficacy of vardenafil in patients with erectile dysfunction: result of a bridging study in Japan. Efficacy and safety of sildenafil citrate (Viagra®) for the treatment of erectile dysfunction in men in Egypt and South Africa Erectile response with vardenafil in sildenafil nonresponders: a multicentre, double‐blind, 12‐week, flexible‐dose, placebo‐controlled erectile dysfunction clinical trial Efficacy of oral sildenafil in hemodialysis patients with erectile dysfunction. A double blind, randomised study of sildenafil citrate for erectile dysfunction in men with multiple sclerosis Time/duration effectiveness of sildenafil versus tadalafil in the treatment of erectile dysfunction in male spinal cord-injured patients The efficacy and tolerability of vardenafil, a new, oral, selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction: the first at-home clinical trial Randomized, Double-Blind, Placebo-Controlled Trial of Sildenafil (Viagra®) for Erectile Dysfunction After Rectal Excision for Cancer and Inflammatory Bowel Disease 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 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 Efficacy and safety of sildenafil citrate in men with erectile dysfunction and stable coronary artery disease. Tadalafil in the treatment of erectile dysfunction following bilateral nerve sparing radical retropubic prostatectomy: a randomized, double-blind, placebo controlled trial. Population Dose-Response Model for Tadalafil in the Treatment of Male Erectile Dysfunction Patient and partner satisfaction with Viagra (sildenafil citrate) treatment as determined by the Erectile Dysfunction Inventory of Treatment Satisfaction Questionnaire. A multicenter, randomized, double-blind, crossover study of patient preference for tadalafil 20 mg or sildenafil citrate 50 mg during initiation of treatment for erectile dysfunction. Efficacy and safety of flexible-dose oral sildenafil citrate (Viagra®) in the treatment of erectile dysfunction in Brazilian and Mexican men Oral sildenafil in the treatment of erectile dysfunction in diabetic men: a randomized double-blind and placebo-controlled study. Asian sildenafil efficacy and safety study (ASSESS-1): a double-blind, placebo-controlled, flexible-dose study of oral sildenafil in Malaysian, Singaporean, and Filipino men with erectile dysfunction. The Assess-1 Study Group. The efficacy and safety of oral sildenafil in Thai men with erectile dysfunction: a randomized, double-blind, placebo controlled, flexible-dose study. A double-blind, randomised- placebo, controlled, parallel group, multicentre, flexible-dose escalation study to assess the efficacy and safety of sildenafil administered as required to male outpatients with erectile dysfunction in Korea Minimal time to successful intercourse after sildenafil citrate: results of a randomized, double-blind, placebo-controlled trial. Efficacy and safety of sildenafil citrate (Viagra) in black and Hispanic American men. Sildenafil citrate (Viagra) is effective and well tolerated for treating erectile dysfunction of psychogenic or mixed aetiology. Sustained efficacy and tolerability with vardenafil over 2 years of treatment in men with erectile dysfunction. Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group. Efficacy and safety of sildenafil citrate in the treatment of men with mild to moderate erectile dysfunction. Sildenafil citrate for the treatment of erectile dysfunction in men with Type II diabetes mellitus Treatment of erectile dysfunction in men with depressive symptoms: results of a placebo-controlled trial with sildenafil citrate. Switching patients with erectile dysfunction from sildenafil citrate to tadalafil: results of a European multicenter, open-label study of patient preference. Sildenafil citrate (Viagra) in erectile dysfunction: near normalization in men with broad-spectrum erectile dysfunction compared with age-matched healthy control subjects. Efficacy of tadalafil for the treatment of erectile dysfunction at 24 and 36 hours after dosing: a randomized controlled trial. Efficacy and treatment satisfaction with on-demand tadalafil (Cialis) in men with erectile dysfunction. Treatment of antidepressant-associated sexual dysfunction with sildenafil: a randomized controlled trial. Sildenafil citrate (Viagra) and erectile dysfunction following external beam radiotherapy for prostate cancer: a randomized, double-blind, placebo-controlled, cross-over study. On-demand IC351 (Cialis™) enhances erectile function in patients with erectile dysfunction Efficacy and safety of oral sildenafil in the treatment of erectile dysfunction: a double-blind, placebo-controlled study of 329 patients. Sildenafil Study Group. Efficacy and safety of fixed-dose oral sildenafil in the treatment of erectile dysfunction of various etiologies. The efficacy and safety of tadalafil in United States and Puerto Rican men with erectile dysfunction. Safety and efficacy of vardenafil for the treatment of men with erectile dysfunction after radical retropubic prostatectomy. Sildenafil for treatment of erectile dysfunction in men with diabetes: a randomized controlled trial. Sildenafil Diabetes Study Group. Efficacy and safety of oral sildenafil (Viagra) in men with erectile dysfunction caused by spinal cord injury
abstract: 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 OBJECTIVE To evaluate the efficacy and safety of tadalafil taken as needed before sexual activity by men with diabetes and erectile dysfunction ( ED ) . RESEARCH DESIGN AND METHODS Men with type 1 or type 2 diabetes and a minimum 3-month history of ED were r and omly allocated to one of three groups : placebo ( n = 71 ) , tadalafil 10 mg ( n = 73 ) , or tadalafil 20 mg ( n = 72 ) taken up to once daily for 12 weeks . Changes from baseline in mean scores on the erectile function domain of the International Index of Erectile Function ( IIEF ) and changes from baseline in the proportion of " yes " responses to question 2 , " Were you able to penetrate ? , " and 3 , " Were you able to complete intercourse ? , " of the Sexual Encounter Profile were co primary outcome measures . RESULTS A total of 191 ( 88 % ) of 216 patients completed the study . Treatment with tadalafil significantly improved all primary efficacy variables , regardless of baseline HbA(1c ) level . Therapy with tadalafil also significantly improved a number of secondary outcome measures , including changes in other IIEF domains , individual IIEF questions , and percentage of positive responses to a global assessment question measuring erection improvement . Treatment with tadalafil did not alter mean HbA(1c ) levels . Tadalafil was well tolerated , with headache and dyspepsia being the most frequent adverse events with active treatment . CONCLUSIONS Tadalafil therapy significantly enhanced erectile function and was well tolerated by men with diabetes and ED Abstract  Variability  in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size BACKGROUND In fixed-dose studies , vardenafil 5 , 10 , and 20 mg improves  erectile function in men with erectile dysfunction ( ED ) . Here , the efficacy and tolerability of vardenafil when used in a flexible-dose regimen was assessed . METHODS In this multicenter trial , 323 patients r and omly received vardenafil 10 mg or placebo .  After 4 weeks , patients could switch to 5 or 20 mg ( or corresponding placebo ) , or remain on 10 mg for an additional 4 weeks ; dose-switching was optional for the last 4 weeks . Efficacy variables included the IIEF-EF domain score , GAQ , and percentage of positive responses to SEP2/SEP3 questions . RESULTS The IIEF-EF domain score significantly improved from a baseline of moderate ED ( 12.6 - 13.1 ) to mild ED in men on  vardenafil  ( 21.0 - 24.2 ) compared with placebo ( 13.7 - 15.6 ) at weeks 4 , 8 , 12 , and last observation carried forward ( LOCF ) ( p<0.005 vs. placebo ) . A significantly greater proportion of men receiving vardenafil at weeks 4 , 8 , 12 , and LOCF reported improved erections ( 80 - 86 % vs. 21 - 36 % for placebo , p<0.005 ) . Successful SEP2 rates increased after vardenafil , reaching 84 % at weeks 8 and 12 vs. 49 - 53 % receiving placebo ( p<0.005 vs. placebo ) . Vardenafil improved successful SEP3 rates ranging from 58 % to 74 % compared to 22 - 34 % for placebo . The most common adverse events , flushing and headache , were generally mild and transient . CONCLUSION In this flexible dose study , vardenafil was well-tolerated , and produced clinical ly relevant improvements in erectile function in men with ED PURPOSE Now that individuals with spina bifida live well into adulthood erectile dysfunction has become a recognized associated medical disorder . To our knowledge no study has dealt specifically with treatment of  erectile dysfunction in men with spina bifida . Therefore , we conducted a prospect i ve , blinded , r and omized , placebo controlled , dose escalation , crossover study to determine the ability to treat erectile dysfunction in men with spina bifida with sildenafil citrate . MATERIAL S AND METHODS Erectile dysfunction was diagnosed in 15 men 19 to 35 years old with spina bifida who were assigned to take 4 sets of tablets , 5 tablets per set , in a r and om order . All patients took 25 and 50 mg . sildenafil and 2 identical looking sets of corresponding placebos 1 hour before planned sexual activity . Efficacy was assessed by the effect of treatment compared to baseline , that is before treatment , on rating of erections ( scored from 0 to 10 ) , duration of erections , frequency of erections based on response to question 1 ( scored from 0 to 5 ) of the International Index of Erectile Function and confidence to obtain an erection based on response to question 15 ( scored from 1 to 5 ) of the International Index of Erectile Function . RESULTS Improved erectile function was reported while on sildenafil by 12 ( 80 % ) men compared to baseline and placebos . There was a significant dose dependent improvement of erectile function with both 25 and 50 mg . sildenafil compared to baseline ( p < 0.05 ) , as mean erectile score increased by 50 % and 88 % , mean duration of erections increased by 192 % and 266 % , mean frequency of erections increased by 61 % and 96 % , and mean level of confidence increased by 33 % and 63 % , respectively . Furthermore , 50 mg . sildenafil provided greater improvement in all 4 parameters compared to 25 mg . The placebo results were not significantly different compared to baseline for any of the parameters . CONCLUSIONS Erectile dysfunction in patients with spina bifida is a medically treatable condition . Sildenafil is effective in this patient population and improves level of sexual confidence OBJECTIVE To determine whether crossover trials with simple pooling of data over different study periods leads to a different estimate of treatment effect compared with parallel group trials in infertility research using pregnancy as the outcome measure . DESIGN An observational study using nine overviews that included trials with both crossover and parallel group design s. These overviews comprised 17 crossover and 17 parallel group trials . In total , there were 5,291 outcomes including 775 pregnancies . The association between study design and treatment effect estimate was analyzed using multiple logistic regression , controlling for differences in the therapeutic interventions and variations in the method ological quality of the trials . SETTING Infertile patients in an academic research environment . PATIENTS Infertile patients undergoing treatment efficacy evaluation in controlled trials . INTERVENTIONS R and om allocation to a variety of treatments including clomiphene citrate , hCG , IUI , tamoxifen , and bromocriptine . MAIN OUTCOME MEASURE Estimate of bias between study design s , based on the interaction of study design and treatment in the logistic regression model . RESULTS Crossover trials produced a larger average estimate of treatment effect compared with trials with a parallel group design , overestimating the odds ratio by 74 % ( 95 % confidence interval , 2 % to 197 % ) . CONCLUSION The use of a crossover design for evaluating infertility treatments with outcomes that prevent patients from completing later phases of the trial should be avoided because it leads to exaggerated estimates of treatment effect and may result in erroneous inferences and clinical decisions . Furthermore , the type of study design should be taken into account when assessing the method ological quality of therapy trials in infertility OBJECTIVES To determine the efficacy , safety , and treatment satisfaction of tadalafil 20 mg for erectile dysfunction ( ED ) in patients evaluated at tertiary-care academic centers . METHODS In this r and omized , double-blind , placebo-controlled trial , patients were r and omly allocated to receive fixed-dose tadalafil  20 mg ( n = 146 )  or placebo ( n = 49 ) for 12 weeks . Efficacy was assessed by the International Index of Erectile Function ( IIEF ) , Sexual Encounter Profile ( SEP ) , and Global Assessment Question ( GAQ ) ; patient and partner treatment satisfaction by the Erectile Dysfunction Inventory of Treatment Satisfaction ( EDITS ) and SEP ; and safety by adverse events , laboratory values , and vital signs . RESULTS Mean baseline IIEF erectile function ( EF ) domain was 12.98 . Fifty-one percent of enrolled patients had severe baseline ED , and 82 % had organic ED . Pre-existing , ED-associated comorbid conditions were common . When compared with patients treated with placebo , those receiving tadalafil reported significant improvement from baseline in the IIEF EF domain ( P < 0.001 ) , successful penetration attempts ( SEP question 2 ; P < 0.001 ) , successful intercourse ( SEP question 3 ; P < 0.001 ) , and all secondary efficacy outcomes ( P < 0.001 ) . Patients and their sexual partners were also significantly more satisfied with tadalafil treatment ( P < 0.001 ) , including overall satisfaction ( P < 0.001 ) and length of time the treatment worked ( P < 0.001 ) . Mild or moderate headache , dyspepsia , and myalgia were the most frequent treatment-emergent adverse events reported . CONCLUSIONS Tadalafil significantly improved erectile function and patient and partner satisfaction and was well tolerated . These results were observed in a tertiary-care , academic center population with a high incidence of severe , organic ED , and comorbid medical conditions , factors known to compromise erectile function and treatment outcome OBJECTIVE In the 5 - 10 % of diabetic men with type 1 diabetes , erectile dysfunction ( ED ) may be a particularly common and unwanted complication . This is the first study focusing exclusively on the effects of sildenafil in men with type 1 diabetes and ED . RESEARCH DESIGN AND METHODS A total of 188 patients were entered into a double-blind , placebo-controlled , parallel-group , flexible-dose study and were r and omized to receive sildenafil ( 25 - 100 mg ; n = 95 ) or placebo ( n = 93 ) for 12 weeks . Efficacy was evaluated using questions three ( Q3 ; achieving an erection ) and four ( Q4 ; maintaining an erection ) from the International Index of Erectile Function ( IIEF ) , a global efficacy question ( GEQ ; " Did treatment improve your erections ? " ) , and a patient event log of sexual activity . RESULTS Improvements in mean scores from baseline to end-of-treatment for IIEF Q3 ( 35.7 vs. 19.9 % ) and Q4 ( 68.4 vs. 26.5 % ) were significant in patients receiving sildenafil compared with those receiving placebo ( P = 0.0001 ) . Moreover , the percent of improved erections ( GEQ , 66.6 vs. 28.6 % ) and successful intercourse attempts ( 63 vs. 33 % ) was significantly increased with sildenafil compared with placebo . Improvements in sexual function were seen irrespective of the degree of ED severity . Adverse events were generally mild to moderate in severity , with headache ( 20 vs. 8 % ) , flushing ( 18 vs. 3 % ) , and dyspepsia ( 8 vs. 1 % ) reported more often in the sildenafil than in placebo-treated patients . CONCLUSIONS Treatment with sildenafil for ED was effective , result ing in an increased percentage of successful attempts at intercourse , and was well tolerated among men with type 1 diabetes Section Editor 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 , r and omised 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 question naire , 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 Our objectives were : ( 1 ) to determine the efficacy , safety , and tolerability of sildenafil citrate ( Viagra ® ) administered to men with broad-spectrum erectile dysfunction ( ED ) in southern Latin America ; and ( 2 ) to correlate Rigiscan ® measurements assessing ED etiology with the investigator 's assessment . A total of 141 men with broad-spectrum ED ( mean age 57 ) were enrolled in a r and omized , 12-week , double-blind , placebo-controlled , flexible-dose escalation study of sildenafil . After the 12-week treatment period , the mean score for the primary efficacy variables had risen significantly : for the sildenafil group , 66.2 % from baseline for question 3 of the International Index of Erectile Function and 77.6 % for question 4 , vs 15.1 % and 21.2 % for the placebo group , respectively ( P<0.0001 ) . Rigiscan ® data confirmed investigator assessment s of etiology . Headache and flushing , usually mild and transient , were the most common adverse events . Sildenafil was an effective , well-tolerated treatment for men in southern Latin America with broad-spectrum ED OBJECTIVE This study evaluated the efficacy and safety of vardenafil treatment for erectile dysfunction ( ED ) in men with diabetes . RESEARCH DESIGN AND METHODS In this prospect i ve multicenter double-blind placebo-controlled fixed-dose parallel-group phase III trial , 452 patients with diabetes ( type 1 or type 2 ) and ED were r and omized to take 10 or 20 mg vardenafil or placebo as needed for 12 weeks . Efficacy responses were assessed by International Index of Erectile Function domain scores , rates of vaginal penetration and successful intercourse , and a global assessment question ( GAQ ) about erection improvement during the previous 4 weeks . RESULTS After 12 weeks of treatment , a dose-dependent ( P = 0.02 ) improvement in erections was noted for the GAQ , with 57 and 72 % of men taking 10 mg or 20 mg vardenafil , respectively , reporting improved erections , in contrast to 13 % after taking placebo ( P < 0.0001 ) . For the erectile function domain , dose-dependent ( P = 0.03 ) final scores for the 10- and 20-mg dose were 17.1 and 19.0 compared with 12.6 for placebo ( P < 0.0001 ) . Both vardenafil doses significantly enhanced the rates of successful penetration ( P < 0.0001 ) and successful intercourse ( P < 0.0001 ) compared with placebo . Vardenafil treatment was effective in increasing intercourse success rates at all levels of baseline ED severity , at each level of plasma HbA(1c ) , and for type 1 and 2 diabetes . Treatment-emergent adverse events were primarily mild to moderate headache ( < or=13 % ) , flushing ( < or=10 % ) , and rhinitis ( < or=10 % ) . CONCLUSIONS Vardenafil statistically improved erectile function and was generally well tolerated in these diabetic patients with ED BACKGROUND The aim of this study was to evaluate the safety and effectiveness of sildenafil in male peritoneal dialysis patients with erectile dysfunction . METHODS Sixteen peritoneal dialysis patients were recruited to this prospect i ve , r and omized , 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 . RESULTS 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 . CONCLUSION 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 Erectile dysfunction ( ED ) and depression are highly prevalent and frequently comorbid . Sildenafil effectively treats ED in men with depression and in men taking antidepressants . We evaluated the efficacy of sildenafil in men with depression in remission and ED . Patients with a history of ED when major depressive disorder ( MDD ) was diagnosed , which persisted after MDD was treated to remission , were r and omized to 12 weeks of treatment with sildenafil ( 50 mg , flexible ) or placebo .  Efficacy was assessed using intercourse success rates , a global efficacy question ( Has treatment improved your erections ? ) , the International Index of Erectile Function ( IIEF ) and Life Satisfaction Checklist ( LSC ) . By week 12 , intercourse success rates were significantly higher among sildenafil- ( 74 % ) compared to placebo-treated patients ( 29 % ; P=0.0001 ) . About 83 % and 34 % of sildenafil- and placebo-treated patients , respectively , reported improved erections ( odds ratio=9.4 , P=0.0001 ) . IIEF scores in the sildenafil group ( n=83 ) were significantly improved compared to those in the placebo group ( n=85 ; P < 0.0001 ) . LSC sexual life item improved significantly among sildenafil- versus placebo-treated patients . The most frequently reported adverse events were transient and mild-to-moderate .  Sildenafil is an effective and well-tolerated treatment for ED in patients with a history of ED at the time of MDD diagnosis , and which persisted after the MDD was treated to remission AIM Vardenafil is a selective and highly potent phosphodiesterase type 5 ( PDE5 ) inhibitor for the treatment of erectile dysfunction ( ED ) , with improved selectivity for PDE5 and demonstrated efficacy for improving sexual function in men with ED . The current study investigated the safety and efficacy of this new PDE5 inhibitor in Japanese men with ED . METHODS This was a prospect i ve , double blind , r and omized clinical trial design ed to evaluate the efficacy and safety of vardenafil . Following a 4-week treatment-free observation period , 283 eligible patients were r and omized to 12 weeks treatment with vardenafil 5 mg , 10 mg , 20 mg , or placebo . Primary efficacy responses were assessed using the scores of Q3 and Q4 of the international index of erectile function ( IIEF ) . RESULTS All three vardenafil doses showed significantly better improvement than the placebo group in Q3 and Q4 scores of the IIEF question naire , either at 12 weeks or at the ' last observation carried forward ' ( LOCF , P < 0.0001 ) . Q3 scores were improved to 4.06 with vardenafil 5 mg , 4.53 with vardenafil 10 mg , and 4.64 with vardenafil 20 mg , versus 3.17 with placebo . Comparable scores for Q4 were 3.47 , 4.15 and 4.31 versus 2.31 for placebo . Up to 86 % of patients achieved improved erections as assessed by the global assessment question ( GAQ ) . Reported adverse event rates were 35.3 % , 45.3 % and 54.5 % with vardenafil 5 mg , 10 mg and 20 mg , respectively , versus 21.1 % in the placebo group . No serious adverse drug reactions were reported . The most common treatment-emergent adverse events were transient headache , flushing and rhinitis , which were mostly mild . CONCLUSION Vardenafil is an effective and well-tolerated treatment for ED and provides improvement in key indices of erectile function among Japanese men with ED . The results of our trial show that up to nearly 90 % of patients achieve improved erections with the administration of vardenafil 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 r and omized , 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 r and omized 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 Associate Editor 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 , r and omized , placebo-controlled study of oral sildenafil ( 50 mg ) administered as required in HD patients with ED was design ed . 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 infa rct ion 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 result ed 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 Objective : Identifying and effectively treating erectile dysfunction ( ED ) can result in an improvement of the quality of life ( QoL ) in men with multiple sclerosis ( MS ) . Methods : This r and omised , double blind ( DB ) , placebo controlled , flexible dose study with an open label extension ( OLE ) assessed efficacy , QoL , and safety of sildenafil citrate in men with MS and ED . Overall , 217 men received sildenafil ( 25–100 mg ; n = 104 ) or placebo ( n = 113 ) for 12 weeks . Efficacy was assessed by the International Index of Erectile Function ( IIEF ) question naire that includes questions on achieving ( Q3 ) and maintaining ( Q4 ) an erection as well as a global efficacy question ( GEQ ) . QoL was also assessed . Results : After 12 weeks , patients receiving sildenafil had higher mean scores for IIEF Q3 and Q4 compared with those receiving placebo ( p<0.0001 ) , and 89 % ( 92/103 ) reported improved erections compared with 24 % ( 27/112 ) of patients receiving placebo ( p<0.0001 ) . At the end of the OLE phase , 95 % of men reported improved erections . Patients receiving placebo during the DB phase showed a nearly fourfold increase in improved erections ( 97 % v 26 % ) . Men receiving sildenafil also showed improvements in five of the eight general QoL questions compared with men receiving placebo ( p<0.05 ) . The total mean score for the QoL question naire improved by 43 % for the sildenafil group versus 13 % for the placebo group ( p<0.0001 ) . Treatment related AEs were predominantly mild in nature , and no patient discontinued due to an AE . Conclusion : Sildenafil treatment for ED in men with MS was effective and well tolerated , and result ed in significant improvements in both general and disease specific QoL variables Study design : A r and omized , blinded , crossover clinical trial comparing sildenafil versus tadalafil for erectile dysfunction ( ED ) in male spinal cord-injured ( SCI ) patients . Objectives : To compare the safety , time/ duration effectiveness , and the impact on the quality of life ( QoL ) of tadalafil 10 mg versus sildenafil 50 mg . Setting : Neurourology Section , Careggi Hospital , Florence , Italy . Methods : During a screening ( visit 1 ) , a diary card was distributed , in which the subjects assessed , after each attempt at intercourse the quality of their erection , responding ( Yes/No ) to both Sexual Encounter Profile Questions 2 ( SEP2 ) and 3 ( SEP3 ) . The subjects made at least four attempts at intercourse . At visit 2 , 15 patients ( group 1 ) were assigned sildenafil and 15 ( group 2 ) started with tadalafil . Responses to baseline International Index of Erectile Function 5 items ( IIEF-5 ) , Questions 13–14 ( IIEF 15 items ) and SEP diary were recorded . Patients attempted intercourse on four separate occasions : within 4 h of taking the first tablet , within 12 h for the second tablet , 24 h for the third , and the fourth from 24 to 36 h. At visit 3 , the investigators evaluated the effectiveness with the same measures used at baseline . After a wash-out period , at visit 4 , Group 1 was given tadalafil , and Group 2 was given sildenafil . Patients were required to observe the same criteria in taking the four tablets as in visit 2 . After 4 weeks ( visit 5 ) , we evaluated the patients as we did in visit 3 . Results : Overall , 28 patients completed the study . No subjects discontinued the drugs due to drawbacks . Tadalafil allowed a majority of men in this trial to achieve both normal sexual functioning up to 24 h postdosing compared to sildenafil ( P<0.01 ) and improved overall sex life satisfaction as well as sexual relations with partner . Conclusion : Based on these data , tadalafil may have the potential to become an important treatment option for ED in SCI patients .Sponsorship : This study was not sponsored Vardenafil , a novel selective phosphodiesterase type 5 inhibitor , was evaluated in its first large-scale at-home trial . A total of 601 men with mild to severe erectile dysfunction ( ED ) were enrolled in this multi-centre , r and omized , double-blind , placebo-controlled trial of 12 weeks of treatment with either placebo or 5 , 10 and 20 mg of vardenafil . Primary endpoints were Q3 ( vaginal penetration ) and Q4 ( maintenance of erection ) of the International Index of Erectile Function ( IIEF ) . In the intent-to-treat population ( n=580 ) , the changes from baseline for 5 , 10 and 20 mg vardenafil ( 1.2 , 1.3 and 1.5 , respectively ) were all improved ( P<0.001 ) over placebo ( 0.2 ) for Q3 and were similarly improved for Q4 ( 1.4 , 1.5 and 1.7 ) compared to placebo ( 0.5 ) ( P<0.001 ) . All vardenafil doses improved all IIEF domains compared to placebo ( P<0.001 ) . The percentage of successful intercourses was between 71 and 75 % for the three vardenafil doses . For the 20 mg dose , 80 % of the patients experienced improved erections ( GAQ ) compared to 30 % for placebo . Most frequent treatment-emergent adverse events were headache ( 7–15 % ) , flushing ( 10–11 % ) and up to 7 % for dyspepsia or rhinitis . Vardenafil treatment result ed in a high efficacy and low adverse-event profile in a population with mixed ED etiologies Abstract PURPOSE : Controlled trials have demonstrated the efficacy of sildenafil for “ mixed etiology ” erectile dysfunction , but this may not be the case if there is underlying pelvic parasympathetic nerve damage . We aim ed to determine the efficacy of sildenafil after rectal excision for rectal cancer and inflammatory bowel disease . METHODS : Patients with erectile dysfunction after rectal excision were r and omly assigned in a double-blind manner to sildenafil or placebo groups . After unblinding , placebo patients crossed over to open sildenafil . Primary end points were improvement in erectile function on a global efficacy question and erectile function question naire scores . Secondary end points were frequency and severity of side effects . RESULTS : Thirty-two patients were r and omly assigned , and two dropped out before r and omization . Fourteen received sildenafil , and 18 received placebo . Eleven ( 79 percent ) of 14 responded to sildenafil , on global efficacy assessment , compared with 3 ( 17 percent ) of 18 taking placebo ( mean difference , 61.9 percent ; 95 percent confidence interval , 34.4 to 89.4 percent ; P = 0.0009 ) . Sildenafil improved both erectile function domain scores ( mean difference , 13.3 ; 95 percent confidence interval , 7.9 to 18.7 ; P = 0.0001 ) and total International Index of Erectile Function scores ( mean difference , 30.6 ; 95 percent confidence interval , 18.7 to 42.6 ; P < 0.0001 ) from pretreatment baseline scores . Placebo did not produce improvement in either erectile function ( mean difference , 1.7 ; 95 percent confidence interval , −0.8 to 4.2 ; P = 0.16 ) or total International Index of Erectile Function scores ( mean difference , 5 ; 95 percent confidence interval , −1.1 to 11.1 ; P = 0.1 ) . Ten ( 100 percent ) of 10 crossover patients not responding to placebo did respond to sildenafil ( difference , 100 percent ; P < 0.0001 ) . Sildenafil improved both erectile function domain scores ( mean difference , 16.8 ; 95 percent confidence interval , 9.7 to 24 ; P = 0.002 ) and total International Index of Erectile Function scores ( mean difference , 29.5 ; 95 percent confidence interval , 15.8 to 43.2 ; P = 0.003 ) from precrossover baseline scores . Seven ( 50 percent ) of 14 patients on sildenafil compared with 4 ( 22 percent ) of 18 on placebo experienced side effects ( difference , 28 percent ; 95 percent confidence interval , −4.4 to 60.4 percent ; P = 0.14 ) , 91 percent of which were mild and well tolerated . CONCLUSION : Sildenafil completely reverses or satisfactorily improves postproctectomy erectile dysfunction in 79 percent of patients . Side effects are usually mild and well tolerated . The damage incurred by the pelvic nerves after proctectomy , less profound than after prostatectomy , is likely to result in a partial parasympathetic nerve lesion The efficacy and safety of sildenafil were evaluated in a r and omised , 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 r and omised 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 population 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 out patients with ED participated in a double-blind , flexible-dose , r and omized-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 This was a double-blind , placebo-controlled , flexible-dose study of the efficacy and safety of sildenafil in men with erectile dysfunction ( ED ) and clinical ly stable coronary artery disease ( CAD ) . Patients were r and omized to receive sildenafil or placebo for 12 weeks . Primary outcomes were questions 3 and 4 of the International Index of Erectile Function ( IIEF ) . Secondary outcomes included the other IIEF questions and functional domains , the Life Satisfaction Checklist , the Erectile Dysfunction Inventory of Treatment Satisfaction , 2 global efficacy assessment questions , and intercourse success rate . By week 12 , sildenafil-treated patients ( n = 70 ) showed significant improvements on questions 3 and 4 compared with placebo-treated patients ( n = 72 ; p < 0.01 ) . Larger percentages of sildenafil-treated patients reported improved erections ( 64 % ) and improved intercourse ( 65 % ) compared with placebo-treated patients ( 21 % and 19 % , respectively ) . Sildenafil-treated patients were highly satisfied with treatment and their sexual life compared with placebo-treated patients . Forty-seven percent of sildenafil- and 32 % of placebo-treated patients experienced adverse events , including transient headache , hypertension , flushing , and dyspepsia . There were no serious drug-related cardiovascular effects . Thus , sildenafil is an effective and well-tolerated treatment for ED in men with CAD . Sildenafil was not associated with additional safety risks in this patient population PURPOSE We evaluated the efficacy and safety of tadalafil 20 mg , taken on dem and , in men with erectile dysfunction following bilateral nerve sparing radical retropubic prostatectomy ( BNSRRP ) . MATERIAL S AND METHODS This r and omized , double-blind , placebo controlled multicenter study consisted of a 4-week treatment-free run-in period ( baseline ) followed by 12 weeks of treatment . A total of 303 men ( mean age 60 years ) with preoperative normal erectile function who had undergone a BNSRRP 12 to 48 months before study were r and omized ( 2:1 ) to tadalafil ( 201 ) or placebo ( 102 ) . The 3 co- primary end points were changes from baseline in the International Index of Erectile Function erectile function domain score , and the percentage of positive responses to Sexual Encounter Profile questions 2 ( successful penetration ) and 3 ( successful intercourse ) . The Global Assessment Question and the Erectile Dysfunction Inventory of Treatment Satisfaction question naire were secondary end points . We defined a priori a subgroup of 201 patients reporting evidence of postoperative tumescence , defined as 50 % or greater " yes " responses to Sexual Encounter Profile question 1 ( ability to achieve at least some erection ) during baseline intercourse attempts and stratified r and omization based on this criterion . RESULTS Patients receiving tadalafil reported greater improvement on all primary and secondary end points ( p < 0.001 ) compared to placebo . For all r and omized patients and for the subgroup with evidence of postoperative tumescence , the mean International Index of Erectile Function erectile function domain score increased for patients receiving tadalafil ( mean + /- SEM 5.3 + /- 0.5 and 5.9 + /- 0.7 , respectively , p < 0.001 vs placebo for both ) . For all r and omized patients who received tadalafil , the mean percentage of successful penetration attempts was 54 % and the mean percentage of successful intercourse attempts was 41 % . For the subgroup with evidence of postoperative tumescence these values were 69 % and 52 % , respectively . Of all patients r and omized to tadalafil 62 % and of the subgroup patients r and omized to tadalafil 71 % reported improved erections . Patients receiving tadalafil reported greater treatment satisfaction on the Erectile Dysfunction Inventory of Treatment Satisfaction than those receiving placebo .  Headache ( 21 % ) , dyspepsia ( 13 % ) and myalgia ( 7 % ) were the most commonly reported adverse events . CONCLUSIONS Tadalafil 20 mg , taken on-dem and , was an efficacious and well tolerated treatment for erectile dysfunction following BNSRRP Abstract Purpose . To determine the population dose-response relationship for tadalafil during on-dem and ( as-needed ) administration for treatment of erectile dysfunction ( ED ) . Methods . A total of 212 male patients with mild , moderate , or severe ED participated in a multicenter , r and omized , double-blind , placebo-controlled , parallel-group study . Patients were r and omized to receive placebo or 2 , 5 , 10 , or 25 mg tadalafil , taken on dem and over an 8-week period . Efficacy was assessed on the basis of questions 2 and 3 of the Sexual Encounter Profile ( SEP ) and questions 3 and 4 of the International Index of Erectile Function ( IIEF ) question aires . These scores were modeled using logistic regression . A fifth patient response , the IIEF EF ( erectile function ) domain score , was modeled as a continuous variable . Results . The dose-response relationship for each efficacy variable was best described with an Emax model , in which maximum effect increased with ED severity at baseline . Response scores increased substantially between 10 and 25 mg tadalafil doses , and the dose-response parameter estimates suggested possibly higher responses at even higher doses . Conclusions . Population dose-response modeling of all five oucome measures indicated that efficacy in all ED severity groups in the studied population generally increased across the 2 to 25 mg tadalafil dose range . Estimates of maximal improvement ( Emax ) in the IIEF EF domain score were 7.5 , 11.4 , and 16.3 points for patients with mild , moderate , and severe ED , respectively . Corresponding tadalafil doses to attain half-maximal improvement ( ED50 estimates ) were 4.7 mg , 7.1 mg , and 10.1 mg OBJECTIVES To assess the efficacy and safety of Viagra ( sildenafil citrate ) in male out patients with erectile dysfunction and patient and partner satisfaction with treatment using the Erectile Dysfunction Inventory of Treatment Satisfaction ( EDITS ) . METHODS A total of 247 patients with erectile dysfunction of broad-spectrum etiology were treated in a r and omized , double-blind , parallel-group , multicenter study conducted at outpatient clinics . Patients receiving oral sildenafil ( 25 , 50 , and 100 mg ) were compared with patients receiving placebo during a 12-week period . The principal efficacy measures were responses to question 3 ( ability to achieve an erection ) and question 4 ( ability to maintain an erection ) on the International Index of Erectile Function and three global efficacy questions . Patient and partner satisfaction with treatment were assessed , for the first time , using the EDITS question naire . RESULTS Efficacy scores for the International Index of Erectile Function questions and the global efficacy questions were significantly higher for patients receiving sildenafil than for those receiving placebo ( P < 0.001 ) . Both patients and partners receiving sildenafil also had significantly higher EDITS scores than those receiving placebo ( P < 0.001 ) . Adverse events were chiefly mild or moderate . Two patients receiving sildenafil and none receiving placebo discontinued treatment because of adverse events . CONCLUSIONS Sildenafil was an effective , well-tolerated treatment for erectile dysfunction in an outpatient setting . Partner evaluations corroborated patient assessment s. The results from the EDITS question naire indicated that after 12 weeks of receiving sildenafil both patients and partners reported higher levels of treatment satisfaction relative to placebo BACKGROUND Tadalafil is a phosphodiesterase 5 ( PDE5 ) inhibitor approved in > 30 countries for the treatment of erectile dysfunction ( ED ) . It has been shown to improve erectile function compared with placebo in Phase III studies , but clinical experience comparing tadalafil with the PDE5 inhibitor sildenafil citrate is lacking . OBJECTIVE This study compared patient preference for tadalafil 20 mg or sildenafil 50 mg during initial treatment for ED . It also compared the tolerability of the 2 agents at these doses . METHODS This r and omized , double-blind , fixed-dose , 2-period crossover trial took place at 13 sites in the United States and Germany . Patients were r and omized 1:1 to receive 4 weeks of treatment with tadalafil 20 mg or sildenafil 50 mg , followed by the alternative treatment , to be taken as needed up to once daily before sexual activity . RESULTS The study enrolled 215 men with ED , 109 r and omized to the tadalafil-sildenafil sequence and 106 to the sildenafil-tadalafil sequence . Their mean age was 49.8 years ; 84.7 % were sildenafil naive and 15.3 % had undergone a previous inadequate trial of sildenafil . Most patients had moderate ED ( 60.5 % ) of > or=1 year 's duration ( 74.9 % ) . Of 190 evaluable patients , 126 ( 66.3 % ) preferred to initiate treatment with tadalafil , compared with 64 ( 33.7 % ) with sildenafil ( P < 0.001 ) . Patients ' preference did not differ by age , duration of ED , treatment sequence , or previous sildenafil exposure . Both medications were well tolerated , with no significant differences in the incidence of treatment-emergent adverse events . Headache ( 11.2 % tadalafil , 8.8 % sildenafil ) , dyspepsia ( 6.0 % and 4.2 % , respectively ) , nasopharyngitis ( 4.7 % and 2.8 % ) , and flushing ( 2.8 % and 4.7 % ) were the most common adverse events . The rate of ocular disturbances was low : 1 patient experienced intermittent bilateral reduction in visual acuity with tadalafil , and 2 exhibited conjunctival hyperemia or eyelid edema with sildenafil . CONCLUSIONS Tadalafil 20 mg was preferred to sildenafil 50 mg for the initiation of ED therapy in this study population . Both medications were well tolerated 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 ) question naire , 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 PURPOSE To determine the efficacy and safety of oral sildenafil citrate in the treatment of erectile dysfunction ( ED ) in diabetic men . MATERIAL S AND METHODS In a r and omized , double-blind , placebo-controlled , and fixed-dose study , a total of 282 men ( mean age , 46.4 years ) with ED ( mean duration , 3.6 years ) and diabetes ( mean duration , 11 years ) were r and omly assigned to receive 100 mg sildenafil ( n=144 ) or placebo ( n=138 ) approximately 1 h before planned sexual activity , but not more than once daily , for 16 weeks . The efficacy of two treatments was assessed using responses to the International Index of Erectile Function ( IIEF ) question naire . RESULTS Two hundred sixty-two ( 93 % ) of men completed the study ( 134/144 in the sildenafil group , 128/138 in the placebo group ) . Positive clinical results were obtained in 68 ( 51 % ) of 134 patients in the sildenafil group compared with 14 ( 11 % ) of 128 patients in the placebo group ( P<.003 ) . Fifty-nine percent of the patients reported at least one successful attempt at sexual intercourse in the sildenafil group as compared with 21 % successful attempts for the placebo group ( P<.002 ) . Drug-related adverse effects occurred in 32 ( 22 % ) of 144 patients taking sildenafil and 4 ( 3 % ) of 138 patients receiving placebo . The most common adverse events were headache ( 20 % sildenafil , 2 % placebo ) , flushing ( 19 % sildenafil , 0 % placebo ) , dyspnea ( 9 % sildenafil , 2 % placebo ) , rhinitis ( 6 % sildenafil , 0 % placebo ) , and cardiovascular effects ( 7 % sildenafil , 0 % placebo ) . Of patients taking sildenafil , four ( 2.7 % ) developed new chest pains , with documented myocardial infa rct ion in two . CONCLUSION Oral sildenafil is a moderately effective treatment for ED in men with diabetes . The response rate was lower and cardiovascular events were higher than previously reported in nondiabetic patients OBJECTIVES To evaluate the efficacy , safety , and tolerability of oral sildenafil in Asian men with erectile dysfunction of various causes ( organic , psychogenic , or mixed ) and of more than 6 months ' duration . METHODS In this double-blind , parallel-group trial conducted at eight centers in Malaysia , the Philippines , and Singapore , 254 men , 26 to 78 years old , were r and omized to 12 weeks of sildenafil or placebo taken as needed 1 hour before anticipated sexual activity . Initially , the sildenafil ( n = 127 ) or matching placebo ( n = 127 ) dose was 50 mg but could be increased to 100 mg or decreased to 25 mg because of a lack of efficacy or intolerance , respectively . Efficacy was assessed by the 15- question International Index of Erectile Function , patients ' event logs of sexual activity , and a global efficacy question about erections . RESULTS The two primary efficacy variables relating to achievement and maintenance of an erection sufficient for sexual intercourse , as assessed by the mean scores for International Index of Erectile Function question 3 ( 4.22 versus 2.59 ) and question 4 ( 4.15 versus 2.41 ) , were both significantly higher with sildenafil than with placebo ( P < 0.0001 ) . In addition , the five separate International Index of Erectile Function domains of sexual function , the percentage of successful intercourse attempts , and the global efficacy assessment of erections revealed significantly greater treatment effects in favor of sildenafil ( P < 0.0001 versus placebo for all variables ) . Treatment-related adverse events occurred in 22.8 % of patients who received sildenafil and in 10.2 % of those who received placebo . CONCLUSIONS Sildenafil is an effective and well-tolerated treatment for Asian men with erectile dysfunction of broad-spectrum etiology OBJECTIVE To evaluate the efficacy and safety of sildenafil citrate ( Viagra ) in a r and omized , double-blind , placebo-controlled , flexible-dose study in Thai men with erectile dysfunction of broad-spectrum etiology and more than 6 months ' duration . MATERIAL AND METHOD 125 patients aged 26 to 77 years were r and omized at 4 centers in Thail and to receive either sildenafil citrate ( 50 mg initially , increased if necessary up to 100 mg or decreased to 25 mg depending on efficacy and /or tolerability ) ( n = 63 ) or a matching placebo ( n = 62 ) taken on an ' as needed ' basis approximately 1 hour prior to anticipated sexual activity for a period of 12 weeks . Efficacy was assessed by the patients ' responses to the 15- question International Index of Erectile Function ( IIEF ) , to questions on the event log of sexual activity , and to the global efficacy assessment question concerning improvement in erections . RESULTS At the conclusion of the study , both the primary efficacy variables relating to the achievement and maintenance of erections sufficient for sexual intercourse and the secondary efficacy variables , which included the 5 separate domains of sexual functioning of the IIEF , the percentage of successful attempts at sexual intercourse , and the global efficacy assessment question concerning improvement in erections , were all significantly improved statistically by sildenafil in comparison with placebo except in the sexual desire domain which showed no difference . The percentage of successful attempts at sexual intercourse in the sildenafil group was 66.16 per cent while in the placebo group it was 33.05 per cent . The percentage of global efficacy assessment was improved in the sildenafil group by 82.5 per cent compared to 36.1 per cent in the placebo group . Adverse events considered treatment-related occurred in 19 patients ( 30.2 % ) receiving sildenafil and 7 ( 11.3 % ) receiving placebo . The most common adverse events with sildenafil were vasodilatation ( flushing ) , headache , and dizziness , which occurred in 14.3 per cent , 6.3 per cent , and 6.3 per cent of patients respectively . All events were mild in nature . CONCLUSIONS Sildenafil is a safe and effective treatment for erectile dysfunction of broad-spectrum etiology in Thai men . Its efficacy appears similar to that reported in other studies in Western population The efficacy and safety of sildenafil was evaluated in a r and omiSed , double-blind , placebo-controlled , flexible-dose study in Korean men aged 28–78 y with erectile dysfunction ( ED ) of broad-spectrum aetiology and more than 6 months duration . A total of 133 patients were r and omised at six centres in Korea to receive either sildenafil ( 50 mg initially , increased if necessary to l00 mg or decreased to 25 mg depending on efficacy and tolerance ) ( n=66 ) or matching placebo ( n=67 ) taken on an ‘ as needed ’ basis l h prior to anticipated sexual activity for a period of 8 weeks . At the end of this time , 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 International Index of Erectile Function ( IIEF ) 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 56.1 % of patients receiving sildenafil and 20.9 % receiving placebo . The most common adverse events with sildenafil  were vasodilatation ( flushing ) , headache and abnormalities in colour vision ( 31.8 , 22.7 and 6.1 % of patients , respectively ) , and most were mild in nature . The efficacy and safety of sildenafil in this population of Korean men appears similar to that reported in other studies in western population OBJECTIVES To determine the minimal time to successful intercourse after taking sildenafil citrate for erectile dysfunction ( ED ) . METHODS Male patients with ED ( mean age 60 years ; mean ED duration 7.0 years ) who were successfully treated with sildenafil ( 100 mg ) for 2 months or longer were r and omized to sildenafil ( n = 115 ) or placebo ( n = 113 ) for 4 weeks of double-blind treatment . Using a stopwatch , patients recorded the time needed to obtain an erection hard enough for sexual intercourse after taking the study drug at least 2 hours after eating . RESULTS Within 14 and 20 minutes of sildenafil dosing , 35 % and 51 % of sildenafil-treated patients , respectively , versus 22 % and 30 % of placebo-treated patients , respectively , had an erection that led to successful intercourse ( P < 0.05 for both ) . The median time to erection leading to successful intercourse after sildenafil dosing was 36 minutes compared with 141 minutes for placebo . CONCLUSIONS In this study , slightly more than one half of a population of prior sildenafil responders achieved an erection that led to successful sexual intercourse within 20 minutes of sildenafil administration , suggesting that the onset of action of sildenafil can be less than 30 minutes in men with ED The objective of this study was to assess the efficacy and safety of sildenafil citrate ( Viagra ) in black American and Hispanic American men with erectile dysfunction ( ED ) of broad-spectrum etiology . A total of 246 black American and 197 Hispanic American men were r and omized to sildenafil ( 50 mg , adjustable to 25 mg or 100 mg , depending on efficacy and tolerability ; n = 124 and n = 99 , respectively ) or matching placebo ( n = 122 and n = 98 , respectively ) . After 6 weeks , patients were given the option of switching to the other blinded treatment for the following 6 weeks . The 12 weeks of double-blind treatment were followed by 12 weeks of open-label extension . Despite differences in prevalence of hypertension , diabetes mellitus , hyperlipidemia , and use of concomitant antihypertensive agents between the 2 study groups , sildenafil was efficacious and well tolerated . After 6 weeks , scores for questions 3 and 4 from the International Index of Erectile Function ( IIEF ) were significantly higher among sildenafil-treated black and Hispanic patients than in placebo-treated patients . In addition , compared with placebo , a significantly larger proportion of sildenafil patients reported improved erections and improved ability to have sexual intercourse . When efficacy results were stratified by ED severity or number of risk factors , scores for IIEF questions 3 and 4 were lower in men with severe ED versus mild-to-moderate ED . Similarly , the percentage of patients reporting improved erections decreased with ED severity and number of risk factors . The proportion of patients switching to the other treatment after 6 weeks was significantly higher in the placebo group ( 71 % to 85 % ) than in the sildenafil group ( 27 % to 28 % ) . The most common adverse events included headache and vasodilation , which were mild to moderate in nature and were comparable between groups . These data demonstrate that despite differences in prevalence rates of comorbidities , efficacy and safety of sildenafil is maintained across different ethnic groups Sildenafil citrate ( Viagra ) has been shown to be an effective treatment for erectile dysfunction ( ED ) of organic aetiology . This study assessed the efficacy and tolerability of sildenafil for treating ED of psychogenic and mixed psychogenic/organic aetiology . Men with ED of psychogenic and mixed aetiology were r and omised in a double-blind , fixed-dose study to placebo ( n = 95 ) or sildenafil 10 mg ( n = 90 ) , 25 mg ( n = 85 ) , or 50 mg ( n = 81 ) once daily for 28 days . Efficacy was evaluated with two global efficacy questions , a patient log of erectile activity , a sexual function question naire and a partner question naire . Patients receiving sildenafil  had significantly more grade 3 ( hard enough for penetration ) or grade 4 ( fully hard ) erections per week than patients receiving placebo , and a greater proportion of patients receiving sildenafil reported that treatment had improved their erections ( p < 0.001 ) . Results of the sexual function question naire demonstrated significant improvement for patients with ED receiving sildenafil compared with patients receiving placebo for frequency , hardness and duration of erections ( p < 0.01 ) , and for enjoyment of sexual intercourse and satisfaction with sex life ( p < 0.05 ) . The results of the partner question naire were consistent with the results reported by patients and showed that treatment with sildenafil was associated with significant improvement in the partners ' own sex lives ( p < 0.001 ) . Adverse events were mostly mild to moderate in nature . The commonest adverse events were headache , dyspepsia , flushing , myalgia , arthralgia and flu syndrome . Discontinuations due to treatment-related adverse events were few , ranging from 1.1 % to 6.2 % for patients receiving different doses of sildenafil and 4.2 % for patients receiving placebo . Sildenafil is an effective and well-tolerated treatment for ED of psychogenic or mixed aetiology with once-daily dosing This r and omised , double-blind study assessed the long-term efficacy and tolerability of vardenafil 10 and 20 mg in men with erectile dysfunction ( ED ) . A total of 566 men who completed an initial 12-month treatment period entered a 12-month extension . In these men , both doses of vardenafil produced improvement in scores for the ' erectile function ' Domain of the International Index of Erectile Function , evident from week 4 and maintained through 2 years . Sexual Encounter Profile diary responses indicated that following treatment , penetration was achieved on 92 - 94 % of attempts and erections that lasted long enough for successful intercourse were achieved on 87 - 89 % of attempts . In response to the General Assessment Question , 90 - 92 % of patients reported improved erections with vardenafil . Most treatment-emergent events were mild and transient with no cardiovascular safety concerns . These results support the long-term efficacy , reliability and tolerability of vardenafil 10 and 20 mg in men with ED BACKGROUND Sildenafil is a potent inhibitor of cyclic guanosine monophosphate hydrolysis [ corrected ] in the corpus cavernosum and therefore increases the penile response to sexual stimulation . We evaluated the efficacy and safety of sildenafil , administered as needed in two sequential double-blind studies of men with erectile dysfunction of organic , psychogenic , and mixed causes . METHODS In a 24-week dose-response study , 532 men were treated with oral sildenafil  ( 25 , 50 , or 100 mg ) or placebo . In a 12-week , flexible dose-escalation study , 329 different men were treated with sildenafil or placebo , with dose escalation to 100 mg based on efficacy and tolerance . After this dose-escalation study , 225 of the 329 men entered a 32-week , open-label extension study . We assessed efficacy according to the International Index of Erectile Function , a patient log , and a global-efficacy question . RESULTS In the dose-response study , increasing doses of sildenafil were associated with improved erectile function ( P values for increases in scores for questions about achieving and maintaining erections were < 0.001 ) . For the men receiving 100 mg of sildenafil , the mean score for the question about achieving erections was 100 percent higher after treatment than at base line ( 4.0 vs. 2.0 of a possible score of 5 ) . In the last four weeks of treatment in the dose-escalation study , 69 percent of all attempts at sexual intercourse were successful for the men receiving sildenafil , as compared with 22 percent for those receiving placebo ( P<0.001 ) . The mean numbers of successful attempts per month were 5.9 for the men receiving sildenafil and 1.5 for those receiving placebo ( P<0.001 ) . Headache , flushing , and dyspepsia were the most common adverse effects in the dose-escalation study , occurring in 6 percent to 18 percent of the men . Ninety-two percent of the men completed the 32-week extension study . CONCLUSIONS Oral sildenafil is an effective , well-tolerated treatment for men with erectile dysfunction BACKGROUND Erectile dysfunction is a common , multi-factorial disorder . AIMS To evaluate the efficacy , tolerability and frequency of use of sildenafil citrate in men with mild to moderate erectile dysfunction of no established organic cause . METHOD This double-blind , r and omised , placebo-controlled , flexible-dose , two-way crossover study was conducted at four centres in the UK in 44 men with mild to moderate erectile dysfunction of no clinical ly obvious organic cause . The study included two 28-day treatment periods , during which time sildenafil or placebo ( 25 - 75 mg , based on efficacy ) was taken as required . RESULTS Compared with placebo , sildenafil was associated with increases in frequency of use , erections adequate for sexual intercourse and level of sexual satisfaction ( P:<0.0001 ) . More patients receiving sildenafil stated they would use the treatment again compared with those receiving placebo ( P:<0.0001 ) . There were no discontinuations due to sildenafil treatment . CONCLUSIONS Sildenafil is effective and well tolerated in men with mild to moderate erectile dysfunction of no clinical ly identifiable organic cause Abstract . Aims /hypothesis : Ninety percent of all men with diabetes have Type II ( non-insulin-dependent ) diabetes mellitus , and erectile dysfunction ( ED ) is common in this patient group . This study evaluated the effects of sildenafil on men with erectile dysfunction and Type II diabetes and compared the results with glycated haemoglobin concentrations and chronic diabetic complications . Methods : Patients ( mean age , 59 years ) in this double-blind , placebo-controlled trial were r and omised to sildenafil ( 25–100 mg ; n = 110 ) or matching placebo ( n = 109 ) for 12 weeks . Primary criteria for efficacy included questions 3 ( achieving an erection ) and 4 ( maintaining an erection ) from the International Index of Erectile Function ( IIEF , score range , 0–5 ) . Secondary outcome measures included a global efficacy question ( GEQ ) , patient event logs , a life satisfaction checklist , and the remaining IIEF questions . Results : After 12 weeks , the mean scores for questions 3 and 4 had improved significantly in patients receiving sildenafil ( 3.42 ± 0.23 and 3.35 ± 0.24 ) compared with placebo ( 1.86 ± 0.22 and 1.84 ± 0.23 ; p < 0.0001 ) . Similarly , the GEQ score was higher in the sildenafil ( 64.6 % ) than the placebo group ( 10.5 % ) . Even when correlating efficacy with glycated haemoglobin concentrations ( ≤ 8.3 % or > 8.3 % , the median concentration found in this study ) or the number of diabetic complications ( 0 or ≥ 1 ) , the mean scores for the GEQ and questions 3 and 4 from the IIEF remained higher for all the sildenafil groups compared with the placebo groups ( p < 0.0001 ) . Conclusion /interpretation : Sildenafil was well-tolerated and effective in improving  erectile dysfunction in men with Type II diabetes , even in patients with poor glycaemic control and chronic complications . [ Diabetologia ( 2001 ) 44 : 1296–1301 OBJECTIVE Depressed men commonly have erectile dysfunction , and men with erectile dysfunction are frequently depressed . Since the etiologic and modulatory relationships between depression and erectile dysfunction have been poorly characterized , a 12-week , r and omized , double-blind , placebo-controlled trial was conducted at 20 urologic clinics to evaluate the effects of sildenafil treatment in men with erectile dysfunction and mild-to-moderate comorbid depressive illness . METHOD Men ( N=152 , mean age=56 years ) with erectile dysfunction for > or = 6 months ( mean=5.7 years ) , a DSM-IV diagnosis of depressive disorder not otherwise specified , and a Hamilton Depression Rating Scale score > or = 12 ( mean at baseline=16.9 ) were r and omly assigned to flexible-dose treatment with sildenafil citrate or matching placebo . Interviewer-rated and self-report instruments were used to assess changes in sexual function , depressive symptoms , and quality of life . Conservative criteria were used to classify erectile dysfunction treatment response and nonresponse . RESULTS Sildenafil was strongly associated with erectile dysfunction treatment response .  Fifty-eight men met the conservative criteria for response ( 48 given sildenafil , 10 given placebo ) , and 78 men did not respond ( 18 given sildenafil , 60 given placebo ) . Mean decreases of 10.6 and 2.3 in Hamilton depression scale scores were seen in treatment responders and nonresponders , respectively ; 76 % of treatment responders showed a > or = 50 % decline in Hamilton depression scale score versus 14 % of nonresponders . Quality of life was similarly improved in treatment responders . CONCLUSIONS Sildenafil is efficacious for erectile dysfunction in men with mild-to-moderate depressive illness . Improvement of erectile dysfunction is associated with marked improvement in depressive symptoms and quality of life BACKGROUND Three inhibitors of phosphodiesterase 5 ( PDE5 ) are now available for the treatment of erectile dysfunction ( ED ) : sildenafil citrate , vardenafil , and tadalafil . Pharmacologic differences between these compounds may result in patient preferences for one over another and may influence treatment decisions made by the physician and patient . Therefore , clinical research is needed to investigate whether individual properties of the PDE5 inhibitors play a role in shaping patient preference . OBJECTIVES The goal of this study was to determine what proportion of ED patients currently taking sildenafil  would , after a period of treatment with tadalafil , elect to resume treatment with sildenafil at the customary dose and what proportion would elect a switch to tadalafil 20 mg for a longer period . The tolerability of both treatments was also investigated . METHODS This was a short-term , multicenter , open-label , 1-way crossover trial conducted in Sweden and Italy . Eligible patients included men aged > or=18 years with a minimum 3-month history of ED who had been taking sildenafil at stable fixed doses of 25 , 50 , or 100 mg as needed for at least 6 weeks and up to 24 weeks . The study consisted of 6 phases : a 1-week screening phase , a 3-week sildenafil assessment phase , a 1-week washout phase , a 6-week tadalafil initiation phase , a 3-week tadalafil assessment phase , and a 6-month extension phase , during which patients received their treatment of choice free of charge . The primary outcome measure was the proportion of patients electing to take sildenafil or tadalafil during the extension phase . RESULTS Of 155 men enrolled , 147 ( 97.8 % ) completed the assessment phases of the trial . Of these 147 men , 133 ( 90.5 % ) elected to receive tadalafil in the 6-month extension phase and 14 ( 9.5 % ) elected to receive sildenafil ( P < 0.001 ) . The proportions preferring tadalafil to sildenafil  were similar irrespective of age group ( > or=50 years , 92 % ; < 50 years , 90 % ) , severity of ED ( mild , 95 % ; moderate , 88 % ; severe , 96 % ) , etiology of ED ( psychogenic , 94 % ; organic , 91 % ; mixed , 87 % ) , and  sildenafil dose at study entry ( 50 mg , 90 % ; 100 mg , 89 % ) . Both medications were well tolerated . The most common treatment-emergent adverse events occurring in > or=2 % of patients during the tadalafil assessment phase included headache ( 4.8 % ) , nasal congestion ( 4.1 % ) , dyspepsia ( 3.4 % ) , flushing ( 2.7 % ) , back pain ( 2.0 % ) , diarrhea ( 2.0 % ) , and nausea ( 2.0 % ) ; the most common treatment-emergent adverse events during the sildenafil assessment phase were flusing ( 7.1 % ) , nasal congestion ( 6.5 % ) , headache ( 4.5 % ) , and nasopharyngitis ( 3.2 % ) . CONCLUSIONS In this short-term , open-label study , patients who were currently taking sildenafil for ED and then received  tadalafil preferred to continue oral therapy with tadalafil over sildenafil by a ratio of approximately 9:1 . Although the study sought to mimic the experience of actual patients receiving treatment for ED , the results are subject to potential limitations due to the design of the study , which included differences in dosing instructions and dosages for sildenafil and tadalafil . Both sildenafil and tadalafil were well tolerated OBJECTIVES To evaluate the efficacy , safety , and tolerability of sildenafil in men with broad-spectrum erectile dysfunction ( ED ) , with reference to age-matched healthy control subjects . METHODS One hundred eleven patients were enrolled in a r and omized , double-blind , placebo-controlled , parallel-group , 12-week , flexible-dose study . Efficacy assessment s included the International Index of Erectile Function ( IIEF ) , a global assessment question , and patient event log data . In a separate , nontreatment study , 109 control subjects also completed the IIEF . RESULTS Mean IIEF scores at baseline were significantly lower for patients with ED than for control subjects without a history of ED . After treatment , mean IIEF scores for patients receiving sildenafil approached values observed in control subjects and were significantly higher than mean scores for patients receiving placebo ( P<0.01 ) . Responses to the global assessment question and patient log data corroborated the IIEF results . Sildenafil was well tolerated , with no discontinuations because of adverse events . CONCLUSIONS The results indicate that sildenafil , an effective oral therapy for the treatment of broad-spectrum ED , is associated with a near normalization of patient erectile function OBJECTIVES To examine the therapeutic effects of tadalafil on erectile dysfunction ( ED ) at 24 and 36 hours after dosing . METHODS A multicenter , r and omized , double-blind , placebo-controlled , parallel-group study of 348 men ( mean age 57 years ) with ED was conducted in Europe and the United States . Patients were stratified by baseline severity of ED using the Erectile Function domain score of the International Index of Erectile Function and then r and omly allocated within the severity group to receive tadalafil 20 mg ( n = 175 ) or placebo ( n = 173 ) . Subsequently , participants were r and omly assigned to two 4-week treatment intervals , during which they were requested to attempt sexual intercourse approximately 24 or 36 hours after tadalafil or placebo dosing . The primary outcome measure was the proportion of successful sexual intercourse attempts ( completed to ejaculation ) according to patient self-report using the Sexual Encounter Profile diary . RESULTS Of the 348 patients , 327 ( 94 % ) completed the trial ( 163 of 175 in the  tadalafil group and 164 of 173 in the placebo group ) . Thirty-six hours after tadalafil dosing , 59.2 % of intercourse attempts were successful versus 28.3 % in the placebo group ( P < 0.001 ) . The proportion of successful intercourse attempts at approximately 24 hours after treatment was also significantly greater with tadalafil ( 52.9 % ) than with placebo ( 29.1 % ; P < 0.001 ) . Tadalafil was well tolerated . The incidences of four treatment-emergent adverse events were significantly greater in the tadalafil group than in the placebo group ( all P < 0.05 ) : headache , flushing , dyspepsia , and myalgia . CONCLUSIONS Tadalafil 20 mg is an effective and well-tolerated treatment for ED that has a period of responsiveness of up to 36 hours OBJECTIVE Tadalafil ( Cialis ) is an inhibitor of phosphodiesterase type 5 , which mediates relaxation of vascular smooth muscle in the corpus cavernosum thus facilitating erection . The purpose of this multicentre , r and omized , double-blind , parallel group , placebo-controlled study was to evaluate efficacy and treatment satisfaction of on-dem and Cialis in men with mild-to-severe erectile dysfunction ( ED ) . METHODS Following a 4-week treatment-free run in period , patients stratified into three severity groups by the International Index of Erectile Function ( IIEF ) Erectile Function ( EF ) domain score were r and omized to receive either placebo or Cialis 20 mg taken on dem and over a 12-week period . Efficacy endpoints were change from baseline in IIEF EF domain scores , responses to Sexual Encounter Profile diary ( SEP ) questions , and responses to the Global Assessment Questions ( GAQ ) . Treatment satisfaction was evaluated using the Erectile Dysfunction Inventory of Treatment Satisfaction ( EDITS ) question naire in two of seven participating countries where vali date d translations were available . RESULTS Of the 443 men who entered the trial , 409 ( mean age , 52 years ) formed the intent-to-treat population . Mean baseline demographics and ED severity measures were balanced between treatment groups except for a higher percentage of patients naïve to sildenafil in the tadalafil group compared to placebo ( 50 % versus 36 % ) . The percentage of patients in each IIEF EF severity class ( mild , moderate and severe ) was 47 % , 30 % and 23 % for placebo patients and 48 % , 29 % and 23 % for tadalafil patients , respectively . Tadalafil was significantly superior to placebo on all primary efficacy measures ( IIEF EF domain scores , SEP15 , GAQ1 ; p < 0.001 ) ; notably 64 % of tadalafil patients achieved a normal IIEF EF domain score at endpoint compared to 16 % of placebo patients ( p < 0.001 ) . Of the 185 patients completing the EDITS question naire ( 137 receiving Cialis and 48 receiving placebo ) , tadalafil-treated patients had a median EDITS score of 84 ( 95%CI 80 , 86 ) , which was significantly higher than the median score for placebo-treated patients of 41 ( 95%CI 32 , 59 ; p < 0.001 ; Wilcoxon test ) . The proportion of patients satisfied with treatment ( defined as final EDITS score greater than 50 ) was 87 % for the tadalafil-treated group and 46 % for the placebo-treated group ( p < 0.001 ; exact test ) . Adverse events were significantly more common with tadalafil than placebo ( p < 0.01 ) and included primarily headache ( 7.2 % versus 1.9 % ) and flushing ( 4.6 % versus 0 % ) . One patient discontinued tadalafil treatment due to back pain . CONCLUSION In men with mild-to-severe ED , tadalafil 20 mg significantly improves erectile function , demonstrates superior treatment satisfaction relative to placebo , and is well tolerated . This is the first study to yield efficacy data on tadalafil in an Eastern European population of men with erectile dysfunction , and the first to measure satisfaction with the EDITS question naire in any study population of men with this condition using tadalafil CONTEXT Sexual dysfunction is a common adverse effect of antidepressants that frequently results in treatment noncompliance . OBJECTIVE To assess the efficacy of sildenafil citrate in men with sexual dysfunction associated with the use of selective and nonselective serotonin reuptake inhibitor ( SRI ) antidepressants . DESIGN , SETTING , AND PATIENTS Prospect i ve , parallel-group , r and omized , double-blind , placebo-controlled trial conducted between November 1 , 2000 , and January 1 , 2001 , at 3 US university medical centers among 90 male out patients ( mean [ SD ] age , 45 [ 8 ] years ) with major depression in remission and sexual dysfunction associated with SRI antidepressant treatment . INTERVENTION Patients were r and omly assigned to take sildenafil ( n = 45 ) or placebo ( n = 45 ) at a flexible dose starting at 50 mg and adjustable to 100 mg before sexual activity for 6 weeks . MAIN OUTCOME MEASURES The primary outcome measure was score on the Clinical Global Impression-Sexual Function ( CGI-SF ) ; secondary measures were scores on the International Index of Erectile Function , Arizona Sexual Experience Scale , Massachusetts General Hospital-Sexual Functioning Question naire , and Hamilton Rating Scale for Depression ( HAM-D ) . RESULTS Among the 90 r and omized patients , 93 % ( 83/89 ) of patients treated per protocol took at least 1 dose of study drug and 85 % ( 76/89 ) completed week 6 end-point assessment s with last observation carried forward analyses . At a CGI-SF score of 2 or lower , 54.5 % ( 24/44 ) of sildenafil compared with 4.4 % ( 2/45 ) of placebo patients were much or very much improved ( P<.001 ) . Erectile function , arousal , ejaculation , orgasm , and overall satisfaction domain measures improved significantly in sildenafil compared with placebo patients . Mean depression scores remained consistent with remission ( HAM-D score < or = 10 ) in both groups for the study duration . CONCLUSION In our study , sildenafil effectively improved erectile function and other aspects of sexual function in men with sexual dysfunction associated with the use of SRI antidepressants . These improvements may allow patients to maintain adherence with effective antidepressant treatment PURPOSE To determine the efficacy of sildenafil citrate ( Viagra ) in patients with erectile dysfunction after three-dimensional conformal external beam radiotherapy ( 3D-CRT ) for prostate cancer . METHODS AND MATERIAL S 406 patients with complaints of erectile dysfunction and who completed radiation at least 6 months before the study were approached by mail .  3D-CRT had been delivered ( mean dose 68 Gy ) . Sixty patients were included and entered a double-blind , placebo-controlled , cross-over study lasting 12 weeks . They received during 2 weeks 50 mg of sildenafil or placebo ; at Week 2 the dose was increased to 100 mg in case of unsatisfactory erectile response . At Week 6 , patients crossed over to the alternative treatment . Data were collected using the International Index of Erectile Function ( IIEF ) question naire , and side effects were recorded . RESULTS Mean age was 68 years . All patients completed the study . For most questions of the IIEF question naire there was a significant increase in mean scores from baseline with sildenafil , but not with placebo . Ninety percent of the patients needed a dose adjustment to 100 mg sildenafil .  Side effects were mild or moderate . CONCLUSION Sildenafil is well tolerated and effective in improving erectile function of patients with ED after 3D-CRT for prostate cancer IC351 ( Cialis ™ ) is a selective inhibitor of PDE5 . The efficacy and safety of on-dem and dosing of IC351 in men with erectile dysfunction was assessed in a multicenter , double-blind , placebo-controlled study . One hundred seventy-nine men ( mean age : 56 y ) were r and omized to receive placebo or IC351 at doses of 2 , 5 , 10 or 25 mg , taken on dem and over a 3-week period . The primary endpoints were change from baseline in responses to Questions 3 ( Q3 ) and 4 ( Q4 ) of the International Index of Erectile Function ( IIEF ) . IC351 significantly improved IIEF Q3 scores at all doses vs placebo ( P≤0.003 ) . IC351 also significantly improved IIEF Q4 scores in all but the 2 mg group ( P≤0.0003 ) . No significant changes in laboratory values , ECGs , or blood pressure were observed . The most common adverse events were headache and dyspepsia . The conclusion of this study was that on-dem and IC351 at doses up to 25 mg was well tolerated and significantly improved erectile function The efficacy and safety of oral sildenafil citrate for the treatment of erectile dysfunction ( ED ) were assessed in a 12-week placebo-controlled study . Men with ED of organic , psychogenic , or mixed aetiology were r and omised to placebo  ( n = 166 ) or 50 mg sildenafil ( n = 163 ) , with adjustment to 100 mg or 25 mg based on efficacy and tolerability . Efficacy assessment s included a global efficacy question , event log data , and an optional partner question naire . At the end of the study , improved erections were reported by 74 % of patients receiving sildenafil versus 16 % for placebo ( p < 0.0001 ) . In the final 4 weeks of treatment , 65 % of all attempts at sexual intercourse were successful for all patients ( responders and non-responders ) receiving sildenafil versus 20 % for placebo ( p < 0.001 ) . The mean number of successful attempts per month was 5.9 for patients receiving sildenafil versus 1.5 for those receiving placebo ( p < 0.0001 ) . The most common adverse events -- headache , flushing , and dyspepsia -- were generally mild to moderate in nature and rarely ( < 1 % ) a reason for discontinuation of treatment . Oral sildenafil is an effective , reliable and well-tolerated treatment for ED of organic , psychogenic or mixed aetiology OBJECTIVES To determine the efficacy and safety of fixed-dose oral sildenafil in patients with erectile dysfunction ( ED ) of various etiologies . METHODS In a 12-week , double-blind , r and omized , placebo-controlled , fixed-dose study , 514 men ( mean age 56 years ) with ED were r and omized to receive 25 , 50 , or 100 mg of sildenafil or placebo . The primary etiology of ED was determined to be organic in 32 % of men , psychogenic in 25 % , or mixed in 43 % . Sildenafil or placebo was taken 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 the IIEF , a global efficacy question , event log data , and a partner question naire . RESULTS Sildenafil significantly increased patients ' ability to achieve and maintain erections ( P < 0.0001 ) , with efficacy increasing with increasing dose . Significant improvements were also observed in the IIEF domains for erectile function , orgasmic function , intercourse satisfaction , and overall sexual satisfaction ( P < 0.0001 ) . The proportion of subjects who felt that treatment with sildenafil  improved their erections was significantly greater ( 67 % to 86 % ) than that with placebo treatment ( 24 % , P < 0.0001 ) . The proportion of successful attempts at sexual intercourse also increased significantly with sildenafil treatment ( P < 0.001 ) . Partner responses corroborated patient reports . Sildenafil was well tolerated at the three doses studied . CONCLUSIONS Oral sildenafil is an effective , well-tolerated treatment for ED of various etiologies PURPOSE We evaluate the efficacy and safety of tadalafil , taken as needed , in men with mild to severe erectile dysfunction ( ED ) and assess sexual intercourse attempt patterns . MATERIAL S AND METHODS In this multicenter , double-blind , placebo controlled , parallel study conducted in the United States and Puerto Rico 207 men with ED were r and omized to placebo or 20 mg tadalafil for 12 weeks . The primary efficacy variables were changes from baseline in the mean International Index of Erectile Function erectile function domain score and mean per patient percentage of " yes " responses to Sexual Encounter Profile ( SEP ) diary questions 2 ( successful penetration ) and 3 ( successful intercourse ) . The Global Assessment Question was a secondary end point and post hoc analyses on sexual intercourse attempt patterns were conducted . RESULTS Men treated with  tadalafil  compared with placebo reported greater mean changes from baseline on the erectile function domain score ( 9.3 vs 0.3 with placebo , p < 0.001 ) and on the mean per patient percentage of successful penetration ( SEP question 2 , 31.6 % vs 2.3 % with placebo , p < 0.001 ) and successful intercourse attempts ( SEP question 3 , 43.6 % vs 3.5 % with placebo , p < 0.001 ) . The per treatment group percentage of successful intercourse attempts during treatment was higher for tadalafil than placebo ( 67.6 % vs 24.1 % , respectively , p < 0.001 ) and most successful intercourse attempts occurred between 4 and 36 hours after taking tadalafil . Of the men treated with tadalafil 82.8 % reported improved erections versus 19.6 % taking placebo ( Global Assessment Question , p < 0.001 ) . The most common treatment emergent adverse events were headache ( 15.7 % vs 6.3 % with placebo ) , back pain ( 8.8 % vs 0 % ) , and dyspepsia ( 7.5 % vs 0 % ) . CONCLUSIONS Tadalafil ( 20 mg ) significantly improved erectile function and patients did not closely temporally link sexual intercourse attempts with taking tadalafil . Tadalafil was also well tolerated in both groups of men with mild to severe ED PURPOSE More than one-third of men may experience erectile dysfunction ( ED ) after nerve sparing radical retropubic prostatectomy . The efficacy and safety of vardenafil , a potent , selective , phosphodiesterase 5 inhibitor , was assessed for the treatment of ED after radical prostatectomy . MATERIAL S AND METHODS In this double-blind study 440 men with ED after nerve sparing radical prostatectomy were r and omized to take placebo , or 10 or 20 mg vardenafil .  Efficacy was measured after 12 weeks using the erectile function domain of the International Index of Erectile Function , diary questions measuring vaginal penetration and intercourse success rates , and a global assessment question ( GAQ ) on erection . RESULTS Of the intent to treat population 70 % had severe ED ( erectile function less than 11 ) at baseline . After 12 weeks both vardenafil doses were significantly superior to placebo ( p < 0.0001 ) for all efficacy variables . Improved erections ( based on GAQ ) were reported by 65.2 % and 59.4 % of patients on 20 and 10 mg vardenafil , respectively , and by only 12.5 % of patients on placebo ( p < 0.0001 ) . Among men with bilateral neurovascular bundle sparing , positive GAQ responses were reported by 71.1 % and 59.7 % of patients on 20 and 10 mg vardenafil , respectively , versus 11.5 % of those on placebo ( p < 0.0001 ) . The average intercourse success rate per patient receiving 20 mg vardenafil was 74 % in men with mild to moderate ED and 28 % in men with severe ED , compared to 49 % and 4 % for placebo , respectively . Few adverse events were observed . They were generally mild to moderate headache , flushing and rhinitis . CONCLUSIONS In men with severe ED after nerve sparing radical retropubic prostatectomy , vardenafil significantly improved key indices of erectile function CONTEXT  Erectile dysfunction  is common in men with diabetes . OBJECTIVE To assess the efficacy and safety of oral sildenafil citrate in the treatment of erectile dysfunction in men with diabetes . DESIGN A multicenter , r and omized , double-blind , placebo-controlled , flexible dose-escalation study conducted May through November 1996 . SETTING Patients ' homes and 19 clinical practice centers in the United States . PATIENTS A total of 268 men ( mean age , 57 years ) with erectile dysfunction ( mean duration , 5.6 years ) and diabetes ( mean duration , 12 years ) . INTERVENTIONS Patients were r and omized to receive sildenafil ( n = 136 ) or placebo ( n = 132 ) as needed , but not more than once daily , for 12 weeks . Patients took the study drug or placebo 1 hour before anticipated sexual activity . The starting dose of sildenafil citrate was 50 mg , with the option to adjust the dose to 100 mg or 25 mg based on efficacy and tolerability , to be taken as needed . MAIN OUTCOME MEASURES Self-reported ability to achieve and maintain an erection for sexual intercourse according to the International Index of Erectile Function and adverse events . RESULTS Two hundred fifty-two patients ( 94 % ) completed the study ( 131/136 in the sildenafil group , 121/132 in the placebo group ) . By intention-to-treat analysis , at 12 weeks , 74 ( 56 % ) of 131 patients in the sildenafil group reported improved erections compared with 13 ( 10 % ) of 127 patients in the placebo group ( P<.001 ) . The proportion of men with at least 1 successful attempt at sexual intercourse was 61 % ( 71/ 117 ) for the sildenafil group vs 22 % ( 25/114 ) for the placebo group ( P<.001 ) . Adverse events related to treatment were reported for 22 ( 16 % ) of 136 patients taking sildenafil and 1 ( 1 % ) of 132 patients receiving placebo . The most common adverse events were headache ( 11 % sildenafil , 2 % placebo ) , dyspepsia ( 9 % sildenafil , 0 % placebo ) , and respiratory tract disorder ( 6 % sildenafil , 2 % placebo ) , predominantly sinus congestion or drainage . The incidence of cardiovascular adverse events was comparable for both groups ( 3 % sildenafil , 5 % placebo ) . CONCLUSION Oral sildenafil is an effective and well-tolerated treatment for erectile dysfunction in men with diabetes Objective : To evaluate the efficacy and safety of 50-mg doses of sildenafil during a 28-day period in patients with erectile dysfunction caused by spinal cord injury ( cord level range , T6 through L5 ) . Background : Sildenafil is an orally active , potent , and selective inhibitor of phosphodiesterase type 5 , an important regulator of cyclic guanosine monophosphate in the human corpus cavernosum . Methods : To be included in this double-blind , placebo-controlled study , all patients had to be able to achieve at least a partial reflexogenic erectile response to penile vibratory stimulation . The study utilized a single triangular sequential trial design . A total of 27 patients were r and omized to receive 50 mg of sildenafil or placebo , taken orally as required ( not more than once daily ) approximately 1 hour before sexual activity . Results : After 28 days of treatment , nine of 12 patients ( 75 % ) on sildenafil and one of 14 patients ( 7 % ) on placebo reported that treatment had improved their erections ( p = 0.0043 ) . Furthermore , eight of 12 patients ( 67 % ) on sildenafil and two of 13 patients ( 15 % ) on placebo indicated that they wished to continue treatment ( p = 0.018 ) . A significant improvement in satisfaction with their sex life was reported by patients taking sildenafil ( p = 0.012 ) . No patients discontinued treatment due to adverse events . Conclusion : Oral sildenafil , taken as required ( not more than once daily ) , significantly improves the quality of erections and satisfaction with sex life in men with erectile dysfunction caused by a spinal cord injury between T6 and L5
target: For common outcomes there was similar efficacy between PDE-5 inhibitors
background: Background There are no r and omised and properly blinded trials directly comparing one PDE-5 inhibitor with another in a normal home setting .
  Valid indirect comparisons with a common comparator must examine equivalent doses , similar duration , similar population s , with the same outcomes reported in the same way .