A dose‐escalation study to assess the efficacy and safety of sildenafil citrate in men with erectile dysfunction Efficacy and safety of sildenafil citrate in the treatment of men with mild to moderate erectile dysfunction. Efficacy of sildenafil citrate for the treatment of erectile dysfunction in men taking serotonin reuptake inhibitors. Clinical efficacy of sildenafil citrate based on etiology and response to prior treatment. Efficacy and safety of sildenafil citrate in men with erectile dysfunction and stable coronary artery disease. A double blind, randomised study of sildenafil citrate for erectile dysfunction in men with multiple sclerosis 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 Efficacy and safety of sildenafil citrate (Viagra®) for the treatment of erectile dysfunction in men in Egypt and South Africa Long-term efficacy and safety of oral Viagra® (sildenafil citrate) in men with erectile dysfunction and the effect of randomised treatment withdrawal Efficacy and safety of flexible-dose oral sildenafil citrate (Viagra®) in the treatment of erectile dysfunction in Brazilian and Mexican men 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 oral sildenafil in the treatment of erectile dysfunction: a double-blind, placebo-controlled study of 329 patients. Sildenafil Study Group. Sildenafil citrate (Viagra) in erectile dysfunction: near normalization in men with broad-spectrum erectile dysfunction compared with age-matched healthy control subjects. Efficacy, safety and patient acceptance of sildenafil citrate as treatment for erectile dysfunction. The efficacy and safety of oral sildenafil in Thai men with erectile dysfunction: a randomized, double-blind, placebo controlled, flexible-dose study. Sildenafil for treatment of erectile dysfunction in men with diabetes: a randomized controlled trial. Sildenafil Diabetes Study Group. Efficacy and safety of sildenafil citrate (Viagra) in black and Hispanic American men.
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 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 OBJECTIVE This study was an evaluation of whether sildenafil citrate is effective for the treatment of  erectile dysfunction in men taking concomitant serotonin-reuptake-inhibiting antidepressants . METHOD A retrospective sub analysis of combined data from 10 phase II/III double-blind , placebo-controlled , fixed- and flexible-dose trials ( 12 - 26 weeks ) identified a group of men with erectile dysfunction receiving 5 to 200 mg/day of sildenafil ( N=65 ) or placebo ( N=33 ) and concomitant serotonin-reuptake-inhibiting antidepressants .  Efficacy was measured by responses to questions from the International Index of Erectile Function on ability to achieve erection , ability to maintain erection , ejaculation frequency , orgasm frequency , and sexual desire . RESULTS Patients with erectile dysfunction receiving sildenafil and concomitant serotonergic antidepressants had significantly greater improvements in ability to achieve and maintain an erection , frequency of ejaculation , and orgasm frequency than did patients receiving placebo , without increased sexual desire . CONCLUSIONS Sildenafil significantly improved  erectile dysfunction  in patients taking concomitant serotonergic antidepressants PURPOSE We assess the clinical efficacy of sildenafil citrate and predictors of satisfactory outcome . MATERIAL S AND METHODS All patients treated with sildenafil citrate within the first 6 weeks of its release were evaluated with a self-administered question naire before and at completion of therapy to assess etiology of erectile dysfunction , level of sexual function , libido , response to previous therapies , response to therapy with sildenafil citrate and quality of life . Sexual function was measured before and during therapy using an abbreviated version of the International Index of Erectile Function , with a successful outcome defined as a level of satisfaction of 4 or 5 on a 5-point scale . RESULTS Followup was obtained in 267 of the 308 patients who entered the study . Mean age plus or minus st and ard deviation was 61+/-9.6 years and duration of erectile dysfunction was 4.1+/-3 years .  Overall satisfaction with sildenafil citrate for the entire patient population was 65 % and response to prior therapies did not affect satisfaction . There was a significant positive correlation between baseline sexual function and response to sildenafil citrate but even patients with severe erectile dysfunction had a 41 % satisfaction rate . Etiology of erectile dysfunction had a significant impact on satisfaction rate , with neurogenic causes of erectile dysfunction ( diabetes , prostate surgery and so forth ) having significantly lower rates than psychogenic or vasculogenic erectile dysfunction . CONCLUSIONS Sildenafil citrate is a highly effective oral agent for the treatment of erectile dysfunction in clinical practice . The best predictors for response to sildenafil citrate therapy are baseline sexual function and etiology of erectile dysfunction . However , we could not identify any patient characteristic that would predict absolute failure for sildenafil citrate therapy . Therefore , all patients with erectile dysfunction who do not have specific contraindications should be considered for sildenafil citrate therapy 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 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 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 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 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 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 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 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 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 PURPOSE We assessed the efficacy and safety of sildenafil citrate as treatment for erectile dysfunction . MATERIAL S AND METHODS A total of 433 completely evaluated men with chronic erectile dysfunction were treated with sildenafil citrate . Response was assessed prospect ively by baseline and followup physician interviews , and by a patient self-administered 15-item question naire on the domains of patient treatment response and satisfaction , partner treatment satisfaction , comparative previous treatment satisfaction , adverse effects , and patient and partner quality of life . RESULTS Of the 304 men ( 70.2 % ) who completed the question naire 278 received sildenafil , including 186 who previously had undergone treatment for erectile dysfunction , principally involving intracavernous injection therapy . A response was elicited by a median dose of 100 mg . in 188 patients ( 67.6 % ) who achieved erection suitable for sexual intercourse . Those with psychogenic erectile dysfunction responded significantly better than those with organic dysfunction ( p < 0.001 ) . Erection suitable for intercourse was attained by 30.8 % of patients with erectile dysfunction after radical prostatectomy and 80 % with cavernous veno-occlusive dysfunction . Of previous intracavernous injection responders 29.9 % were refractory to sildenafil , while 33 . 3 % of previous intracavernous injection nonresponders responded to sildenafil . The sildenafil response was considered inferior to the intracavernous injection response by 43.6 % of the men who previously responded to intracavernous injection , of whom 51.5 % continued to receive intracavernous injection as the only treatment ( 19.5 % ) or as an alternative to sildenafil ( 32 % ) . Adverse effects in 53.6 % of cases were assessed as mild in 56.4 % , moderate in 38.3 % and severe in 5.3 % . Multiple adverse effects were reported by 62.4 % of patients , while 17 ( 6.1 % ) discontinued sildenafil as a direct result of intolerable adverse effects . The most common adverse effects were facial flushing in 33.5 % of cases , headaches in 23.4 % , nasal congestion in 12.6 % , dyspepsia in 10.1 % and dizziness in 10.8 % . Baseline patient and partner quality of life scores significantly improved after sildenafil treatment ( p < 0.001 ) , while significantly improved quality of life was noticed by 51.5 % and 43.1 % , respectively . CONCLUSIONS Sildenafil citrate is effective oral first line treatment for erectile dysfunction . Although more than 50 % of men reported adverse effects , most were considered mild and rarely result ed in treatment cessation . There was a trend in those on intracavernous injection who responded to sildenafil to continue intracavernous injection as the only therapy or as an alternative to sildenafil . Also , we noted that some cases refractory to sildenafil responded to intracavernous injection . These findings imply that intracavernous injection remains an effective erectile dysfunction treatment option 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 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 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
In data pooled from 6 parallel-group , fixed-dose trials , efficacy appeared slightly greater at higher doses .
Treatment response appeared to vary between patient subgroups , although relative to placebo , sildenafil significantly improved erectile function in all evaluated subgroups .
In trials with parallel-group design and flexible dosing , men r and omized to receive sildenafil were less likely than those receiving placebo to drop out for any reason and no more likely to drop out due to an adverse event or laboratory abnormality .
Sildenafil was not significantly associated with serious cardiovascular events or death .
CONCLUSIONS Sildenafil improves erectile function and is generally well tolerated .
Treatment response seems to vary between patient subgroups , although sildenafil has greater efficacy than placebo in all evaluated subgroups
OBJECTIVE To determine the efficacy and safety of sildenafil citrate in the treatment of male erectile dysfunction .