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 .
Treatment of men with erectile dysfunction with transurethral alprostadil. Medicated Urethral System for Erection (MUSE) Study Group.
BACKGROUND Erectile dysfunction in men is common . We evaluated a system by which alprostadil ( prostagl and in E1 ) is delivered transurethrally to treat this disorder . METHODS Alprostadil was delivered transurethrally in a double-blind , placebo-controlled study of 1511 men , 27 to 88 years of age , who had chronic erectile dysfunction from various organic causes . The men were first tested in the clinic with up to four doses of the drug ( 125 , 250 , 500 , and 1000 microg ) ; those who had sufficient responses were r and omly assigned to treatment with either the effective dose of alprostadil or placebo for three months at home . RESULTS During in-clinic testing , 996 men ( 65.9 percent ) had erections sufficient for intercourse . Of these men , 961 reported the results of at least one home treatment ; 299 of the 461 treated with alprostadil ( 64.9 percent ) had intercourse successfully at least once , as compared with 93 of the 500 who received placebo ( 18.6 percent , P<0.001 ) . On average , 7 of 10 alprostadil administrations were followed by intercourse in men responsive to treatment . The efficacy of alprostadil was similar regardless of age or the cause of erectile dysfunction , including vascular disease , diabetes , surgery , and trauma ( P<0.001 for all comparisons with placebo ) . The most common side effect was mild penile pain , which occurred after 10.8 percent of alprostadil treatments , but the pain rarely result ed in refusal to continue in the study . Hypotension occurred in the clinic in 3.3 percent of men receiving alprostadil .  Hypotension-related symptoms were uncommon at home . No men had priapism or penile fibrosis . CONCLUSIONS In men with erectile dysfunction , transurethral alprostadil therapy result ed in erections in the clinic and in intercourse at home
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 .