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 .
Efficacy and safety of fixed-dose oral sildenafil in the treatment of erectile dysfunction of various etiologies.
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
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 .