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 .
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.
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
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 .