These efficacy variables appeared greater at higher doses , although there are no significant differences between 10 and 20 mg dose .
Specific adverse events with vardenafil  included flushing , dyspepsia , headache , and rhinitis .
Vardenafil was not significantly associated with serious cardiovascular events or death .
Vardenafil , in all treatment regimens , shows to possess superior efficacy to placebo in the treatment of patients with erectile dysfunction .
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.
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
These efficacy variables appeared greater at higher doses , although there are no significant differences between 10 and 20 mg dose .
Specific adverse events with vardenafil  included flushing , dyspepsia , headache , and rhinitis .
Vardenafil was not significantly associated with serious cardiovascular events or death .
Vardenafil , in all treatment regimens , shows to possess superior efficacy to placebo in the treatment of patients with erectile dysfunction .