For common outcomes there was similar efficacy between PDE-5 inhibitors
Background There are no r and omised and properly blinded trials directly comparing one PDE-5 inhibitor with another in a normal home setting .
Valid indirect comparisons with a common comparator must examine equivalent doses , similar duration , similar population s , with the same outcomes reported in the same way .
The efficacy and tolerability of vardenafil, a new, oral, selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction: the first at-home clinical trial
Vardenafil , a novel selective phosphodiesterase type 5 inhibitor , was evaluated in its first large-scale at-home trial . A total of 601 men with mild to severe erectile dysfunction ( ED ) were enrolled in this multi-centre , r and omized , double-blind , placebo-controlled trial of 12 weeks of treatment with either placebo or 5 , 10 and 20 mg of vardenafil . Primary endpoints were Q3 ( vaginal penetration ) and Q4 ( maintenance of erection ) of the International Index of Erectile Function ( IIEF ) . In the intent-to-treat population ( n=580 ) , the changes from baseline for 5 , 10 and 20 mg vardenafil ( 1.2 , 1.3 and 1.5 , respectively ) were all improved ( P<0.001 ) over placebo ( 0.2 ) for Q3 and were similarly improved for Q4 ( 1.4 , 1.5 and 1.7 ) compared to placebo ( 0.5 ) ( P<0.001 ) . All vardenafil doses improved all IIEF domains compared to placebo ( P<0.001 ) . The percentage of successful intercourses was between 71 and 75 % for the three vardenafil doses . For the 20 mg dose , 80 % of the patients experienced improved erections ( GAQ ) compared to 30 % for placebo . Most frequent treatment-emergent adverse events were headache ( 7–15 % ) , flushing ( 10–11 % ) and up to 7 % for dyspepsia or rhinitis . Vardenafil treatment result ed in a high efficacy and low adverse-event profile in a population with mixed ED etiologies
For common outcomes there was similar efficacy between PDE-5 inhibitors
Background There are no r and omised and properly blinded trials directly comparing one PDE-5 inhibitor with another in a normal home setting .
Valid indirect comparisons with a common comparator must examine equivalent doses , similar duration , similar population s , with the same outcomes reported in the same way .