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 .
Safety and efficacy of vardenafil in patients with erectile dysfunction: result of a bridging study in Japan.
AIM Vardenafil is a selective and highly potent phosphodiesterase type 5 ( PDE5 ) inhibitor for the treatment of erectile dysfunction ( ED ) , with improved selectivity for PDE5 and demonstrated efficacy for improving sexual function in men with ED . The current study investigated the safety and efficacy of this new PDE5 inhibitor in Japanese men with ED . METHODS This was a prospect i ve , double blind , r and omized clinical trial design ed to evaluate the efficacy and safety of vardenafil . Following a 4-week treatment-free observation period , 283 eligible patients were r and omized to 12 weeks treatment with vardenafil 5 mg , 10 mg , 20 mg , or placebo . Primary efficacy responses were assessed using the scores of Q3 and Q4 of the international index of erectile function ( IIEF ) . RESULTS All three vardenafil doses showed significantly better improvement than the placebo group in Q3 and Q4 scores of the IIEF question naire , either at 12 weeks or at the ' last observation carried forward ' ( LOCF , P < 0.0001 ) . Q3 scores were improved to 4.06 with vardenafil 5 mg , 4.53 with vardenafil 10 mg , and 4.64 with vardenafil 20 mg , versus 3.17 with placebo . Comparable scores for Q4 were 3.47 , 4.15 and 4.31 versus 2.31 for placebo . Up to 86 % of patients achieved improved erections as assessed by the global assessment question ( GAQ ) . Reported adverse event rates were 35.3 % , 45.3 % and 54.5 % with vardenafil 5 mg , 10 mg and 20 mg , respectively , versus 21.1 % in the placebo group . No serious adverse drug reactions were reported . The most common treatment-emergent adverse events were transient headache , flushing and rhinitis , which were mostly mild . CONCLUSION Vardenafil is an effective and well-tolerated treatment for ED and provides improvement in key indices of erectile function among Japanese men with ED . The results of our trial show that up to nearly 90 % of patients achieve improved erections with the administration of vardenafil
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 .