Vardenafil restores erectile function to normal range in men with erectile dysfunction

Introduction. The ability of oral phosphodiesterase type 5 (PDE5) inhibitor therapy to restore erectile function to normal is an important attribute to men with erectile dysfunction (ED). Aim. To assess the ability of vardenafil to restore normal erectile function in men with general ED. Methods. In two fixed-dose, parallel-group, double-blind, placebo-controlled, pivotal studies, patients received vardenafil (5, 10, or 20mg) or placebo for 12/26 weeks. Main Outcome Measure. In this retrospective analysis, the percentage of patients "returning to normal" erectile function at week 12 (as defined by scores ≥26 on erectile function domain of International Index of Erectile Function [IIEF-EF]) was determined, with further stratification by baseline ED severity, etiology, age, and duration of ED. Results. Vardenafil 5, 10, and 20 mg returned 32%, 43%, and 49% of patients, respectively, to normal erectile function after 12 weeks, compared with 10% of patients receiving placebo (P