On-demand IC351 (Cialis™) enhances erectile function in patients with erectile dysfunction

IC351 (Cialis(TM)) is a selective inhibitor of PDES. The efficacy and safety of on-demand dosing of IC351 in men with erectile dysfunction was assessed in a multicenter, double-blind, placebo-controlled study. One hundred seventy-nine men (mean age: 56 y) were randomized to receive placebo or IC351 at doses of 2, 5, 10 or 25 mg, taken on demand over a 3-week period. The primary endpoints were change from baseline in responses to Questions 3 (Q3) and 4 (Q4) of the International Index of Erectile Function (IIEF). IC351 significantly improved IIEF Q3 scores at all doses vs placebo (P less than or equal to 0.003). IC351 also significantly improved IIEF Q4 scores in all but the 2 mg group (P less than or equal to 0.0003), No significant changes in laboratory values, ECGs, or blood pressure were observed. The most common adverse events were headache and dyspepsia. The conclusion of this study was that on demand IC351 at doses up to 25 mg was well tolerated and significantly improved erectile function.