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

IC351 (Cialis(TM)) is a selective inhibitor of PDES. The efficacy and safet y of on-demand dosing of IC351 in men with erectile dysfunction was assesse d in a multicenter, double-blind, placebo-controlled study. One hundred sev enty-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 pr imary endpoints were change from baseline in responses to Questions 3 (Q3) and 4 (Q4) of the International Index of Erectile Function (IIEF). IC351 si gnificantly 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 b ut 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 commo n 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 signif icantly improved erectile function.