On-demand IC351 (Cialistrade mark) enhances erectile function in patients with erectile dysfunction.
Source: Int J Impot Res 2001 Feb; 13(1): 2-9
Padma-Nathan H, McMurray JG, Pullman WE, Whitaker JS, Saoud JB, Ferguson KM, Rosen RC.
Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
IC351 (Cialistrade mark) is a selective inhibitor of PDE5. 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=0.003). IC351 also significantly improved IIEF Q4 scores in all but the 2 mg group (P=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.