An integrated analysis of alprostadil topical cream for the treatment of erectile dysfunction in 1732 patients

Objective. To assess the safety and efficacy of topical alprostadil cream for erectile dysfunction (ED). Methods. Patients with an ED score of 25 or less on the erectile function domain of the International Index of Erectile Function (IIEF) were randomly assigned to placebo or topical alprostadil cream (100, 200, or 300 mu g) for at-home use for 12 weeks in two multicenter, double-blind, parallel-group studies. Patients receiving organic nitrates and patients with diabetes were included. Primary end points included the change in score for the erectile function domain of the IIEF and the change from baseline for the Sexual Encounter Profile (SEP) questions 2 (vaginal penetration success) and 3 (maintenance of erection to ejaculation). Safety was based on observed and reported adverse events and clinical laboratory results. Data from each study were pooled into a single integrated analysis. Results. A total of 1732 patients received placebo (n = 434) or topical alprostadil cream at 100 mu g (n 434), 200 mu g (n = 430), or 300 mu g (n = 434). The mean changes from baseline to end point in IIEF erectile function (EF) domain scores were -0.7, 1.6, 2.5, and 2.4 points for each group, respectively (P < 0.001). Scores on SEP questions 2 and 3 improved slightly but significantly for all drug treatment groups compared with placebo (P < 0.001). Most adverse events were localized to the application site and resolved within 2 hours. Conclusions. Topical alprostadil cream significantly improves ED in a broad range of patients. Most adverse events were limited to the application site and were generally well tolerated.