Comparison of dapoxetine versus paroxetine in patients with premature ejaculation: a double-blind, placebo-controlled, fixed-dose, randomized study.

PURPOSE: To compare the efficacy and safety of dapoxetine, paroxetine, and placebo for the oral pharmacotherapy of premature ejaculation.

MATERIALS AND METHODS: Three hundred forty potent men with premature ejaculation were recruited to this study. Patients were randomly assigned to receive 60 mg dapoxetine (group 1, n = 115), or 20 mg paroxetine (group 2, n = 113) or placebo (group 3, n = 112) orally daily during a 12-week period for each agent. The efficacy of the 3 treatments was assessed every 2 weeks during treatment and at the end of study using responses to International Index of Erectile Function (IIEF), intravaginal ejaculatory latency time (IELT) evaluation, mean intercourse satisfaction domain, mean weekly coitus episodes and adverse drug effects.

RESULTS: At the end of the 12-week treatment with dapoxetine, paroxetine, and placebo, the mean IELT was increased from 38, 31 and 34 seconds to 179, 370 and 55 seconds, respectively (P = 0.01 in group 1 and P = 0.001 in group 2). Baseline mean intercourse satisfaction domain values of International Index of Erectile Function of 10, 11, and 11 reached 14, 17 and 12 at the end of the 12-week treatment in groups 1, 2, and 3 respectively (P = 0.03 in groups 1, 2). The mean weekly intercourse episodes increased from pretreatment values of 1.4, 1.3, and 1.3 to 2.2, 2.5 and 1.4, for dapoxetine, paroxetine and placebo, respectively (P = 0.04 in groups 1, 2). The incidence of adverse effects with dapoxetine and paroxetine was significantly higher (P = 0.04 in groups 1, 2) compared to that of placebo.

CONCLUSIONS: Paroxetine appears to provide significantly better results in terms of IELT and intercourse satisfaction versus dapoxetine. Each treatment was well tolerated.