Efficacy of Dapoxetine for the treatment of premature ejaculation: a meta-analysis of randomized clinical trials on intravaginal ejaculatory latency time, patient-reported outcomes, and adverse events.

OBJECTIVE

To evaluate the efficacy of dapoxetine in the treatment of premature ejaculation (PE) with a meta-analysis method.

METHOD: We looked for randomized controlled trials (RCTs) from MEDLINE, EMBASE, Cochrane library, "International Standard Randomized Controlled Trial Number Register," and "ClinicalTrials.gov," which reported efficacy of dapoxetine for PE. Two reviewers searched and examined the RCTs independently. The meta-analysis was performed by RevMan5.0 software.

RESULTS

We included 5 RCTs comparing dapoxetine with placebo. Dapoxetine was more effective than placebo for intravaginal ejaculatory latency time (weighted mean difference = 1.47; 95% confidence interval [CI] = 1.22-1.71; P <.00001). For the 4 patient-reported outcomes, dapoxetine was also more effective (for clinical global impression of change, odds ratio [OR] = 3.19; 95% CI, 2.47-4.11; P <.00001; for composite patient-reported outcomes criteria for clinical benefit, OR = 2.29; 95% CI, 1.74-3.00; P <.00001; for satisfaction with sexual intercourse, OR = 1.89; 95% CI, 1.68-2.12; P <.00001; for decrease in personal distress related to ejaculation, OR = 0.72; 95% CI, 0.57-0.90; P <.00001).

CONCLUSION

Dapoxetine is effective and well tolerated for either lifelong or acquired PE. But the long-term benefits and safety remain to be investigated.