Dapoxetine for premature ejaculation: an updated meta-analysis of randomized controlled trials.

Purpose: Dapoxetine is the first oral agent approved for the treatment of premature ejaculation (PE). However, some countries have not approved its use. The goal of this meta-analysis was to provide more information about the efficacy and safety of dapoxetine in patients with PE.

Methods: We performed a meta-analysis of randomized controlled trials (RCTs) comparing dapoxetine with a placebo in patients with PE. Relevant eligible RCTs were identified through comprehensive searches of the Cochrane Central Register of Controlled Trials, EMBASE, and PubMed. Efficacy (intravaginal ejaculatory latency time (IELT), patient global impression of change, perceived control over ejaculation, and satisfaction with sexual intercourse) and safety (treatment-emergent adverse events and discontinuation rates) were studied by using Review Manager version 5.1.0.

Findings: Six RCTs involving 5934 patients met the inclusion criteria. The main outcome (IELT) in the dapoxetine group was improved significantly compared with IELT in the placebo group (mean difference, 1.59 [95% CI, 1.30 to 1.88]; P < 0.00001). The 60-mg dose of dapoxetine was more beneficial than the 30-mg dose for IELT (mean difference, -0.47 [95 % CI, -0.73 to -0.20]; P = 0.0005). Although the occurrence of treatment-emergent adverse events in the dapoxetine group was nearly twice that in the placebo group (50.5% vs 27.9%), reports of severe adverse events were rare.

Implications: Data from the meta-analysis revealed that treatment with dapoxetine was significantly efficacious in patients with PE. Although adverse events such as nausea, dizziness, diarrhea, insomnia, and headache were common, dapoxetine's overall safety profile was acceptable.