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We conducted a systematic review and meta-analysis of published randomised controlled trials of dapoxetine for premature ejaculation. We systematically searched Embase, PubMed, Cochrane, Web of Knowledge, FDA.gov and Clinical Trials.gov for studies reporting dapoxetine in men with premature ejaculation. Efficacy endpoints included intravaginal ejaculatory latency times (IELT), personal distress related to ejaculation (PDRE) and treatment-emergent adverse events (TEAEs) was used to evaluate safety. Data were analysed using a random-effects model. Electronic search identified 276 papers. The final analysis included eight papers (n = 8422 subjects). Analysis of the pooled results indicated efficacy in both IELT (weighted mean difference (WMD) = 1.67, 95% confidence interval (CI) 1.45-1.89) and PDRE (relative risk = 1.26, 95% CI 1.18-1.35). Subgroup analysis indicated efficacy (i.e. increase in IELT) for 30- and 60-mg on-demand dapoxetine (WMD 1.38 (95% CI 1.01-1.75) and 1.62 (95% CI 1.40-1.84) respectively), as well as daily use of 60 mg dapoxetine (WMD 2.18, 95% CI 1.71-2.64). The safety profile was acceptable. Based on the different effects of magnitude of the three dosing regimens, we recommend a stepwise approach, starting with 30 mg on demand, then 60 mg on demand and finally 60 mg dapoxetine daily. [ABSTRACT FROM AUTHOR]