P-01-035 Efficacy and Tolerability of Dapoxetine in the Treatment of Chinese Patients with Premature Ejaculation

Clinical trials of dapoxetine reported in the literature have mainly been performed in Western populations. By comparison, there are far fewer studies on the efficacy and tolerability of dapoxetine in Chinese patients with PE. This study investigates the efficacy and tolerability of dapoxetine treatment in Chinese men with PE. This study was open and prospective in its design, and included patients treated in our hospital with dapoxetine from February 2014 to February 2015. All patients received dapoxetine 30mg prn (1–3 hours before sexual intercourse) for 4 weeks. Data on their IELT and Premature Ejaculation Pro_le (PEP) were recorded before and after the completion of dapoxetine treatment regimen. Data on the Clinical Global Impression of Change (CGIC) and treatment-emergent adverse events (TEAEs) were collected in the one-month follow-up after treatment completion. A total of 202 patients with PE completed the study. Among these patients, 36.6% (n = 74) reported a CGIC rating of “better” or “much better”. A total of 64.4% (n = 130) of PE patients reported dapoxetine treatment to be effective compared with 35.6% (n = 72) who reported no effect. There was no report that dapoxetine treatment was associated with a CGIC rating of “slightly worse”, “worse” or “much worse”. The IELT before treatment was 0.88 minute, and increased significantly to 2.90 minutes after dapoxetine therapy (P < 0.05). Signi_cantly better outcomes on PEP measures were also reported with dapoxetine treatment. Incidence of TEAEs was 22.8% in dapoxetine-treated patients. Reported TEAEs include dizziness (10.9%; n = 22), nausea (7.9%; n = 16), diarrhea (4.0%; n = 8), insomnia (3.5%; n = 7) and ejaculatory difficulty (2.5%; n = 5). All side effects reported were mild; only 1.4% (n = 3) of patients discontinued treatment due to dizziness or nausea.