Safety and efficacy of escitalopram in the treatment of premature ejaculation: a double-blind, placebo-controlled, fixed-dose, randomized study.

摘要

PURPOSE: To evaluate the efficacy and safety of most selective serotonin reuptake inhibitor drug, escitalopram, in delaying ejaculation in patients with premature ejaculation (PE). MATERIALS AND METHODS: A total of 276 married men (mean age, 34.4 years) with PE were randomly assigned to receive 10 mg of escitalopram (n = 138; Group 1) or placebo (n = 138; Group 2) for 12 weeks. Pretreatment evaluation included history and physical examination, intravaginal ejaculatory latency time (IELT), International Index of Erectile Function (IIEF), and Meares-Stamey test. The efficacy of 2 treatments was assessed every 2 weeks during treatment, at the end of study, and in 3- and 6-month follow-up after cessation of treatment. RESULTS: At the end of 12-week treatment, the escitalopram group had a 4.9-fold (95% confidence interval [CI], 3.14-6.12) increase of the geometric mean IELT, whereas after placebo, the geometric mean IELT did not increase significantly (1.4-fold increase; 95% CI, 0.86-1.68; P = 0.001). Baseline mean intercourse satisfaction domain values of IIEF 10 and 11 reached to 16 and 10 at 12-week treatment in Groups 1 and 2, respectively (P = 0.01). At the end of 6-month follow-up period, the geometric mean IELT in escitalopram and placebo group demonstrated 3.1- (95% CI, 2.16-4.4) and 1.3-fold (95% CI, 0.78-1.62) increase, respectively (P = 0.001). Three- and 6-month intercourse satisfaction domain values of IIEF were 15 and 14 in Groups 1 and 10 and 10 (P = 0.01) in Group 2, respectively. Mean number of adverse events was 22 for escitalopram and 9 for placebo (P = 0.04). CONCLUSIONS: Oral escitalopram is an effective treatment for PE with long-term benefit for the patient after it is withdrawn. Further studies are required to draw final conclusions on the efficacy of this drug in PE.