Efficacy of dapoxetine in the treatment of premature ejaculation
Abstract
INTRODUCTION: Premature ejaculation (PE) is a common male sexual disorder which is associated with substantial personal and interpersonal negative psychological factors. Pharmacotherapy of PE with off-label antidepressant SSRI drugs is common. Development and regulatory approval of drugs specifically for the treatment of PE will reduce reliance on off-label treatments and serve to fill a unmet treatment need.
AIM: To review evidence supporting the efficacy and safety of dapoxetine in the treatment of PE.
METHODS: MEDLINE and the proceedings of major international and regional scientific meetings during the period 1994-2010 were searched for publications or abstracts using the word dapoxetine in the title, abstract or keywords. This search was then manually cross-referenced for all papers. This review encompasses studies of dapoxetine pharmacokinetics, animal studies, human phase 1, 2 and 3 efficacy and safety studies and drug-interaction studies.
RESULTS: Dapoxetine is a potent selective serotonin re-uptake inhibitor, which is administered on-demand 1-3 hours prior to planned sexual contact. Dapoxetine is rapidly absorbed and eliminated, resulting in minimal accumulation and has dose-proportional pharmacokinetics, which are unaffected by multiple dosing. Dapoxetine 30 mg and 60 mg has been evaluated in 5 randomized, double-blind, placebo-controlled studies in 6081 men aged ≥18 years. Outcome measures included stopwatch-measured intravaginal ejaculatory latency time (IELT),…
How strong is the evidence?
Evidence Hub reads this as a randomized trial. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 6,081 participants or records.
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