Dapoxetine Shown to Be Safe for Premature Ejaculation

Home , Dapoxetine

RESEARCH HIGHLIGHTS Nature Reviews Urology 10, 558 (2013); published online 10 September 2013; doi:10.1038/nrurol.2013.208

SEXUAL DYSFUNCTION Dapoxetine shown to be safe for premature ejaculation

Although the selective serotonin reuptake Unlike previous phase III the highest incidence of adverse events. inhibitor (SSRI) dapoxetine has marketing trials, no events of syncope A number of factors at baseline were approval in several countries for the ‘‘ associated with dapoxetine-related on-demand treatment of premature were noted in the dapoxetine adverse effects, including cardiovascular ejaculation, only now have the adverse group... disorder, metabolic disorders and effects of the drug been comprehensively alcohol consumption. examined in a large study. the course’’ of the 12-week study, 62% of Unlike other SSRIs, dapoxetine is This prospective, open-label, patients in the experimental group did not rapidly metabolized, which lends itself observational, safety study enrolled have more than 10 doses of dapoxetine. to on-demand use. Furthermore, the otherwise healthy men with premature Overall, adverse events were noted in drug’s pharmacokinetic profile probably ejaculation (mean age 40.5 years), and 12% of the men in the dapoxetine group contributes to its better safety profile assigned them to either dapoxetine and 9% in the alternative care group, with compared with other SSRIs, even at (n = 6,712) or alternative care (n = 3,316). nausea, headache and vertigo being the a dose of 60 mg. However, in patients The alternative interventions included most commonly reported effects. Very low with contraindications (including use of other oral drugs (such as the tricyclic levels of fatigue and diarrhoea were also antidepressant, CYP3A4 inhibitor and antidepressant clomipramine and noted. Unlike previous phase III trials, triptan therapies), cautious low-dosing the SSRIs paroxetine, fluoxetine no events of syncope were noted in the at 30 mg should be considered first. and sertraline), topical treatments dapoxetine group, and only one patient Mina Razzak or behavioural counselling. in the alternative care group (assigned to Men in the dapoxetine group received paroxetine) experienced syncope. either 30 mg or 60 mg doses, but could In the dapoxetine group, men >65 years Original article Mirone, V. et al. Results from a prospective change dose depending on patient were more likely to report an adverse observational study of men with premature ejaculation preference or if the low-dose regimen event, whereas in the alternative care treated with dapoxetine or alternative care: the PAUSE study. Eur. Urol. doi:10.1016/j.eururo.2013.08.018 did not have the desired effect. Over group men aged 30–39 years of age had