Results from a prospective observational study of men with premature ejaculation treated with dapoxetine or alternative care: the PAUSE study

Background: Dapoxetine hydrochloride is a selective serotonin reuptake inhibitor andthe first drug approved for the on-demand treatment of premature ejaculation (PE). Itssafety was established in a thorough clinical development program.Objective: To characterize the safety profile of dapoxetine in PE treatment and to reportthe incidence, severity, and type of adverse events.Design, setting, and participants: We conducted a 12-wk, open-label, observationalstudy with a 4-wk, postobservational contact. A total of 10 028 patients were enrolled,with 6712 patients (67.6%) treated with dapoxetine 30–60 mg (group A)and 3316(32.4%) treated with alternative care/nondapoxetine (group B).Interventions: Treatment with dapoxetine or alternative care/nondapoxetine.Outcome measurements and statistical analysis: Treatment-emergent adverse events(TEAEs) and concomitant therapy use during the 12-wk observational and the postobservationalperiod were reported.Results and limitations: The mean age for all patients was 40.5 yr. In group A, 93.0% ofthe patients were initially prescribed dapoxetine 30 mg. Treatment options for group Bpatients included clomipramine, paroxetine, fluoxetine, sertraline, topical drugs, condoms,and behavioral counseling. Both treatment regimens were well tolerated. TEAEswere reported by 12.0% and 8.9% of group A and group B, respectively, with the highestincidence observed in patients aged >65 yr for group A (21.4%) and 30–39 yr (9.8%) forgroup B. The most commonly reported TEAEs were nausea, headache, and vertigo, with ahigher incidence in group A (3.1%, 2.6%, and 1.0%, respectively) than in group B (oraldrugs: 2.3%, 1.3%, and 0.9%, respectively). There were no cases of syncope in group A andone case in group B. A major limitation is that this was a nonrandomized, open-label,short-term study lacking efficacy data.Conclusions: The results of this postmarketing observational study demonstrated thatdapoxetine for treatment of PE has a good safety profile and low prevalence of TEAEs.Syncope and major cardiovascular adverse events were not reported. The high level ofadherence by healthcare providers to the contraindications, special warnings, andprecautions for dapoxetine minimizes the risk for its use in routine clinical practice.The current risk minimization measures for its identified and potential risks areeffective.