(259) Comparison of Dapoxetine vs Paroxetine vs Clomipramine for Premature Ejaculation Patients.

Introduction: Premature ejaculation (PE) is a common male sexual dysfunction. The International Society for Sexual Medicine (ISSM) defines PE as the inability to delay ejaculation during all or nearly all vaginal penetrations with latency time before or within 1 minute of penetration for lifelong PE and within 3 minutes for acquired PE and negative personal consequences such as distress, bother, frustration. The introduction of Selective Serotonin reuptake inhibitors (SSRIs) and Tricyclic antidepressants (TCA) revolutionized the treatment of PE. However not many studies have compared the efficacy and safety of these drugs in a single study. Objective: To compare the clinical efficacy and safety of Dapoxetine, Paroxetine, and Clomipramine for the oral pharmacotherapy of PE. Methods: Men presenting with self-reported PE were evaluated with full medical/sexual history, comorbidities, focused physical examination, assessment for Erectile function, any investigations suggested by these findings. IELT was determined by stopwatch method for every intercourse attempt. IELT were recorded before and after using the above medications in each group. ISSM definition of PE formed basis of diagnosis. All patients were married potent men in a stable relationship for at least 6 months and possible sexual intercourse equal or greater than one per week. None of the patients had received other treatment for PE for at least 4 weeks before the start of the study. All subjects gave their written informed consent before entering the study. Standardized assessment measures such as validated questionnaires & Patient Reported Outcomes (PRO) used as adjunct for assessment. Results: 48 Patients with PE were recruited in this study. Patients were randomly assigned to receive 60 mg Dapoxetine 'on-demand'(group 1, n = 24), or 20 mg Paroxetine daily (group 2, n = 12) or 50 mg Clomipramine (group 3, n = 12) orally daily during a 12-week period for each agent. After 12 weeks of treatment with Dapoxetine, Paroxetine and Clomipramine, the IELT was increased from the pretreatment mean of 35 seconds to 184 seconds, from 32 seconds to 178 seconds and from 34 seconds to 169 seconds, respectively (P = 0.01 in group 1 and 2,P = 0.02 in group 3). Baseline and 12-week mean intercourse satisfaction domain values of the IIEF were 10, 11, 10 and 14, 15, 13 in groups 1, 2, and 3 respectively. The mean number of coitus per week pretreatment and at 12-week treatment were 1.4, 1.3 and 1.3/week which rose to 2.4, 2.3 and 2.2 for Dapoxetine, Paroxetine and Clomipramine, respectively. The most common adverse effects of each drug were nausea, diarrhea, headache and perspiration. Conclusions: Oral SSRIs & TCA are safe and effective treatments for PE. Dapoxetine, although approved, does Not appear to be widely used; cost could be an issue. Its use can result in better QoL for the patient and their sexual partner. Paroxetine has the advantage of improving IELT with well-tolerated side effects. It has good efficacy in the treatment of PE. Higher dose of Clomipramine results in a longer IELT without higher risk of adverse events. Larger studies with different dosages and treatment regimens are required to yield more credible outcomes. Disclosure: No. [ABSTRACT FROM AUTHOR]