Baseline Characteristics and Treatment Outcomes for Men with Acquired or Lifelong Premature Ejaculation with Mild or No Erectile Dysfunction: Integrated Analyses of Two Phase 3 Dapoxetine Trials

Abstract

Introduction Premature ejaculation (PE) is classified as an acquired or lifelong condition but data on baseline characteristics and response to treatment of men with acquired or lifelong PE and mild erectile dysfunction (ED) or normal erectile function (EF) is limited. Aim To present integrated analyses of baseline characteristics and treatment outcomes from phase 3 dapoxetine trials in men with acquired or lifelong PE and mild or no ED. Methods Data were analyzed from two randomized, double-blind, placebo-controlled, phase 3 clinical trials (International and Asia-Pacific) that evaluated efficacy and safety of dapoxetine (30 mg or 60 mg as needed [PRN]) in patients with PE. Men were ≥18 years, in a stable monogamous relationship for ≥6 months, met DSM-IV-TR criteria for PE for ≥6 months, had an International Index of Erectile Function EF domain score ≥21, and had an intravaginal ejaculatory latency time (IELT) ≤2 minutes in ≥75% of intercourse episodes. Main Outcome Measures Demographics, sexual history, and PE symptomatology at baseline, and mean IELT and patient-reported outcomes (PROs) at study end (week 12), were analyzed for men with acquired or lifelong PE and mild or no ED (EF score 21–25 vs. ≥26). Results Baseline characteristics except duration of PE were similar in men with acquired and lifelong PE, with no other differentiating features by ED status. Dapoxetine treatment improved significantly mean IELT (arithmetic and geometric) and PRO responses (perceived control over ejaculation, satisfaction with sexual intercourse, ejaculation-related personal distress, and interpersonal difficulty) for acquired and lifelong subtypes, but presence of mild ED diminished PRO responsiveness in both subtypes, particularly those with lifelong PE. Conclusions Baseline characteristics and treatment outcomes were generally similar in men with acquired and lifelong PE. The presence of mild ED appears to be associated with a more modest treatment response, irrespective of lifelong or acquired PE subtype.

Pharmacology for the Treatment of Premature Ejaculation

“…In randomized clinical trials, dapoxetine 30 or 60 mg taken 1 to 2 h before intercourse was effective from the first dose on IELT and also reported to increase ejaculatory control, decrease distress, and increase satisfaction. Dapoxetine has shown a similar efficacy profile in men with lifelong and acquired PE (Porst et al, 2010).…”

“…They were responsible for study discontinuation in 4% (30 mg) and 10% (60 mg) of subjects (Porst et al, 2010). According to ISSM, there is level 1a evidence to support the efficacy and safety of on-demand dosing of dapoxetine for the treatment of lifelong and acquired PE ; Table 2).…”

Results from a Prospective Observational Study of Men with Premature Ejaculation Treated with Dapoxetine or Alternative Care: The PAUSE Study

“…Key study design features that differed from previous phase 3 studies [7][8][9][10][11] in the clinical development program were a lack of strict patient-exclusion criteria (eg, age <18 yr, comorbid erectile dysfunction, psychiatric or CV disorders) and the ability of participating physicians to select the starting dose of dapoxetine and adjust the dosage during the course of the study. An important strength of this study was the thorough and comprehensive collection of adverse event data.…”

Pathophysiology of Acquired Premature Ejaculation

“…Consistent with the predominant organic etiology of acquired PE, men with this complaint are usually older, have a higher mean BMI and a greater incidence of comorbid disease including hypertension, sexual desire disorder, diabetes mellitus, chronic prostatitis, and ED compared to lifelong, variable and subjective PE (13)(14)(15)(16)39,40,46).…”