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 |
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| Authors: | Hartmut Porst Chris G. McMahon Stanley E. Althof Ira Sharlip Scott Bull Joseph W. Aquilina Fisseha Tesfaye David A. Rivas |
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| Affiliation: | 2. Australian Centre for Sexual Health, St. Leonards, Sydney, NSW, Australia;3. Case Western Reserve University School of Medicine, Center for Marital and Sexual Health of South Florida, West Palm Beach, FL, USA;4. University of California, San Francisco, CA, USA;5. Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA;1. Department of Advanced Biomedical Sciences, Federico II University, Naples, Italy;2. Clinical and Experimental Research Center, IRCCS San Raffaele, Rome, Italy;3. Division of Cardiology, Second University of Naples, Naples, Italy;4. Department of Vascular and Endovascular Surgery, Federico II University, Naples, Italy;1. Santa Clara Valley Medical Center, Santa Clara, CA, USA;2. Glaxo Smith Kline, Research Triangle Park, NC, USA;3. Glaxo Smith Kline, King of Prussia, PA, USA |
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| Abstract: | IntroductionPremature 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.AimTo 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.MethodsData 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 MeasuresDemographics, 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).ResultsBaseline 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.ConclusionsBaseline 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. Porst H, McMahon CG, Althof SE, Sharlip I, Bull S, Aquilina JW, Tesfaye F, and Rivas DA. 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. |
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