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.
BACKGROUND
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.


OBJECTIVE
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.


METHODS
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.
Porst
Hartmut
H
Private Urology and Andrology Practice and Hospital, Hamburg, Germany. Electronic address: Porst20354@aol.com.
McMahon
Chris G
CG
Australian Centre for Sexual Health, St. Leonards, Sydney, NSW, Australia.
Althof
Stanley E
SE
Case Western Reserve University School of Medicine, Center for Marital and Sexual Health of South Florida, West Palm Beach, FL, USA.
Sharlip
Ira
I
University of California, San Francisco, CA, USA.
Bull
Scott
S
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.
Aquilina
Joseph W
JW
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.
Tesfaye
Fisseha
F
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.
Rivas
David A
DA
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.
D000328:Adult; D001596:Benzylamines / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004542:Ejaculation / Q000187:drug effects*; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000009:adverse effects / Q000627:therapeutic use*; D017060:Patient Satisfaction; D011788:Quality of Life / Q000523:psychology; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D012735:Sexual Dysfunction, Physiological / Q000188:drug therapy*
D001596:Benzylamines; D009281:Naphthalenes; D017367:Selective Serotonin Reuptake Inhibitors; C080598:dapoxetine