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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.J Sex Med. 2010 Jun; 7(6):2231-2242.JS
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.
Links
MeSH
Pub Type(s)
Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Language
eng
PubMed ID
20412423
Citation
Porst, Hartmut, et al. "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." The Journal of Sexual Medicine, vol. 7, no. 6, 2010, pp. 2231-2242.
Porst H, McMahon CG, Althof SE, et al. 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. J Sex Med. 2010;7(6):2231-2242.
Porst, H., McMahon, C. G., Althof, S. E., Sharlip, I., Bull, S., Aquilina, J. W., Tesfaye, F., & Rivas, D. A. (2010). 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. The Journal of Sexual Medicine, 7(6), 2231-2242. https://doi.org/10.1111/j.1743-6109.2010.01820.x
Porst H, et al. 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. J Sex Med. 2010;7(6):2231-2242. PubMed PMID: 20412423.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR
T1 - 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.
AU - Porst,Hartmut,
AU - McMahon,Chris G,
AU - Althof,Stanley E,
AU - Sharlip,Ira,
AU - Bull,Scott,
AU - Aquilina,Joseph W,
AU - Tesfaye,Fisseha,
AU - Rivas,David A,
Y1 - 2010/04/19/
PY - 2010/4/24/entrez
PY - 2010/4/24/pubmed
PY - 2011/2/1/medline
SP - 2231
EP - 2242
JF - The journal of sexual medicine
JO - J Sex Med
VL - 7
IS - 6
N2 - 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.
SN - 1743-6109
UR - https://www.unboundmedicine.com/medline/citation/20412423/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_
L2 - https://linkinghub.elsevier.com/retrieve/pii/S1743-6095(15)33052-6
DB - PRIME
DP - Unbound Medicine
ER -
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