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Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials.
J Sex Med. 2011 Feb; 8(2):524-39.JS

Abstract

INTRODUCTION

Dapoxetine has been evaluated for the on-demand treatment of premature ejaculation (PE) in five phase 3 studies in various populations worldwide and has recently been approved in several countries.

AIM

To present integrated efficacy and safety data from phase 3 trials of dapoxetine.

METHODS

Data were from five randomized, multicenter, double-blind, placebo-controlled studies conducted in over 25 countries. Men (N=6,081)≥18 years who met the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision criteria for PE; four studies required a baseline intravaginal ejaculatory latency time (IELT) of ≤2 minutes. Dapoxetine 30 and 60 mg on demand (prn; 1-3 hours before intercourse) were evaluated for either 12 or 24 weeks in four studies; one study evaluated dapoxetine 60 mg daily (qd; included in safety assessments only) or prn for 9 weeks.

MAIN OUTCOME MEASURES

End points included stopwatch-measured IELT, Premature Ejaculation Profile (PEP) items, clinical global impression of change (CGIC) in PE, and adverse events (AEs).

RESULTS

Average IELT (mean [standard deviation], geometric mean [standard error]) increased from baseline (across groups, 0.9 [0.49] minutes, 0.8 [1.01] minutes) to a significantly greater extent with dapoxetine 30 (3.1 [3.91] minutes, 2.0 [1.03] minutes) and 60 mg (3.6 [3.85] minutes, 2.3 [1.03] minutes) vs. placebo (1.9 [2.43] minutes, 1.3 [1.02] minutes; P<0.001 for all) at week 12 (geometric mean fold increase, 2.5, 3.0, and 1.6, respectively). All PEP items and CGIC improved significantly with both doses of dapoxetine vs. placebo (P<0.001 for all). The most common AEs included nausea, dizziness, and headache, and evaluation of validated instruments demonstrated no anxiety, akathisia, suicidality, or changes in mood with dapoxetine use and no discontinuation syndrome following abrupt withdrawal.

CONCLUSIONS

In this diverse population, dapoxetine significantly improved all aspects of PE and was generally well tolerated.

Links

Aggregator Full Text
Publisher Full Text
linkinghub.elsevier.com
onlinelibrary.wiley.com

Authors+Show Affiliations

McMahon CG
Australian Centre for Sexual Health, St Leonards, New South Wales, Australia. cmcmahon@acsh.com.au
Althof SE
No affiliation info available
Kaufman JM
No affiliation info available
Buvat J
No affiliation info available
Levine SB
No affiliation info available
Aquilina JW
No affiliation info available
Tesfaye F
No affiliation info available
Rothman M
No affiliation info available
Rivas DA
No affiliation info available
Porst H
No affiliation info available

MeSH

AdultBenzylaminesClinical Trials, Phase III as TopicEjaculationFemaleHumansMaleNaphthalenesPatient SatisfactionRandomized Controlled Trials as TopicSerotonin Uptake InhibitorsSexual Dysfunctions, PsychologicalTreatment Outcome

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21059176

Clinical Trial Links

Clinical trial which this article describes [1]
Clinical trial which this article describes [2]
Clinical trial which this article describes [3]
Clinical trial which this article describes [4]
Clinical trial which this article describes [5]
Research and Clinical Value of New Classification for Premature Ejaculation: Multi-Center Research

Citation

McMahon, Chris G., et al. "Efficacy and Safety of Dapoxetine for the Treatment of Premature Ejaculation: Integrated Analysis of Results From Five Phase 3 Trials." The Journal of Sexual Medicine, vol. 8, no. 2, 2011, pp. 524-39.
McMahon CG, Althof SE, Kaufman JM, et al. Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials. J Sex Med. 2011;8(2):524-39.
McMahon, C. G., Althof, S. E., Kaufman, J. M., Buvat, J., Levine, S. B., Aquilina, J. W., Tesfaye, F., Rothman, M., Rivas, D. A., & Porst, H. (2011). Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials. The Journal of Sexual Medicine, 8(2), 524-39. https://doi.org/10.1111/j.1743-6109.2010.02097.x
McMahon CG, et al. Efficacy and Safety of Dapoxetine for the Treatment of Premature Ejaculation: Integrated Analysis of Results From Five Phase 3 Trials. J Sex Med. 2011;8(2):524-39. PubMed PMID: 21059176.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials. AU - McMahon,Chris G, AU - Althof,Stanley E, AU - Kaufman,Joel M, AU - Buvat,Jacques, AU - Levine,Stephen B, AU - Aquilina,Joseph W, AU - Tesfaye,Fisseha, AU - Rothman,Margaret, AU - Rivas,David A, AU - Porst,Hartmut, Y1 - 2010/11/08/ PY - 2010/11/10/entrez PY - 2010/11/10/pubmed PY - 2011/6/7/medline SP - 524 EP - 39 JF - The journal of sexual medicine JO - J Sex Med VL - 8 IS - 2 N2 - INTRODUCTION: Dapoxetine has been evaluated for the on-demand treatment of premature ejaculation (PE) in five phase 3 studies in various populations worldwide and has recently been approved in several countries. AIM: To present integrated efficacy and safety data from phase 3 trials of dapoxetine. METHODS: Data were from five randomized, multicenter, double-blind, placebo-controlled studies conducted in over 25 countries. Men (N=6,081)≥18 years who met the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision criteria for PE; four studies required a baseline intravaginal ejaculatory latency time (IELT) of ≤2 minutes. Dapoxetine 30 and 60 mg on demand (prn; 1-3 hours before intercourse) were evaluated for either 12 or 24 weeks in four studies; one study evaluated dapoxetine 60 mg daily (qd; included in safety assessments only) or prn for 9 weeks. MAIN OUTCOME MEASURES: End points included stopwatch-measured IELT, Premature Ejaculation Profile (PEP) items, clinical global impression of change (CGIC) in PE, and adverse events (AEs). RESULTS: Average IELT (mean [standard deviation], geometric mean [standard error]) increased from baseline (across groups, 0.9 [0.49] minutes, 0.8 [1.01] minutes) to a significantly greater extent with dapoxetine 30 (3.1 [3.91] minutes, 2.0 [1.03] minutes) and 60 mg (3.6 [3.85] minutes, 2.3 [1.03] minutes) vs. placebo (1.9 [2.43] minutes, 1.3 [1.02] minutes; P<0.001 for all) at week 12 (geometric mean fold increase, 2.5, 3.0, and 1.6, respectively). All PEP items and CGIC improved significantly with both doses of dapoxetine vs. placebo (P<0.001 for all). The most common AEs included nausea, dizziness, and headache, and evaluation of validated instruments demonstrated no anxiety, akathisia, suicidality, or changes in mood with dapoxetine use and no discontinuation syndrome following abrupt withdrawal. CONCLUSIONS: In this diverse population, dapoxetine significantly improved all aspects of PE and was generally well tolerated. SN - 1743-6109 UR - https://www.unboundmedicine.com/medline/citation/21059176/Efficacy_and_safety_of_dapoxetine_for_the_treatment_of_premature_ejaculation:_integrated_analysis_of_results_from_five_phase_3_trials_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1743-6095(15)33407-X DB - PRIME DP - Unbound Medicine ER -