PMID- 21059176
OWN - NLM
STAT- MEDLINE
DCOM- 20110606
LR  - 20221207
IS  - 1743-6109 (Electronic)
IS  - 1743-6095 (Linking)
VI  - 8
IP  - 2
DP  - 2011 Feb
TI  - Efficacy and safety of dapoxetine for the treatment of premature ejaculation: 
      integrated analysis of results from five phase 3 trials.
PG  - 524-39
LID - 10.1111/j.1743-6109.2010.02097.x [doi]
AB  - 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.
CI  - (c) 2010 International Society for Sexual Medicine.
FAU - McMahon, Chris G
AU  - McMahon CG
AD  - Australian Centre for Sexual Health, St Leonards, New South Wales, Australia. 
      cmcmahon@acsh.com.au
FAU - Althof, Stanley E
AU  - Althof SE
FAU - Kaufman, Joel M
AU  - Kaufman JM
FAU - Buvat, Jacques
AU  - Buvat J
FAU - Levine, Stephen B
AU  - Levine SB
FAU - Aquilina, Joseph W
AU  - Aquilina JW
FAU - Tesfaye, Fisseha
AU  - Tesfaye F
FAU - Rothman, Margaret
AU  - Rothman M
FAU - Rivas, David A
AU  - Rivas DA
FAU - Porst, Hartmut
AU  - Porst H
LA  - eng
SI  - ClinicalTrials.gov/NCT00210613
SI  - ClinicalTrials.gov/NCT00210704
SI  - ClinicalTrials.gov/NCT00211094
SI  - ClinicalTrials.gov/NCT00211107
SI  - ClinicalTrials.gov/NCT00229073
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
DEP - 20101108
PL  - Netherlands
TA  - J Sex Med
JT  - The journal of sexual medicine
JID - 101230693
RN  - 0 (Benzylamines)
RN  - 0 (Naphthalenes)
RN  - 0 (Serotonin Uptake Inhibitors)
RN  - GB2433A4M3 (dapoxetine)
SB  - IM
MH  - Adult
MH  - Benzylamines/adverse effects/*therapeutic use
MH  - Clinical Trials, Phase III as Topic
MH  - Ejaculation/*drug effects/physiology
MH  - Female
MH  - Humans
MH  - Male
MH  - Naphthalenes/adverse effects/*therapeutic use
MH  - Patient Satisfaction
MH  - Randomized Controlled Trials as Topic
MH  - Selective Serotonin Reuptake Inhibitors/adverse effects/*therapeutic use
MH  - Sexual Dysfunctions, Psychological/*drug therapy
MH  - Treatment Outcome
EDAT- 2010/11/10 06:00
MHDA- 2011/06/07 06:00
CRDT- 2010/11/10 06:00
PHST- 2010/11/10 06:00 [entrez]
PHST- 2010/11/10 06:00 [pubmed]
PHST- 2011/06/07 06:00 [medline]
AID - S1743-6095(15)33407-X [pii]
AID - 10.1111/j.1743-6109.2010.02097.x [doi]
PST - ppublish
SO  - J Sex Med. 2011 Feb;8(2):524-39. doi: 10.1111/j.1743-6109.2010.02097.x. Epub 2010 
      Nov 8.