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Efficacy and safety of dapoxetine in men with premature ejaculation and concomitant erectile dysfunction treated with a phosphodiesterase type 5 inhibitor: randomized, placebo-controlled, phase III study.J Sex Med. 2013 Sep; 10(9):2312-25.JS
Abstract
INTRODUCTION
Men with comorbid erectile dysfunction (ED) and premature ejaculation (PE) may be concomitantly prescribed a phosphodiesterase type 5 (PDE5) inhibitor and dapoxetine.
AIM
Evaluate efficacy and safety of dapoxetine 30 mg and 60 mg on demand (prn) in men with PE and ED who were being treated with PDE5 inhibitors.
METHODS
This randomized, double-blind, placebo-controlled, flexible-dose, multicenter study enrolled men ≥18 years who met diagnostic criteria for PE including intravaginal ejaculatory latency time (IELT) of ≤2 minutes in ≥75% of sexual intercourse episodes; were on stable regimen of a PDE5 inhibitor; and had International Index of Erectile Function-erectile function domain score ≥21. Subjects received placebo, dapoxetine 30 mg, or dapoxetine 60 mg prn (1-3 hours before intercourse) for 12 weeks.
MAIN OUTCOME MEASURE
Stopwatch-measured average IELT, Clinical Global Impression of Change (CGIC) in PE, Premature Ejaculation Profile (PEP), and treatment-emergent adverse events (TEAEs).
RESULTS
Of 495 subjects randomized, 429 completed the study. Arithmetic mean average IELT significantly increased with dapoxetine vs. placebo at end point (5.2 vs. 3.4 minutes) and weeks 4, 8, and 12 (P ≤ 0.002 for all). Men who described their PE at least "better" using the CGIC were significantly greater with dapoxetine vs. placebo at end point (56.5% vs. 35.4%) and weeks 4, 8, and 12 (P ≤ 0.001 for all). Significantly better outcomes were also reported with dapoxetine vs. placebo on PEP measures. Incidence of TEAEs was 20.0% and 29.6% in placebo- and dapoxetine-treated subjects, respectively (P = 0.0135). TEAEs led to discontinuation in 1.6% of subjects in both groups. Most frequent TEAEs were known adverse drug reactions of dapoxetine treatment including nausea (9.2%), headache (4.4%), diarrhea (3.6%), dizziness (2.4%), and dizziness postural (2.4%).
CONCLUSIONS
In men with PE and comorbid ED on a stable regimen of PDE5 inhibitor, dapoxetine provided meaningful treatment benefit and was generally well tolerated.
Links
MeSH
Pub Type(s)
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Language
eng
PubMed ID
23845016
Clinical Trial Links
Citation
McMahon, Chris G., et al. "Efficacy and Safety of Dapoxetine in Men With Premature Ejaculation and Concomitant Erectile Dysfunction Treated With a Phosphodiesterase Type 5 Inhibitor: Randomized, Placebo-controlled, Phase III Study." The Journal of Sexual Medicine, vol. 10, no. 9, 2013, pp. 2312-25.
McMahon CG, Giuliano F, Dean J, et al. Efficacy and safety of dapoxetine in men with premature ejaculation and concomitant erectile dysfunction treated with a phosphodiesterase type 5 inhibitor: randomized, placebo-controlled, phase III study. J Sex Med. 2013;10(9):2312-25.
McMahon, C. G., Giuliano, F., Dean, J., Hellstrom, W. J., Bull, S., Tesfaye, F., Sharma, O., Rivas, D. A., & Aquilina, J. W. (2013). Efficacy and safety of dapoxetine in men with premature ejaculation and concomitant erectile dysfunction treated with a phosphodiesterase type 5 inhibitor: randomized, placebo-controlled, phase III study. The Journal of Sexual Medicine, 10(9), 2312-25. https://doi.org/10.1111/jsm.12236
McMahon CG, et al. Efficacy and Safety of Dapoxetine in Men With Premature Ejaculation and Concomitant Erectile Dysfunction Treated With a Phosphodiesterase Type 5 Inhibitor: Randomized, Placebo-controlled, Phase III Study. J Sex Med. 2013;10(9):2312-25. PubMed PMID: 23845016.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR
T1 - Efficacy and safety of dapoxetine in men with premature ejaculation and concomitant erectile dysfunction treated with a phosphodiesterase type 5 inhibitor: randomized, placebo-controlled, phase III study.
AU - McMahon,Chris G,
AU - Giuliano,Francois,
AU - Dean,John,
AU - Hellstrom,Wayne J G,
AU - Bull,Scott,
AU - Tesfaye,Fisseha,
AU - Sharma,Om,
AU - Rivas,David A,
AU - Aquilina,Joseph W,
Y1 - 2013/07/11/
PY - 2013/7/13/entrez
PY - 2013/7/13/pubmed
PY - 2014/7/9/medline
KW - Concomitant Treatment
KW - Dapoxetine
KW - Erectile Dysfunction
KW - Phosphodiesterase Type 5 Inhibitor
KW - Premature Ejaculation
SP - 2312
EP - 25
JF - The journal of sexual medicine
JO - J Sex Med
VL - 10
IS - 9
N2 - INTRODUCTION: Men with comorbid erectile dysfunction (ED) and premature ejaculation (PE) may be concomitantly prescribed a phosphodiesterase type 5 (PDE5) inhibitor and dapoxetine. AIM: Evaluate efficacy and safety of dapoxetine 30 mg and 60 mg on demand (prn) in men with PE and ED who were being treated with PDE5 inhibitors. METHODS: This randomized, double-blind, placebo-controlled, flexible-dose, multicenter study enrolled men ≥18 years who met diagnostic criteria for PE including intravaginal ejaculatory latency time (IELT) of ≤2 minutes in ≥75% of sexual intercourse episodes; were on stable regimen of a PDE5 inhibitor; and had International Index of Erectile Function-erectile function domain score ≥21. Subjects received placebo, dapoxetine 30 mg, or dapoxetine 60 mg prn (1-3 hours before intercourse) for 12 weeks. MAIN OUTCOME MEASURE: Stopwatch-measured average IELT, Clinical Global Impression of Change (CGIC) in PE, Premature Ejaculation Profile (PEP), and treatment-emergent adverse events (TEAEs). RESULTS: Of 495 subjects randomized, 429 completed the study. Arithmetic mean average IELT significantly increased with dapoxetine vs. placebo at end point (5.2 vs. 3.4 minutes) and weeks 4, 8, and 12 (P ≤ 0.002 for all). Men who described their PE at least "better" using the CGIC were significantly greater with dapoxetine vs. placebo at end point (56.5% vs. 35.4%) and weeks 4, 8, and 12 (P ≤ 0.001 for all). Significantly better outcomes were also reported with dapoxetine vs. placebo on PEP measures. Incidence of TEAEs was 20.0% and 29.6% in placebo- and dapoxetine-treated subjects, respectively (P = 0.0135). TEAEs led to discontinuation in 1.6% of subjects in both groups. Most frequent TEAEs were known adverse drug reactions of dapoxetine treatment including nausea (9.2%), headache (4.4%), diarrhea (3.6%), dizziness (2.4%), and dizziness postural (2.4%). CONCLUSIONS: In men with PE and comorbid ED on a stable regimen of PDE5 inhibitor, dapoxetine provided meaningful treatment benefit and was generally well tolerated.
SN - 1743-6109
UR - https://www.unboundmedicine.com/medline/citation/23845016/Efficacy_and_safety_of_dapoxetine_in_men_with_premature_ejaculation_and_concomitant_erectile_dysfunction_treated_with_a_phosphodiesterase_type_5_inhibitor:_randomized_placebo_controlled_phase_III_study_
L2 - https://linkinghub.elsevier.com/retrieve/pii/S1743-6095(15)30484-7
DB - PRIME
DP - Unbound Medicine
ER -
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