Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials

Pryor, Jon L.; Althof, Stanley E.; Steidle, Christopher P.; Rosen, Raymond C.; Shabsigh, Ridwan; Miloslavsky, Maja; Kell, Sherron

doi:10.1016/s0140-6736(06)69373-2

Cited by 321 publications

(369 citation statements)

References 30 publications

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“…Results from placebo-controlled, randomized, multicenter phase-3 trials have demonstrated that men with PE receiving dapoxetine 30 or 60 mg experienced increased intravaginal ejaculatory latency and higher levels of control over ejaculation and satisfaction with sexual intercourse (Pryor et al, 2006). In this study, the dose-effect relations were not determined, and the overall dose effect was not reported.…”

Section: Introductionmentioning

confidence: 71%

“…Nausea was the most commonly reported adverse effect, occurring with greater frequency in the dapoxetine 100-mg group (16.1%) compared to the 60-mg group (5.6%) and placebo group (0.7%). Pryor et al (2006) conducted two randomized, double-blind, placebo-controlled, multicenter studies of identical design in 2614 men diagnosed with PE according to DSM-IV definition, one evaluating the 30-mg dose of dapoxetine and the other evaluating the 60 mg dose. Mean IELT at the baseline was 0.90 (SD 0.47) min, 0.92 (0.50) min, and 0.91 (0.48) min, and at study end point (week 12 or final visit) was 1.75 (2.21) min for placebo, 2.78 (3.48) min for 30 mg dapoxetine, and 3.32 (3.68) min for 60 mg dapoxetine.…”

Section: Discussionmentioning

confidence: 99%

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RETRACTED ARTICLE: Safety and Efficacy of Dapoxetine in the Treatment of Premature Ejaculation: A Double-Blind, Placebo-Controlled, Fixed-Dose, Randomized Study

Safarinejad¹

2007

Neuropsychopharmacol

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The aim of the study was to evaluate the efficacy and safety of a selective serotonin reuptake inhibitor (SSRI) drug dapoxetine in delaying ejaculation in patients with premature ejaculation (PE). A total of 212 potent men with PE were randomly assigned to receive 30 mg orally dapoxetine (group 1, N ¼ 106) twice daily or similar regimen of placebo (group 2, N ¼ 106) during a 12-week period for each agent. Pretreatment evaluation included history and physical examination, geometric mean intravaginal ejaculatory latency time (IELT, primary outcome measure), and International Index of Erectile Function (IIEF). The efficacy of two treatments was assessed every 2 weeks during treatment, at the end of study, and in 3-month follow-up after cessation of treatment. We measured geometric mean IELT. Thus, the IELT values were logarithmically transformed before statistical analysis, and the results are reported as fold increases from baseline with associated 95% confidence intervals (CI). The independent sample two-tailed t-test was used to compare the IELTs. At the end of 12-week treatment, the dapoxetine group had a 2.9-(95% CI, 1.84-4.16) fold increase of the geometric mean IELT, while after placebo the geometric mean IELT did not increase significantly (1.4-fold increase; 95% CI, 0.84-1.63) (p ¼ 0.001). The mean weekly intercourse episodes increased from pretreatment values of 1.16 and 1.14 to 2.2 and 1.4, for dapoxetine and placebo, respectively (p ¼ 0.04). Baseline mean intercourse satisfaction domain values of IIEF, 12 and 11, reached to 16 and 10 at the 12-week treatment in groups 1 and 2, respectively (p ¼ 0.04). At the end of 3-month follow-up period, the geometric mean IELT in dapoxetine and placebo group demonstrated 1.4-(95% CI, 0.66-1.46) and 1.3-(95% CI, 0.77-1.63) fold increase, respectively (p ¼ 0.1). Three-month intercourse satisfaction domain value of IIEF was 11 in group 1 and 10 in group 2 (p ¼ 0.1). Mean number of adverse events was 19 for dapoxetine and 7 for placebo (p ¼ 0.02). Dapoxetine has moderately better results in terms of IELT and intercourse satisfaction vs placebo without long-term benefit for the patient after it is withdrawn. Further studies are necessary to draw final conclusions on the efficacy of this drug in PE.

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Section: Introductionmentioning

confidence: 71%

Section: Discussionmentioning

confidence: 99%

RETRACTED ARTICLE: Safety and Efficacy of Dapoxetine in the Treatment of Premature Ejaculation: A Double-Blind, Placebo-Controlled, Fixed-Dose, Randomized Study

Safarinejad¹

2007

Neuropsychopharmacol

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“…Patient-reported perception of control over ejaculation and satisfaction with sexual intercourse was also significantly better than both baseline values and placebo. 80 The most common adverse events with 30 and 60 mg dapoxetine in these 12-week trials in the United States were nausea (8.7% and 20.1%, respectively versus 1.9% with placebo), diarrhoea (3.9% and 6.8%, respectively versus 1.4% with placebo), headache (5.9% and 6.8%, respectively versus 4.0% with placebo) and dizziness (3.0% and 6.2%, respectively versus 0.8% with placebo), and 5% of all subjects discontinued because of adverse events. 80 Another well-designed, randomized, double-blind, multicentre, placebo-controlled, phase 3, randomized clinical trial was published in 2009.…”

Section: On-demand Therapy Of Ssrismentioning

confidence: 99%

Current therapeutic strategies for premature ejaculation and future perspectives

Xin¹,

Zhu²,

Yuan³

et al. 2011

Asian J Androl

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Premature ejaculation (PE) is a common sexual disorder in men that is mediated by disturbances in the peripheral and central nervous systems. Although all pharmaceutical treatments for PE are currently used 'off-label', some novel oral agents and some newer methods of drug administration now provide important relief to PE patients. However, the aetiology of this condition has still not been unified, primarily because of the lack of a standard animal model for basic research and the absence of a widely accepted definition and assessment tool for evidence-based clinical studies in patients with PE. In this review, we focus on the current therapeutic strategies and future treatment perspectives for PE. Ejaculation is a tightly coordinated activity with different ejaculatory organs and a spinal reflex initiated by genital and/or brain stimulation through the peripheral sensory receptors and regions, afferent pathways, the central nervous system ejaculatory centre of the brain (namely, sensory and motor areas located in the para-ventricular nucleus of the hypothalamus and the medial preoptic area). The spinal ejaculatory centre, located at the T 12 -L 1-2 spinal cord level (paragigantocellular), and its efferent pathway modulate the function of the ejaculatory organs. Ejaculation is also mediated by a complex interaction of central serotonergic and dopaminergic neurons with the secondary involvement of cholinergic, adrenergic, oxytocinergic and GABAergic neurons.Ejaculation consists of two main phases, the emission phase and the expulsion phase. The emissions include seminal fluid and secretions of the prostate and bulbourethral glands. In this phase, the contraction of accessory ejaculatory organs induces the accumulation of semen in the posterior urethra. Expansion of the posterior urethra creates a feeling of emission and sensory information that is transmitted to the spine via dorsal nerve sensory pathway and along the spinal cord up to the brain ejaculatory centre during the sexual arousal phase. The expulsion phase consists of the highly regular rhythmic contraction of striated muscles and the relaxation of smooth muscles in the ejaculatory ducts. The ejaculated semen can be divided into a number of components by serial biochemical analysis. 1 These include secretions from the seminal vesicles, prostate and bulbourethral (Cowper's) glands and spermatozoa.

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“…[6,[26][27][28][29][30] These multicenter, randomized, placebo-controlled studies were conducted with 30 and 60 mg doses of dapoxetine. Four of the five placebo-controlled studies were conducted with the proposed dapoxetine dosing regimens (30 or 60 mg as required), [26,[28][29][30] whereas one placebo-controlled study was conducted with dapoxetine 60 mg as required or 60 mg once daily. [27] The phase III clinical studies are registered at ClinicalTrials.gov as NCT00229073, [26] NCT00210613, [27] NCT00210704, [28] NCT00211107, [29] and NCT00211094.…”

Section: Phase III Randomized Placebocontrolled Studiesmentioning

confidence: 99%

“…Four of the five placebo-controlled studies were conducted with the proposed dapoxetine dosing regimens (30 or 60 mg as required), [26,[28][29][30] whereas one placebo-controlled study was conducted with dapoxetine 60 mg as required or 60 mg once daily. [27] The phase III clinical studies are registered at ClinicalTrials.gov as NCT00229073, [26] NCT00210613, [27] NCT00210704, [28] NCT00211107, [29] and NCT00211094. [29] Overall, dapoxetine treatment was generally safe and well tolerated with the tested dosing regimens.…”

Section: Phase III Randomized Placebocontrolled Studiesmentioning

confidence: 99%

Cardiovascular Safety Profile of Dapoxetine during the Premarketing Evaluation

et al. 2011

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The cardiovascular safety profile of dapoxetine, a novel selective serotonin reuptake inhibitor (SSRI) developed as an on-demand oral treatment for premature ejaculation (PE) in men, is evaluated. The cardiovascular assessment of dapoxetine was conducted throughout all stages of drug development, with findings from preclinical safety pharmacology studies, phase I clinical pharmacology studies investigating the effect of dapoxetine on QT/corrected QT (QTc) intervals in healthy men, and phase III, randomized, placebo-controlled studies evaluating the safety (and efficacy) of the drug. Preclinical safety pharmacology studies did not suggest an adverse electrophysiologic or hemodynamic effect with concentrations of dapoxetine up to 2-fold greater than recommended doses. Phase I clinical pharmacology studies demonstrated that dapoxetine did not prolong the QT/QTc interval and had neither clinically significant electrocardiographic effects nor evidence of delayed repolarization or conduction effects, with dosing up to 4-fold greater than the maximum recommended dosage. Phase III clinical studies of dapoxetine in men with PE indicated that dapoxetine was generally safe and well tolerated with the dosing regimens used (30 mg and 60 mg as required). Events of syncope were reported during the clinical development program, with the majority occurring during study visits (on site) on day 1 following administration of the first dose when various procedures (e.g. orthostatic maneuvers, venipunctures) were performed, suggesting that the procedures contributed to the incidence of syncope. This was consistent with previous reports showing that these and similar factors contribute to or trigger vasovagal syncope. Findings of the dapoxetine development program demonstrate that dapoxetine is associated with vasovagal-mediated (neurocardiogenic) syncope. No other associated significant cardiovascular adverse events were identified.

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Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials

Cited by 321 publications

References 30 publications

RETRACTED ARTICLE: Safety and Efficacy of Dapoxetine in the Treatment of Premature Ejaculation: A Double-Blind, Placebo-Controlled, Fixed-Dose, Randomized Study

RETRACTED ARTICLE: Safety and Efficacy of Dapoxetine in the Treatment of Premature Ejaculation: A Double-Blind, Placebo-Controlled, Fixed-Dose, Randomized Study

Current therapeutic strategies for premature ejaculation and future perspectives

Cardiovascular Safety Profile of Dapoxetine during the Premarketing Evaluation

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