Dapoxetine for the Treatment of Men with Premature Ejaculation (PE): Dose-Finding Analysis.

Althof, Stanley E.; Gittelman, Marc; Steidle, Christopher P.; Ho, Kai-Fai; Kell, Sherron; Nilsson-Neijber, Anders

doi:10.1097/00007611-200510001-00109

Cited by 16 publications

(27 citation statements)

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“…The most common adverse events associated with dapoxetine are nausea, diarrhea, dizziness, and headache (Hellstrom et al, 2005). Nausea is fairly significant, with an incidence of 20% reported in patients taking the 60 mg dose of dapoxetine.…”

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RETRACTED ARTICLE: Safety and Efficacy of Dapoxetine in the Treatment of Premature Ejaculation: A Double-Blind, Placebo-Controlled, Fixed-Dose, Randomized Study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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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: 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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“…In study 1, 128/157 randomized subjects completed the study [Hellstrom et al 2005]. Subjects were randomized to receive dapoxetine 20 mg, dapoxetine 40 mg or placebo for 4 weeks with no washout period between treatment arms.…”

Section: Clinical Efficacymentioning

confidence: 99%

Dapoxetine: a new option in the medical management of premature ejaculation

McMahon

2012

Therapeutic Advances in Urology

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Premature ejaculation (PE) is a common male sexual disorder which is associated with substantial personal and interpersonal negative psychological consequences. Pharmacotherapy of PE with off-label antidepressant selective serotonin reuptake inhibitors (SSRIs) is common, effective and safe. Development and regulatory approval of drugs specifically for the treatment of PE will reduce reliance on off-label treatments and serve to fill an unmet treatment need. The objective of this article is to review evidence supporting the efficacy and safety of dapoxetine in the treatment of PE. MEDLINE, Web of Science, PICA, EMBASE and the proceedings of major international and regional scientific meetings were searched for publications or abstracts published during the period 1993-2012 that used the word 'dapoxetine' in the title, abstract or keywords. This search was then manually cross referenced for all papers. This review encompasses studies of dapoxetine pharmacokinetics, animal studies, human phase I, II and III studies, independent postmarketing and pharmacovigilance efficacy and safety studies and drug-interaction studies. Dapoxetine is a potent SSRI which is administered on demand 1-3 h prior to planned sexual contact. It is rapidly absorbed and eliminated, resulting in minimal accumulation, and has doseproportional pharmacokinetics which are unaffected by multiple dosing. Dapoxetine 30 mg and 60 mg has been evaluated in five industry-sponsored randomized, double-blind, placebo-controlled studies in 6081 men aged at least 18 years. Outcome measures included stopwatch-measured intravaginal ejaculatory latency time (IELT), Premature Ejaculation Profile (PEP) inventory items, Clinical Global Impression of Change (CGIC) in PE, and adverse events. Mean IELT, all PEP items and CGIC improved significantly with both doses of dapoxetine versus placebo (all p <0.001). The most common treatment-related adverse effects included nausea (11.0% for 30 mg, 22.2% for 60 mg), dizziness (5.9% for 30 mg, 10.9% for 60 mg), and headache (5.6% for 30 mg, 8.8% for 60 mg), and evaluation of validated rated scales demonstrated no SSRI class-related effects with dapoxetine use. Dapoxetine, as the first drug developed for PE, is an effective and safe treatment for PE and represents a major advance in sexual medicine.

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“…Derived from Hellstrom (2004), Hellstrom et al (2005).*p = 0.042 vs placebo.**p < 0.0001 vs placebo. Abbreviations : AE, adverse events; IELT, intravaginal ejaculatory latency time.…”

Section: Treatmentmentioning

confidence: 99%

Dapoxetine, a novel selective serotonin transport inhibitor for the treatment of premature ejaculation

Kendirci¹,

Salem²,

Hellstrom³

2007

Therapeutics and Clinical Risk Management

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Premature ejaculation (PE) is the most common male sexual disorder, estimated to affect up to 30% of men. Over the past one or two decades, clinical investigators have participated in an increasing number of studies that are helping in our understanding of PE, which will undoubtedly facilitate future treatments. Apart from a number of behavioral approaches, the treatment of PE consists of primarily off-label use of oral selective serotonin reuptake inhibitors (SSRIs) via either on-demand or daily delivery. However, various undesirable side-effects of these medications have led researchers to search for and develop new therapeutic approaches for PE. Dapoxetine is a short-acting SSRI developed specifi cally for the treatment of PE. Early trials with dapoxetine have documented successful outcomes without serious short-or longterm side-effects. This review addresses the defi nition, classifi cation, diagnosis, physiology, and neurobiopathology of PE, and evaluates therapeutic strategies with novel treatments for PE.

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Dapoxetine for the Treatment of Men with Premature Ejaculation (PE): Dose-Finding Analysis.

Cited by 16 publications

References 0 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

Dapoxetine: a new option in the medical management of premature ejaculation

Dapoxetine, a novel selective serotonin transport inhibitor for the treatment of premature ejaculation

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