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

@article{Pryor2006EfficacyAT,
  title={Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials},
  author={Jon L. Pryor and Stanley E. Althof and Christopher P. Steidle and Raymond C. Rosen and Wayne J.G. Hellstrom and Ridwan Shabsigh and Maja Miloslavsky and Sherron H Kell},
  journal={The Lancet},
  year={2006},
  volume={368},
  pages={929-937}
}
BACKGROUND No drugs are approved for treatment of premature ejaculation. Our aim was to determine the efficacy and tolerability of on-demand dapoxetine in patients with severe premature ejaculation. METHODS We determined the efficacy of dapoxetine in a prospectively predefined integrated analysis of two 12-week randomised, double-blind, placebo-controlled, phase III trials of identical design done independently, in parallel, at 121 sites in the USA. Men with moderate-to-severe premature… Expand
Safety and Efficacy of Dapoxetine in the Treatment of Premature Ejaculation: A Double-Blind, Placebo-Controlled, Fixed-Dose, Randomized Study
TLDR
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results in terms of IELT and intercourse satisfaction vs placebo without long-term benefit for the patient after it is withdrawn, and further studies are necessary to draw final conclusions on the efficacy of this drug in PE. Expand
Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries.
TLDR
Dapoxetine significantly improved all aspects of PE and was generally well tolerated in this broad population of men. Expand
Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials.
TLDR
In this diverse population, dapoxetine significantly improved all aspects of PE and was generally well tolerated. Expand
Safety and efficacy of citalopram in the treatment of premature ejaculation: a double-blind placebo-controlled, fixed dose, randomized study
TLDR
It is indicated that citalopram has significantly better results in terms of IVELT and intercourse satisfaction versus placebo and to prolong the efficacy of this drug in PE. Expand
Safety and efficacy of epelsiban in the treatment of men with premature ejaculation: a randomized, double-blind, placebo-controlled, fixed-dose study.
TLDR
Stopwatch timed IELT recordings and a modified version of the patient-reported outcome questionnaire the IPE were used in this study to determine the effect of epelsiban when taken orally prior to intercourse in subjects diagnosed with PE. Expand
Treatment of premature ejaculation in the Asia-Pacific region: results from a phase III double-blind, parallel-group study of dapoxetine.
TLDR
Dapoxetine treatment significantly prolonged IELT and improved PEP measures and was generally well tolerated in men with PE in the Asia-Pacific region. Expand
Results from a prospective observational study of men with premature ejaculation treated with dapoxetine or alternative care: the PAUSE study.
TLDR
Dapoxetine for treatment of PE has a good safety profile and low prevalence of TEAEs, and the high level of adherence by healthcare providers to the contraindications, special warnings, and precautions for dapoxettine minimizes the risk for its use in routine clinical practice. Expand
Tadalafil and Fluoxetine in Premature Ejaculation: Prospective, Randomized, Double-Blind, Placebo-Controlled Study
TLDR
Fluoxetine plus tadalafil significantly increased the intravaginal ejaculatory latency time (IELT) from baseline in men with lifelong premature ejaculation when compared to placebo, tadalAFil or fluoxetines. Expand
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.
TLDR
In men with PE and comorbid ED on a stable regimen of PDE5 inhibitor, dapoxetine provided meaningful treatment benefit and was generally well tolerated. Expand
Dapoxetine: in premature ejaculation.
TLDR
Oral dapoxetine therapy for up to 12 months was generally well tolerated in men with premature ejaculation, with the nature of treatment-emergent adverse events generally similar across the clinical studies and between dap oxetine and placebo. Expand
...
1
2
3
4
5
...

References

SHOWING 1-10 OF 37 REFERENCES
The efficacy of fluoxetine in the treatment of premature ejaculation: a double-blind placebo controlled study.
TLDR
Fluoxetine may be regarded as a safe and effective alternative in the treatment of premature ejaculation and was found to be significantly longer than that in group 2. Expand
Treatment of premature ejaculation with sertraline hydrochloride: a single-blind placebo controlled crossover study.
TLDR
Sertraline appears to be a useful agent in the pharmacological treatment of premature ejaculation. Expand
Effect of SSRI antidepressants on ejaculation: a double-blind, randomized, placebo-controlled study with fluoxetine, fluvoxamine, paroxetine, and sertraline.
TLDR
In men with lifelong rapid ejaculation, paroxetine delayed ejaculation most strongly, whereas fluvoxamine delayed ejaculations the least, which suggests that ejaculation-delaying side effects of some SSRIs investigated in men with generalized rapid ejaculations may be extrapolated to men with less-rapid ejaculation. Expand
Relevance of methodological design for the interpretation of efficacy of drug treatment of premature ejaculation: a systematic review and meta-analysis
TLDR
At daily treatment, the overall efficacy of paroxetine, clomipramine, sertraline and fluoxetines is comparable, but paroxettine exerts the strongest ejaculation delay. Expand
Treatment of premature ejaculation with paroxetine hydrochloride as needed: 2 single-blind placebo controlled crossover studies.
TLDR
Paroxetine appears to be superior to placebo in the pharmacological treatment of premature ejaculation when administered on a chronic or as needed basis. Expand
Treatment of premature ejaculation with paroxetine hydrochloride
TLDR
Paroxetine hydrochloride appears to be a useful agent in the pharmacological treatment of premature ejaculation when administered on a chronic, an ‘ on-demand’ basis following chronic treatment or initial ‘on demand” basis. Expand
Single‐ and Multiple‐Dose Pharmacokinetics of Dapoxetine Hydrochloride, a Novel Agent for the Treatment of Premature Ejaculation
TLDR
Dapoxetine showed time‐invariant pharmacokinetics and dose proportionality between doses, and its Pharmacokinetics was unaffected by multiple dosing, and the pharmacokinetic of dapxetine metabolites, desmethyldapoxettine and dap oxetine‐N‐oxide, was similarly unaffected bymultiple dosing. Expand
SSRI-induced sexual dysfunction: fluoxetine, paroxetine, sertraline, and fluvoxamine in a prospective, multicenter, and descriptive clinical study of 344 patients.
TLDR
There was a significant increase in the incidence of sexual dysfunction when physicians asked the patients direct questions when SD was spontaneously reported, and patients experienced substantial improvement in sexual function when the dose was diminished or the drug was withdrawn. Expand
Selective serotonin reuptake inhibitors in the treatment of affective disorders—III. Tolerability, safety and pharmacoeconomics
TLDR
Knowledge of the differences that exist among the SSRIs in respect of tolerability and safety will aid physicians in the selection of the most beneficial treatment strategy for their patients, as well as translating into significantly different economic outcomes within the group. Expand
Lifelong premature ejaculation: definition, serotonergic neurotransmission and drug treatment
TLDR
Based on fundamental insights into serotonergic neurotransmission, it is suggested that on-demand conventional SSRI treatment will not lead to similarly impressive ejaculation delay as that found after daily conventional SSri treatment. Expand
...
1
2
3
4
...