Abstract
Dapoxetine, a selective serotonin reuptake inhibitor, is the first oral pharmacological agent indicated for the treatment of men aged 18–64 years with premature ejaculation.
In four randomized, double-blind, placebo-controlled, multicentre studies of 12–24 weeks’ duration, oral dapoxetine 30 or 60 mg (administered as needed) was effective in the treatment of men with premature ejaculation, inducing significantly (p < 0.001) greater improvements from baseline than placebo in the primary efficacy endpoint (mean intravaginal ejaculatory latency time [IELT] or mean average IELT [defined as the average of IELT values over the previous 4 weeks], as measured by the female partner utilizing a stopwatch).
For the most part, dapoxetine recipients achieved significantly better outcomes than placebo recipients with regard to the secondary endpoints, including the Premature Ejaculation Profile (PEP) domains and the Clinical Global Impression or Patient Global Impression ratings of change in premature ejaculation, across these clinical studies.
The beneficial effects of dapoxetine therapy on the perceived control over ejaculation and satisfaction with sexual intercourse PEP domains were sustained in a 9-month noncomparative extension phase of two identical 12-week, double-blind studies.
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 dapoxetine and placebo.
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Acknowledgements and Disclosures
This manuscript was reviewed by: M.D. Waldinger, Department of Psychiatry and Neurosexology, Haga Hospital Leyenburg, The Hague, the Netherlands; K.R. Wylie, Sexual Medicine, Royal Hallamshire Hospital, Sheffield, England.
The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
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Hoy, S.M., Scott, L.J. Dapoxetine. Drugs 70, 1433–1443 (2010). https://doi.org/10.2165/11204750-000000000-00000
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DOI: https://doi.org/10.2165/11204750-000000000-00000