THE EVIDENCE FOR THE EFFICIENCY AND SAFETY OF DAPOXETINE IN TREATING PREMATURE EJACULATION


Cite item

Full Text

Open Access Open Access
Restricted Access Access granted
Restricted Access Subscription or Fee Access

Abstract

The aim of the study is to assess the evidence on the efficacy and safety of dapoxetine in premature ejaculation (PE). The analysis includes results of randomized placebo-controlled trials, integrative reviews and one meta-analysis on the clinical efficacy and safety of dapoxetine. All studies have shown higher efficacy of dapoxetine in patients with PE compared with placebo. Its administration at a dosage of 30 and 60 mg results in an increase in the coitus duration up to approximately 3 and 3.5 minutes, respectively. The safety profile of dapoxetine allows using it in clinical practice. Dapoxetine is a novel and effective PE drug on the Russian market.

Full Text

Restricted Access

About the authors

N. D Akhvlediani

I.M. Sechenov First MSMU of Minzdrav of Russia (Sechenov University)

Email: nikandro@mail.ru
Dr.Med.Sci., Professor at the Department of Urology

I. P Matyukhov

I.M. Sechenov First MSMU of Minzdrav of Russia (Sechenov University)

Email: matyukhovip@gmail.com
Ph.D., Physician at the Diagnostic Department, Research Institute for Uronephrology and Human Reproductive Health

References

  1. Althof S.E., McMahon C.G., Waldinger M.D., Serefoglu E.C., Shindel A.W., Adaikan P.G., Becher E., Dean J., Giuliano F., Hellstrom W.J., Giraldi A., Glina S., Incrocci L., Jannini E., McCabe M., Parish S., Rowland D., Segraves R.T., Sharlip I., Torres L.O. An update of the International Society of Sexual Medicine’s guidelines for thediagnosis and treatment of premature ejaculation (PE). J Sex Med. 2014;11(6):1392-422. doi: 10.1111/jsm.12504.
  2. Porst H., Montorsi F., Rosen R.C., Gaynor L., Grupe S., Alexander J. The Premature Ejaculation Prevalence and Attitudes (PEPA) survey: prevalence, comorbidities, and professional help-seeking. Eur Urol. 2007;51(3):816-23; discussion 824. doi: 10.1016/j.eururo.2006.07.004.
  3. Waldinger M.D. The neurobiological approach to premature ejaculation. J Urol 2002;168:2359-2367. doi: 10.1097/01.ju.0000035599.35887.8f.
  4. Zhu L., Mi Y., You X., Wu S., Shao H., Dai F., Peng T., Qin F., Feng N. A meta-analysis of the effects of the 5-hydroxytryptamine transporter gene-linked promoter region polymorphism on susceptibility to lifelong premature ejaculation. PLoS One. 2013;8( 1):e54994. Doi: 10.1371/ journal.pone.0054994.
  5. Waldinger M.D. Pharmacotherapy for premature ejaculation. Expert Opin Pharmacother. 2015;16(17) :2615-2624. doi: 10.1517/14656566.2015.1096928.
  6. Mendelevich V.D., Zalmunin K.Y. Paradoxes of evidence in Russian addiction medicine. Int J Risk Saf Med. 2015;27(Suppl. 10:S102-103. doi: 10.3233/JRS-150708.
  7. The Federal Law «On the fundamentals of protecting the health of citizens in the Russian Federation». M.: Normatika. 2017. 72 p. (Федеральный закон «Об основах охраны здоровья граждан в Российской Федерации». М., 2017;72 с.)
  8. Sadeghi-Nejad H., Watson R. Premature ejaculation: current medical treatment and new directions (CME). J Sex Med. 2008;5(5):1037-1050; quiz 1051-2. doi: 10.1111/j.1743-6109.2008.00831.x.
  9. Kendirci M., Salem E., Hellstrom W.J. Dapoxetine, a novel selective serotonin transport inhibitor for the treatment of premature ejaculation. Ther Clin Risk Manag. 2007;3:277-289. PMCID: PMC1936309.
  10. Modi N.B., Dresser M.J., Simon M. et al. Single- and multiple-dose pharmacokinetics of dapoxetine hydrochloride, a novel agent for the treatment of premature ejaculation. J Clin Pharmacol. 2006;46:301-309. doi: 10.1177/0091270005284850.
  11. Andersson K.E., Mulhall J.P., Wyllie M.G. Pharmacokinetic and pharmacodynamic features of dapox-etine, a novel drug for ‘on-demand’ treatment of premature ejaculation. BJU Int 2006;97:311-315. doi: 10.1111/j.1464-410X.2006.05911.x.
  12. Pryor J.L., Althof S.E., Steidle C., Rosen R.C., Hellstrom W.J., Shabsigh R., Miloslavsky M., Kell S. Dapoxetine Study Group. Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials. Lancet. 2006;368(9539):929-937. doi: 10.1016/S0140-6736(06)69373-2.
  13. Kaufman J.M., Rosen R.C., Mudumbi R.V., Tesfaye F., Hashmonay R., Rivas D. Treatment benefit of dapoxetine for premature ejaculation: results from a placebo-controlled phase III trial. BJU Int. 2009;103(5):651-658. doi: 10.1111/j.1464-410X.2008.08165.x.
  14. Buvat J., Tesfaye F., Rothman M., Rivas D.A., Giuliano F. Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries. Eur Urol. 2009;55(4):957-967. doi: 10.1016/j.eururo.2009.01.025.
  15. McMahon C., Kim S.W., Park N.C., Chang C.P., Rivas D., Tesfaye F., Rothman M., Aquilina J. Dapoxetine 3003 Study Investigators. Treatment of premature ejaculation in the Asia-Pacific region: results from a phase III double-blind, parallel-group study of dapoxetine. J Sex Med. 2010;7(1 Pt 1):256-268. doi: 10.1111/j.1743-6109.2009.01560.x.
  16. Porst H., McMahon C.G., Althof S.E., Sharlip I., Bull S., Aquilina J.W., Tesfaye F., Rivas D.A. Baseline characteristics and treatment outcomes for men with acquired or lifelong premature ejaculation with mild or no erectile dysfunction: integrated analyses of two phase 3 dapoxetine trials. J Sex Med. 2010;7(6):2231-2242. doi: 10.1111/j.1743-6109.2010.01820.x.
  17. McMahon C.G., Althof S.E., Kaufman J.M., Buvat J., Levine S.B., Aquilina J.W., Tesfaye F., Rothman M., Rivas D.A., Porst H. Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials. J Sex Med. 2011;8(2):524-539. doi: 10.1111/j.1743-6109.2010.02097.x.
  18. McMahon C.G., Giuliano F., Dean J., Hellstrom W.J., Bull S., Tesfaye F., Sharma O., Rivas D.A., Aquilina J.W. 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):2312-2325. doi: 10.1111/jsm.12236.
  19. Yue F.G., Dong L., Hu T.T., Qu X.Y. Efficacy of Dapoxetine for the treatment of premature ejaculation: a meta-analysis of randomized clinical trials on intravaginal ejaculatory latency time, patient-reported outcomes, and adverse events. Urology. 2015;85(4):856-861. doi: 10.1016/j.urology.2015.01.009.
  20. McCarty E., Dinsmore W. Dapoxetine: an evidence-based review of its effectiveness in treatment of premature ejaculation. Core Evid. 2012;7:1-
  21. doi: 10.2147/CE.S13841.
  22. http://www.grls.rosminzdrav.ru/Grls_View_v2.aspx? routingGuid=ac041539-bb30-4409-ba29-5a90153d358a&t=68af6333-bb61-42df-8df3-048b8d88dedf
  23. http://www.grls.rosminzdrav.ru/Grls_View_v2.aspx? routingGuid=597584d2-765f-413b-986e-486f107d7219&t

Supplementary files

Supplementary Files
Action
1. JATS XML

Copyright (c) 2017 Bionika Media

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies