Dapoxetine: An evidence-based review of its effectiveness in treatment of premature ejaculation

Core Evidence

Volumn 7, Issue , 2012, Pages 1-14

  McCarty, E J ^a   Dinsmore, W W ^a  

^a ROYAL VICTORIA HOSPITAL   (United Kingdom)

Author keywords

Dapoxetine; Intravaginal ejaculatory latency time; Patient reported outcomes; Premature ejaculation

Indexed keywords

DAPOXETINE;

ABDOMINAL PAIN; ANXIETY; ASTHENIA; BACKACHE; CLINICAL GLOBAL IMPRESSION SCALE; DIARRHEA; DISTRESS SYNDROME; DIZZINESS; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG WITHDRAWAL; ERECTILE DYSFUNCTION; FATIGUE; FLUSHING; HEART PALPITATION; HUMAN; HYPERHIDROSIS; INSOMNIA; INTERPERSONAL STRESS; LATENT PERIOD; LIBIDO DISORDER; NAUSEA; PREMATURE EJACULATION; REVIEW; RHINOPHARYNGITIS; SEXUAL SATISFACTION; SIDE EFFECT; SOMNOLENCE; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION; VOMITING; XEROSTOMIA;

EID: 84870414526     PISSN: 15551741     EISSN: None     Source Type: Journal    
DOI: 10.2147/CE.S13841     Document Type: Review

References (56)

1. Feige AM, Pinsky MR, Hellstrom WJ. Dapoxetine for premature ejaculation. Clin Pharmacol Ther. 2011;89(1):125-128.
2. McMahon CG. Dapoxetine for premature ejaculation. Expert Opin Pharmacother. 2010;11(10):1741-1752.
3. Althof SE. Prevalence, characteristics and implications of premature ejaculation/rapid ejaculation. J Urol. 2006;175(3 Pt 1):842-848. (Pubitemid 43199993)
4. Carson C, Gunn K. Premature ejaculation: definition and prevalence. Int J Impot Res. 2006;18 Suppl 1:S5-S13. (Pubitemid 44330307)
5. Porst H, Montorsi F, Rosen RC, 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):816-823.
6. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC: American Psychiatric Association; 2000.
7. Colpi GM, Hargreave TB, Papp GK, Pomerol JM, Weidner W. Guidelines on Disorders of Ejaculation, 2001. Arnhem, The Netherlands: European Association of Urology; 2005.
8. McMahon CG, Althof SE, Waldinger MD, et al. An evidence-based definition of lifelong premature ejaculation: report of the International Society for Sexual Medicine (ISSM) ad hoc committee for the definition of premature ejaculation. J Sex Med. 2008;5(7):1590-1606. (Pubitemid 352044417)
9. Giuliano F, Hellstrom WJ. The pharmacological treatment of premature ejaculation. BJU Int. 2008;102(6):668-675.
10. Rowland D, Perelman M, Althof S, et al. Self-reported premature ejaculation and aspects of sexual functioning and satisfaction. J Sex Med. 2004;1(2):225-232. (Pubitemid 40424658)
11. Sotomayor M. The burden of premature ejaculation: the patient's perspective. J Sex Med. 2005;2 Suppl 2:110-114. (Pubitemid 40740370)
12. Hellstrom WJ. Emerging treatments for premature ejaculation: focus on dapoxetine. Neuropsychiatr Dis Treat. 2009;5:37-46.
13. Waldinger MD, Zwinderman AH, Schweitzer DH, Olivier B. Relevance of methodological design for the interpretation of efficacy of drug treatment of premature ejaculation: a systematic review and meta-analysis. Int J Impot Res. 2004;16(4):369-381. (Pubitemid 39273766)
14. Hiemke C, Härtter S. Pharmacokinetics of selective serotonin reuptake inhibitors. Pharmacol Ther. 2000;85(1):11-28.
15. Modi NB, Dresser MJ, Simon M, Lin D, Desai D, Gupta S. Single- and multiple-dose pharmacokinetics of dapoxetine hydrochloride, a novel agent for the treatment of premature ejaculation. J Clin Pharmacol. 2006;46(3):301-309. (Pubitemid 43260317)
16. Thyssen A, Sharma O, Tianmei S, et al. Pharmacokinetics of dapoxetine hydrochloride in healthy Chinese, Japanese, and Caucasian men. J Clin Pharmacol. 2010;50(12):1450-1460.
17. Waldinger MD, Schweitzer DH, Olivier B. On-demand SSRI treatment of premature ejaculation: pharmacodynamic limitations for relevant ejaculation delay and consequent solutions. J Sex Med. 2005;2(1):121-131. (Pubitemid 40468200)
18. Moreira ED Jr, Brock G, Glasser DB, et al GSSAB Investigators' Group. Help-seeking behaviour for sexual problems: the global study of sexual attitudes and behaviors. Int J Clin Pract. 2005;59(1):6-16. (Pubitemid 40260106)
19. Kendirci M, Salem E, Hellstrom WJ. Dapoxetine, a novel selective serotonin transport inhibitor for the treatment of premature ejaculation. Ther Clin Risk Manag. 2007;3(2):277-289. (Pubitemid 46881455)
20. Waldinger MD. Recent advances in the classification, neurobiology and treatment of premature ejaculation. Adv Psychosom Med. 2008;29:50-69.
21. Waldinger MD, Schweizer DH. Changing paradigms from a historical DSM-III and DSM-IV view toward an evidence based definition of premature ejaculation. Part II - proposals for DSM-V and ICD-11. J Sex Med. 2006;3(4):693-705.
22. Waldinger MD, Schweizer DH. The use of old and recent DSM definitions of premature ejaculation in observational studies: a contribution to the present debate for a new classification of PE in the DSM-V. J Sex Med. 2008;5(5):1079-1087. (Pubitemid 351606697)
23. Waldinger MD. Premature ejaculation: different pathophysiologies and etiologies determine its treatment. J Sex Marital Ther. 2008;34(1):1-13. (Pubitemid 351517582)
24. Patel K, Hellstrom WJ. Central regulation of ejaculation and the therapeutic role of serotonergic agents in premature ejaculation. Curr Opin Investig Drugs. 2009;10(7):681-690.
25. Jern P, Santtila P, Johansson A, et al. Evidence for a genetic etiology to ejaculatory dysfunction. Int J Impot Res. 2009;21(1):62-67.
26. Safarinejad MR. Analysis of association between the 5-HTTLPR and STin2 polymorphisms in the serotonin-transporter gene and clinical response to a selective serotonin reuptake inhibitor (sertraline) in patients with premature ejaculation. BJU Int. 2010;105(1):73-78.
27. Abdel-Hamid IA, El Naggar EA, El Gilany AH. Assessment of as needed use of pharmacotherapy and the pause-squeeze technique in premature ejaculation. Int J Impot Res. 2001;13(1):41-45. (Pubitemid 32274649)
28. Hawton K, Catalan J, Martin P, Fagg J. Long-term outcome of sex therapy. Behav Res Ther. 1986;24(6):665-675. (Pubitemid 17213221)
29. McCabe MP. Evaluation of a cognitive behavior therapy program for people with sexual dysfunction. J Sex Marital Ther. 2001;27(3):259-271. (Pubitemid 32374398)
30. Busato W, Galindo CC. Topical anaesthetic use for treating premature ejaculation: a double-blind, randomized, placebo-controlled study. BJU Int. 2004;93(7):1018-1021. (Pubitemid 38758626)
31. Morales A, Barada J, Wyllie MG. A review of the current status of topical treatments for premature ejaculation. BJU Int. 2007;100(3):493-501. (Pubitemid 47205483)
32. Atikeler MK, Gecit I, Senol FA. Optimum usage of prilocaine-lidocaine cream in premature ejaculation. Andrologia. 2002;34(6):356-359. (Pubitemid 35463780)
33. Henry R, Morales A. Topical lidocaine-prilocaine spray for the treatment of premature ejaculation: a proof of concept study. Int J Impot Res. 2003;15(4):277-281. (Pubitemid 37101662)
34. Dinsmore WW, Hackett G, Goldmeier D, et al. Topical eutectic mixture for premature ejaculation (TEMPE): a novel aerosol-delivery form of lidocaine-prilocaine for treating premature ejaculation. BJU Int. 2007;99(2):369-375. (Pubitemid 46103119)
35. McMahon CG, Stuckey BG, Anderson M, et al. Efficacy of sildenafil citrate (Viagra) in men with premature ejaculation. J Sex Med. 2005;2(3):368-375. (Pubitemid 40744377)
36. McMahon CG, McMahon CN, Leow LJ, Winestock CG. Efficacy of type-5 phosphodiesterase inhibitors in the drug treatment of premature ejaculation: a systematic review. BJU Int. 2006;98(2):259-272.
37. Waldinger MD, Hengeveld MW, Zwinderman AH. Paroxetine treatment of premature ejaculation: a double-blind, randomized, placebo-controlled study. Am J Psychiatry. 1994;151(9):1377-1379. (Pubitemid 24281766)
38. Waldinger MD, Hengeveld MW, Zwinderman AH, Olivier B. Effect of SSRI antidepressants on ejaculation: a double-blind, randomized, placebo-controlled study with fluoxetine, fluvoxamine, paroxetine, and sertraline. J Clin Psychopharmacol. 1998;18(4):274-281. (Pubitemid 28353869)
39. Koyuncu H, Serefoglu EC, Yencilek E, Atalay H, Akbas NB, Sanca K. Escitalopram treatment for premature ejaculation has a negative effect on semen parameters. Int J Impot Res. 2011. [Epub ahead of print.]
40. Andersson KE, Mulhall JP, Wyllie MG. Pharmacokinetic and pharmacodynamics features of dapoxetine, a novel drug for 'on-demand' treatment of premature ejaculation. BJU Int. 2006;97(2):311-315.
41. Lakemedelsverket Medical Products Agency. Public assessment report: scientific discussion: Priligy dapoxetine hydrochloride film-coated tablets, 30 and 60 mg; December 2008. Available at: http://www.lakemedelsverket.se/SPC-PIL/ Pdf/par/Priligy%20film-coated%20tablet.pdf. Accessed November 6, 2011.
42. Clark W, Mucklow J. Gathering and weighing the evidence. In: Panton R, Chapman S, editors. Medicines Management. London, UK: BMJ Books and Pharmaceutical Press; 1998.
43. Safarinejad MR. Safety and efficacy of dapoxetine in the treatment of premature ejaculation: a double-blind, placebo-controlled, fixed-dose, randomized study. Neuropsychopharmacology. 2008;33(6):1259-1265. (Pubitemid 351521708)
44. McMahon C, Kim SW, Park NC, et al 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.
45. McMahon CG, Althof SE, Kaufman JM, et al. 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.
46. Pryor JL, Althof SE, Steidle C; 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. (Pubitemid 44331385)
47. Porst H, McMahon CG, Althof SE, et al. 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.
48. Buvat J, Tesfaye F, Rothman M, Rivas DA, 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.
49. Shabsigh R, Patrick DL, Rowland DL, Bull SA, Tesfaye F, Rothman M. Perceived control over ejaculation is central to treatment benefit in men with premature ejaculation: results from phase III trials with dapoxetine. BJU Int. 2008;102(7):824-828.
50. Patrick DL, Giuliano F, Ho KF, Gagnon DD, McNulty P, Rothman M. The premature ejaculation profile: validation of self-reported outcome measures for research and practice. BJU Int. 2009;103(3):358-364.
51. Althof SE, Brock GB, Rosen RC, et al. Validity of the patient-reported Clinical Global Impression of Change as a measure of treatment response in men with premature ejaculation. J Sex Med. 2010;7(6):2243-2252.
52. Kaufman JM, Rosen RC, Mudumbi RV, 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.
53. Dresser MJ, Desai D, Gidwani S. Dapoxetine, a novel treatment for premature ejaculation does not have pharmacokinetic interactions with phosphodiesterase-5 inhibitors. Int J Impot Res. 2006;18:104-110. (Pubitemid 43050030)
54. Steidle C, Miloslavsky M, Bull S; The Dapoxetine Study Group. Long-term efficacy of dapoxetine for the treatment of premature ejaculation (PE). Poster presented at the Fall meeting of the Sexual Medicine Society of North America, New York, NY; November 17-20, 2005.
55. Kowey PR, Mudumbi RV, Aquilina JW, DiBattiste PM. Cardiovascular safety profile of dapoxetine during the premarketing evaluation. Drugs R D. 2011;11(1):1-11.
56. McCarty EJ, Dinsmore WW. Premature ejaculation: treatment update. Int J STD AIDS. 2010;21(2):77-78.