Efficacy and safety of dapoxetine/sildenafil combination tablets in the treatment of men with premature ejaculation and concomitant erectile dysfunction—DAP-SPEED Study

Premature ejaculation (PE) and erectile dysfunction (ED) are the most prevalent sexual disorders in men. ED is commonly reported among patients with PE. Although recent guidelines recommend to treat ED first in men with both PE and ED, this recommendation is not based on evidence and there are limited data about the efficacy and safety of dapoxetine/sildenafil combination therapy for these patients. The aim of this study is to evaluate the clinical efficacy and safety of the dapoxetine/sildenafil combination (Dapoxil ® 30/50 mg film-coated tablet) in the treatment of patients with PE and concomitant ED. In a single-center, single-arm, open-label clinical study conducted between October 2016 and September 2017, 74 patients with lifelong or acquired PE and ED were included. All patients were instructed to record their intravaginal ejaculatory latency time (IELT) with a stopwatch for 4 weeks. After the screening, they were requested to complete Premature Ejaculation Diagnostic Tool (PEDT), Premature Ejaculation Profile (PEP), and International Index of Erectile Function-Erectile Function (IIEF-EF) questionnaires before the treatment. The patients received on demand Dapoxil ® 1–3 h before sexual intercourse for the next 4 weeks (2 days a week and no more than once a day). The patients were also assessed with global impression of change (GIC) question for the treatment satisfaction and the side effects were recorded. The study was completed with 53 patients (53/74, 71.62%). Mean age of the patients was 45.32 ± 10.05 years. At the end of the 4-week treatment period, the geometric mean IELT of the patients significantly increased (from 22.72 ± 15.16 to 68.25 ± 82.33 s; p < 0.001). Similarly, significant improvements were observed in the mean PEP index score (0.86 ± 0.72 vs. 2.36 ± 1.13; p < 0.001) and mean IIEF-EF domain score (13.17 ± 3.33 vs. 24.60 ± 3.96; p < 0.001). According to the GIC results, 81.13% of the patients were satisfied with the treatment. Non-serious adverse events occurred in 10 patients (18.87%) and 4 (7.55%) of these patients dropped out of the treatment. The most common adverse events were headache, palpitation, and flushing. The dapoxetine/sildenafil combination therapy significantly improves the IELT values and patient reported outcome measures of PE patients who also suffer from ED. Although several side effects were reported, these were mild and transient.

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References

Serefoglu EC, McMahon CG, Waldinger MD, Althof SE, Shindel A, Adaikan G, et al. An evidence-based unified definition of lifelong and acquired premature ejaculation: report of the Second International Society for Sexual Medicine Ad Hoc Committee for the Definition of Premature Ejaculation. Sex Med. 2014;2:41–59.

Patrick DL, Althof SE, Pryor JL, Rosen R, Rowland DL, Ho KF, et al. Premature ejaculation: an observational study of men and their partners. J Sex Med. 2005;2:358–67.

Rowland DL, Patrick DL, Rothman M, Gagnon DD. The psychological burden of premature ejaculation. J Urol. 2007;177:1065–70.

Althof SE, McMahon CG, Waldinger MD, Serefoglu EC, Shindel AW, Adaikan PG, et al. An update of the International Society of Sexual Medicine’s Guidelines for the Diagnosis and Treatment of Premature Ejaculation (PE). Sex Med. 2014;2:60–90.

Pryor JL, Althof SE, Steidle C, Rosen RC, Hellstrom WJ, Shabsigh R, et al. Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials. Lancet. 2006;368:929–37.

Yue FG, Dong L, Hu TT, Qu XY. 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;85:856–61.

Castiglione F, Albersen M, Hedlund P, Gratzke C, Salonia A, Giuliano F. Current pharmacological management of premature ejaculation: a systematic review and meta-analysis. Eur Urol. 2016;69:904–16.

Park HJ, Park NC, Kim TN, Baek SR, Lee KM, Choe S. Discontinuation of dapoxetine treatment in patients with premature ejaculation: a 2-year prospective observational study. Sex Med. 2017;5:e99–e105.

Mondaini N, Fusco F, Cai T, Benemei S, Mirone V, Bartoletti R. Dapoxetine treatment in patients with lifelong premature ejaculation: the reasons of a “Waterloo”. Urology. 2013;82:620–4.

NIH Consensus Conference. Impotence. NIH Consensus Development Panel on Impotence. JAMA. 1993;270:83–90.

Fugl-Meyer K, Fugl-Meyer AR. Sexual disabilities are not singularities. Int J Impot Res. 2002;14:487–93.

McMahon CG, Lee G, Park JK, Adaikan PG. Premature ejaculation and erectile dysfunction prevalence and attitudes in the Asia-Pacific region. J Sex Med. 2012;9:454–65.

Montague DK, Jarow J, Broderick GA, Dmochowski RR, Heaton JP, Lue TF, et al. AUA guideline on the pharmacologic management of premature ejaculation. J Urol. 2004;172:290–4.

Hatzimouratidis K, Giuliano F, Moncada I, Muneer A, Salonia A, Verze P, Guideline Associates: Parnham A, Serefoglu EC. EAU guidelines on erectile dysfunction, premature ejaculation, penile curvature and priapism. Arnhem, The Netherlands: EAU Guidelines Office; 2018.

Bai Y, Pu C, Han P, Li J, Yuan H, Tang Y, et al. Selective serotonin reuptake inhibitors plus phosphodiesterase-5 inhibitors for premature ejaculation: a systematic review and meta-analysis. Urology. 2015;86:758–64.

Sun Y, Luo D, Yang L, Tang C, Yang T, Hu X, et al. Efficacy of phosphodiesterase-5 inhibitor in men with premature ejaculation: a new systematic review and meta-analysis. Urology. 2015;86:947–54.

Men C, Yu L, Yuan H, Cui Y. Efficacy and safety of phosphodiesterase type 5 inhibitors on primary premature ejaculation in men receiving selective serotonin reuptake inhibitors therapy: a systematic review and meta-analysis. Andrologia. 2016;48:978–85.

Asimakopoulos AD, Miano R, Finazzi Agro E, Vespasiani G, Spera E. Does current scientific and clinical evidence support the use of phosphodiesterase type 5 inhibitors for the treatment of premature ejaculation? A systematic review and meta-analysis. J Sex Med. 2012;9:2404–16.

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;98:259–72.

Dresser MJ, Desai D, Gidwani S, Seftel AD, Modi NB. Dapoxetine, a novel treatment for premature ejaculation, does not have pharmacokinetic interactions with phosphodiesterase-5 inhibitors. Int J Impot Res. 2006;18:104–10.

Serefoglu EC, Cimen HI, Ozdemir AT, Symonds T, Berktas M, Balbay MD. Turkish validation of the premature ejaculation diagnostic tool and its association with intravaginal ejaculatory latency time. Int J Impot Res. 2009;21:139–44.

Serefoglu EC, Yaman O, Cayan S, Asci R, Orhan I, Usta MF, et al. The comparison of premature ejaculation assessment questionnaires and their sensitivity for the four premature ejaculation syndromes: results from the Turkish society of andrology sexual health survey. J Sex Med. 2011;8:1177–85.

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;103:358–64.

Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997;49:822–30.

Waldinger MD, Hengeveld MW, Zwinderman AH, Olivier B. An empirical operationalization study of DSM-IV diagnostic criteria for premature ejaculation. Int J Psychiatry Clin Pract. 1998;2:287–93.

Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, et al. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010;10:1.

Saitz TR, Serefoglu EC. Advances in understanding and treating premature ejaculation. Nat Rev Urol. 2015;12:629–40.

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;16:369–81.

Salonia A, Rocchini L, Sacca A, Pellucchi F, Ferrari M, Carro UD, et al. Acceptance of and discontinuation rate from paroxetine treatment in patients with lifelong premature ejaculation. J Sex Med. 2009;6:2868–77.

McMahon CG, Porst H. Oral agents for the treatment of premature ejaculation: review of efficacy and safety in the context of the recent International Society for Sexual Medicine criteria for lifelong premature ejaculation. J Sex Med. 2011;8:2707–25.

Salonia A, Maga T, Colombo R, Scattoni V, Briganti A, Cestari A, et al. A prospective study comparing paroxetine alone versus paroxetine plus sildenafil in patients with premature ejaculation. J Urol. 2002;168:2486–9.

Mattos RM, Marmo Lucon A, Srougi M. Tadalafil and fluoxetine in premature ejaculation: prospective, randomized, double-blind, placebo-controlled study. Urol Int. 2008;80:162–5.

Lee WK, Lee SH, Cho ST, Lee YS, Oh CY, Yoo C, et al. Comparison between on-demand dosing of dapoxetine alone and dapoxetine plus mirodenafil in patients with lifelong premature ejaculation: prospective, randomized, double-blind, placebo-controlled, multicenter study. J Sex Med. 2013;10:2832–41.

Corona G, Rastrelli G, Limoncin E, Sforza A, Jannini EA, Maggi M. Interplay between premature ejaculation and erectile dysfunction: a systematic review and meta-analysis. J Sex Med. 2015;12:2291–300.

Uckert S, Oelke M, Stief CG, Andersson KE, Jonas U, Hedlund P. Immunohistochemical distribution of cAMP- and cGMP-phosphodiesterase (PDE) isoenzymes in the human prostate. Eur Urol. 2006;49:740–5.

Uckert S, Bazrafshan S, Scheller F, Mayer ME, Jonas U, Stief CG. Functional responses of isolated human seminal vesicle tissue to selective phosphodiesterase inhibitors. Urology. 2007;70:185–9.

McMahon CG, Giuliano F, Dean J, Hellstrom WJ, Bull S, Tesfaye F, et al. 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;10:2312–25.

Yuan J, Zhang R, Yang Z, Lee J, Liu Y, Tian J, et al. Comparative effectiveness and safety of oral phosphodiesterase type 5 inhibitors for erectile dysfunction: a systematic review and network meta-analysis. Eur Urol. 2013;63:902–12.

Acknowledgements

The authors would like to thank Neutec Ar-Ge San & Tic AS Clinical Research Department for their cooperation.

Funding

This study has been sponsored by Neutec Ar-Ge San & Tic AS (Turkey).

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University of Health Sciences, Bakirkoy Dr. Sadi Konuk Training & Research Hospital, Department of Urology, Istanbul, Turkey

University of Health Sciences, Okmeydani Training & Research Hospital, Department of Urology, Istanbul, Turkey

Mehmet Gokhan Culha

Bahceci Health Group, Department of Urology, Istanbul, Turkey

Ege Can Serefoglu

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Tuken, M., Culha, M.G. & Serefoglu, E.C. Efficacy and safety of dapoxetine/sildenafil combination tablets in the treatment of men with premature ejaculation and concomitant erectile dysfunction—DAP-SPEED Study. Int J Impot Res 31, 92–96 (2019). https://doi.org/10.1038/s41443-019-0122-2

Received : 22 November 2018

Revised : 29 December 2018

Accepted : 10 January 2019

Published : 31 January 2019

Issue Date : March 2019

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