Articles

Letter to the Editor

Re: David Bar-Or, Kristin M. Salottolo, Alessandro Orlando, James V. Winkler. A Randomized Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of the Tramadol Orally Disintegrating Tablet for the Treatment of Premature Ejaculation Within Less Than 2 Minutes. Eur Urol 2012;61:736–43

By: Christopher C.K. Holowast

European Urology, Volume 61 Issue 1, April 2012, Pages e23-e24

Published online: 01 April 2012

Abstract Full Text Full Text PDF (73 KB)

Refers to article:

A Randomized Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of the Tramadol Orally Disintegrating Tablet for the Treatment of Premature Ejaculation Within Less Than 2 Minutes

David Bar-Or, Kristin M. Salottolo, Alessandro Orlando and James V. Winkler for the Tramadol ODT Study Group1.

Accepted 18 August 2011

April 2012 (Vol. 61, Issue 4, pages 736 - 743)

The International Society of Sexual Medicine recently published an evidence-based definition of lifelong premature ejaculation (PE) as “a male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration, and the inability to delay ejaculation on all or nearly all vaginal penetrations, and negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy”[1]. To date, the only approved oral drug to treat premature ejaculation is dapoxetine.

Tramadol has been shown to be effective for on-demand treatment of PE in two placebo-controlled studies (one single blind, one double blind) [2] and [3]. In these trials, tramadol 50mg significantly increased intravaginal ejaculatory latency time (IELT), and measures of sexual satisfaction and ejaculatory control compared with placebo (p<0.05 for all). However, the sample sizes for both studies were small (about 60 subjects). Therefore, the results of the large, randomized, double-blind, placebo-controlled multicenter study by Bar-Or et al are welcomed [4]. In this study, the on-demand 62mg tramadol orally disintegrating tablet (ODT) was shown to be an effective treatment for PE, in the improvement of both IELT and Premature Ejaculation Profile scores, at a low and safe therapeutic dose. This treatment provides a new option for managing mild to severe PE.

I would like to raise a few pertinent issues. The results published were the end results after 12 wk of treatment. The authors mentioned that the subjects were assessed every 3 wk. It would be interesting to elucidate the results at these intervals because it would give us an idea of the efficacy of this drug at these intervals. This information would be important for patient counseling later.

The other issue about which most of us worry is the long-term effect of drug dependence, for which opioids are notorious. It would be of great help if these patients can be followed up for a longer period to assess the safety of tramadol ODT. A long follow-up would also enable us to assess for the development of drug tolerance.

It is interesting to note that patients with erectile dysfunction (ED) were excluded from this study. It has been reported that ED and PE can co-occur in up to 30% of patients [5]. There may be patients with ED who are effectively treated with phosphodiesterase type 5 inhibitors (PDE5-Is) but who may have PE. Therefore, it is important to assess this group of patients because the interaction between PDE5-Is and tramadol ODT is not known.

It is heartening to know that tramadol ODT is as efficacious and safe as dapoxetine. It is hoped that cost would not be an issue and that patients are not deprived of the opportunity to receive treatment.

This excellent publication by Bar-Or et al is much appreciated because it gives us an option besides dapoxetine for the treatment of PE. The editor should also be applauded for publishing such clinically important articles.

Conflicts of interest

The author has nothing to disclose.

References

  • [1] S.E. Althof, C.H. Abdo, J. Dean, et al. International Society for Sexual Medicine's guidelines for the diagnosis and treatment of premature ejaculation. J Sex Med. 2010;7:2947-2969 Crossref.
  • [2] M.R. Safarinejad, S.Y. Hosseini. Safety and efficacy of tramadol in the treatment of premature ejaculation: a double-blind, placebo-controlled, fixed-dose, randomized study. J Clin Psychopharmacol. 2006;26:27-31 Crossref.
  • [3] E.A. Salem, S.K. Wilson, N.K. Bissada, J.R. Delk, W.J. Hellstrom, M.A. Cleves. Tramadol HCl has promise in on-demand use to treat premature ejaculation. J Sex Med. 2008;5:188-193
  • [4] D. Bar-Or, K.M. Salottolo, A. Orlando, J.V. Winkler. A randomized double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of two doses of the tramadol orally disintegrating tablet for the treatment of premature ejaculation within less than 2minutes. Eur Urol. 2012;61:736-743 Abstract, Full-text, PDF, Crossref.
  • [5] R.E. Payne, R. Sadovsky. Identifying and treating premature ejaculation: importance of the sexual history. Cleve Clin J Med. 2007;74(Suppl 3):S47-S53

Footnotes

Department of Surgery, Universiti Kebangsaan Malaysia Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Kuala Lumpur, Malaysia

lowast Department of Surgery, Universiti Kebangsaan Malaysia Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Kuala Lumpur, Malaysia. Tel. +6 03 91546202; Fax: +6 03 91456684.

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