re: david bar-or, kristin m. salottolo, alessandro orlando, james v. winkler. a randomized...
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E U R O P E A N U R O L O G Y 6 1 ( 2 0 1 2 ) e 2 3 – e 2 4
ava i lable at www.sciencedirect .com
journal homepage: www.europeanurology.com
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
The International Society of Sexual Medicine recently
published an evidence-based definition of lifelong prema-
ture 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) [2,3]. In these trials, tramadol
50 mg 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 62 mg 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.
DOI of original article: 10.1016/j.eururo.2011.08.039
0302-2838/$ – see back matter # 2011 European Association of Urology. Publis
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] Althof SE, Abdo CH, Dean J, et al. International Society for Sexual
Medicine’s guidelines for the diagnosis and treatment of premature
ejaculation. J Sex Med 2010;7:2947–69.
[2] Safarinejad MR, Hosseini SY. 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.
[3] Salem EA, Wilson SK, Bissada NK, Delk JR, Hellstrom WJ, Cleves MA.
Tramadol HCl has promise in on-demand use to treat premature
ejaculation. J Sex Med 2008;5:188–93.
[4] Bar-Or D, Salottolo KM, Orlando A, Winkler JV. A randomized
double-blind, placebo-controlled multicenter study to evaluate
the efcacy and safety of two doses of the tramadol orally disin-
tegrating tablet for the treatment of premature ejaculation within
less than 2 minutes. Eur Urol 2012;61:736–43.
hed by Elsevier B.V. All rights reserved. doi:10.1016/j.eururo.2011.09.007
E U R O P E A N U R O L O G Y 6 1 ( 2 0 1 2 ) e 2 3 – e 2 4e24
[5] Payne RE, Sadovsky R. Identifying and treating premature ejacula-
tion: importance of the sexual history. Cleve Clin J Med 2007;
74(Suppl 3):S47–53.
Christopher C.K. Ho*
Department of Surgery, Universiti Kebangsaan Malaysia
Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak,
56000 Cheras, Kuala Lumpur,
Malaysia
*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
E-mail address: [email protected] (C.C.K. Ho)
September 6, 2011
Published online on September 15, 2011