E U R O P E A N U R O L O G Y 6 2 ( 2 0 1 2 ) e 4 0

avai lable at www.sciencedirect .com

journal homepage: www.europeanurology.com

Letter to the Editor

Reply to Neeraj Kumar Goyal, Apul Goel and Rahul

Yadav’s Letter to the Editor re: Matthias Oelke, Francois

Giuliano, Vincenzo Mirone, Lei Xu, David Cox, Lars

Viktrup. Monotherapy with Tadalafil or Tamsulosin

Similarly Improved Lower Urinary Tract Symptoms

Suggestive of Benign Prostatic Hyperplasia in an Inter-

national, Randomised, Parallel, Placebo-controlled

Clinical Trial. Eur Urol 2012;61:917–25

The authors of the recently published placebo-controlled

trial on monotherapy of the phosphodiesterase 5 inhibitor

tadalafil or the a1-blocker tamsulosin for the treatment of

lower urinary tract symptoms suggestive of benign

prostatic hyperplasia (LUTS/BPH) [1] would like to express

thanks for the comments made by Goyal and colleagues. In

our 12-wk trial, tadalafil 5 mg or tamsulosin 0.4 mg was

used once daily in male patients with or without erectile

dysfunction (ED). Both drugs reduced LUTS/BPH to a similar

extent, as measured by the International Prostate Symptom

Score, but only tadalafil increased quality of life measures

associated with LUTS/BPH and improved ED, as measured

by the International Index of Erectile Function–Erectile

Function domain.

We are asked to explain the significant improvements in

ED observed at a ‘‘suboptimal dose’’ of tadalafil. In this

regard, the authors would like to clarify that once-daily

doses of tadalafil 2.5 mg and 5 mg have both been licensed

in the European Union to treat ED since 2007 [2] and in the

United States for this indication since 2008 [3] and have

since been approved for this indication in other countries

around the globe including Australia, Brazil, Canada, Korea,

Mexico, Russia, and Taiwan. Previously published studies

have evaluated the risk–benefit balance for tadalafil 2.5 mg

or 5 mg once daily for the treatment of ED; although no

direct-comparison studies have been performed, the

efficacy and safety findings of tadalafil once daily are

consistent with those for tadalafil dosed as needed [4]. Thus

the once-daily dose of tadalafil 5 mg evaluated in the study

of men with LUTS/BPH referenced above [1] has been

DOIs of original articles: http://dx.doi.org/10.1016/j.eururo.2012.01.013, htt

0302-2838/$ – see back matter # 2012 European Association of Urology. Published by

approved by regulatory authorities, has been available for

the treatment of ED for some time, and provides patients

and physicians with a treatment alternative to as-needed

therapy with 10 mg or 20 mg tadalafil. Tadalafil 5 mg once

daily has also been approved in the United States to treat

signs and symptoms of benign prostatic hyperplasia since

2011 [3] and is currently under regulatory review for this

indication in the European Union.

Conflicts of interest: Matthias Oelke has received lecturer and/or

consultant honoraria in the field of LUTS/BPH from Astellas,

GlaxoSmithKline, Eli Lilly and Company, and Merckle-Recordati.

Funding support: Eli Lilly and Company was involved in the design and

conduct of the study; collection, management, and analysis of the data;

and preparation, review, and approval of the manuscript.

References

[1] Oelke M, Giuliano F, Mirone V, Xu L, Cox D, Viktrup L. Monotherapy

with tadalafil or tamsulosin similarly improved lower urinary tract

symptoms suggestive of benign prostatic hyperplasia in an inter-

national, randomised, parallel, placebo-controlled clinical trial.

Eur Urol 2012;61:917–25.

[2] CIALIS [summary of product characteristics]. Houten, The

Netherlands: Eli Lilly; 2011. http://www.ema.europa.eu/docs/en_

GB/document_library/EPAR_-_Product_Information/human/

000436/WC500026318.pdf.

[3] CIALIS [package insert]. Indianapolis, IN: Eli Lilly; 2010. http://pi.

lilly.com/us/cialis-pi.pdf.

[4] Donatucci CF, Wong DG, Guiliano F, et al. Efficacy and safety of

tadalafil once daily: considerations for the practical application of a

daily dosing option. Curr Med Res Opin 2008;24:3383–92.

Matthias Oelke

Department of Urology, OE 6240, Hannover Medical School,

Carl-Neuberg-Str. 1, 30625 Hannover, Germany

E-mail address: oelke.matthias@mh-hannover.de

May 9, 2012

Published online on May 18, 2012

p://dx.doi.org/10.1016/j.eururo.2012.05.012

Elsevier B.V. All rights reserved. http://dx.doi.org/10.1016/j.eururo.2012.05.011