Re: Tadalafil Once Daily for Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia: A Randomized Placebo- and Tamsulosin-Controlled 12-Week Study in Asian Men

Abstract

for this article http://dx.doi.org/10.1016/j.juro.2014.02.068 available at http://jurology.com/ Editorial Comment: This study is another manufacturer sponsored clinical trial examining the role of multiple doses of tadalafil, tamsulosin (0.2 mg) and placebo. Consistent with virtually every phosphodiesterase type 5 study in men with lower urinary tract symptoms (LUTS), those taking tadalafil had improvement in symptoms with no improvement in peak flow rate. Despite the number of studies now published on tadalafil for male LUTS, the data remain unsatisfying. There continues to be a worrisome disconnect between subjective and objective improvement in men using tadalafil for LUTS. This finding is unique to tadalafil and different from every other agent approved for male LUTS. The question remains, why? Our group has hypothesized that the tadalafil data are compromised by the lack of a true blinding being established in clinical trials. That is, since sexual function improved in men who claim baseline erectile dysfunction as well as in those who do not, study subjects know they are receiving tadalafil. This is what drives the LUTS improvement, rather than any physiological phenomena. We have repeatedly asked for the manufacturer to publicly release the data on erectile function changes in all men enrolled in the tadalafil for benign prostatic hyperplasia clinical trials, regardless of baseline sexual function. To date, they have not. I strongly suspect that there is meaningful improvement in erectile function even in men who self-categorize as not having erectile dysfunction. One can only surmise that our hypothesis is accurate and that men taking tadalafil achieve meaningful improvement in sexual function regardless of erectile function. The answers are easily obtainable and would address this question definitively. By withholding data, the manufacturer of tadalafil is doing a disservice to the urological community and, more importantly, our patients. Steven A. Kaplan, MD Suggested Reading Barry MJ, Fowler FJ Jr, O’Leary MP et al: The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol 1992; 148: 1549. Re: Relationship between Predictors of the Risk of Clinical Progression of Benign Prostatic Hyperplasia and Metabolic Syndrome in Men with Moderate to Severe Lower Urinary Tract Symptoms H. Kwon, H. C. Kang and J. H. Lee Department of Family Medicine, Yonsei University College of Medicine, Seoul, Korea Urology 2013; 81: 1325e1329. Abstract for this article http://dx.doi.org/10.1016/j.juro.2014.02.069 available at http://jurology.com/for this article http://dx.doi.org/10.1016/j.juro.2014.02.069 available at http://jurology.com/