BENIGN PROSTATIC HYPERPLASIA
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that a placebo/sham study will be required, and recruitment for that type of study will be quite challenging. That being said, the role of PAE remains to be defined but I suspect that, like the ethanol injection experience, there will be reports of something besides prostate that was embolized. If that occurs, PAE will join other putative technologies in the dustbin. Steven A. Kaplan, MD
Re: Reasons for Prescription Change of a1-Blockers in Patients with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia T. N. Kim, J. K. Nam, K. S. Lee, T. H. Kim, S. W. Park, D. G. Shin, H. J. Park, W. Lee, Z. Z. Lee and M. K. Chung Departments of Urology, Medical Research Institute, Pusan National University Hospital, Dong-a University Hospital and Cancer Center, Dongnam Institute of Radiological and Medical Science, Pusan and Yangsan Pusan National University Hospital, Yangsan, Korea Urology 2014; 84: 427e432.
Abstract for this article http://dx.doi.org/10.1016/j.juro.2015.01.028 available at http://jurology.com/ Editorial Comment: We are trained to analyze clinical data based on trial design. Thus, we prefer high levels of evidence that usually entails well controlled, randomized, placebo controlled trials. However, we often forget that these are large studies powered to show even the most minimal differences between active drug and placebo. Moreover, the study population tends to be highly select and optimized to demonstrate a clinical effect. But to gain the best perspective, should we not be just as interested in day-to-day clinical practice, ie the real world? This study, while having some methodology issues, is interesting and carries with it a number of salient messages. The authors analyzed the reason for prescription changes in a cohort of 3,200 men who had been given an a1-blocker for treating symptoms secondary to benign prostatic hyperplasia. A prescription change to another a1-blocker was made in 694 men (21.7%), which may be somewhat surprising. One would have expected a greater degree of variability. This finding may partly reflect the experience in Korea, where cost and generic pressures may be different than in the United States. Another factor cited by the authors is the lack of sufficient time for patient-doctor interaction, such that medications are often switched without thorough discussion. Perhaps this is a troubling trend in the United States as well. Lack of efficacy was the primary reason for prescription changes, followed by adverse events. Mean duration of the initial prescription was about 11 weeks, although this varied if the reason given was adverse events (6.3 weeks) vs lack of efficacy (14.8). This finding implies that men are usually given a 3-month trial to ascertain if the a1-blocker will work. The bottom line in an era of time and cost pressure sustainability of an initial prescribed medication will be disappointingly low. Steven A. Kaplan, MD
Suggested Reading Marks LS, Gittelman MC, Hill LA et al: Rapid efficacy of the highly selective alpha1A-adrenoreceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol 2009; 181: 2634.
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that a placebo/sham study will be required, and recruitment for that type of study will be quite challenging. That being said, the role of PAE remains to be defined but I suspect that, like the ethanol injection experience, there will be reports of something besides prostate that was embolized. If that occurs, PAE will join other putative technologies in the dustbin. Steven A. Kaplan, MD
Re: Reasons for Prescription Change of a1-Blockers in Patients with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia T. N. Kim, J. K. Nam, K. S. Lee, T. H. Kim, S. W. Park, D. G. Shin, H. J. Park, W. Lee, Z. Z. Lee and M. K. Chung Departments of Urology, Medical Research Institute, Pusan National University Hospital, Dong-a University Hospital and Cancer Center, Dongnam Institute of Radiological and Medical Science, Pusan and Yangsan Pusan National University Hospital, Yangsan, Korea Urology 2014; 84: 427e432.
Abstract for this article http://dx.doi.org/10.1016/j.juro.2015.01.028 available at http://jurology.com/ Editorial Comment: We are trained to analyze clinical data based on trial design. Thus, we prefer high levels of evidence that usually entails well controlled, randomized, placebo controlled trials. However, we often forget that these are large studies powered to show even the most minimal differences between active drug and placebo. Moreover, the study population tends to be highly select and optimized to demonstrate a clinical effect. But to gain the best perspective, should we not be just as interested in day-to-day clinical practice, ie the real world? This study, while having some methodology issues, is interesting and carries with it a number of salient messages. The authors analyzed the reason for prescription changes in a cohort of 3,200 men who had been given an a1-blocker for treating symptoms secondary to benign prostatic hyperplasia. A prescription change to another a1-blocker was made in 694 men (21.7%), which may be somewhat surprising. One would have expected a greater degree of variability. This finding may partly reflect the experience in Korea, where cost and generic pressures may be different than in the United States. Another factor cited by the authors is the lack of sufficient time for patient-doctor interaction, such that medications are often switched without thorough discussion. Perhaps this is a troubling trend in the United States as well. Lack of efficacy was the primary reason for prescription changes, followed by adverse events. Mean duration of the initial prescription was about 11 weeks, although this varied if the reason given was adverse events (6.3 weeks) vs lack of efficacy (14.8). This finding implies that men are usually given a 3-month trial to ascertain if the a1-blocker will work. The bottom line in an era of time and cost pressure sustainability of an initial prescribed medication will be disappointingly low. Steven A. Kaplan, MD
Suggested Reading Marks LS, Gittelman MC, Hill LA et al: Rapid efficacy of the highly selective alpha1A-adrenoreceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol 2009; 181: 2634.
