Proportion of tadalafil‐treated patients with clinically meaningful improvement in lower urinary tract symptoms associated with benign prostatic hyperplasia – integrated data from 1 499 study participants

2015 
available at http://www.ncbi.nlm.nih.gov/pubmed/25195970 Editorial Comment: There is often a disconnect between what the clinician and the patient believe is a significant clinical response. We tend to try to bring objective measures to a subjective response. In addition, we often continue to use the same metrics even if they are no longer relevant or useful. Two decades ago Barry et al, in a landmark study, reported that a 3-point change in the AUA symptom index was clinically meaningful. 1 But that implies that the symptom index remains meaningful and, in fact, encompasses the spectra of other issues such as nocturia, pain and changes in quality of life. Given that there are numerous projects under way to develop a more global and relevant symptom score for men and women, the classic 3-point increase may no longer be the outcome we should be trying to attain. In fact, one could argue that what matters is which symptoms are reduced, not how much they are reduced. For example nocturia is a much more bothersome problem than hesitancy yet is scored equally. Furthermore, is a 3-point decrease in a man with a baseline score of 20 as meaningful as in a man with a baseline score of 10? One could justifiably argue that it is not. In this study a 3-point decrease was noted in 71.1% of men treated with tadalafil and in 56.0% of those receiving placebo. Does a 15% attributable difference justify its use? However, I suspect that in those men with urgency (not measured) the separation between tadalafil and placebo may be greater. Given my own belief that tadalafil is more of a bladder drug than a prostate drug, it may be more apt for overactive bladder than classic benign prostatic hyperplasia type symptoms.
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