OBJECTIVE - To analyze the proportion of men taking tadalafil 5mg once-daily who reach a combined improvement (henceforth known as a combined responder) in symptoms of both erectile dysfunction (ED) and lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH).
MATERIALS AND METHODS - Data from men aged ≥45 years randomized to tadalafil 5mg once-daily or placebo enrolled in one of four randomized, placebo-controlled LUTS/BPH clinical trials were analyzed (N=927). A novel classification of combined responders to ED and LUTS/BPH treatment ("combined responder") was defined, based on published criteria for improvement in both the Erectile Function domain of the International Index of Erectile Function (IIEF-EF) scale and the total International Prostate Symptom Score (IPSS). Descriptive analyses assessed the covariate distribution by responder status. Un-adjusted and adjusted logistic regressions provided odds ratios (ORs, 95% confidence interval) comparing combined responders to all others (partial and non-responders).
RESULTS - Among men randomized to tadalafil 5mg, 40. 5% were combined responders (N=189). Among placebo randomized men, 18. 3% were combined responders (N=84). Combined responders, in the total population, had the highest baseline IPSS and lowest baseline IIEF-EF scores, corresponding to the highest level of dysfunction. The majority of men were ≤65 years of age, white, non-obese, non-smokers, and regular alcohol consumers. Only treatment, baseline IPSS, baseline IIEF-EF, obesity, and psychoactive medication use were significantly associated with responder status (p≤0. 05). Tadalafil-treated men had 2. 8 times significantly increased adjusted-odds of being combined responders vs. non-responders (p<0. 0001). For each unit decrease in baseline IIEF-EF or alcoholic drink/week there was a 4% significant increase in the adjusted-odds of being a combined responder to tadalafil therapy.
CONCLUSIONS - This novel measure of combined response is useful in differentiating patients with clinically relevant symptom improvement for both ED and LUTS/BPH following treatment with tadalafil 5mg once-daily versus placebo. This combined responder measure may be useful in future assessment of treatment benefits across patient groups following various types of treatment intervention (e. g. , surgical vs pharmacotherapy vs non-pharmacologic intervention). This article is protected by copyright. All rights reserved.
BJU international. 2016 Jan 13 [Epub ahead of print]
Claus Roehrborn, Kathryn B Egan, Martin Miner, Xiao Ni, David G Wong, Raymond C Rosen
Department of Urology, University of Texas Southwestern Medical Center. , New England Research Institutes, Inc, Watertown, MA. , Men's Health Center, The Miriam Hospital, Providence, RI. , Global Statistical Sciences and Advanced Analytics, Eli Lilly and Company, Indianapolis, Indiana. , Eli Lilly and Company, Indianapolis, Indiana, USA. , New England Research Institutes, Inc, Watertown, MA.