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.
