Efficacy and Safety of Tadalafil 5mg Once Daily in the Treatment of Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia (LUTS/BPH) in Men Aged 75 years or Older: Integrated Analyses of Pooled Data From Multinational, Randomised, Plac

To assess efficacy and safety of tadalafil in men ≥75 years with lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) and additional safety in men ≥75 years with erectile dysfunction (ED).

Integrated analysis of 12 Phase II-III randomised, double-blind and/or open-label extension studies to evaluate short-term (12-26 weeks) efficacy and short- and longer-term (42-52 weeks) safety in men <75 vs. ≥75 years. All men received once-daily tadalafil 5mg or placebo. Efficacy outcome was International Prostate Symptom Score (IPSS). Safety measurements included treatment-emergent adverse events (TEAEs), adverse events (AEs) leading to discontinuation (AEDC), serious adverse events (SAEs), and cardiovascular (CV) AEs. All analyses were intent-to-treat. Changes from baseline to efficacy endpoint and differences in changes between treatment groups were estimated as least-squares means using analysis of covariance models.

Change in mean IPSS was significantly different in men <75 vs. ≥75 years across tadalafil and placebo groups (treatment-by-age interaction p=0.034). Tadalafil was not statistically significantly better than placebo in men ≥75 years, but effect size varied between studies. Maintenance of efficacy with tadalafil was observed across age groups. Short-term tadalafil safety findings for men <75 vs. ≥75 years included: TEAEs (52 [33.8%] vs. 503 [30.1%]), AEDC (3 [1.9%] vs. 50 [3.0%]), SAEs (4 [2.6%] vs. 15 [0.9%]), and CV AEs (4 [2.6%] vs. 30 [1.8%]). Long-term tadalafil safety data did not reveal clinically relevant differences between age groups. Limitations include exclusion of men with serious co-existing conditions and limited sample sizes of men ≥75 years.

Efficacy with once-daily tadalafil 5mg in the treatment of LUTS/BPH differed between men <75 vs. ≥75 years, with significant efficacy in the <75-year-old population. Elderly men had more concomitant diseases and used more drugs, which may have reduced efficacy. The small sample size precluded uni/multivariate analyses to assess plausible interference from confounding factors. Tadalafil had a reassuring safety profile and no evidence of increased CV AEs in aging men. This article is protected by copyright. All rights reserved.

BJU international. 2016 Dec 18 [Epub ahead of print]

Matthias Oelke, Adrian Wagg, Yasushi Takita, Hartwig Büttner, Lars Viktrup

Department of Urology, Hannover Medical School, Hannover, Germany., Geriatric Medicine, University of Alberta, Edmonton, Alberta, Canada., Medicines Development Unit Japan, Eli Lilly Japan, Kobe, Hyogo, Japan., Eli Lilly Biomedicines BU - Men's Health Therapeutic Area Europe, c/o Lilly Deutschland, GmbH, Bad Homburg, Germany., Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA.