Efficacy and Safety of Vibegron in Men ≥75 Years of Age With Symptoms of Overactive Bladder on Pharmacotherapy For Benign Prostatic Hyperplasia: A Subgroup Analysis of the COURAGE Trial

Document Type

Conference Proceeding

Publication Date

5-2026

Publication Title

Journal of Urology

Abstract

NTRODUCTION AND OBJECTIVES: Vibegron is a selectiveb3-adrenergic receptor agonist approved by the US Food and Drug Administration for the treatment of overactive bladder (OAB)symptoms in adults and adult males on pharmacological therapy for benign prostatic hyperplasia (BPH). We report efficacy and safety of vibegron from the COURAGE trial in the subgroup of men ≥75 y with persistent OAB symptoms on pharmacotherapy for BPH.METHODS: COURAGE (NCT03902080) was a phase 3,multicenter, randomized, double-blind, placebo-controlled trial that evaluated efficacy and safety of once-daily vibegron 75 mg vs placebo. Men ≥45 y with OAB and BPH receiving a stable dose of a-blocker ± 5a-reductase inhibitors were randomized 1:1 to vibegron or placebo for 24 weeks. This subanalysis assessed change from baseline in the mean number of daily micturitions, urgency episodes, and nightly nocturia episodes and adverse events (AEs) in patients ≥75 y and < 75 y. RESULTS: Of the 1080 participants included in the COURAGE trial efficacy analyses, 192 were ≥75 y (92 received vibegron, 100received placebo). Demographics and baseline clinical characteristics were generally similar between ≥75 y and < 75 y subgroups; however, respectively, 96.4% and 85.7% were White, 75.0% and 63.7% had preexisting hypertension, 37.5% and 26% had urinary in continence, and patients ≥75 y were more likely to have had prior therapies. Clinically significant reductions from baseline at week 12 and 24 were observed in average daily number of micturitions, urgency episodes, and nocturia episodes with vibegron vs placebo (Figure). These results were comparable to outcomes in men < 75 y. For men ≥75 y, 52.1% of patients receiving vibegron had ≥1 treatment-emergent AE (TEAE),compared with 43.5% for men < 75. The most common TEAEs in men ≥75 y receiving vibegron were hypertension (5.2%), hematuria(4.2%), and upper respiratory tract infection (4.2%). For men < 75 y, these TEAEs were reported in 9.8%, 1.5%, and 1.3% of patients receiving vibegron, respectively. TEAEs were similar to placebo in both subgroups. CONCLUSIONS: Vibegron was associated with substantial improvements in clinical efficacy outcomes vs placebo and was safe and well tolerated in men ≥75 y with persistent OAB symptoms on pharmacotherapy for BPH, comparable to men < 75 y.

Volume

215

Issue

5S

First Page

e326

Last Page

e327

Comments

American Urological Association Annual Meeting, May 15-18, 2026, Washington, DC

DOI

10.1097/01.JU.0001191356.52697.6d.20

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