The Phase 3 Open-Label COURAGE Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Men With Overactive Bladder Symptoms on Pharmacotherapy For Benign Prostatic Hyperplasia

Document Type

Conference Proceeding

Publication Date

5-2025

Publication Title

Journal of Urology

Abstract

INTRODUCTION AND OBJECTIVE: In the phase 3, randomized, controlled COURAGE trial, vibegron, a β3-adrenergic receptor agonist, was associated with significant improvements vs placebo in all primary and key secondary efficacy endpoints and was safe and well tolerated in men with overactive bladder (OAB) symptoms on a stable dose of pharmacotherapy for benign prostatic hyperplasia (BPH; ie, α-blocker ± 5α-reductase inhibitors). Long-term safety and efficacy of vibegron were evaluated in an open-label extension (OLE) study. METHODS: Eligible participants in the US and Poland who completed 24 weeks of once-daily vibegron 75 mg or placebo in the COURAGE trial received once-daily vibegron 75 mg for 28 weeks. The primary outcome was safety, assessed by adverse events (AEs), clinical laboratory assessments, vital signs, postvoid residual (PVR) urine volume, and International Prostate Symptom Score (IPSS) total score. Secondary outcomes were change from baseline to week 52 in mean daily micturitions, urgency episodes, nightly nocturia episodes, urge urinary incontinence episodes, IPSS-Storage, and volume voided per micturition. Baseline was defined as the last measurement before the start of vibegron. RESULTS: A total of 276 participants who completed the COURAGE trial enrolled (142 from the vibegron [52-week cohort] and 134 from the placebo cohorts). Of the 276 participants, most (90.6%) completed the study; 9 participants (3.3%) discontinued study drug owing to AEs, 2 of which were due to urinary retention considered not related to study drug. In the 52-week cohort, the incidences of AEs were similar during double-blind (35.9%) and open-label (29.6%) treatment with vibegron. The most commonly reported AEs during the OLE were hypertension (6.3%), COVID-19 (5.6%), and hepatic enzyme increased (2.1%). There were no clinically relevant changes in clinical laboratory parameters or vital signs. No participant sustained PVR urine volume ≥200 mL at ≥2 consecutive assessments. Among participants receiving vibegron for 52 weeks, median (IQR) IPSS total score decreased from baseline to week 52 (-7.0 [-11.0, -2.0]). Improvements in all secondary outcomes were observed for participants receiving vibegron for 52 weeks (Table 1). CONCLUSIONS: Vibegron demonstrated favorable long-term safety and efficacy for up to 52 weeks in men with OAB symptoms receiving pharmacologic treatment for BPH.

Volume

213

Issue

5S

First Page

e360

Last Page

e361

Comments

American Urological Association Annual Meeting, April 26-29, 2025, Las Vegas, NV

DOI

10.1097/01.JU.0001109832.07222.c5.15

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