P2-12 Efficacy and Safety of Vibegron in Men With Benign Prostatic Hyperplasia and Symptoms of Overactive Bladder: Results From the Phase 3 Randomized Controlled Courage Trial

You have accessJournal of UrologyParadigm-shifting, Practice-changing Clinical Trials in Urology (P2)1 May 2024P2-12 EFFICACY AND SAFETY OF VIBEGRON IN MEN WITH BENIGN PROSTATIC HYPERPLASIA AND SYMPTOMS OF OVERACTIVE BLADDER: RESULTS FROM THE PHASE 3 RANDOMIZED CONTROLLED COURAGE TRIAL Janet Owens-Grillo, Elizabeth Thomas, Eric S. Rovner, Kevin Cline, Salim Mujais, and David R. Staskin Janet Owens-GrilloJanet Owens-Grillo , Elizabeth ThomasElizabeth Thomas , Eric S. RovnerEric S. Rovner , Kevin ClineKevin Cline , Salim MujaisSalim Mujais , and David R. StaskinDavid R. Staskin View All Author Informationhttps://doi.org/10.1097/01.JU.0001015816.87470.c9.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Symptoms of overactive bladder (OAB) may persist in men being treated for benign prostatic hyperplasia (BPH). Vibegron is a selective β3 agonist being investigated for the treatment of OAB in men with pharmacologically treated BPH. We report efficacy and safety of vibegron from a phase 3 trial in men with pharmacologically treated BPH and persistent OAB symptoms. 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 α-blocker ± 5α-reductase inhibitors were randomized 1:1 to vibegron or placebo for 24 weeks. Coprimary endpoints were change from baseline (CFB) to Week 12 in mean daily micturitions and urgency episodes. Secondary endpoints were CFB to Week 12 in mean nocturia and daily urge urinary incontinence (UUI) episodes, international prostate symptom score (IPSS)–storage score, and volume voided per micturition. Safety was assessed by adverse events (AEs) and standard urologic assessment. RESULTS: Of 1105 patients randomized, 965 (87.3%) completed the trial; mean age was 67.1 y. Vibegron was associated with significant reductions vs placebo at Week 12 in least squares (LS) mean daily micturitions (LS mean difference [LSMD], –0.74; p<0.0001) and urgency episodes (LSMD, –0.95; p<0.0001; Figure 1). Vibegron was also associated with significant reductions vs placebo at Week 12 in nocturia episodes (LSMD, –0.22; p=0.0015), UUI episodes (LSMD, –0.80; p=0.0034), and IPSS storage scores (LSMD, –0.9; p<0.0001) and a significant increase vs placebo in volume voided per micturition (LSMD, 15.07 mL; p<0.0001). Overall, 45.0% and 39.0% of patients receiving vibegron and placebo, respectively, had ≥1 treatment-emergent AE, most commonly (≥2% of patients) hypertension (9.0% vs 8.3%, respectively), COVID-19 (4.0% vs 3.1%), urinary tract infection (2.5% vs 2.2%), and hematuria (2.0% vs 2.5%). CONCLUSIONS: Vibegron was associated with significant improvements vs placebo in all primary and secondary efficacy endpoints and was safe and well tolerated in this phase 3 trial in men with pharmacologically treated BPH and persistent OAB symptoms. Download PPT Source of Funding: Sumitomo Pharma America © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5S2May 2024Page: e8 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Janet Owens-Grillo More articles by this author Elizabeth Thomas More articles by this author Eric S. Rovner More articles by this author Kevin Cline More articles by this author Salim Mujais More articles by this author David R. Staskin More articles by this author Expand All Advertisement PDF downloadLoading ...