Efficacy and Safety of Vibegron for Persistent Symptoms of Overactive Bladder in Men Being Pharmacologically Treated for Benign Prostatic Hyperplasia: Results From the Phase 3 Randomized Controlled COURAGE Trial

Open AccessJournal of UrologyAdult Urology6 May 2024Efficacy and Safety of Vibegron for Persistent Symptoms of Overactive Bladder in Men Being Pharmacologically Treated for Benign Prostatic Hyperplasia: Results From the Phase 3 Randomized Controlled COURAGE Trial David Staskin, Janet Owens-Grillo, Elizabeth Thomas, Eric Rovner, Kevin Cline, and Salim Mujais David StaskinDavid Staskin , Janet Owens-GrilloJanet Owens-Grillo Corresponding Author: Janet Owens-Grillo ( (email protected) ). , Elizabeth ThomasElizabeth Thomas , Eric RovnerEric Rovner , Kevin ClineKevin Cline , and Salim MujaisSalim Mujais View All Author Informationhttps://doi.org/10.1097/JU.0000000000003999AboutPDF ToolsAdd to favoritesDownload CitationsTrack Citations ShareFacebookLinked InTwitterEmail Abstract Purpose: Efficacy and safety of vibegron, a β3-adrenergic receptor agonist, was assessed among men with symptoms of overactive bladder (OAB) receiving pharmacologic treatment for benign prostatic hyperplasia (BPH) in a phase 3 randomized controlled trial. Materials and Methods: Men ≥ 45 years with OAB symptoms and BPH, treated with α-blocker with/without 5α-reductase inhibitors, were randomized 1:1 to vibegron or placebo for 24 weeks. Coprimary endpoints were change from baseline (CFB) at week 12 in mean daily micturitions and urgency episodes. Secondary endpoints were CFB at week 12 in mean nightly nocturia and daily urge urinary incontinence (UUI) episodes, International Prostate Symptom Score (IPSS)‒storage score, and volume voided per micturition. Safety was evaluated via adverse events (AEs). Results: Of 1105 participants randomized, 965 (87.3%) completed the trial. At week 12, vibegron was associated with significant reductions vs placebo in daily micturitions (least squares mean difference LSMD; 95% CI, –0.74 –1.02, –0.46; P < .0001) and urgency episodes (–0.95 –1.37, –0.54; P < .0001). Vibegron was also associated with significant improvements vs placebo at week 12 in nocturia episodes (LSMD, –0.22 −0.36, −0.09; P = .002), UUI episodes (–0.80 −1.33, −0.27; P = .003), IPSS‒storage scores (–0.9 –1.2, –0.6; P < .0001), and volume voided (15.07 mL 9.13-21.02; P < .0001). AE rates were similar in vibegron (45.0%) and placebo (39.0%) arms; AEs occurring in ≥ 2% of participants were 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: In this trial, vibegron met all primary and secondary endpoints and was safe and well tolerated in men with OAB symptoms and pharmacologically treated BPH. Download PPT This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.© 2024 The Author(s). Published on behalf of the American Urological Association, Education and Research, Inc.FiguresReferencesRelatedDetails Advertisement Copyright & Permissions© 2024 The Author(s). Published on behalf of the American Urological Association, Education and Research, Inc.Keywordsanticholinergicsbeta-3 adrenergic agonistoveractive bladderbenign prostatic hyperplasiaMetrics Author Information David Staskin More articles by this author Janet Owens-Grillo Corresponding Author: Janet Owens-Grillo ( (email protected) ). More articles by this author Elizabeth Thomas More articles by this author Eric Rovner More articles by this author Kevin Cline More articles by this author Salim Mujais More articles by this author Expand All Advertisement PDF downloadLoading ...