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JU INSIGHT Vibegron for Overactive Bladder in Men Treated for Benign Prostatic Hyperplasia: The COURAGE Trial
By: David Staskin, MD, Tufts University School of Medicine, Boston, Massachusetts; Janet Owens-Grillo, PhD, MS, Sumitomo Pharma America, Inc, Marlborough, Massachusetts; Elizabeth Thomas, MS, Sumitomo Pharma America, Inc, Marlborough, Massachusetts; Eric Rovner, MD, Medical University of South Carolina, Charleston; Kevin Cline, MD, Louisiana State University Health, Shreveport; Salim Mujais, MD, Sumitomo Pharma America, Inc, Marlborough, Massachusetts | Posted on: 14 Aug 2024
Staskin D, Owens-Grillo J, Thomas E, Rovner E, Cline K, Mujais S. Vibegron for overactive bladder in men treated for benign prostatic hyperplasia: the COURAGE trial. J Urol. 2024;212(2):256-266. doi:10.1097/JU.0000000000003999
Study Need and Importance
Men with benign prostatic hyperplasia (BPH) may experience overactive bladder (OAB) symptoms, including urinary frequency, urgency, nocturia, and urge urinary incontinence (UUI). OAB symptoms can negatively impact quality of life and may not be alleviated by treatment with α-blockers and 5α-reductase inhibitors for BPH. Vibegron is a β3-adrenergic receptor agonist approved to treat OAB. We present efficacy and safety results from the phase 3 placebo-controlled COURAGE trial, which evaluated the efficacy and safety of once-daily vibegron 75 mg in men with OAB symptoms receiving pharmacologic treatment with α-blockers with/without 5α-reductase inhibitors for BPH.
***P < .001. BL indicates baseline.
What We Found
In the trial (N = 1105), vibegron was associated with significant reductions vs placebo at week 12 in mean daily micturitions and urgency episodes (Figure), as well as in nocturia episodes, UUI episodes, International Prostate Symptom Score storage scores, and volume voided per micturition. Improvements in all end points were apparent at the first time point assessed and were generally maintained through the end of the study. Greater proportions of participants who received vibegron vs placebo experienced ≥ 50% reductions in urgency episodes and ≥ 75% reductions in UUI episodes. Adverse events, including hypertension and UTI, occurred at similar rates in vibegron and placebo arms. Urinary retention occurred in < 1% of patients in both arms.
Limitations
Patients were enrolled based on BPH diagnosis without evaluation of detrusor function. All participants received treatment for BPH, precluding assessment of vibegron in patients with untreated BPH.
Interpretation for Patient Care
Among men with persistent OAB symptoms and pharmacologically treated BPH who participated in the phase 3 COURAGE trial, vibegron 75 mg was associated with significant, clinically meaningful improvements in key OAB symptoms. Vibegron was safe and well tolerated with adverse event rates similar to placebo, including the incidence of hypertension and urinary retention.
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