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Vibegron improves overactive bladder symptoms in pharmacologically treated BPH


Treatment with vibegron (Gemtesa) led to significant improvements in overactive bladder (OAB) symptoms vs placebo in men receiving pharmacological treatments for benign prostatic hyperplasia (BPH), according to results from the phase 3 COURAGE trial presented at the 2024 AUA Annual Meeting.1,2

There was a statistically significant reduction in average daily micturition episodes and average daily urgency episodes with vibegron vs placebo.

There was a statistically significant reduction in average daily micturition episodes and average daily urgency episodes with vibegron vs placebo.

Data at week 12 following treatment showed that there was a statistically significant reduction in average daily micturition episodes, at -2.04 with vibegron vs -1.30 with placebo (P < .0001). There was also a statistically significant reduction in average daily urgency episodes with the intervention at -2.88 vs -1.93 (P < .0001), respectively. Vibegron led to improvements in these parameters as early as week 2 and the benefits were maintained through week 24 of the trial.

Treatment with vibegron also led to significant reductions vs placebo in other important end points, including daily episodes of nocturia, at -0.88 vs -0.66 (P = .0015), and urge urinary incontinence (UUI) episodes at -2.19 vs -1.39 (P = .0034). A benefit was also observed in international prostate symptom score (IPSS)-storage score at -3.0 vs -2.1 (P < .0001), respectively, and vibegron also led to a significant increase in volume voided per micturition at 25.63 mL vs 10.56 mL with placebo (P < .0001).

“In the phase 3 COURAGE trial of men experiencing persistent OAB symptoms with pharmacologically treated BPH, treatment with vibegron was associated with significant, clinically meaningful improvements in all co-primary and secondary efficacy end points,” said presenting author David Staskin, MD, an associate professor of urology at Tufts University School of Medicine and the director of the Center for Male and Female Pelvic Health at St. Elizabeth’s Medical Center in Boston, Massachusetts.

The efficacy analysis for the COURAGE trial included 965 men aged ≥45 years with OAB symptoms and BPH who were being treated with an α-blocker with/without 5α-reductase inhibitors (5-ARIs).

Patient characteristics were well balanced between the study arms. Across all patients, the mean age was 67.1 years, 87.6% of patients were White, and 9.8% of patients were Black or African American. Fifty-six percent of patients were from the United States. About two-thirds (65.7%) of patients had pre-existing hypertension and 27.5% had incontinence at baseline. About one-fourth(23.1%) of patients were taking 5-ARIs. The mean number of daily micturitions was 11.9, the mean number of daily urgency episodes was 9.0, the mean number of nightly nocturia episodes was 2.7, the mean number of daily UUI episode was 3.3.

Patients were randomized in a 1:1 ratio to vibegron at 75 mg daily or placebo. The co-primary end points were change from baseline to week 12 in mean daily micturitions and urgency episodes. Secondary end points were change from baseline in mean nocturia and daily UUI episodes, IPSS storage score, and volume voided per micturition.

Vibegron treatment was safe and well tolerated. Any grade treatment-related treatment emergent adverse events (TEAEs) occurred in 9.9% of the vibegron arm vs 9.4% of the placebo arm. There were no treatment-related serious TEAEs in either arm. The only TEAE occurring in more than 5% in either arm was hypertension at 9% vs 8.3% in the vibegron vs placebo arms, respectively.

Vibegron is approved by the FDA for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. The treatment currently does not have an approved indication for OAB symptoms in men with pharmacologically treated BPH.


1.Staskin D. Efficacy and safety of vibegron in men with BPH and symptoms of OAB: Results from the phase 3 COURAGE trial. Presented at: 2024 American Urological Association Annual Meeting. May 2-6, San Antonio, Texas. Abstract P2.

2. Sumitomo Pharma Presents Urology and Oncology Data at AUA 2024 Annual Meeting. Published online and accessed May 7, 2024. https://www.prnewswire.com/news-releases/sumitomo-pharma-presents-urology-and-oncology-data-at-aua-2024-annual-meeting-302138144.html

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