Vibegron has Promising Effect in Patients With Overactive Bladder

The EMPOWUR study was a phase 3, international, 12-week study of adults with wet (incontinence) or dry OAB. The researchers included a total of 506 patient, among which 430 (85%) completed the study. Patients who completed 12 weeks of once-daily vibegron 75 mg or tolterodine 4 mg extended-release in EMPOWUR continued double-blind treatment and, patients who completed 12 weeks of placebo were randomly assigned 1:1 to receive double-blind vibegron or tolterodine.

The major outcome assessed was safety, measured by incidence of adverse events. The researchers also assessed change from baseline at week 52 in the average daily number of micturition and urgency episodes (all patients) and, urge and total urinary incontinence episodes (patients with overactive bladder wet) based on 7-day diary data.

Key findings of the study were:

• Among 430 patients, 12 patients (2.4%) discontinued due to adverse events.
• The common adverse events reported with vibegron/tolterodine (>5% in either group) were hypertension (8.8%/8.6%), urinary tract infection (6.6%/7.3%), headache (5.5%/3.9%), nasopharyngitis (4.8%/5.2%) and dry mouth (1.8%/5.2%).
• Upon analysis, they found that vibegron significantly improved rates of urge urinary incontinence and total incontinence from baseline to week 52.
• They noted that among patients with overactive bladder-wet, 61.0% receiving vibegron experienced ≥75% reduction in urge urinary incontinence episodes after 52 weeks of treatment vs 54.4% with tolterodine, while 40.8% vs 34.2% experienced a 100% reduction.

The authors concluded, "Vibegron demonstrated favorable long-term safety, tolerability and efficacy in patients with overactive bladder, consistent with results of the 12-week study."

For further information:

https://www.auajournals.org/doi/10.1097/JU.0000000000001574