EMPOWUR is an international Phase 3, double-blind, placebo- and active (tolterodine)-controlled study of vibegron in OAB wet and dry patients. A total of 1,518 eligible participants were randomized to 75 mg vibegron, placebo, and extended-release 4 mg tolterodine that acted as positive control (Table 1).
Primary endpoints included a change in the average number of daily urge urinary incontinence (UUI) episodes in patients with 1 or more episodes per day and change in daily urinary voids. Subjects were followed for 12 weeks with 4 weeks of safety assessment.
Data analysis showed a statistically significant reduction in UUI episodes (Figure 1) and the daily number of voids (Figure 2) in vibegron group compared to placebo.
In addition, vibegron significantly increased urine volume per void by 21 ml compared to placebo at 12-week assessment (p<0.0001). A limited number of adverse events was noted (Table 2).
In conclusion, vibegron provided a significant improvement on OAB symptoms. It was well tolerated in subpopulations based on age and prior anticholinergic use with minimal adverse events compared to placebo.
Presented by: David Staskin, MD, Tufts University School of Medicine, Boston, Massachusetts
Written by: Hanna Stambakio, BS, Clinical Research Coordinator, Division of Urology, University of Pennsylvania @AStambakio at American Urological Association's 2019 Annual Meeting (AUA 2019), May 3 – 6, 2019 in Chicago, Illinois