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).
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.
Figure 1
Figure 2
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).
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