Vibegron effective versus placebo but not tolterodine for adults with overactive bladder symptoms (EMPOWUR)

Référence

Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN Jr. International phase III, randomized, double-blind, placebo and active controlled study to evaluate the safety and efficacy of vibegron in patients with symptoms of overactive bladder: EMPOWUR. J Urology 2020;204(2):316-324.

Sommaire

Vibegron may help reduce the symptoms of OAB, including voiding urgency and incontinence, by stimulating beta-3 adrenergic receptors, thereby causing the relaxation of bladder smooth muscle. These investigators identified adults, 18 years or older, who met standard diagnostic criteria for OAB (ie, urinary urgency with or without urge incontinence). After a 2-week single-blind (patient) placebo run-in period, eligible participants (n = 1518) randomly received (concealed allocation assignment) vibegron (75 mg once daily), tolterodine (4 mg once daily), or placebo. Patients masked to their treatment group assignment self-assessed outcomes using paper diaries. The majority (85.2%) of patients were women and 42.9% were 65 years or older. Complete follow-up occurred for 90.4% of study participants at 12 weeks. Using per-protocol analysis (ie, including only patients who complied with the study protocol), the mean difference in micturition frequency was significantly less in the vibegron group than in the placebo group (mean difference -0.5 episodes per day; 95% CI -0.8 to -0.2). Similarly, urge incontinence episodes significantly decreased in the vibegron group compared with the placebo group (mean difference -0.6 episodes per day; -0.9 to -0.3). A secondary outcome, the proportion of patients with at least a 75% reduction in urge incontinence episodes, was also significantly lower in the vibegron group compared with the placebo group (52.4% vs 36.8%; number needed to treat = 6.5; 4.6 - 10.7). No significant differences in micturition or urge incontinence frequency occurred between vibegron and tolterodine. In addition, no significant group differences occurred in dropout rates due to adverse events.