Efficacy and Safety of Vibegron for the Treatment of Overactive Bladder in Women: A Subgroup Analysis From the Double-Blind, Randomized, Controlled EMPOWUR Trial

Authors

Diane K. Newman DNP
Elizabeth Thomas MS
Heather Greene MPH
Cornelia Haag-Molkenteller MD
Susann Varano MD, Sacred Heart University

Document Type

Peer-Reviewed Article

Publication Date

1-2023

Abstract

Importance The international phase 3 EMPOWUR trial demonstrated efficacy and safety of vibegron, a newer b3-adrenergic receptor agonist, in adults with overactive bladder (OAB). Women are disproportionately affected by OAB, especially those with bothersome symptoms, such as urge urinary incontinence (UUI). Objective This subgroup analysis from EMPOWUR assessed efficacy and safety of vibegron in women. Study Design In EMPOWUR, patients with OAB were randomized 5:5:4 to 12 weeks of treatment with once-daily vibegron 75 mg, placebo, or tolterodine 4-mg extended release. Efficacy end points included change from baseline at week 12 in mean daily number of micturitions, UUI episodes, and urgency episodes. Safety was assessed through adverse events (AEs). Results Of the patients included in the analysis, 1286 (84.9%) were women (vibegron, n = 463; placebo, n = 459; tolterodine, n = 364). At week 12, women receiving vibegron showed significant reductions (95% confidence intervals of least squares mean differences does not include 0) from baseline versus placebo in mean daily micturitions, UUI episodes, and urgency episodes, with least squares mean differences (95% confidence intervals) of −0.5 (−0.8 to −0.2), −0.7 (−1.0 to −0.4), and −0.8 (−1.3 to −0.4), respectively. Treatment-emergent AE incidence was similar with vibegron (39%) and placebo (35%); the most common AE with incidence higher with vibegron (4.3%) than placebo (2.6%) was headache. Conclusions In this subgroup analysis, women receiving vibegron showed significant reductions in key efficacy end points versus placebo and favorable safety profile, consistent with the overall results from EMPOWUR, suggesting that vibegron is efficacious and safe for the treatment of OAB in this patient population.

Comments

Susann Varano, MD is an adjunct professor in the Physician Assistant program at Sacred Heart University.

DOI

10.1097/SPV.0000000000001258

PMID

36384907

Recommended Citation

Newman, D., Thomas, E., Greene, H., Haag-Molkenteller, C., & Varano, S. (2023). Efficacy and safety of vibegron for the treatment of overactive bladder in women: A subgroup analysis from the double-blind, randomized, controlled EMPOWUR trial. Urogynecology, 29(1), 48-57. https://doi.org/10.1097/SPV.0000000000001258

Publication

Urogynecology

Volume

29

Issue

1

Publisher

Wolters Kluwer

Pages

48-57

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-No Derivative Works 4.0 International License.