An Evaluation of the Efficacy and Safety of Vibegron in the Treatment of Overactive Bladder

Jeffrey Frankel; David Staskin; Susann Varano; Michael J Kennelly; Rachael A Jankowich; Cornelia Haag-Molkenteller

doi:10.2147/TCRM.S310371

An Evaluation of the Efficacy and Safety of Vibegron in the Treatment of Overactive Bladder

Ther Clin Risk Manag. 2022 Mar 3:18:171-182. doi: 10.2147/TCRM.S310371. eCollection 2022.

Authors

Jeffrey Frankel¹, David Staskin², Susann Varano³, Michael J Kennelly⁴, Rachael A Jankowich⁵, Cornelia Haag-Molkenteller⁵

Affiliations

¹ Seattle Urology Research Center, Seattle, WA, USA.
² Tufts University School of Medicine, Boston, MA, USA.
³ Clinical Research Consulting, Milford, CT, USA.
⁴ Carolinas Medical Center, Charlotte, NC, USA.
⁵ Urovant Sciences, Irvine, CA, USA.

Abstract

Pharmacologic treatment for overactive bladder (OAB), which is characterized by bothersome symptoms such as urgency and urge urinary incontinence (UUI), includes anticholinergics and β₃-adrenergic receptor agonists. Anticholinergics are associated with adverse effects including dry mouth, constipation, cognitive impairment, and increased risk of dementia. Therefore, the drug class of β₃-adrenergic receptor agonists may represent an effective, safe treatment option. Vibegron, a β₃-adrenergic receptor agonist, was approved for use in Japan (2018) and the United States (2020). Over the past 3 years, 2 phase 3 trials (EMPOWUR, EMPOWUR extension) have been conducted with once-daily vibegron 75 mg for the treatment of OAB, and additional secondary and subgroup analyses have detailed the efficacy and safety of vibegron. In the international phase 3 EMPOWUR trial, treatment with vibegron was associated with significant improvements compared with placebo in efficacy outcomes of micturition frequency, UUI episodes, urgency episodes, and volume voided as early as week 2 that were sustained throughout the 12-week trial. The 40-week EMPOWUR extension study, following the 12-week treatment period, demonstrated sustained efficacy in patients receiving vibegron for 52 weeks. Treatment with vibegron was also associated with improvements in patient-reported measures of quality of life. Across studies, vibegron was generally safe and well tolerated. A separate, dedicated ambulatory blood pressure monitoring study showed that treatment with vibegron was not associated with clinically meaningful effects on blood pressure or heart rate. Across all studies, vibegron was efficacious, safe, and well tolerated and thus represents a valuable treatment option for patients with OAB. Here, nearly 1 year after US approval, we review the published data on efficacy and safety of vibegron 75 mg for the treatment of OAB.

Keywords: adrenergic agonist; urinary bladder overactive; urinary incontinence; vibegron; β-adrenergic receptor.

Publication types

Review