Effects of Vibegron on Ambulatory Blood Pressure in Patients With Overactive Bladder: Results From a Double-Blind Study
Jennifer King, PharmD1, Michael A. Weber, MD2, William B. White, MD3, Ann Walker, MS4, Paul N. Mudd, Jr., PharmD, MBA1, Cornelia Haag-Molkenteller, MD, PhD1.
1Urovant Sciences, Irvine, CA, USA, 2State University of New York Downstate College of Medicine, Brooklyn, NY, USA, 3Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, CT, USA, 4Apex Biostatistics, Inc, Apex, NC, USA.
Background: Ambulatory blood pressure monitoring (ABPM) is a sensitive method used to determine whether small changes in blood pressure (BP) and heart rate (HR) are induced by new drugs. This randomized, double-blind, placebo-controlled ABPM trial was used to characterize the BP and HR profile of the novel β3-adrenergic receptor agonist vibegron in patients with OAB. Methods: Patients were randomized to once-daily vibegron 75 mg or placebo for 28 days. The primary endpoint was change from baseline (CFB) to day 28 in mean daytime (waking hours) ambulatory systolic BP (SBP). Key secondary endpoints were CFB to day 28 in mean daytime ambulatory diastolic BP (DBP) and HR and in mean 24-hour ambulatory SBP, DBP, and HR. Point estimates for treatment group means and treatment differences were presented with a 2-sided 90% confidence interval (CI). For the primary endpoint, the upper limit of the CI was evaluated against a criterion of 3.5 mmHg. Results: A total of 214 patients with OAB were randomized; of these, 96 in the vibegron group and 101 in the placebo group had evaluable ABPM measurements at baseline and day 28. Mean age was 59.3 years and 74.6% were female; 39.6% and 30.7% of patients receiving vibegron or placebo, respectively, had pre-existing hypertension. The least squares mean difference (LSMD; 90% CI) CFB to day 28 in daytime SBP was 0.81 (‒0.88, 2.49) mmHg for vibegron vs placebo (Table). Changes in daytime DBP and HR were comparable for vibegron and placebo (Table). The 90% CIs include 0, implying no statistically significant differences were seen in mean 24-hour SBP (Figure), DBP, or HR (Table). The most commonly reported treatment-emergent adverse event was hypertension (vibegron: n=5 [4.7%, 95% CI=1.6%‒10.7%]; placebo: n=4 [3.7%, 95% CI=1.0%‒9.2%]); no event of hypertension with vibegron was considered treatment related. Conclusions: In patients with OAB, once-daily vibegron was not associated with clinically meaningful or statistically significant effects on BP or HR and had a safety profile comparable with placebo.
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