PD66-11 EFFECTS OF VIBEGRON ON AMBULATORY BLOOD PRESSURE IN PATIENTS WITH OVERACTIVE BLADDER: RESULTS FROM A DOUBLE-BLIND STUDY

Abstract

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Non-neurogenic Voiding Dysfunction III (PD66)1 Sep 2021PD66-11 EFFECTS OF VIBEGRON ON AMBULATORY BLOOD PRESSURE IN PATIENTS WITH OVERACTIVE BLADDER: RESULTS FROM A DOUBLE-BLIND STUDY Michael A. Weber, William B. White, Jennifer King, Ann Walker, Paul N. Mudd, and Cornelia Haag-Molkenteller Michael A. WeberMichael A. Weber More articles by this author , William B. WhiteWilliam B. White More articles by this author , Jennifer KingJennifer King More articles by this author , Ann WalkerAnn Walker More articles by this author , Paul N. MuddPaul N. Mudd More articles by this author , and Cornelia Haag-MolkentellerCornelia Haag-Molkenteller More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002110.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: 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. Source of Funding: Urovant Sciences © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e1163-e1163 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Michael A. Weber More articles by this author William B. White More articles by this author Jennifer King More articles by this author Ann Walker More articles by this author Paul N. Mudd More articles by this author Cornelia Haag-Molkenteller More articles by this author Expand All Advertisement Loading ...