Cardiovascular safety of vibegron, a new β3‐adrenoceptor agonist, in older patients with overactive bladder: Post‐hoc analysis of a randomized, placebo‐controlled, double‐blind comparative phase 3 study

Abstract

Aims: To examine the safety and efficacy of vibegron, a new β3-adrenoceptor agonist, in patients aged ≥65 years, with a focus on the effects on cardiovascular system and overactive bladder (OAB) symptoms.Methods: A post-hoc subgroup analysis was performed of a randomized, placebo-controlled, double-blind comparative phase 3 study of vibegron, including those assigned to receive either vibegron 50 mg (V50), vibegron 100 mg (V100), or placebo for 12 weeks. Subjects were stratified into two subgroups based on age: a <65-year subgroup and a ≥65-year subgroup. Safety (changes in systolic and diastolic blood pressure, pulse rate, and residual urine volume) and efficacy (changes in the numbers of micturitions, urgency episodes, urgency urinary incontinence [UUI] episodes, and the voided volume/micturition) were assessed in the subgroups treated with vibegron vs. placebo. Results: There were no significant differences in the cardiovascular outcomes (blood pressure and pulse rate), nor in the changes in residual urine volume, between the V50/100 and placebo groups in the <65-year or ≥65-year subgroup after 12-week treatment. Adverse events were slightly increased in the ≥65-year subgroup. In the efficacy analysis, V50/100 demonstrated similar efficacy in the <65-year and ≥65-year subgroups; an increasing trend in the voided volume/micturition was observed in subjects aged ≥65 years compared to subjects aged <65 years.Conclusions: Vibegron was suggested to be similarly effective in patients ≥65 and <65 years and to have minimal influence on cardiovascular parameters.

A Randomized, Double-Blind, Placebo-Controlled, Bridging Study to Evaluate the Efficacy and Safety of Vibegron in Treating Korean Patients With Overactive Bladder

“…Consequently, the safety analysis of β3 agonists always focuses on possible cardiovascular outcomes including abnormal blood pressure and pulse rate. Thus far, vibegron seems to have minimal impact on cardiovascular parameters [16].…”

“…In such context, only one patient in mirabegron had elevated blood pressure and headache in forementioned study [25]. A Japanese post hoc analysis on vibegron 50 mg, 100 mg, or placebo for 12-week demonstrated no cardiovascular AEs including high blood pressure, palpitation, and tachycardia in those with vibegron 50 mg [16]. Future studies with more patients and longer follow-up is warranted.…”

Comment on: Pharmacist‐driven interventions to de‐escalate urinary antimuscarinics in the Programs of All‐Inclusive Care for the Elderly

“…8 Additionally, an analysis of a vibegron clinical trial in Japan found no change in blood pressure over the 12-week study period in patients ≥65 years of age. 9 In clinical trials, vibegron also did not increase blood pressure in patients with pre-existing hypertension. In EMPOWUR, no clinically relevant changes from baseline in blood pressure were observed over 12 weeks of vibegron treatment in patients who were or were not hypertensive at baseline.…”