International Phase III, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Safety and Efficacy of Vibegron in Patients with Symptoms of Overactive Bladder: EMPOWUR.
Abstract
PURPOSE
To assess efficacy, safety, and tolerability of vibegron, a novel, potent, highly selective β3-adrenoceptor agonist, administered 12 weeks at 75 mg once-daily to patients with overactive bladder in an international phase III trial with placebo and active control.
MATERIALS AND METHODS
Adult patients with overactive bladder with ≥8.0 micturitions/day were randomized 5:5:4 to vibegron 75 mg, placebo, or extended-release tolterodine 4 mg. Up to 25% of patients could have dry overactive bladder (<1.0 urge-incontinence episodes/day). Patients completed 7-day voiding diaries at baseline and weeks 2, 4, 8, and 12.
RESULTS
Of 1,518 randomized patients, 90.4% completed the trial. At 12 weeks, micturitions decreased by an adjusted mean of 1.8 episodes/day for vibegron versus 1.3 for placebo (p<0.001; co-primary endpoint), and 1.6 for tolterodine. Among incontinent patients, urge-incontinence episodes decreased by an adjusted mean 2.0 episodes/day for vibegron versus 1.4 for placebo (p<0.0001; co-primary endpoint), and 1.8 for tolterodine. Moreover, vibegron was statistically significantly superior to placebo for key secondary measures of number of urgency episodes, volume per micturition, and proportion of incontinent patients with a ≥75% reduction in urge-incontinence episodes (all p<0.01). Among vibegron-treated patients, 1.7% discontinued treatment because of adverse events, versus 1.1% for placebo and 3.3% for tolterodine. Incidence of hypertension was 1.7% for vibegron…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,518 participants or records.
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