Vibegron for the Treatment of Patients With Dry Overactive Bladder: A Subgroup Analysis From the EMPOWUR Trial
Michael Kennelly, MD1, David Staskin, MD2, Jeffrey Frankel, MD3, Susann Varano, MD4, Diane K. Newman, DNP, ANP-BC5, Matt T. Rosenberg, MD6, Denise Shortino, MS7, Rachael A. Jankowich, RN, MSN7, Paul N. Mudd, Jr., PharmD, MBA7.
1Carolinas Medical Center, Charlotte, NC, USA, 2Tufts University School of Medicine, Boston, MA, USA, 3Seattle Urology Research Center, Seattle, WA, USA, 4Clinical Research Consulting, Milford, CT, USA, 5Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA, 6Mid-Michigan Health Centers, Jackson, MI, USA, 7Urovant Sciences, Irvine, CA, USA.
Background: Overactive bladder (OAB) is characterized by urinary urgency, often accompanied by frequency and nocturia, with or without urge urinary incontinence (UUI), referred to as OAB wet and dry, respectively. In the phase 3 EMPOWUR trial, vibegron—a β3-adrenergic agonist approved for the treatment of adult patients with OAB—was associated with significant improvements in daily number of urgency episodes (the need to urinate immediately) and micturitions vs placebo (P<0.01). These post hoc analyses of EMPOWUR assessed efficacy outcomes in patients with OAB wet and OAB dry. Methods: In the EMPOWUR trial, patients were randomly assigned 5:5:4 to receive vibegron 75 mg, placebo, or active control (tolterodine 4 mg extended release), respectively, for 12 weeks. OAB wet criteria included an average of ≥8 micturitions and ≥1 UUI episode per diary day. Up to 25% of patients could have OAB dry, defined as an average of ≥8 micturitions, ≥3 urgency episodes, and <1 UUI episode per diary day. Outcomes assessed included change from baseline (CFB) in average daily number of urgency episodes and micturitions. Results: Of the 1463 patients included in the full analysis set, 1127 (77%) had OAB wet (vibegron, N=403; placebo, N=405; active control, N=319), and 336 (23%) had OAB dry (vibegron, N=123; placebo, N=115; active control, N=98). Vibegron was associated with significant reductions vs placebo in least squares (LS) mean (95% CI) CFB at week 12 in urgency episodes for the wet (-3.0 [‒3.3, ‒2.6] vs -2.4 [‒2.7, ‒2.0], respectively; P<0.05) and dry (-2.6 [‒3.2, ‒2.0] vs -1.6 [‒2.2, ‒0.9]; P<0.05) populations; significant reductions were also seen with vibegron vs placebo at weeks 2, 4, and 8 for both populations (P<0.05, each). Vibegron was associated with significant reductions vs placebo in LS mean (95% CI) CFB at week 12 in number of micturitions for the wet (-2.1 [‒2.4, ‒1.9] vs -1.7 [‒1.9, ‒1.5], respectively; P<0.01) and dry (-1.8 [‒2.3, ‒1.3] vs -1.0 [‒1.5, ‒0.5]; P<0.05) populations; significant reductions were also seen with vibegron vs placebo at weeks 2, 4, and 8 in the wet population and at weeks 4 and 8 in the dry population (P <0.05, each). Conclusions: Once-daily vibegron 75 mg is associated with significant reductions vs placebo in daily urgency episodes and number of micturitions in patients with OAB wet and dry, suggesting that vibegron works similarly for these endpoints in OAB wet and in OAB dry.
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