Once Daily Vibegron Improves Quality of Life Measures in Patients with Overactive Bladder

To assess the effect of vibegron treatment on quality of life (QoL) measured in a large Phase 2b study in patients with overactive bladder (OAB). King’s Health Questionnaire (KHQ) is a disease-specific instrument that measures QoL in patients with urinary incontinence; it is used widely in clinical studies as a valid, reliable, clinically sensitive endpoint. Domains include general health perception (GHP), incontinence impact (II), role limitations (R-L), physical limitations (P-L), social limitations (S-L), personal relationships (PR), emotions (EM), sleep/energy (S/E), and severity (SV) measures. KHQ data were analyzed from an international, phase 2b, randomized, double-blind, placebo- and active comparator study (n=1393 patients) that investigated the efficacy and safety of vibegron. The study was conducted in two parts: in dose-ranging Part 1 (8 weeks; equal randomization), patients received 1 of 7 treatments: once-daily vibegron monotherapy (V3, V15, V50, V100 mg); tolterodine ER 4 mg/day (TER4); placebo; or V50/TER4 for 4 weeks plus V50 for 4 weeks. In Part 2 (4 weeks; randomization 2:2:2:1; different group of patients from Part 1), patients received once-daily V100, TER4, V100/TER4, or placebo for 4 weeks. Mean change from baseline to endpoint in QoL variables was assessed using a constrained longitudinal data analysis model. In Part 1, 50 and 100 mg vibegron both significantly (p<0.05) improved QoL versus placebo at week 8 in four domains (II, R-L, P-L, SV). Similar results were observed in Part 2, with significant benefit also seen in a fifth domain, S-L. No clinically meaningful between-group differences in baseline characteristics were noted. 50 and 100 mg vibegron significantly improve QoL in OAB patients as measured by the KHQ.