Vibegron improves quality-of-life measures in patients with overactive bladder: Patient-reported outcomes from the EMPOWUR study

Abstract

Background: Quality of life (QOL) can be significantly impacted by symptoms of overactive bladder (OAB). Vibegron is a highly selective β₃ -adrenergic receptor agonist that showed efficacy in treatment of symptoms of OAB in the randomised, double-blind, placebo- and active-controlled phase 3 EMPOWUR trial. Here we report patient-reported QOL outcomes from the EMPOWUR trial.

Methods: Patients were randomly assigned 5:5:4 to receive vibegron 75 mg, placebo or tolterodine 4 mg extended release, respectively, for 12 weeks. Patients completed the OAB questionnaire (OAB-q) at baseline and at week 12 and the patient global impression (PGI) scales for severity, control, frequency and leakage at baseline and at weeks 4, 8 and 12. Change from baseline at week 12 and responder rates (OAB-q: patients achieving a ≥10-point improvement; PGI: patients reporting best possible response) were assessed. Vibegron was compared with placebo, and no comparisons were made between vibegron and tolterodine.

Results: Of the 1518 patients randomised, 1463 (placebo, n = 520; vibegron, n = 526; tolterodine, n = 417) had evaluable data for efficacy measures and were included in the analysis. Mean baseline OAB-q and PGI scores were comparable among treatment groups. At week 12, patients receiving vibegron had greater improvements from baseline in OAB-q subscores of coping, concern, sleep, health-related QOL total and symptom bother (P < .01 each) compared with patients receiving placebo; a greater proportion of patients receiving vibegron vs placebo were responders in the OAB-q coping (P < .05) and symptom bother scores (P < .0001). Compared with placebo, a greater proportion of patients who received vibegron achieved the best response on all PGI end-points at week 12 (P < .05 each) and were classified as responders (P < .05 each).

Conclusions: In the 12-week EMPOWUR trial, treatment with vibegron was associated with significantly greater and clinically meaningful improvement in OAB-q and PGI scores compared with placebo, consistent with improvements in OAB symptoms.

Clinical trial registration: ClinicalTrials.gov identifier number NCT03492281.

FIGURE 1

LS mean change from baseline at week 12 in OAB‐q scores. The n value for each treatment group varied for each OAB‐q subscale score. For coping, concern, sleep, social interaction and HRQL total, increases indicate improvement; for symptom bother, decreases indicate improvement. HRQL, health‐related quality of life; LS, least squares; OAB‐q, overactive bladder questionnaire. *P < .05; **P < .01; ***P < .001

FIGURE 2

Post hoc analysis of percentage of patients reporting the best response for each PGI measure at week 12. For PGI‐severity, responses included none (best response), mild, moderate and severe. For PGI‐control, responses included complete control (best response), a lot of control, some control, only a little control and no control. For PGI‐frequency and PGI‐leakage, responses included never (best response), rarely, sometimes, often and very often. For PGI‐change, responses included much better (best response), moderately better, a little better, no change, a little worse, moderately worse and much worse. Percentages were calculated based on the number of patients included in the logistic regression model, where each patient had values at baseline and at week 12. PGI, patient global impression. *P < .05; **P < .01; ***P < .001. ^†Placebo, n = 378; vibegron, n = 382; tolterodine, n = 289

FIGURE 3

Post hoc analysis of percentage of patients selecting each response at baseline and week 12 for PGI (A) severity, (B) control, (C) frequency, (D) leakage and (E) change. Percentages were calculated based on the number of patients at each visit. PGI, patient global impression. *P < .05; **P < .01; ***P < .001 (for the distribution compared with placebo)