Vibegron improves quality-of-life measures in patients with overactive bladder: Patient-reported outcomes from the EMPOWUR study.
| Autor: | Frankel J; Seattle Urology Research Center, Seattle, WA, USA., Varano S; Clinical Research Consulting, Milford, CT, USA., Staskin D; Tufts University School of Medicine, Boston, MA, USA., Shortino D; Urovant Sciences, Irvine, CA, USA., Jankowich R; Urovant Sciences, Irvine, CA, USA., Mudd PN Jr; Urovant Sciences, Irvine, CA, USA. |
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| Jazyk: | angličtina |
| Zdroj: | International journal of clinical practice [Int J Clin Pract] 2021 May; Vol. 75 (5), pp. e13937. Date of Electronic Publication: 2021 Jan 22. |
| DOI: | 10.1111/ijcp.13937 |
| Abstrakt: | Background: Quality of life (QOL) can be significantly impacted by symptoms of overactive bladder (OAB). Vibegron is a highly selective β 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. (© 2020 The Authors. International Journal of Clinical Practice published by John Wiley & Sons Ltd.) |
| Databáze: | MEDLINE |
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