A Randomized, Double-Blind, Placebo-Controlled, Bridging Study to Evaluate the Efficacy and Safety of Vibegron in Treating Korean Patients With Overactive Bladderopen access
- Authors
- 신정현; 정성진; 김선옥; 오철영; 정경진; 신동길; 김태효; 권준범; 신주현; 배웅진; 이규성; 주명수
- Issue Date
- Jun-2023
- Publisher
- 대한배뇨장애요실금학회
- Keywords
- Urinary bladder; Overactive; Vibegron; β3-adrenoreceptor agonist
- Citation
- International Neurourology Journal, v.27, no.2, pp.106 - 115
- Journal Title
- International Neurourology Journal
- Volume
- 27
- Number
- 2
- Start Page
- 106
- End Page
- 115
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/88783
- DOI
- 10.5213/inj.2346022.011
- ISSN
- 2093-4777
- Abstract
- Purpose: Vibegron, a novel, potent β3 agonist, has been approved for clinical use in overactive bladder (OAB) treatment in Ja pan and the Unites States. We performed a bridging study to investigate the efficacy and safety of a daily 50-mg vibegron (code name JLP-2002) dose in Korean patients with OAB.
Methods: A multicenter, randomized, double-blind, placebo-controlled study was conducted from September 2020 to August 2021. Adult patients with OAB with a symptom duration of more than 6 months entered a 2-week placebo run-in phase. Eligi bility was assessed at the end of this phase and selected patients entered a double-blind treatment phase after 1:1 randomiza tion to either the placebo or vibegron (50 mg) group. The study drug was administered once daily for 12 weeks and follow-up visits were scheduled at weeks 4, 8, and 12. The primary endpoint was the change in mean daily micturition at the end of treat ment. The secondary endpoints included changes in OAB symptoms (daily micturition, nocturia, urgency, urgency inconti nence, and incontinence episodes, and mean voided volume per micturition) and safety. A constrained longitudinal data mod el was used for statistical analysis.
Results: Patients who took daily vibegron had significant improvements over the placebo group in both primary and second ary endpoints, except for daily nocturia episodes. The proportions of patients with normalized micturition and resolution of urgency incontinence and incontinence episodes were significantly higher in vibegron group than in the placebo. Vibegron also improved the patients’ quality of life with higher satisfaction rates. The incidence of adverse events in the vibegron and placebo groups was similar with no serious, unexpected adverse drug reactions. No abnormality in electrocardiographs was observed as well as no significant increase in postvoid residual volume.
Conclusions: Once daily vibegron (50 mg) for 12 weeks was effective, safe, and well-tolerated in Korean patients with OAB.
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