To assess efficacy and safety of mirabegron 25 mg/day and 50 mg/day for overactive bladder in Chinese participants.
Participants of ≥18 years with overactive bladder symptoms lasting for ≥12 weeks, a mean of ≥8 micturitions per 24 h, and a mean of at least one episode of Grade 3 or 4 urgency or urge incontinence per 24 h based on the Patient Perception of Intensity of Urgency Scale over a 3-day micturition diary period were randomized 2:1 to open-label treatment with oral mirabegron 50 mg or 25 mg once daily for 12 weeks (15 sites in China, January 2021-March 2022). A dose escalation from 25 mg/day to 50 mg/day was permitted at weeks 4 and 8 according to the investigators' discretion. The primary efficacy endpoint was the change from baseline to Week 12 in the mean number of micturitions per 24 h in those randomized to mirabegron 50 mg/day. Secondary efficacy endpoints were the change in mean number of micturitions at weeks 4 and 8 in the mirabegron 50 mg/day group and weeks 4, 8, and 12 in the mirabegron 25 mg/day group, change from baseline to weeks 4, 8, and 12 in Grade 3 or 4 urgency episodes on the Patient Perception of Intensity of Urgency Scale, episodes of daytime incontinence, nighttime incontinence, and urgency incontinence, and Overactive Bladder Symptom Score for mirabegron 50 mg/day and 25 mg/day groups.
Statistically significant reduction (p<0.001) from baseline to Week 12 was observed in mean micturitions per 24 h for participants randomized to mirabegron 50 mg/day: mean±standard error: 11.71±0.43 at baseline, 7.80±0.24 at Week 12; adjusted mean change: -3.73 (95% confidence interval -4.30 to -3.16). Both doses showed statistically significant improvement in secondary efficacy endpoints at weeks 4, 8, and 12 versus baseline. Safety was consistent with mirabegron's known safety profile.
The results support a mirabegron dosage of 50 mg/day for the treatment of OAB in China.
Asian journal of urology. 2024 Jul 27 [Epub]
Zhipeng Zhang, Deyi Luo, Zhong Chen, Peng Zhang, Ganping Zhong, Keji Xie, Zhuoqun Xu, Xudong Li, Jianye Wang, Yingfan Yang, Farid Abdul Hadi, Arianne Schild
Department of Urology, Beijing Hospital, National Center of Gerontology and Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China., Department of Urology, West China Hospital, Sichuan University, Chengdu, China., Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China., Department of Urology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China., Department of Urology, Lanzhou University Second Hospital, Lanzhou, China., Department of Urology, Guangzhou First People's Hospital, Guangzhou, China., Department of Urology, Wuxi People's Hospital, Wuxi, China., Department of Urology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China., Medical Affairs, Astellas Pharma (China), Inc., Shenyang, China., Medical Affairs, Astellas Pharma Singapore Pte. Ltd., Singapore., Analytics & Data Science, Astellas Pharma Global Development, Inc., Northbrook, IL, USA.