在中国膀胱过度活动症患者中开展米拉贝琼开放标签、随机、授权后研究

IF 2.4 3区医学 Q2 UROLOGY & NEPHROLOGY

Asian Journal of Urology Pub Date : 2025-01-01 DOI:10.1016/j.ajur.2024.04.007

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

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摘要

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An open-label, randomized, post-authorization study of mirabegron in Chinese participants with overactive bladder

Objective

To assess efficacy and safety of mirabegron 25 mg/day and 50 mg/day for overactive bladder in Chinese participants.

Methods

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.

Results

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.

Conclusion

The results support a mirabegron dosage of 50 mg/day for the treatment of OAB in China.

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来源期刊

Asian Journal of Urology UROLOGY & NEPHROLOGY-

CiteScore

4.00

自引率

3.80%

发文量

100

审稿时长

4 weeks

期刊介绍： Asian Journal of Urology (AJUR), launched in October 2014, is an international peer-reviewed Open Access journal jointly founded by Shanghai Association for Science and Technology (SAST) and Second Military Medical University (SMMU). AJUR aims to build a communication platform for international researchers to effectively share scholarly achievements. It focuses on all specialties of urology both scientifically and clinically, with article types widely covering editorials, opinions, perspectives, reviews and mini-reviews, original articles, cases reports, rapid communications, and letters, etc. Fields of particular interest to the journal including, but not limited to: • Surgical oncology • Endourology • Calculi • Female urology • Erectile dysfunction • Infertility • Pediatric urology • Renal transplantation • Reconstructive surgery • Radiology • Pathology • Neurourology.