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Cited 20 time in webofscience Cited 23 time in scopus
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Mirabegron as a treatment for overactive bladder symptoms in men (MIRACLE study): Efficacy and safety results from a multicenter, randomized, double-blind, placebo-controlled, parallel comparison phase IV study

Authors
Shin, Dong GilKim, Hyeon WooYoon, Sang JinSong, Sang HoonKim, Young HoLee, Young GooJoo, Kwan JoongBae, Jae HyunKang, Taek WonJeong, Seong JinWoo, Seung HyoYoo, Eun SangSon, HwancheolKoo, Kyo ChulKim, Soo Woong
Issue Date
Jan-2019
Publisher
WILEY
Keywords
adrenergic beta-3 receptor agonists; male; micturition; urgency
Citation
NEUROUROLOGY AND URODYNAMICS, v.38, no.1, pp 295 - 304
Pages
10
Indexed
SCI
SCIE
SCOPUS
Journal Title
NEUROUROLOGY AND URODYNAMICS
Volume
38
Number
1
Start Page
295
End Page
304
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/2516
DOI
10.1002/nau.23852
ISSN
0733-2467
1520-6777
Abstract
Aims To evaluate the efficacy and safety of mirabegron in males with overactive bladder (OAB) symptoms. Methods In total, 464 males with OAB symptoms were enrolled from 14 institutes and were sorted into either the mirabegron 50 mg (n = 310) or placebo (n = 154) groups. The change in (i) the mean number of 24-h micturition episodes; (ii) OAB Symptom Scale (OABSS); and (iii) International Prostate Symptom Score (IPSS) from baseline to 12 weeks of treatment were compared between the two groups. Safety assessments included treatment-emergent adverse events, blood pressure, pulse rate, postvoid residual volume, and maximum urinary flow rate. After 12 weeks, the study was extended for 14 additional weeks by administering mirabegron 50 mg to both groups. Results The reduction in the mean number of 24-h micturition episodes from baseline to 12 weeks of treatment was similar between the two groups. However, significantly greater changes from baseline to 12 weeks were observed in total OABSS, OABSS urgency incontinence score (Q4), IPSS storage subscore (Q2 + Q4 + Q7), and IPSS urgency score (Q4) in the mirabegron group (P = 0.01 for all). According to the extended study, the changes of all efficacy variables from baseline to 26 weeks were similar between both groups. The safety assessment results were also similar between the two groups at 12 and 26 weeks. Conclusion A daily 50 mg dose of mirabegron for 12 weeks reduced OAB symptoms in men, and no significant adverse events compared to the placebo group were noted.
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Bae, Jae Hyun
Ansan Hospital (Department of Urology, Ansan Hospital)
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