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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
Author(s) -
Shin Dong Gil,
Kim Hyeon Woo,
Yoon Sang Jin,
Song Sang Hoon,
Kim Young Ho,
Lee Young Goo,
Joo Kwan Joong,
Bae Jae Hyun,
Kang Taek Won,
Jeong Seong Jin,
Woo Seung Hyo,
Yoo Eun Sang,
Son Hwancheol,
Koo Kyo Chul,
Kim Soo Woong
Publication year - 2019
Publication title -
neurourology and urodynamics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 90
eISSN - 1520-6777
pISSN - 0733-2467
DOI - 10.1002/nau.23852
Subject(s) - mirabegron , overactive bladder , medicine , miracle , placebo , urology , double blind , multicenter study , safety profile , randomized controlled trial , adverse effect , alternative medicine , theology , pathology , philosophy
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.