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
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- Dong Gil Shin
- Pusan National University Hospital Busan Korea
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- Hyeon Woo Kim
- Pusan National University Hospital Busan Korea
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- Sang Jin Yoon
- Gacheon University Gil Medical Center Incheon Korea
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- Sang Hoon Song
- Asan Medical Center Seoul Korea
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- Young Ho Kim
- Soon Chun Hyang University Bucheon Hospital Bucheon Korea
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- Young Goo Lee
- Hallym University Kangnam Sacred Heart Hospital Seoul Korea
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- Kwan Joong Joo
- Kangbuk Samsung Hospital Seoul Korea
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- Jae Hyun Bae
- Korea University Ansan Hospital Ansan Korea
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- Taek Won Kang
- Chonnam National University Hospital Gwangju Korea
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- Seong Jin Jeong
- Seoul National University Bundang Hospital Seongnam Korea
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- Seung Hyo Woo
- Eulji University Hospital Daejeon Korea
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- Eun Sang Yoo
- Kyungpook National University Hospital Daegu Korea
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- Hwancheol Son
- Seoul National University Boramae Medical Center Seoul Korea
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- Kyo Chul Koo
- Gangnam Severance Hospital Seoul Korea
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- Soo Woong Kim
- Seoul National University Hospital Seoul Korea
抄録
<jats:sec><jats:title>Aims</jats:title><jats:p>To evaluate the efficacy and safety of mirabegron in males with overactive bladder (OAB) symptoms.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>In total, 464 males with OAB symptoms were enrolled from 14 institutes and were sorted into either the mirabegron 50 mg (<jats:italic>n</jats:italic> = 310) or placebo (<jats:italic>n</jats:italic> = 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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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 (<jats:italic>P</jats:italic> = 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.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>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.</jats:p></jats:sec>
収録刊行物
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- Neurourology and Urodynamics
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Neurourology and Urodynamics 38 (1), 295-304, 2018-10-12
Wiley