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

Dong Gil Shin, Hyeon Woo Kim, Sang Jin Yoon, Sang Hoon Song, Young Ho Kim, Young Goo Lee, Kwan Joong Joo, Jae Hyun Bae, Taek Won Kang, Seong Jin Jeong, Seung Hyo Woo, Eun Sang Yoo, Hwancheol Son, Kyo Chul Koo, Soo Woong Kim

    Research output: Contribution to journalArticlepeer-review

    26 Citations (Scopus)

    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.

    Original languageEnglish
    Pages (from-to)295-304
    Number of pages10
    JournalNeurourology and Urodynamics
    Volume38
    Issue number1
    DOIs
    Publication statusPublished - 2019 Jan

    Bibliographical note

    Publisher Copyright:
    © 2018 Wiley Periodicals, Inc.

    Keywords

    • adrenergic beta-3 receptor agonists
    • male
    • micturition
    • urgency

    ASJC Scopus subject areas

    • Clinical Neurology
    • Urology

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