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 journalArticle

2 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
JournalNeurourology and Urodynamics
DOIs
Publication statusAccepted/In press - 2018 Jan 1

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Overactive Urinary Bladder
Placebos
Safety
Prostate
Urination
Therapeutics
Residual Volume
Heart Rate
mirabegron
Blood Pressure

Keywords

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

ASJC Scopus subject areas

  • Clinical Neurology
  • Urology

Cite this

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. / 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.

In: Neurourology and Urodynamics, 01.01.2018.

Research output: Contribution to journalArticle

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. / 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. In: Neurourology and Urodynamics. 2018.
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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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T2 - Efficacy and safety results from a multicenter, randomized, double-blind, placebo-controlled, parallel comparison phase IV study

AU - Shin, Dong Gil

AU - Kim, Hyeon Woo

AU - Yoon, Sang Jin

AU - Song, Sang Hoon

AU - Kim, Young Ho

AU - Lee, Young Goo

AU - Joo, Kwan Joong

AU - Bae, Jae Hyun

AU - Kang, Taek Won

AU - Jeong, Seong Jin

AU - Woo, Seung Hyo

AU - Yoo, Eun Sang

AU - Son, Hwancheol

AU - Koo, Kyo Chul

AU - Kim, Soo Woong

PY - 2018/1/1

Y1 - 2018/1/1

N2 - 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.

AB - 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.

KW - adrenergic beta-3 receptor agonists

KW - male

KW - micturition

KW - urgency

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