Upcoming event

Safety and efficacy of mirabegron: analysis of a large integrated clinical trial database of patients with overactive bladder receiving mirabegron, antimuscarinics, or placebo

  • Christopher R. Chapple 1,
  • Francisco Cruz 2,
  • Linda Cardozo 3,
  • David Staskin 4,
  • Sender Herschorn 5,
  • Nurul Choudhury 6,
  • Matthias Stoelzel 7,
  • John Heesakkers 8,
  • Emad Siddiqui 9
1 Royal Hallamshire Hospital, Sheffield, UK 2 Department of Urology, Faculty of Medicine, Hospital S João, Porto, Portugal 3 Department of Urogynaecology, King's College Hospital, London, UK 4 Tufts University School of Medicine, Boston, MA, USA 5 Department of Urology, University of Toronto, Toronto, Canada 6 Astellas Pharma Europe Ltd., Chertsey, Surrey, UK 7 Department of Data Science, Astellas Pharma Europe, Leiden, The Netherlands 8 Department of Urology, Radboud University Medical Centre, Nijmegen, The Netherlands 9 Department of Global Medical Affairs, Astellas Pharma, Chertsey, UK


Mirabegron, a β3-adrenoreceptor agonist, is an alternative drug to antimuscarinics for overactive bladder (OAB) symptoms.


To summarise safety and efficacy reporting of mirabegron treatment for OAB symptoms.

Design, setting, and participants

Pooled data analysed from 10 phase 2–4, double-blind, 12-wk mirabegron monotherapy studies in adults with OAB who had received one or more doses of study drug.


Mirabegron: 25 and 50 mg; antimuscarinics: solifenacin (2.5, 5, and 10 mg) and tolterodine extended release (4 mg).

Outcome measurements and statistical analysis

Baseline OAB-related characteristics, intrinsic and extrinsic factors, and analyses by age (<65 vs ≥65 yr and <75 vs ≥75 yr) and sex were assessed. Solifenacin 2.5 and 10 mg groups were not included in the efficacy analyses (small patient numbers). Safety was evaluated using the proportion of treatment-emergent adverse events. Efficacy variables were derived from bladder diaries (baseline and week 12).

Results and limitations

Baseline hypertension and diabetes were more frequent across treatment groups in the older versus younger age groups and in men versus women. Within sexes, frequencies were similar between treatment groups. Some differences were observed in baseline characteristics, including type of incontinence and medical history between sexes. No previously unreported safety concerns were identified. Improvements in efficacy (mean number of incontinence episodes/24 h, micturitions/24 h, urgency episodes/24 h, volume voided/micturition, and nocturia episodes) versus placebo were observed in all treatment groups. Significant treatment-by-subgroup interactions included change from baseline in the mean number of incontinence episodes/24 h by age (<65 vs ≥65 yr), nocturia by age (<65 vs ≥65 yr and <75 vs ≥75 yr), and urgency episodes by previous OAB medication.


Data from this integrated database of 10 mirabegron studies reaffirm the safety and efficacy profiles of mirabegron, solifenacin, and tolterodine in adults of different age groups and sexes.