title: The efficacy and tolerability of the β3-adrenoceptor agonist mirabegron for the treatment of symptoms of overactive bladder in older patients.
abstract: BACKGROUND
  mirabegron is a β3-adrenoceptor agonist developed for the treatment of symptoms of overactive bladder (OAB). As the prevalence of OAB increases with age, a prospective subanalysis of individual and pooled efficacy and tolerability data from three 12-week, randomised, Phase III trials, and of tolerability data from a 1-year safety trial were conducted in order to evaluate the efficacy and tolerability of mirabegron in subgroups of patients aged ≥65 and ≥75 years.
  
  
  METHODS
  primary efficacy outcomes were change from baseline to final visit in the mean number of incontinence episodes/24 h and the mean number of micturitions/24 h. Tolerability was assessed by the incidence of treatment-emergent adverse events (TEAEs).
  
  
  RESULTS
  over 12 weeks mirabegron 25 mg and 50 mg once-daily reduced the mean numbers of incontinence episodes and micturitions/24 h from baseline to final visit in patients aged ≥65 and ≥75 years. Mirabegron was well tolerated: in both age groups, hypertension and urinary tract infection were among the most common TEAEs over 12 weeks and 1 year. The incidence of dry mouth, a typical anticholinergic TEAE, was up to sixfold higher among the older patients randomised to tolterodine than any dose of mirabegron.
  
  
  CONCLUSIONS
  these analyses have demonstrated the efficacy of mirabegron over 12 weeks and the tolerability of mirabegron over 12 weeks and 1 year in OAB patients aged ≥65 and ≥75 years, supporting mirabegron as a therapeutic option in older patients with OAB.
authors.affiliation: Department of Geriatric Medicine, University of Alberta, Alberta, Canada.
authors.forename: Adrian
authors.initials: A
authors.lastname: Wagg
authors.affiliation: Department of Urogynaecology, Kings College London, London, UK.
authors.forename: Linda
authors.initials: L
authors.lastname: Cardozo
authors.affiliation: Department of Urology, NYU Langone Medical Center, New York City, NY, USA.
authors.forename: Victor W
authors.initials: VW
authors.lastname: Nitti
authors.affiliation: Department of Urology, University Hospital of the Canary Islands, Santa Cruz de Tenerife, Tenerife, Spain.
authors.forename: David
authors.initials: D
authors.lastname: Castro-Diaz
authors.affiliation: Department of Urology, Hoag Memorial Presbyterian Hospital, Newport Beach, Long Beach, CA, USA.
authors.forename: Stephen
authors.initials: S
authors.lastname: Auerbach
authors.affiliation: Department of Biostatistics, Astellas Pharma Global Development, Inc., Northbrook, IL, USA.
authors.forename: Mary Beth
authors.initials: MB
authors.lastname: Blauwet
authors.affiliation: Astellas Pharma Europe Ltd, Chertsey, Surrey, UK and Department of Urology, Ealing Hospital, London, UK.
authors.forename: Emad
authors.initials: E
authors.lastname: Siddiqui
mesh_terms: D000083:Acetanilides / Q000009:adverse effects / Q000627:therapeutic use*; D058667:Adrenergic beta-3 Receptor Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D000367:Age Factors; D000368:Aged; D017326:Clinical Trials, Phase III as Topic; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D013844:Thiazoles / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000187:drug effects* / Q000503:physiopathology; D053201:Urinary Bladder, Overactive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D014549:Urinary Incontinence / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D014554:Urination / Q000187:drug effects; D064804:Urological Agents / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000083:Acetanilides; D058667:Adrenergic beta-3 Receptor Agonists; D013844:Thiazoles; D064804:Urological Agents; C520025:mirabegron
keywords: age; efficacy; mirabegron; older people; overactive bladder; tolerability