title: Phase III Study to Assess Long-Term (52-Week) Safety and Efficacy of Mirabegron, a β3-Adrenoceptor Agonist, in Japanese Patients with Overactive Bladder.
abstract: OBJECTIVE
  To investigate safety, tolerability and efficacy of long-term (52 weeks) open-label treatment with mirabegron 50 mg, with an optional dose increase to 100 mg, in patients with overactive bladder (OAB).
  
  
  METHODS
  Patients received mirabegron 50 mg once daily for 52 weeks. If efficacy was insufficient at week 8, the dose could be increased to 100 mg. Safety was evaluated based on vital signs, adverse events (AEs), laboratory findings, electrocardiogram and post-void residual volume. Treatment efficacy was assessed with a 3-day micturition diary and the King's Health Questionnaire (KHQ).
  
  
  RESULTS
  Two hundred and four patients were enrolled; mirabegron dose was maintained at 50 mg in 153 patients and increased to 100 mg in 50 patients. Mirabegron was well tolerated at both doses. Incidences of AEs and treatment-related AEs were 91.4% and 33.6% in patients on 50 mg, and 100% and 30.0% in patients on 100 mg, respectively. Time course changes in systolic or diastolic blood pressure and pulse rate were not considered clinically significant. At the end of treatment (EOT), patients on 50 mg and 100 mg showed improvement in frequency and urgency. Improvements from baseline to EOT in quality of life scores were observed for all KHQ domains.
  
  
  CONCLUSIONS
  There were no safety or tolerability concerns associated with mirabegron 50 mg (with an optional dose increase to 100 mg) over 52 weeks. Improvement in micturition variables was maintained with mirabegron 50 mg from weeks 8 to 52.
authors.affiliation: Division of Bioengineering and LUTD Research, Nihon University, School of Engineering, Koriyama, Japan.
authors.forename: Osamu
authors.initials: O
authors.lastname: Yamaguchi
authors.affiliation: Astellas Pharma Inc, Tokyo, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Ikeda
authors.affiliation: Astellas Pharma Inc, Tokyo, Japan.
authors.forename: Sumito
authors.initials: S
authors.lastname: Ohkawa
mesh_terms: D000083:Acetanilides / Q000008:administration & dosage* / Q000009:adverse effects; D058667:Adrenergic beta-3 Receptor Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D013844:Thiazoles / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*; D053202:Urinary Incontinence, Urge / Q000188:drug therapy; D055815:Young Adult
chemical_list: D000083:Acetanilides; D058667:Adrenergic beta-3 Receptor Agonists; D013844:Thiazoles; C520025:mirabegron
keywords: dose titration; long-term; mirabegron; overactive bladder