PMID- 28120446
OWN - NLM
STAT- MEDLINE
DCOM- 20170606
LR  - 20170606
IS  - 1757-5672 (Electronic)
IS  - 1757-5664 (Linking)
VI  - 9
IP  - 1
DP  - 2017 Jan
TI  - Phase III Study to Assess Long-Term (52-Week) Safety and Efficacy of Mirabegron, 
      a beta(3) -Adrenoceptor Agonist, in Japanese Patients with Overactive Bladder.
PG  - 38-45
LID - 10.1111/luts.12107 [doi]
AB  - OBJECTIVES: 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.
CI  - (c) 2015 Wiley Publishing Asia Pty Ltd.
FAU - Yamaguchi, Osamu
AU  - Yamaguchi O
AD  - Division of Bioengineering and LUTD Research, Nihon University, School of 
      Engineering, Koriyama, Japan.
FAU - Ikeda, Yasushi
AU  - Ikeda Y
AD  - Astellas Pharma Inc, Tokyo, Japan.
FAU - Ohkawa, Sumito
AU  - Ohkawa S
AD  - Astellas Pharma Inc, Tokyo, Japan.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20150707
PL  - Australia
TA  - Low Urin Tract Symptoms
JT  - Lower urinary tract symptoms
JID - 101506777
RN  - 0 (Acetanilides)
RN  - 0 (Adrenergic beta-3 Receptor Agonists)
RN  - 0 (Thiazoles)
RN  - MVR3JL3B2V (mirabegron)
SB  - IM
MH  - Acetanilides/*administration & dosage/adverse effects
MH  - Adrenergic beta-3 Receptor Agonists/*administration & dosage/adverse effects
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Quality of Life
MH  - Thiazoles/*administration & dosage/adverse effects
MH  - Treatment Outcome
MH  - Urinary Bladder, Overactive/*drug therapy
MH  - Urinary Incontinence, Urge/drug therapy
MH  - Young Adult
OTO - NOTNLM
OT  - dose titration
OT  - long-term
OT  - mirabegron
OT  - overactive bladder
EDAT- 2017/01/26 06:00
MHDA- 2017/06/07 06:00
CRDT- 2017/01/26 06:00
PHST- 2015/03/12 00:00 [received]
PHST- 2015/04/28 00:00 [revised]
PHST- 2015/05/07 00:00 [accepted]
PHST- 2017/01/26 06:00 [entrez]
PHST- 2017/01/26 06:00 [pubmed]
PHST- 2017/06/07 06:00 [medline]
AID - 10.1111/luts.12107 [doi]
PST - ppublish
SO  - Low Urin Tract Symptoms. 2017 Jan;9(1):38-45. doi: 10.1111/luts.12107. Epub 2015 
      Jul 7.