PMID- 26663687
OWN - NLM
STAT- MEDLINE
DCOM- 20160920
LR  - 20151215
IS  - 1757-5672 (Electronic)
IS  - 1757-5664 (Linking)
VI  - 7
IP  - 2
DP  - 2015 May
TI  - Efficacy and Safety of the Selective beta3 -Adrenoceptor Agonist Mirabegron in 
      Japanese Patients with Overactive Bladder: A Randomized, Double-Blind, 
      Placebo-Controlled, Dose-Finding Study.
PG  - 84-92
LID - 10.1111/luts.12053 [doi]
AB  - OBJECTIVES: To evaluate the efficacy and safety of the beta3 -adrenoceptor agonist, 
      mirabegron, compared with placebo in Japanese patients with overactive bladder 
      (OAB). METHODS: Patients with OAB symptoms for >/=24 weeks, >/=8 micturitions/24 h on 
      average, and >/=1 episode of urgency and/or urgency incontinence/24 h were 
      randomized to mirabegron (25, 50 or 100 mg) or placebo for 12 weeks. The primary 
      endpoint was change from baseline to end of study in the mean number of 
      micturitions/24 h. Secondary endpoints included micturition variables related to 
      urgency, incontinence, volume voided, and quality of life based on the King's 
      Health Questionnaire (KHQ). Safety was evaluated based on adverse events (AEs), 
      laboratory findings, vital signs, electrocardiogram, and post-void residual 
      volume. RESULTS: In total, 842 patients were randomized to placebo (n = 214), 
      mirabegron 25 mg (n = 211), 50 mg (n = 208), or 100 mg (n = 209). The primary 
      endpoint was significantly improved in each mirabegron group compared with 
      placebo (P < 0.001; Williams' multiple comparison test). The maximal efficacy in 
      the primary endpoint was observed at the 50 mg dose. Significant improvements 
      were also observed in incontinence, urgency incontinence, mean volume voided, and 
      3 of the 9 domains from the KHQ (incontinence impact, physical limitations, and 
      severity measures) at each mirabegron dose. Urgency episodes decreased, and mean 
      volume voided increased, dose-dependently. The incidence of AEs in each 
      mirabegron dose was comparable with placebo. CONCLUSIONS: Mirabegron demonstrated 
      significant improvements in OAB symptoms compared with placebo and was well 
      tolerated.
CI  - (c) 2014 Wiley Publishing Asia Pty Ltd.
FAU - Yamaguchi, Osamu
AU  - Yamaguchi O
AD  - Division of Bioengineering and LUTD Research, School of Engineering, Nihon 
      University, Koriyama, Japan.
FAU - Marui, Eiji
AU  - Marui E
AD  - Department of Human Arts Sciences, University and Graduate School of Human Arts 
      Sciences, Saitama, Japan.
FAU - Igawa, Yasuhiko
AU  - Igawa Y
AD  - Department of Continence Medicine, The University of Tokyo Graduate School of 
      Medicine, Tokyo, Japan.
FAU - Takeda, Masayuki
AU  - Takeda M
AD  - Department of Urology, University of Yamanashi, Yamanashi, Japan.
FAU - Nishizawa, Osamu
AU  - Nishizawa O
AD  - Department of Urology, Shinshu University, Matsumoto, 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
SI  - ClinicalTrials.gov/NCT00527033
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140311
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/*therapeutic use
MH  - Adrenergic beta-3 Receptor Agonists/*therapeutic use
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Thiazoles/*therapeutic use
MH  - Treatment Outcome
MH  - Urinary Bladder, Overactive/*drug therapy
OTO - NOTNLM
OT  - dose-response
OT  - efficacy
OT  - mirabegron
OT  - overactive bladder
OT  - safety
EDAT- 2015/12/15 06:00
MHDA- 2016/09/22 06:00
CRDT- 2015/12/15 06:00
PHST- 2013/11/20 00:00 [received]
PHST- 2014/01/14 00:00 [revised]
PHST- 2014/01/21 00:00 [accepted]
PHST- 2015/12/15 06:00 [entrez]
PHST- 2015/12/15 06:00 [pubmed]
PHST- 2016/09/22 06:00 [medline]
AID - 10.1111/luts.12053 [doi]
PST - ppublish
SO  - Low Urin Tract Symptoms. 2015 May;7(2):84-92. doi: 10.1111/luts.12053. Epub 2014 
      Mar 11.