PMID- 24471907
OWN - NLM
STAT- MEDLINE
DCOM- 20140721
LR  - 20221207
IS  - 1464-410X (Electronic)
IS  - 1464-4096 (Linking)
VI  - 113
IP  - 6
DP  - 2014 Jun
TI  - Phase III, randomised, double-blind, placebo-controlled study of the 
      beta3-adrenoceptor agonist mirabegron, 50 mg once daily, in Japanese patients with 
      overactive bladder.
PG  - 951-60
LID - 10.1111/bju.12649 [doi]
AB  - OBJECTIVE: To evaluate the efficacy and safety of the beta3-adrenoceptor agonist 
      mirabegron, in a Japanese population with overactive bladder (OAB). PATIENTS AND 
      METHODS: This randomised, double-blind, placebo-controlled phase III study 
      enrolled adult patients experiencing OAB symptoms for >/=24 weeks. Patients with >/= 
      8 micturitions/24 h and >/=1 urgency episode/24 h or >/=1 urgency incontinence 
      episode/24 h were randomised to once-daily placebo, mirabegron 50 mg or 
      tolterodine 4 mg (as an active comparator, without testing for non-inferiority of 
      efficacy and safety) for 12 weeks. The primary endpoint was the change in the 
      mean number of micturitions/24 h from baseline to final assessment. Secondary 
      endpoints included micturition variables related to urgency and/or incontinence 
      and quality-of-life domain scores on the King's Health Questionnaire. Safety 
      assessments included adverse events (AEs), post-void residual urine volume, 
      laboratory variables, vital signs and 12-lead electrocardiogram. RESULTS: A total 
      of 1139 patients were randomised to receive placebo (n = 381), mirabegron 50 mg 
      (n = 380) or tolterodine 4 mg (n = 378). Demographic and baseline characteristics 
      were similar among the treatment groups. At final assessment, mirabegron was 
      significantly superior to placebo in terms of mean [sd] change from baseline in 
      number of micturitions/24 h (-1.67 [2.212] vs -0.86 [2.354]; P < 0.001) and mean 
      [sd] change from baseline in number of urgency episodes/24 h (-1.85 [2.555] vs 
      -1.37 [3.191]; P = 0.025), incontinence episodes/24 h (-1.12 [1.475] vs -0.66 
      [1.861]; P = 0.003), urgency incontinence episodes/24 h (-1.01 [1.338] vs -0.60 
      [1.745]; P = 0.008), and volume voided/micturition (24.300 [35.4767] vs 9.715 
      [29.0864] mL; P < 0.001). The incidence of AEs in the mirabegron group was 
      similar to that in the placebo group. Most AEs were mild and none were severe. 
      CONCLUSIONS: Mirabegron 50 mg once daily is an effective treatment for OAB 
      symptoms, with a low occurrence of side effects in a Japanese population.
CI  - (c) 2014 The Authors. BJU International (c) 2014 BJU International.
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
FAU - Kakizaki, Hidehiro
AU  - Kakizaki H
FAU - Homma, Yukio
AU  - Homma Y
FAU - Igawa, Yasuhiko
AU  - Igawa Y
FAU - Takeda, Masayuki
AU  - Takeda M
FAU - Nishizawa, Osamu
AU  - Nishizawa O
FAU - Gotoh, Momokazu
AU  - Gotoh M
FAU - Yoshida, Masaki
AU  - Yoshida M
FAU - Yokoyama, Osamu
AU  - Yokoyama O
FAU - Seki, Narihito
AU  - Seki N
FAU - Ikeda, Yasushi
AU  - Ikeda Y
FAU - Ohkawa, Sumito
AU  - Ohkawa S
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140317
PL  - England
TA  - BJU Int
JT  - BJU international
JID - 100886721
RN  - 0 (Acetanilides)
RN  - 0 (Adrenergic beta-3 Receptor Agonists)
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Cresols)
RN  - 0 (Muscarinic Antagonists)
RN  - 0 (Thiazoles)
RN  - 33RU150WUN (Phenylpropanolamine)
RN  - 5T619TQR3R (Tolterodine Tartrate)
RN  - MVR3JL3B2V (mirabegron)
SB  - IM
CIN - BJU Int. 2014 Jun;113(6):847-8. PMID: 24905658
MH  - Acetanilides/*administration & dosage
MH  - Adrenergic beta-3 Receptor Agonists/*administration & dosage
MH  - Aged
MH  - Asian People
MH  - Benzhydryl Compounds/administration & dosage
MH  - Cresols/administration & dosage
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Muscarinic Antagonists/administration & dosage
MH  - Phenylpropanolamine/administration & dosage
MH  - Thiazoles/*administration & dosage
MH  - Tolterodine Tartrate
MH  - Urinary Bladder, Overactive/*drug therapy
OTO - NOTNLM
OT  - efficacy
OT  - mirabegron
OT  - overactive bladder
OT  - safety
OT  - beta3-adrenoceptor agonist
EDAT- 2014/01/30 06:00
MHDA- 2014/07/22 06:00
CRDT- 2014/01/30 06:00
PHST- 2014/01/30 06:00 [entrez]
PHST- 2014/01/30 06:00 [pubmed]
PHST- 2014/07/22 06:00 [medline]
AID - 10.1111/bju.12649 [doi]
PST - ppublish
SO  - BJU Int. 2014 Jun;113(6):951-60. doi: 10.1111/bju.12649. Epub 2014 Mar 17.