PMID- 23182126
OWN - NLM
STAT- MEDLINE
DCOM- 20130708
LR  - 20220408
IS  - 1873-7560 (Electronic)
IS  - 0302-2838 (Linking)
VI  - 63
IP  - 2
DP  - 2013 Feb
TI  - Efficacy and tolerability of mirabegron, a beta(3)-adrenoceptor agonist, in patients 
      with overactive bladder: results from a randomised European-Australian phase 3 
      trial.
PG  - 283-95
LID - S0302-2838(12)01235-3 [pii]
LID - 10.1016/j.eururo.2012.10.016 [doi]
AB  - BACKGROUND: Mirabegron, a beta(3)-adrenoceptor agonist, has been developed for the 
      treatment of overactive bladder (OAB). OBJECTIVE: To assess the efficacy and 
      tolerability of mirabegron versus placebo. DESIGN, SETTING, AND PARTICIPANTS: 
      Multicenter randomised double-blind, parallel-group placebo- and 
      tolterodine-controlled phase 3 trial conducted in 27 countries in Europe and 
      Australia in patients >/= 18 yr of age with symptoms of OAB for >/= 3 mo. 
      INTERVENTION: After a 2-wk single-blind placebo run-in period, patients were 
      randomised to receive placebo, mirabegron 50mg, mirabegron 100mg, or tolterodine 
      extended release 4 mg orally once daily for 12 wk. OUTCOME MEASUREMENTS AND 
      STATISTICAL ANALYSIS: Patients completed a micturition diary and quality-of-life 
      (QoL) assessments. Co-primary efficacy end points were change from baseline to 
      final visit in the mean number of incontinence episodes and micturitions per 24h. 
      The primary comparison was between mirabegron and placebo with a secondary 
      comparison between tolterodine and placebo. Safety parameters included adverse 
      events (AEs), laboratory assessments, vital signs, electrocardiograms, and 
      postvoid residual volume. RESULTS AND LIMITATIONS: A total of 1978 patients were 
      randomised and received the study drug. Mirabegron 50-mg and 100-mg groups 
      demonstrated statistically significant improvements (adjusted mean change from 
      baseline [95% confidence intervals]) at the final visit in the number of 
      incontinence episodes per 24h (-1.57 [-1.79 to -1.35] and -1.46 [-1.68 to -1.23], 
      respectively, vs placebo -1.17 [-1.39 to -0.95]) and number of micturitions per 
      24h (-1.93 [-2.15 to -1.72] and -1.77 [-1.99 to -1.56], respectively, vs placebo 
      -1.34 [-1.55 to -1.12]; p<0.05 for all comparisons). Statistically significant 
      improvements were also observed in other key efficacy end points and QoL 
      outcomes. The incidence of treatment-emergent AEs was similar across treatment 
      groups. The main limitation of this study was the short (12-wk) duration of 
      treatment. CONCLUSIONS: Mirabegron represents a new class of treatment for OAB 
      with proven efficacy and good tolerability. TRIAL IDENTIFICATION: This study is 
      registered at ClinicalTrials.gov, identifier NCT00689104.
CI  - Copyright (c) 2012 European Association of Urology. Published by Elsevier B.V. All 
      rights reserved.
FAU - Khullar, Vik
AU  - Khullar V
AD  - St. Mary's Hospital, Imperial College, London, UK. vik.khullar@imperial.ac.uk
FAU - Amarenco, Gerard
AU  - Amarenco G
FAU - Angulo, Javier C
AU  - Angulo JC
FAU - Cambronero, Javier
AU  - Cambronero J
FAU - Hoye, Kjetil
AU  - Hoye K
FAU - Milsom, Ian
AU  - Milsom I
FAU - Radziszewski, Piotr
AU  - Radziszewski P
FAU - Rechberger, Tomasz
AU  - Rechberger T
FAU - Boerrigter, Peter
AU  - Boerrigter P
FAU - Drogendijk, Ted
AU  - Drogendijk T
FAU - Wooning, Marianne
AU  - Wooning M
FAU - Chapple, Christopher
AU  - Chapple C
LA  - eng
SI  - ClinicalTrials.gov/NCT00689104
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20121106
PL  - Switzerland
TA  - Eur Urol
JT  - European urology
JID - 7512719
RN  - 0 (Acetanilides)
RN  - 0 (Adrenergic beta-3 Receptor Agonists)
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Cresols)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Muscarinic Antagonists)
RN  - 0 (Thiazoles)
RN  - 33RU150WUN (Phenylpropanolamine)
RN  - 5T619TQR3R (Tolterodine Tartrate)
RN  - MVR3JL3B2V (mirabegron)
SB  - IM
CIN - Eur Urol. 2013 Feb;63(2):306-8. PMID: 23201469
CIN - J Urol. 2013 Jun;189(6):2204-5. PMID: 23663617
MH  - Acetanilides/*therapeutic use
MH  - Adrenergic beta-3 Receptor Agonists/*therapeutic use
MH  - Aged
MH  - Australia
MH  - Benzhydryl Compounds/*therapeutic use
MH  - Cresols/*therapeutic use
MH  - Delayed-Action Preparations/therapeutic use
MH  - Double-Blind Method
MH  - Europe
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Muscarinic Antagonists/*therapeutic use
MH  - Phenylpropanolamine/*therapeutic use
MH  - Quality of Life
MH  - Single-Blind Method
MH  - Surveys and Questionnaires
MH  - Thiazoles/*therapeutic use
MH  - Tolterodine Tartrate
MH  - Treatment Outcome
MH  - Urinary Bladder, Overactive/complications/*drug therapy
MH  - Urinary Incontinence, Urge/drug therapy/etiology
MH  - Urination/drug effects
EDAT- 2012/11/28 06:00
MHDA- 2013/07/09 06:00
CRDT- 2012/11/28 06:00
PHST- 2012/09/07 00:00 [received]
PHST- 2012/10/10 00:00 [accepted]
PHST- 2012/11/28 06:00 [entrez]
PHST- 2012/11/28 06:00 [pubmed]
PHST- 2013/07/09 06:00 [medline]
AID - S0302-2838(12)01235-3 [pii]
AID - 10.1016/j.eururo.2012.10.016 [doi]
PST - ppublish
SO  - Eur Urol. 2013 Feb;63(2):283-95. doi: 10.1016/j.eururo.2012.10.016. Epub 2012 Nov 
      6.