北京大学医学部机构知识库
Advanced  
IR@PKUHSC  > 北京大学第二临床医学院  > 泌尿外科  > 期刊论文
学科主题: 临床医学
题名:
Results of a randomized, double-blind, parallel-group, placebo- and active-controlled, multicenter study of mirabegron, a 3-adrenoceptor agonist, in patients with overactive bladder in Asia
作者: Kuo, Hann-Chorng1,2; Lee, Kyu-Sung3; Na, Yanqun4; Sood, Rajeev5; Nakaji, Shigeru6; Kubota, Yosuke7; Kuroishi, Kentarou8
关键词: clinical trial ; efficacy ; mirabegron ; overactive bladder ; phase III ; randomized ; safety
刊名: NEUROUROLOGY AND URODYNAMICS
发表日期: 2015-09-01
DOI: 10.1002/nau.22645
卷: 34, 期:7, 页:685-692
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Urology & Nephrology
研究领域[WOS]: Urology & Nephrology
关键词[WOS]: BETA(3)-ADRENOCEPTOR AGONIST ; PHASE-III ; METAANALYSIS ; EFFICACY ; MUSCLE
英文摘要:

AimsTo assess the efficacy and safety of mirabegron 50mg once daily compared with placebo and the active control, tolterodine extended-release (ER) 4mg once daily, in patients with symptoms of overactive bladder (OAB) in Taiwan, Korea, China, and India.

MethodsA 12-week multinational, randomized, double-blind, parallel-group placebo- and active-controlled trial. The primary efficacy endpoint was change from baseline to final visit in mean number of micturitions/24hr. Secondary endpoints were: mean number of urgency episodes, incontinence episodes and urge incontinence episodes/24hr, mean number of nocturia episodes per night, mean volume voided per micturition, and quality-of-life (QoL) scores as assessed by the King′s Health Questionnaire (KHQ).

ResultsOf 1,126 patients who were randomized to receive double-blind study drug, 921 patients (300, 311, and 310 in the placebo, mirabegron 50mg, and tolterodine ER 4mg groups, respectively) completed the treatment period. Demographic characteristics were similar across treatment groups. A statistically significant improvement versus placebo in mean number of micturitions/24hr was seen with mirabegron 50mg at all timepoints (P<0.05) as well as final visit (-0.57 with 95% confidence intervals [CIs] of [-1.04, -0.09], P=0.019). There was no significant difference between treatment groups in improvement from baseline to final visit in any of the secondary outcome measures except volume voided per micturition. The overall incidence of drug-related adverse events was 17.2%, 15.8%, and 21.3%, in the placebo, mirabegron 50mg, and tolterodine ER 4mg groups, respectively.

ConclusionsMirabegron 50mg once daily for 12 weeks was superior to placebo in reducing the frequency of micturitions in patients with symptoms of OAB in Taiwan, Korea, China, and India. Neurourol. Urodynam. 34:???-???, 2015. (c) 2014 Wiley Periodicals, Inc.

语种: 英语
项目资助者: Astellas
WOS记录号: WOS:000359710200015
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/67988
Appears in Collections:北京大学第二临床医学院_泌尿外科_期刊论文

Files in This Item:

There are no files associated with this item.


作者单位: 1.Buddhist Tzu Chi Gen Hosp, Dept Urol, Hualien, Taiwan
2.Tzu Chi Univ, Hualien, Taiwan
3.Sungkyunkwan Univ, Sch Med, Samsung Med Ctr, Dept Urol, Seoul, South Korea
4.Peking Univ, Peoples Hosp, Dept Urol, Beijing 100871, Peoples R China
5.DR Ram Manohar Lohia Hosp, Dept Urol, New Delhi, India
6.PGI MER, New Delhi, India
7.Astellas Pharma Global Dev, Asian Dev, Tokyo, Japan
8.Astellas Pharma Global Dev, Data Sci, Tokyo, Japan

Recommended Citation:
Kuo, Hann-Chorng,Lee, Kyu-Sung,Na, Yanqun,et al. Results of a randomized, double-blind, parallel-group, placebo- and active-controlled, multicenter study of mirabegron, a 3-adrenoceptor agonist, in patients with overactive bladder in Asia[J]. NEUROUROLOGY AND URODYNAMICS,2015,34(7):685-692.
Service
Recommend this item
Sava as my favorate item
Show this item's statistics
Export Endnote File
Google Scholar
Similar articles in Google Scholar
[Kuo, Hann-Chorng]'s Articles
[Lee, Kyu-Sung]'s Articles
[Na, Yanqun]'s Articles
CSDL cross search
Similar articles in CSDL Cross Search
[Kuo, Hann-Chorng]‘s Articles
[Lee, Kyu-Sung]‘s Articles
[Na, Yanqun]‘s Articles
Related Copyright Policies
Null
Social Bookmarking
Add to CiteULike Add to Connotea Add to Del.icio.us Add to Digg Add to Reddit

Items in IR are protected by copyright, with all rights reserved, unless otherwise indicated.

 

 

Valid XHTML 1.0!
Copyright © 2007-2017  北京大学医学部 - Feedback
Powered by CSpace