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学科主题临床医学
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
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
2015-09-01
DOI10.1002/nau.22645
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
WOS记录号WOS:000359710200015
资助机构Astellas
引用统计
被引频次:35[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/67988
专题北京大学第二临床医学院_泌尿外科
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
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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.
APA Kuo, Hann-Chorng.,Lee, Kyu-Sung.,Na, Yanqun.,Sood, Rajeev.,Nakaji, Shigeru.,...&Kuroishi, Kentarou.(2015).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.NEUROUROLOGY AND URODYNAMICS,34(7),685-692.
MLA Kuo, Hann-Chorng,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".NEUROUROLOGY AND URODYNAMICS 34.7(2015):685-692.
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