当前位置: 首页 > 详情页

The efficacy and safety of ropinirole prolonged release tablets as adjunctive therapy in Chinese subjects with advanced Parkinson's disease: A multicenter, double-blind, randomized, placebo-controlled study

文献详情

资源类型:

收录情况: ◇ SCIE

机构: [a]Department of Neurology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, No. 1 Shuaifuyuan, Wangfujing, Beijing 100730, China [b]Department of Neurology, Huashan Hospital Affiliated to Fudan University, Shanghai, China [c]Department of Neurology, Beijing Tiantan Hospital Affiliated to Capital MU, Beijing, China [d]Department of Neurology, Ruijin Hospital affiliated to Shanghai Jiao Tong University, School of Medicine, Shanghai, China [e]Department of Neurology, The Chinese PLA General Hospital, Beijing, China [f]Department of Neurology, The Second Affiliated Hospital Zhejiang University College Of Medicine, Zhejiang Province, China [g]Department of Neurology, The 2nd Affiliated Hospital of Soochow University, Jiangsu, China [h]Department of Neurology, The 1st Affiliated Hospital of Xi’an Jiaotong Univ, Shanxi, China [i]Department of Neurology, Tianjin Medical University General Hospital, Tianjin, China [j]GlaxoSmithKline (China) R&D Company Limited, Shanghai, China [k]GlaxoSmithKline (China) Investment Co, Ltd, Shanghai, China
出处:
ISSN:

关键词: Parkinson's disease Ropinirole PR Chinese subjects

摘要:
Aim: The first evaluation of the efficacy and safety of ropinirole prolonged release (PR) as an adjunct to L-dopa in Chinese patients with advanced Parkinson's disease (PD) not optimally controlled with L-dopa. Methods: In a 24-week, double-blind, placebo-controlled, parallel-group study, subjects with advanced PD were randomized 1:1 to ropinirole PR (N = 175) or placebo (N = 170) as add-on therapy to L-dopa. Primary outcome measure was change from baseline in awake time spent "off". Starting dose of ropinirole PR was 2 mg/day, titrated based on clinical response (maximum 24 mg/day). Results: At week 24, the mean dose of ropinirole PR was 11.4 mg/day with a mean reduction of L-dopa from 506.6 to 411.6 mg/day. Subjects receiving ropinirole PR experienced a significant reduction of "off" time (2.1 h) compared with placebo (0.4 h). Secondary outcome measures including hours of "on" time without troublesome dyskinesis were significantly increased in the ropinirole PR group (1.7 h) compared with placebo (0.3 h). Subjects classified as responders were significantly more frequent in the ropinirole PR (22.8%) than placebo group (2.5%). Efficacy outcomes including Unified Parkinson's disease Rating Scale and PDQ-39 subscales of mobility were significantly improved in the ropinirole PR versus placebo group. The most frequent adverse event experienced in the ropinirole PR group was dyskinesia. Conclusions: This study demonstrated for the first time in Chinese subjects that ropinirole PR improved Parkinson's disease symptoms, permitting a reduction in L-dopa dose. The adverse events observed were consistent with the established safety profile of ropinirole, with no new safety signal identified. (C) 2013 Elsevier Ltd. All rights reserved.

基金:
语种:
被引次数:
WOS:
中科院(CAS)分区:
出版当年[2012]版:
大类 | 3 区 医学
小类 | 3 区 临床神经病学
最新[2023]版:
大类 | 3 区 医学
小类 | 3 区 临床神经病学
JCR分区:
出版当年[2011]版:
Q1 CLINICAL NEUROLOGY
最新[2023]版:
Q2 CLINICAL NEUROLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2011版] 出版当年五年平均 出版前一年[2010版] 出版后一年[2012版]

第一作者:
第一作者机构: [a]Department of Neurology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, No. 1 Shuaifuyuan, Wangfujing, Beijing 100730, China
通讯作者:
通讯机构: [a]Department of Neurology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, No. 1 Shuaifuyuan, Wangfujing, Beijing 100730, China
推荐引用方式(GB/T 7714):
APA:
MLA:

资源点击量:16409 今日访问量:0 总访问量:869 更新日期:2025-01-01 建议使用谷歌、火狐浏览器 常见问题

版权所有©2020 首都医科大学宣武医院 技术支持:重庆聚合科技有限公司 地址:北京市西城区长椿街45号宣武医院