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
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重点科室诊疗科室神经病学中心神经病学中心首都医科大学附属天坛医院[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神经内科泌尿外科苏州大学附属第二医院[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
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.
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):
Zhenxin Zhang,Jian Wang,Xiaoying Zhang,et al.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[J].PARKINSONISM & RELATED DISORDERS.2013,19(11):1022-1026.doi:10.1016/j.parkreldis.2013.07.009.
APA:
Zhenxin Zhang,Jian Wang,Xiaoying Zhang,Shengdi Chen,Zhenfu Wang...&Rongxuan Zhu.(2013).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.PARKINSONISM & RELATED DISORDERS,19,(11)
MLA:
Zhenxin Zhang,et al."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".PARKINSONISM & RELATED DISORDERS 19..11(2013):1022-1026