Efficacy and safety of rasagiline in Chinese patients with early Parkinson’s disease: a randomized, double-blind, parallel, placebo-controlled, fixed-dose study,Translational Neurodegeneration

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Efficacy and safety of rasagiline in Chinese patients with early Parkinson’s disease: a randomized, double-blind, parallel, placebo-controlled, fixed-dose study
Translational Neurodegeneration ( IF 12.6 ) Pub Date : 2018-12-06 , DOI: 10.1186/s40035-018-0137-5
Zhenxin Zhang ₁ , Jian Wang ₂ , Shengdi Chen ₃ , Chunfeng Liu ₄ , Baorong Zhang ₅ , Rong Peng ₆ , Shenggang Sun ₇ , Xiangru Sun ₈ , Gang Zhao ₉ , Qiumin Qu ₁₀ , Yansheng Li ₁₁ , Suiqiang Zhu ₁₂ , Xiaoping Pan ₁₃ , Ming Shao ₁₄ , Yanping Wang ₁₅

Affiliation

1Peking Union Medical College Hospital, Beijing, China.
2Huashan Hospital, Fudan University, Shanghai, China.
3Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
4The Second Affiliated Hospital of Soochow University, Suzhou, China.
5The Second Affiliated Hospital, School of Medicine, Zhejiang University, Zhejiang, Hangzhou China.
6West China Hospital, Sichuan University, Chengdu, China.
7Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.
8Peking University First Hospital, Beijing, China.
9Xijing Hospital, The First Affiliated Hospital of The Fourth Military Medical University, Xi'an, China.
10The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
11Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
12Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China.
14The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
15The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.

Rasagiline is a monoamine oxidase-B inhibitor used for Parkinson’s disease (PD) treatment, but its effectiveness on Chinese patients is unclear. This study aimed to evaluate the efficacy and safety of rasagiline monotherapy in Chinese patients with early PD. A 26-weeks, randomized, double-blind, placebo-controlled study has been performed at 15 sites in China and enrolled outpatients (≥35 years old) with idiopathic PD without a history of using any dopaminergic drugs. Participants were randomized 1:1 to receive rasagiline 1 mg once daily or placebo. The primary endpoint was the change of the Unified Parkinson’s Disease Rating Scale (UPDRS) total score from baseline to 26 weeks treatment. Secondary endpoints included changes in UPDRS subscale scores from part I to III. Health status was assessed with the PD Questionnaire (PDQ)-39 and EuroQol-Five-Dimension (EQ-5D) questionnaire. Safety profile was collected until 30 weeks after randomization. A total of 130 patients (n = 65/group) were recruited, and 127 (rasagiline, n = 64; placebo, n = 63) were included in the full analysis set. Baseline characteristics were comparable between the two groups. The decrease in the mean UPDRS total score was greater in the rasagiline group than in the placebo group (− 3.18 ± 0.95 vs. − 0.18 ± 0.98, P = 0.025), and the mean UPDRS part I non-motor symptoms score (− 0.54 ± 0.15 vs. -0.08 ± 0.15, P = 0.003) were significantly decreased in the rasagiline group compared with placebo treated patients. An improvement trend was observed in the active treatment group for the subscales evaluation with parts II and III, while the difference to placebo was not statistically significant. Life quality assessed by the EQ-5D visual analog scale improved in the rasagiline group but worsened in placebo treated patients. The overall incidence of treatment-emergent adverse events (AEs) was slightly lower in the rasagiline group (41.5%) than in the placebo group (46.2%). Rasagiline is effective, safe, and well tolerated as monotherapy for the treatment of Chinese PD patients. Clinicaltrials.gov : NCT01556165 . Registered 13 Mar 2012.

更新日期：2018-12-06

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