Efficacy and safety of rasagiline in Chinese patients with early Parkinson’s disease:a randomized, double-blind,parallel,placebo-controlled,fixed-dose study
作者机构：Peking Union Medical College HospitalBeijingChina Huashan HospitalFudan UniversityShanghaiChina Ruijin HospitalShanghai Jiaotong University School of MedicineShanghaiChina The Second Affiliated Hospital of Soochow UniversitySuzhouChina The Second Affiliated HospitalSchool of MedicineZhejiang UniversityZhejiangHangzhouChina West China HospitalSichuan UniversityChengduChina Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and TechnologyWuhanChina Peking University First HospitalBeijingChina Xijing HospitalThe First Affiliated Hospital of The Fourth Military Medical UniversityXi’anChina The First Affiliated Hospital of Xi’an Jiaotong UniversityXi’anChina Renji HospitalShanghai Jiaotong University School of MedicineShanghaiChina Tongji Hospital of Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanChina Guangzhou First People’s HospitalSchool of MedicineSouth China University of TechnologyGuangzhouChina The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhouChina The Second Affiliated Hospital of Guangzhou Medical UniversityGuangzhouChina
出 版 物：《Translational Neurodegeneration》 (转化神经变性病（英文）)
年 卷 期：2018年第7卷第1期
页 面：352-360页
核心收录：
基 金：H. Lundbeck A/S (Copenhagen, Denmark) H. Lundbeck A/S, Copenhagen, Denmark
主 题：Parkinson’s disease Monoamine oxidase inhibitor Rasagiline Monotherapy China
摘 要：Background:Rasagiline is a monoamine oxidase-B inhibitor used for Parkinson’s disease(PD)treatment,but its effectiveness on Chinese patients is *** study aimed to evaluate the efficacy and safety of rasagiline monotherapy in Chinese patients with early ***: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 *** were randomized 1:1 to receive rasagiline 1 mg once daily or *** primary endpoint was the change of the Unified Parkinson’s Disease Rating Scale(UPDRS)total score from baseline to 26 weeks *** 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)*** profile was collected until 30 weeks after ***:A total of 130 patients(n=65/group)were recruited,and 127(rasagiline,n=64;placebo,n=63)were included in the full analysis *** characteristics were comparable between the two *** 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 *** 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 *** quality assessed by the EQ-5D visual analog scale improved in the rasagiline group but worsened in placebo treated *** overall incidence of treatment-emergent adverse events(AEs)was slightly lower in the rasagiline group(41.5%)than in the placebo group(46.2%).Conclusions:Rasagiline is effective,safe,and well tolerated as monotherapy for the
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