The efficacy and safety of pramipexole ER versus IR in Chinese patients with Parkinson’s disease: a randomized, double-blind, double-dummy, parallel-group study

作     者：Ying Wang Shenggang Sun Suiqiang Zhu Chunfeng Liu Yiming Liu Qing Di Huifang Shang Yan Ren Changhong Lu Mark Forrest Gordon Nolwenn Juhel Shengdi Chen for the Pramipexole ER Study Team 

作者机构：Ruijin Hospital affiliated to Shanghai Jiao Tong University School of MedicineShanghaiChina Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and TechnologyWuhanChina Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and TechnologyWuhanChina The Second Affiliated Hospital of Soochow UniversitySuzhouChina Qilu Hospital affiliated to Shandong UniversityJinanChina Nanjing Brain HospitalNanjingChina West China Hospital affiliated to Sichuan UniversityChengduChina First Affiliated Hospital of China Medical UniversityShenyangChina Boehringer Ingelheim International Trading(Shanghai)CoLtdShanghaiChina Boehringer Ingelheim PharmaceuticalsIncRidgefieldCTUSA Boehringer Ingelheim France S.A.SReimsFrance Department of NeurologyRuijin Hospital affiliated to Shanghai Jiaotong University School of MedicineShanghaiChina 不详 

出 版 物：《Translational Neurodegeneration》 (转化神经变性病（英文）)

年 卷 期：2014年第3卷第1期

页      面：80-88页

学科分类：1002[医学-临床医学] 10[医学] 

基　　金：Boehringer lngelheim lnternational GmbH sponsored this study 

主　　题：Parkinson’s disease Pramipexole ER Pramipexole IR Non-inferiority Unified Parkinson’s Disease Rating Scale(UPDRS) Safety 

摘      要：Objective:To evaluate the non-inferiority of pramipexole extended-release(ER)versus immediate-release(IR)in Chinese patients with Parkinson’s disease(PD)in a double-blind,randomized,parallel-group ***:Subjects were Chinese patients with idiopathic PD with diagnosis≥2 years prior to trial,age≥30 years old at diagnosis,and Modified Hoehn and Yahr score 2-4 during‘on’-*** received treatment with pramipexole ER(n=234)or IR(n=239).Non-inferiority was based on the primary endpoint,the change from baseline to end of maintenance(week 18)in the UPDRS(Parts II+III)total ***:For the primary endpoint,the adjusted mean changes(standard error)of UPDRS Parts II+III at week 18 were−13.81(0.655)and−13.05(0.643)for ER and IR formulations,respectively,using ANCOVA adjusted for treatment and centre(fixed effect)and baseline(covariate).The adjusted mean between group difference was 0.8 for the 2-sided 95%CI(−1.047,2.566).Since the lower limit of the 2-sided 95%CI(−1.047)for treatment difference was higher than the non-inferiority margin of−4,non-inferiority between pramipexole ER and IR was *** incidence of adverse events(AEs)was 68.8%in the ER arm and 73.6%in the IR arm with few severe AEs(ER:2.1%;IR:3.8%).Conclusion:Based on the UPDRS II+III score,pramipexole ER was non-inferior to pramipexole *** safety profiles of pramipexole ER and IR were *** results were based on comparable mean daily doses and durations of treatment for both formulations.