PMID- 30534374 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220331 IS - 2047-9158 (Print) IS - 2047-9158 (Electronic) IS - 2047-9158 (Linking) VI - 7 DP - 2018 TI - Efficacy and safety of rasagiline in Chinese patients with early Parkinson's disease: a randomized, double-blind, parallel, placebo-controlled, fixed-dose study. PG - 32 LID - 10.1186/s40035-018-0137-5 [doi] LID - 32 AB - BACKGROUND: 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. METHODS: 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. RESULTS: 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%). CONCLUSIONS: Rasagiline is effective, safe, and well tolerated as monotherapy for the treatment of Chinese PD patients. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01556165. Registered 13 Mar 2012. FAU - Zhang, Zhenxin AU - Zhang Z AUID- ORCID: 0000-0003-1659-8951 AD - 1Peking Union Medical College Hospital, Beijing, China. ISNI: 0000 0000 9889 6335. GRID: grid.413106.1 FAU - Wang, Jian AU - Wang J AD - 2Huashan Hospital, Fudan University, Shanghai, China. ISNI: 0000 0001 0125 2443. GRID: grid.8547.e FAU - Chen, Shengdi AU - Chen S AD - 3Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China. ISNI: 0000 0004 0368 8293. GRID: grid.16821.3c FAU - Liu, Chunfeng AU - Liu C AD - 4The Second Affiliated Hospital of Soochow University, Suzhou, China. ISNI: 0000 0004 1762 8363. GRID: grid.452666.5 FAU - Zhang, Baorong AU - Zhang B AD - 5The Second Affiliated Hospital, School of Medicine, Zhejiang University, Zhejiang, Hangzhou China. ISNI: 0000 0004 1759 700X. GRID: grid.13402.34 FAU - Peng, Rong AU - Peng R AD - 6West China Hospital, Sichuan University, Chengdu, China. ISNI: 0000 0001 0807 1581. GRID: grid.13291.38 FAU - Sun, Shenggang AU - Sun S AD - 7Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China. ISNI: 0000 0004 0368 7223. GRID: grid.33199.31 FAU - Sun, Xiangru AU - Sun X AD - 8Peking University First Hospital, Beijing, China. ISNI: 0000 0004 1764 1621. GRID: grid.411472.5 FAU - Zhao, Gang AU - Zhao G AD - 9Xijing Hospital, The First Affiliated Hospital of The Fourth Military Medical University, Xi'an, China. ISNI: 0000 0004 1799 374X. GRID: grid.417295.c FAU - Qu, Qiumin AU - Qu Q AD - 10The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. GRID: grid.452438.c FAU - Li, Yansheng AU - Li Y AD - 11Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China. ISNI: 0000 0004 0368 8293. GRID: grid.16821.3c FAU - Zhu, Suiqiang AU - Zhu S AD - 12Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. ISNI: 0000 0004 0368 7223. GRID: grid.33199.31 FAU - Pan, Xiaoping AU - Pan X AD - Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, China. FAU - Shao, Ming AU - Shao M AD - 14The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. GRID: grid.470124.4 FAU - Wang, Yanping AU - Wang Y AD - 15The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. GRID: grid.412534.5 LA - eng SI - ClinicalTrials.gov/NCT01556165 PT - Journal Article DEP - 20181206 PL - England TA - Transl Neurodegener JT - Translational neurodegeneration JID - 101591861 PMC - PMC6282325 OTO - NOTNLM OT - China OT - Monoamine oxidase inhibitor OT - Monotherapy OT - Parkinson's disease OT - Rasagiline COIS- The trial was performed in accordance with the principles of Good Clinical Practice and the Declaration of Helsinki. The study was approved by all the appropriate institutional review boards and regulatory agencies. All participants provided written informed consent. This trial has been registered in clinicaltrials.gov as NCT01556165, Lundbeck Protocol 13485A.Not applicable.The authors declare that they have no competing interests. EDAT- 2018/12/12 06:00 MHDA- 2018/12/12 06:01 PMCR- 2018/12/06 CRDT- 2018/12/12 06:00 PHST- 2018/05/31 00:00 [received] PHST- 2018/11/01 00:00 [accepted] PHST- 2018/12/12 06:00 [entrez] PHST- 2018/12/12 06:00 [pubmed] PHST- 2018/12/12 06:01 [medline] PHST- 2018/12/06 00:00 [pmc-release] AID - 137 [pii] AID - 10.1186/s40035-018-0137-5 [doi] PST - epublish SO - Transl Neurodegener. 2018 Dec 6;7:32. doi: 10.1186/s40035-018-0137-5. eCollection 2018.