Safety and Effectiveness of Rasagiline in Chinese Patients with Parkinson’s Disease: A Prospective, Multicenter, Non-interventional Post-marketing Study

• Published in: Drug safety Vol. 46; no. 7; pp. 637 - 646
• Main Authors: Su, Wen, Liang, Zhanhua, Mao, Wei, Shao, Ming, Hu, Xingyue, Wu, Yuncheng, Wei, Wenshi, Liu, Zhenguo, Zhang, Kezhong, Tang, Beisha, Cao, Shuai, Song, Zhuolun, Chen, Haibo
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.07.2023; Springer Nature B.V
• Subjects: Clinical trials; Cohort analysis; Cohort Studies; Disorders; Dopamine; Drug dosages; Drug Safety and Pharmacovigilance; Drug Therapy, Combination; Drug-Related Side Effects and Adverse Reactions - complications; Drug-Related Side Effects and Adverse Reactions - epidemiology; East Asian People; Effectiveness; Gastrointestinal diseases; Humans; Levodopa; Levodopa - adverse effects; Marketing; Medicine; Medicine & Public Health; Mental disorders; Movement disorders; Nervous system; Neurodegenerative diseases; Original; Original Research Article; Parkinson Disease - drug therapy; Parkinson's disease; Patients; Pharmacology/Toxicology; Prospective Studies; Rasagiline; Safety; Side effects; Signs and symptoms; Statistical analysis; Subgroups; Therapy; Treatment Outcome; China
• ISSN: 0114-5916; 1179-1942
• DOI: 10.1007/s40264-023-01288-2

Introduction Rasagiline is indicated for treating idiopathic Parkinson’s disease (PD) as monotherapy and adjunct therapy to levodopa in patients. Objectives To assess the post-marketing safety and tolerability of rasagiline in Chinese PD patients, as well as its effectiveness in improving motor symptoms. Methods This prospective, non-interventional, multicenter, cohort study included PD patients administered rasagiline monotherapy or adjunct therapy to levodopa. The primary outcome was the incidence of adverse drug reactions (ADRs) according to MedDRA ® (version 22.0), and the secondary outcomes were the Parkinson’s Disease Unified Rating Scale (UPDRS) part III, Clinical Global Impression-Severity (CGI-S), and Clinical Global Impression-Global-Improvement (CGI-I), assessed at Weeks 4, 12, and 24. Results In total, 734 patients, 95 in the monotherapy subgroup and 639 in the adjunct therapy subgroup, were included in the safety population. The incidence rates of all ADRs were comparable between the monotherapy (15.8%) and adjunct therapy (13.6%) subgroups. The most common ADRs by system organ class were nervous system disorders (5.6%), gastrointestinal disorders (3.3%), psychiatric disorders (1.8%), vascular disorders (1.2%), and general disorders and administration site conditions (1.1%). Five (0.7%) participants experienced 5 serious ADRs. Improvements in UPDRS part III, CGI-S and CGI-I at Weeks 4, 12 and 24 from baseline were observed. Conclusions Safety data in this study indicated no extra safety concerns. Rasagiline is generally safe and well tolerated in Chinese PD patients. The safety profile and tolerability were in line with the established safety profile. Moreover, rasagiline reduced the severity of PD motor symptoms, confirming findings by previous clinical trials.