Clinical Experience with Generic Rasagiline (Ralago®) in Patients with Parkinson’s Disease: An Open-Label, Multicenter, Observational Study

D. Pintér, J. Lajtos, J. Janszky, N. Kovács
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引用次数: 1

Abstract

Background: Antiparkinsonian pharmacotherapy represents one of the most important expenses related to Parkinson’s disease. The application of generic drugs may help to reduce the economic burden of the disease; however, efficacy and safety of these products have been less studied. Objective: To investigate the efficacy and safety of generic rasagiline (Ralago®) from a clinical perspective. Methods: The Clinical Global Impression of Severity scale was used to rate the most important motor and non-motor symptoms at baseline and 12 weeks after the initiation of Ralago®. Patients also identified symptoms which were the main sources of their disability and distress in everyday life. Results: A total of 499 patients were enrolled (231 females, mean age: 73.2 ± 9.1 years, mean duration of disease: 3.6 ± 3.7 years). Of them, 486 patients completed the study protocol. Both motor and non-motor symptoms showed improvement during 12-week Ralago® treatment. Adverse events were rare, and the majority of them were not considered as serious. Conclusions: The generic rasagiline (Ralago®) is an effective and safe generic product.
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雷沙吉兰(Ralago®)治疗帕金森病患者的临床经验:一项开放标签、多中心、观察性研究
背景:抗帕金森药物治疗是与帕金森病相关的最重要的费用之一。使用仿制药可能有助于减轻该病的经济负担;然而,这些产品的有效性和安全性研究较少。目的:从临床角度探讨雷沙吉兰(Ralago®)的有效性和安全性。方法:使用临床总体印象严重程度量表在基线和开始Ralago®后12周对最重要的运动和非运动症状进行评分。患者还确定了导致他们在日常生活中残疾和痛苦的主要症状。结果:共纳入499例患者(女性231例,平均年龄73.2±9.1岁,平均病程3.6±3.7年)。其中,486名患者完成了研究方案。在为期12周的Ralago®治疗期间,运动和非运动症状均有所改善。不良事件很少发生,多数不认为严重。结论:雷沙吉兰(Ralago®)是一种安全有效的仿制药。
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