Abstract

Objective

The aim of this study was to evaluate the safety and effectiveness of rotigotine under daily clinical practice in Parkinson’s disease patients.

Methods

The study was a prospective, non-interventional, observational study targeting patients who were treated with rotigotine for the first time, with a 1-year follow-up period from September 2013 to August 2016.

Results

There were 603 patients in the safety population and 599 patients in the effectiveness population. The mean age was 71.6 years, and the age group of ≥65 and ≥80 years accounted for 80% and 18.6% of all patients, respectively. The frequency of adverse drug reaction (ADR) was 34.3%, and common ADRs were application site reaction (20.2%), typical for transdermal patches. However, the majority of patients recovered or was recovering from these ADRs and were non-serious. Although ADRs related to non-motor symptoms of Parkinson’s disease were observed, most of them were non-serious. Total scores of the Unified Parkinson's Disease Rating Scale Part III (UPDRS-III) (ON-time) significantly decreased from baseline in the effectiveness population. In the analysis of overall improvement in 12 months of post-treatment, ≥70% of patients achieved mild or greater improvement. The safety profiles and improvements in the UPDRS-III score were similar in both the ≥80 years of age group and younger age group.

Conclusion

There were no new or notable safety concerns observed, and the effectiveness of rotigotine was suggested in daily clinical practice.

中文翻译：

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罗替戈汀在帕金森病患者中的真实世界安全性和有效性：日本上市后监测研究的分析

摘要

客观的

本研究的目的是评估罗替戈汀在帕金森病患者日常临床实践中的安全性和有效性。

方法

该研究是一项前瞻性、非干预性、观察性研究，针对首次接受罗替戈汀治疗的患者，随访时间为2013年9月至2016年8月，为期1年。

结果

安全人群中有 603 名患者，有效性人群中有 599 名患者。平均年龄为71.6岁，≥65岁和≥80岁年龄组分别占所有患者的80%和18.6%。药物不良反应 (ADR) 的频率为 34.3%，常见的 ADR 为应用部位反应 (20.2%)，典型为透皮贴剂。然而，大多数患者已经康复或正在从这些 ADR 中康复，并且并不严重。尽管观察到与帕金森病的非运动症状相关的不良反应，但大多数是非严重的。在有效性人群中，统一帕金森病评定量表第三部分 (UPDRS-III) (ON-time) 的总分从基线显着下降。在治疗后 12 个月的整体改善分析中，≥70% 的患者获得了轻微或更大的改善。UPDRS-III 评分的安全性和改进在≥80 岁年龄组和年轻年龄组中相似。

结论

没有观察到新的或显着的安全问题，并且在日常临床实践中提出了罗替戈汀的有效性。