Real-world safety and effectiveness of rotigotine in patients with Parkinson's disease: analysis of a post-marketing surveillance study in Japan

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.