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

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.

Keywords:

• Parkinson’s disease
• rotigotine
• dopamine agonist
• elderly
• safety
• levodopa equivalent dose

Author contributions

Hidefumi Ito and Hiroyuki Kondo contributed to analysis and interpretation of the data. Tomoyo Takayama contributed to study design and data collection. All authors contributed to drafting and revising the manuscript and provided final approval of the publication version.

Acknowledgments

The authors would like to thank all patients who participated in this study, as well as supporters and physicians of the study sites. The authors received medical writing assistance from Shiori Mikami (SunFlare Co., Ltd., Tokyo, Japan) for the preparation of the initial and final drafts of the manuscript, and the fee was funded by Otsuka Pharmaceutical Co., Ltd.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

The study was funded by Otsuka Pharmaceutical Co., Ltd., Japan. Otsuka Pharmaceutical Co., Ltd. has provided oversight on the conduct of the study, including design, collection, compilation, and analysis of data. Of the authors, Tomoyo Takayama, Hiroyuki Kondo, and Yasuhiko Fukuta are employees of Otsuka Pharmaceutical Co., Ltd. Hidefumi Ito received a consultation fee from Otsuka Pharmaceutical Co., Ltd.