Switch from oral pramipexole or ropinirole to rotigotine transdermal system in advanced Parkinson’s disease: an open-label study

Abstract

Objective: Investigate safety, feasibility and efficacy of switching therapy in patients with advanced-stage Parkinson’s disease (PD) inadequately controlled with pramipexole (≤ 3.5 mg/day) or ropinirole (≤ 14 mg/day) to rotigotine transdermal system (≤ 14 mg/24 h; dose adjustments ≤ 16 mg/24 h permitted).

Methods: PD0009 (ClinicalTrials.gov: NCT01711866) was an open-label study in patients with advanced-stage PD receiving levodopa, and experiencing sleep disturbance or early-morning motor impairment. Pramipexole/ropinirole was switched to equivalent dose rotigotine overnight or in two stages. During the 4-week treatment period rotigotine dose adjustments were permitted (up to 16 mg/24 h). Primary variable: Clinical Global Impressions (CGI) item 4: side effects (assessing safety) at end of treatment.

Results: 79/87 (91%) patients completed the study; 2 (2%) withdrew due to adverse events (AEs). Most (84; 97%) had CGI item 4 score < 3 indicating switch did not interfere with functioning; three experienced drug-related AEs interfering with functioning (score = 3). 62% patients improved on Patient Global Impression of Change, assessing effectiveness. AEs occurring ≥ 5%: application site pruritus (10%), application site erythema (7%), dizziness (7%), dyskinesia (7%), erythema (6%), pruritus (6%). Unified Parkinson’s Disease Rating Scale II and III, Parkinson’s Disease Sleep Scale-2 and Pittsburgh Sleep Quality Index were unchanged. Numerical improvements in ‘off’ time, awakenings and nocturias were observed.

Conclusions: Switch from pramipexole or ropinirole to rotigotine (up to 14 mg/24 h) was feasible and possibly associated with some benefit.

Keywords:

• Parkinson’s disease
• pramipexole
• ropinirole
• rotigotine transdermal system
• safety

Acknowledgements

The sponsors were involved in the design of the study, the analysis and interpretation of data and in the decision to submit the paper for publication. The authors acknowledge the Asia Pacific Rotigotine Switching Study Group for their contributions to data acquisition: Korea: Jae Woo Kim (Dong-A University Medical Center), Sang Jin Kim (Inje University Busan Paik Hospital), Beom Seok Jeon (Seoul National University Hospital), Young-Ho Sohn (Severance Hospital), Jong-Min Kim (Seoul National University Bundang Hospital), Do Young Kwon (Korea University Ansan Hospital), Sun Ju Chung (Asan Medical Center), Ho-Won Lee (Kyungpook National University Medical Center), Mee Young Park (Yeongnam University Hospital); Taiwan: Chin-Chang Huang (Chang-Gung Memorial Hospital), Chon-Haw Tsai (China Medical University Hospital), Ruey-Meei Wu (National Taiwan University Hospital); Malaysia: Siew Hung Sim (Hospital Umum Sarawak); Singapore: Louis Tan (National Neuroscience Institute), Eng King Tan (Singapore General Hospital); USA: Alan Jacobs (Neurology Specialists), Matthews Gwynn (NeuroTrials Research), Chandra Gehi (Pinnacle Research Group), Mark A Goldstein (JEM Research Institute), Jose Gamez (Galiz Research), Mark Fisher (Lynn Health Science Institute). The authors also acknowledge Azita Tofighy, Publications Manager, UCB Pharma, Brussels, Belgium, for publication coordination.

Declaration of interest

This study was supported by UCB Pharma, Monheim am Rhein, Germany and Otsuka Pharmaceutical Co., Ltd, Tokyo, Japan. Writing and editorial assistance was funded by UCB Pharma, Brussels, Belgium and carried out by Emily Thompson, PhD, Evidence Scientific Solutions, London, UK. JH Kim, SJ Chung, BS Jeon and JW Kim received grant payments from the sponsor for enrolling patients in the study. L Bauer is an employee of UCB Pharma, Monheim am Rhein, Germany and holds stock from this employment. BS Jeon received research grant support from Korean Ministry of Health, Seoul National University Hospital, Lundbeck, Novartis, Ipsen, Samil and AbbVie; has served as a paid consultant for Lundbeck and has received honoraria from Ipsen. P Singh and S Thierfelder are employees of UCB Pharma, Monheim am Rhein, Germany. J Ikeda is an employee of Otsuka Pharmaceutical Co., Ltd, Tokyo, Japan. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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