Overnight switch from ropinirole to transdermal rotigotine patch in patients with Parkinson disease
1 Departments of Neurology and Movement Disorder Center, Parkinson Disease Study Group, and Neuroscience Research Institute, BK21, College of Medicine, Seoul National University Hospital, Seoul, Korea
2 Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
3 Parkinson/Alzheimer Center, Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
4 Department of Neurology, College of Medicine, Dong-A University, Busan, Korea
5 Department of Neurology, Seoul National University Bundang Hospital, College of Medicine, Seoul National University, Seongnam, Korea
6 Department of Neurology, BK21 and MRC, Kyung Hee University College of Medicine, Seoul, Korea
7 UCB BioSciences GmbH, a member of the UCB Group of Companies, Monheim, Germany
8 Schwarz BioSciences Inc, a member of the UCB Group of Companies, Raleigh, NC, USA
BMC Neurology 2011, 11:100 doi:10.1186/1471-2377-11-100Published: 10 August 2011
A recent trial involving predominantly Caucasian subjects with Parkinson Disease (PD) showed switching overnight from an oral dopaminergic agonist to the rotigotine patch was well tolerated without loss of efficacy. However, no such data have been generated for Korean patients.
This open-label multicenter trial investigated PD patients whose symptoms were not satisfactorily controlled by ropinirole, at a total daily dose of 3 mg to 12 mg, taken as monotherapy or as an adjunct to levodopa. Switching treatment from oral ropinirole to transdermal rotigotine was carried out overnight, with a dosage ratio of 1.5:1. After a 28-day treatment period, the safety and tolerability of switching was evaluated. Due to the exploratory nature of this trial, the effects of rotigotine on motor and nonmotor symptoms of PD were analyzed in a descriptive manner.
Of the 116 subjects who received at least one treatment, 99 (85%) completed the 28-day trial period. Dose adjustments were required for 11 subjects who completed the treatment period. A total of 76 treatment-emergent adverse events (AEs) occurred in 45 subjects. No subject experienced a serious AE. Thirteen subjects discontinued rotigotine prematurely due to AEs. Efficacy results suggested improvements in both motor and nonmotor symptoms and quality of life after switching. Fifty-two subjects (46%) agreed that they preferred using the patch over oral medications, while 31 (28%) disagreed.
Switching treatment overnight from oral ropinirole to transdermal rotigotine patch, using a dosage ratio of 1.5:1, was well tolerated in Korean patients with no loss of efficacy.
This trial is registered with the ClincalTrails.gov Registry (NCT00593606).