Overnight switch from oral dopaminergic agonists to transdermal rotigotine patch in subjects with Parkinson disease.
OBJECTIVE
To assess safety, tolerability, and efficacy outcomes of an overnight switch from oral ropinirole, pramipexole, or cabergoline to rotigotine, a dopaminergic agonist with transdermal delivery over 24 hours in subjects with established Parkinson disease (PD).


METHODS
In this open-label multicenter study, we hypothesized that the selected doses of transdermal rotigotine would provide at least equivalent antiparkinsonian actions in subjects with idiopathic PD not adequately controlled with oral ropinirole (up to 9 mg/d), pramipexole (up to 2 mg/d), or cabergoline (up to 3 mg/d). The tolerability of the rotigotine switch was evaluated by the number of subjects completing the scheduled 28-day treatment period, need for rotigotine dose reductions, and dropouts due to adverse events. Efficacy assessment relied on changes in Unified Parkinson's Disease Rating Scale from the baseline to the end of treatment in PD symptoms and subject preference of dopaminergic agonist.


RESULTS
Of 116 PD subjects enrolled, 104 completed the 28-day rotigotine treatment. Fifteen subjects required rotigotine dose adjustment; of these, 11 completed the trial. The most common adverse events (generally mild or moderate in intensity) were application site reactions, nausea, and somnolence. The change to rotigotine was well tolerated. Rotigotine was preferred by 77% of subjects who were not adequately controlled by their previous oral dopaminergic agonist. The predetermined rotigotine substitutions provided improvements over baseline in Unified Parkinson's Disease Rating Scale II and III subscales.


CONCLUSIONS
Subjects and clinicians found the overnight switch to rotigotine convenient, well tolerated, and effective for control of PD signs and symptoms for subjects previously receiving low-to-moderate doses of oral dopaminergic agonists.
LeWitt
Peter A
PA
Department of Neurology, Wayne State University School of Medicine, and Henry Ford Hospital-Franklin Pointe Medical Center, 26400 West 12 Mile Road, Southfield, MI 48034, USA. plewitt@ameritech.net
Boroojerdi
Babak
B
MacMahon
Douglas
D
Patton
James
J
Jankovic
Joseph
J
D000279:Administration, Cutaneous; D000284:Administration, Oral; D000368:Aged; D018491:Dopamine Agonists / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy*; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D012720:Severity of Illness Index; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage*; D013876:Thiophenes / Q000008:administration & dosage*; D016896:Treatment Outcome
D018491:Dopamine Agonists; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; C047508:rotigotine