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A Dopamine Agonist Patch for Early PD

This trial confirms efficacy of once-daily skin patch delivery of rotigotine, a nonergoline dopamine agonist, for early PD.

Novel drug-delivery systems designed to provide constant dopaminergic stimulation may theoretically improve long-term motor outcomes in Parkinson disease (PD). Researchers conducted a manufacturer-sponsored, placebo-controlled trial of the safety and efficacy of rotigotine, a nonergoline dopamine agonist delivered as a once-daily transdermal patch. They randomized 96 patients to receive placebo and 181 to receive rotigotine, titrated up to 6 mg per day over a 3-week period, followed by maintenance for 6 months. The primary outcome was change in the combined activities-of-daily-living (ADL) and motor subscales of the Unified Parkinson Disease Rating Scale (UPDRS) from baseline to end of maintenance.

A slightly larger proportion of placebo than rotigotine recipients completed the study (84% vs. 78%). The placebo group deteriorated at 6 months, while the rotigotine group improved (mean difference, 5.28 UPDRS units; P<0.0001), primarily in the motor rather than the ADL subscale. Common adverse events occurring more frequently with rotigotine included application-site reaction (44% vs. 12%), nausea (41% vs. 17%), somnolence (33% vs. 20%), dizziness (19% vs. 13%), and headache (16% vs. 9%). Hallucinations did not occur with rotigotine.

Comment: This study corroborates previously published results with the rotigotine patch (Arch Neurol 2003; 60:1721). It leaves unaddressed the question of whether constant rather than pulsatile delivery of dopaminergics protects against long-term motor complications. The FDA recently approved the rotigotine transdermal patch for early PD. Prolonged-release oral ropinirole may also be on the horizon (Neurology 2007; 68:1108). Let the competition begin, but let’s keep in mind that constant drug delivery is only a theoretical advantage; there could conceivably be disadvantages as well.

— Frederick J. Marshall, MD

Dr. Marshall is Associate Professor of Neurology, University of Rochester, NY.

Published in Journal Watch Neurology May 22, 2007

Citation(s):

Watts RL et al. Randomized, blind, controlled trial of transdermal rotigotine in early Parkinson disease. Neurology 2007 Jan 23; 68:272-6.

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