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- W2077211651 abstract "Elizabeth Mechcatie is a senior writer for Elsevier Global Medical News. For the first time, a transdermal drug delivery system is available for treating Parkinson's disease patients, an option that provides practical and theoretical benefits for this population, according to experts. The Food and Drug Administration recently approved the patch containing rotigotine, a nonergotamine dopamine agonist previously not available in any form in the United States, for the signs and symptoms of early-stage idiopathic Parkinson's. Approval was based on three randomized, double-blind, placebo-controlled studies of 1,154 patients with early Parkinson's, who were not on other drugs for Parkinson's. The patch is marketed as Neupro by the German company Schwarz Pharma LLC. A transdermal delivery system is one clear advantage for patients already taking many pills, said Dr. David Standaert, professor of neurology and director of the division of movement disorders at the University of Alabama at Birmingham. The pharmacology of rotigotine is a little different from that of the most widely used dopamine agonists, pramipexole and ropinirole, but the main difference is the transdermal system, he said in an interview. Another advantage is that the continuous delivery of medication over 24 hours provides a stable blood level. Research suggests that peaks and troughs with conventional dopaminergic drugs may cause problems associated with oral therapy. However, there is no evidence that the steady level provided by the patch will translate into long-term clinical benefits, said Dr. Standaert, who also is director of the university's Center for Neurodegeneration and Experimental Therapeutics. He was not involved in rotigotine studies and has no financial ties to the maker but has consulted on the pharmacologic properties of rotigotine to UCB, the U.S. pharmaceutical company in the process of acquiring Schwarz Pharma. There are theoretical and practical advantages to having patch therapy for Parkinson's, agreed Dr. Michael Pourfar, a neurologist in the division of movement disorders, at North Shore University Hospital, Manhasset, N.Y. Because there are effective dopamine agonists available for Parkinson's, he said he would not want patients to think they must switch medications. “But I do think this is something that will improve quality of life for many.” For some, the patch could replace six pills a day. Rotigotine is delivered through the silicone-based patch that is applied to clean, dry intact skin and is replaced every 24 hours. It is available in three strengths: 2 mg, 4 mg, and 6 mg/24 hr. Recommended dosing is to start at 2 mg. When additional therapeutic effects are needed, the dose may be increased weekly by 2 mg/24 hours if tolerated. In studies, the lowest effective dose was 4 mg/24 hours, and in dose-ranging studies, doses above 6 mg/24 hours were not more effective and were tied to a higher rate of adverse reactions. The patch is applied on the abdomen, thigh, hip, flank, shoulder, or upper arm at the same time every day, avoiding same-site application more than once every 14 days. The change from baseline for the combined scores for the activities of daily living and motor components of the Unified Parkinson's Disease Rating Scale (UPDRS) was the primary outcome in the three studies, which enrolled early-stage PD patients not on dopamine agonist treatment, whose mean age was 60–63 years. In a 28-week multicenter North American study, 277 patients received up to a 6 g/24 hours dose of rotigotine or placebo. The mean reduction in the combined UPDRS score from baseline was 4.0, versus a mean 1.39 increase from baseline in the placebo, a statistically significant difference of 5.3. Side effects included dizziness, nausea, vomiting, drowsiness, and insomnia. The patch is not yet approved for advanced disease, but in a placebo-controlled, 24-week study of 351 patients with advanced PD, those treated with two doses of the patch had significant reductions in daily “off” time than those on placebo (Neurology 2007;68:1262–7)." @default.
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- W2077211651 date "2007-07-01" @default.
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- W2077211651 title "Rotigotine Patch Approved for Early-Stage Parkinson's" @default.
- W2077211651 doi "https://doi.org/10.1016/s1526-4114(07)60176-0" @default.
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