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| |  Rotigotine Safe for Advanced Parkinson's Disease: Presented at ANA By Andrew N. Wilner, MD SALT LAKE CITY, Utah -- September 24, 2008 -- Rotigotine may be safely used in patients with advanced-stage Parkinson's disease, according to a presentation here at the American Neurological Association (ANA) 133rd Annual Meeting. Rotigotine is a nonergolinic dopamine receptor agonist that is applied as a once-daily patch, explained study presenter Peter LeWitt, MD, Wayne State University School of Medicine, Detroit, Michigan. This analysis combined the safety data from 2 randomised, double-blind, placebo-controlled, clinical trials of rotigotine in patients with advanced-stage Parkinson's disease who were inadequately controlled with their current treatment. The study results were presented on September 23. The trials contained 219 placebo patients a mean of 65.6 years old (66% male) and 434 rotigotine patients a mean of 64.9 years old (65% male) who had Parkinson's disease for at least 3 years, Hoehn and Yahr stage score 2 to 4 in both the "on" and "off" state, bradykinesia, and at least 1 cardinal feature of Parkinson's disease (resting tremor, rigidity, impairment of postural reflexes). Mean duration of disease was 8 years in the placebo group and 8.3 years in the rotigotine group. Patients were receiving a stable dose of L-dopa and their symptoms were not adequately controlled. The mean rotigotine dose ranged from 8 to16 mg/day. Treatment-emergent adverse events occurred in 82% of the rotigotine group and 80% of the placebo group. The most frequently reported adverse events to rotigotine were reactions at the application and instillation site (31% for rotigotine and 12% for placebo), somnolence (23% and 19%, respectively), nausea (21% and 16%, respectively), dyskinesia (14% and 5%, respectively), and dizziness (13% and 10%, respectively). Other common adverse events such as insomnia, headache, vomiting, and hallucination were similar in frequency to placebo. Adverse events were generally more frequent in the titration phase. Discontinuation of treatment due to adverse events occurred in 13% of the rotigotine group and 8% of the placebo group. Adverse events most frequently leading to study discontinuation in the rotigotine group were nausea (4%), vomiting (2%), and application and instillation-site reactions (2%). Rotigotine had no clinically significant effects on laboratory parameters, electrocardiogram, or vital signs. "This nonergot dopaminergic agonist offers a safe clinical profile, as shown in prospective, randomised, controlled, clinical trials and in postmarketing surveillance," Dr. LeWitt concluded. The drug is approved by the US Food and Drug Administration for treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease. Its maker, UCB, voluntarily withdrew the drug from the market because of product crystallisation. Funding for this study was provided by UCB.
[Presentation title: Safety and Tolerability of Rotigotine in Advanced Parkinson's Disease. Abstract T-83]
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