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| |  AAN MEETING: Permax Monotherapy Beneficial In Parkinson's TORONTO, ON -- April 22, 1999 -- Data presented at the American Academy of Neurology meeting today show that Permax(R) (pergolide mesylate) monotherapy is useful in the treatment of the early stages of Parkinson's disease. The drug provided relief to "de novo" Parkinson's disease patients or patients not previously treated for the disease. "Permax has already been well established as an adjunct to levodopa therapy in patients with advanced Parkinson's disease," said Alberto Lledo, M.D., Ph.D., Lilly Research Centre UK. "These are the first studies to show that the use of Permax as a single therapy is effective in improving motor function and activities of daily living." Permax is a potent dopamine agonist that significantly improves tremor, speech and walking in Parkinson's disease patients due to its long half-life and its unique mechanism of action. Parkinson's disease patients do not produce enough dopamine, a neurotransmitter or "chemical messenger," in the brain that controls movement. Dopamine agonists attempt to mimic the role of dopamine. Permax directly stimulates the D1, D2, and D3 receptor sites in the brain to increase neurotransmitter activity in the nerve pathways. Clinical Study/Results In the past, only small, non-controlled studies have been conducted to investigate Permax in monotherapy. The results presented today come from two recent multicenter, double-blind, placebo-controlled randomized clinical trials with identical protocols and study designs that allow for a joined safety and efficacy analysis. A total of 206 patients were randomized in the studies, with 104 patients receiving placebo and 102 receiving Permax. The study showed a statistically significant improvement in the Permax-treated group for all outcome measures, demonstrating the utility of this drug for first-line monotherapy. Permax was well tolerated throughout the studies. Nausea, dizziness, insomnia and anorexia were the only side effects that were statistically significantly more common in the pergolide group than in the placebo group. The Unified Parkinson’s Disease Rating Scale (UPDRS), which describes and assesses a patient’s Parkinson’s disease-related disability, was the primary measurement of efficacy. Researchers also used the Schwab and England Scale to rate the patient’s ability to perform daily activities in terms of speed and independence. In clinical trials with Permax as adjunct therapy, "adverse effects were those typically associated with dopamine agonists. They were in most instances mild, transient, and associated with the introduction of therapy." The most commonly observed adverse events were: nervous system complaints, including dyskinesias, hallucinations, somnolence, insomnia; digestive complaints, including nausea, constipation, diarrhea, dyspepsia, and respiratory system complaints, including rhinitis.
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