Company Press Release
SOURCE: Elan Pharmaceuticals, Inc.
Clinical Studies Show Permax(R) (Pergolide Mesylate) Monotherapy
Beneficial in
Treatment of Parkinson's Disease
- Researchers say early-stage patients demonstrate significant
improvement after receiving Permax -
TORONTO, April 22, 1999/PRNewswire/ -- Data presented at the American
Academy of Neurology meeting today show that Permax® (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.
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.
Copyright © 1999 PRNewswire.
--
Judith Richards, London, Ontario, Canada
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