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Anne Gibbons wrote:
>I was wondering if Permax can be used as monotherapy (without
>Sinemet). Both Requip and Mirapex have been touted as this, but can
>the earlier agonists such as Permax also do the job alone.
>Ann Gibbons    cg  Joe  65/2

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.

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.

All contents Copyright (c) 1999 P\S\L Consulting Group Inc.
--
Judith Richards, London, Ontario, Canada
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