June 17, 1998
Company Press Release
SOURCE: Pharmacia & Upjohn
Mirapex May Help Reduce Tremor in Parkinson's Patients, Preliminary Data
Suggest
BRIDGEWATER, N.J., June 17 /PRNewswire/ -- Preliminary data from two
clinical studies by Pharmacia & Upjohn and Boehringer Ingelheim
Pharmaceuticals, Inc. suggest that Mirapex Tablets (pramipexole
dihydrochloride tablets) may reduce tremor in Parkinson's disease
patients. The studies were presented at the 8th meeting of the
European Neurological Society (ENS) in Nice, France last week.
Parkinson's disease involves progressive loss of brain nerve
cells producing dopamine, a neurochemical that transmits nerve signals
necessary for normal muscle movements. Symptoms include tremors, rigid
muscles, difficulty in initiating movement, a stooped posture, a
shuffling gait and slow movement. Tremor is considered one of the
most noticeable signs of this disease. Tremor in Parkinson's patients
is often called ``rest tremor'' as it occurs at rest and usually abates
when the affected limb is in motion. The presence of tremor
significantly affects Parkinson's patients' quality of life as it can
inhibit basic activities of daily living, such as eating, sleeping and
getting dressed.
In a double-blind, placebo-controlled trial involving 354
patients with advanced Parkinson's disease, 174 patients treated for 24
months with Mirapex following a 7-week dose escalation period showed
46.8 percent improvement from baseline in tremor at rest as measured by
individual items on Part III of the Unified Parkinson's Disease Rating
Scale (UPDRS) compared with a reduction of 32.5 percent for 180 patients
treated with placebo. The study was presented by Wolfgang H. Oertel,
M.D., professor of neurology at Philipps University, Marburg, Germany at
the ENS meeting. All 354 patients were receiving concomitant levodopa.
In another double-blind, placebo-controlled study by Oertel in
47 patients with advanced Parkinson's disease, a subset of 16
tremor-dominant patients was analyzed. Based on UPDRS Part II/III,
there was a reduction of tremor by 60 percent from baseline in 11
patients treated for 12 weeks with Mirapex, while 5 patients in the
placebo group showed no improvement from baseline. All 16 patients were
receiving concomitant levodopa.
``Preliminary results from these studies warrant further
investigation of the long-term impact of Mirapex on the symptomatic
reduction of tremor at rest in Parkinson's patients, and a comparison
with levodopa or other dopamine agonists, as no controlled study has
compared their effects on rest tremor,'' said Oertel.
Levodopa, a medication the body converts into dopamine, is
commonly used to treat Parkinson's patients. However, levodopa's
effectiveness usually diminishes over time and many patients experience
recurring symptoms and drug side effects, including spontaneous
uncontrolled body movements and sudden temporary loss of mobility.
Synthesized by Boehringer Ingelheim and developed jointly with
P&U, Mirapex belongs to a class of compounds called dopamine agonists,
which stimulates dopamine receptors in the brain. Mirapex was approved
by the U.S. Food and Drug Administration (FDA) in July 1997, and in
Canada in February 1998, for the treatment of the signs and symptoms of
idiopathic Parkinson's disease in early-stage patients without levodopa
and in advanced-stage patients with levodopa.
The most common side effects of Mirapex reported in clinical
trials for early-stage Parkinson's disease were nausea, dizziness,
drowsiness and insomnia. The most common side effects of Mirapex taken
with levodopa observed in clinical trials for advanced-stage Parkinson's
disease were postural hypotension (low blood pressure caused by a change
in posture), dyskinesias (impaired movement), extrapyramidal syndrome
(involuntary movements), insomnia, dizziness and hallucinations. All
patients should be informed that postural hypotension may occur more
frequently during initial treatment, and hallucinations can occur at any
time during the course of treatment.
--
Judith Richards, London, Ontario, Canada
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