Company Press Release
First US Parkinson's Disease Study Exclusively in Minority Patients
Shows Significant Benefit of MIRAPEX(R) (pramipexole dihydrochloride
tablets)
http://biz.yahoo.com/prnews/991013/wa_pharmac_1.html
SEATTLE, Oct. 13, 1999 /PRNewswire/ -- The first study conducted
exclusively in minority patients of a Parkinson's disease drug shows
that MIRAPEX® (pramipexole dihydrochloride tablets) plus levodopa
significantly improves symptoms in patients with advanced Parkinson's
disease. The PRIME (Pramipexole in Ethnic Minorities with Parkinson's
Disease) study was created in response to the low number of minorities
enrolled in previous Parkinson's disease clinical trials.
``Approximately one-fifth of all Parkinson's disease is diagnosed in
minorities, yet only about five percent of the patients in clinical
trials are minority group members -- including patients of
African-American, Asian and Hispanic descent,'' noted principal
investigator Caroline Tanner, MD, PhD, of The Parkinson's Institute in
Sunnyvale, CA and member of the Parkinson's Study Group. ``This study
looked at non-Caucasian Parkinson's patients and found MIRAPEX to be
effective in these individuals.'' The results were presented at Symposia
on Etiology, Pathogenesis and Treatment of Parkinson's Disease and Other
Movement Disorders meeting, in concurrence with the annual meeting of
the American Neurological Association.
The study, conducted at 18 centers across the country by the Parkinson's
Study Group (PSG), included 144 patients (51 women, 93 men) with
advanced Parkinson's disease who were already on levodopa therapy.
Participants randomized into the eleven week study were all of
African-American (48 patients), Asian-American (42 patients) or
Hispanic-American (54 patients) heritage. Patients continued on levodopa
and were titrated to a maximum of 4.5mg/day of pramipexole or matching
placebo tablets.
A significant improvement in Parkinson's disease signs and symptoms as
measured by the Unified Parkinson's Disease Rating Scale (UPDRS) --
including activities of daily living and motor symptoms -- was seen in
the patients receiving the combination of levodopa plus pramipexole
versus the patients receiving levodopa plus placebo.
Patients receiving the combination of products reported improvements in
their ability to do basic tasks, including eating, bathing and dressing.
Physicians also noted improvements in motor skills for patients treated
with pramipexole and levodopa compared with placebo. In addition, 40
percent of the patients in the treatment group registered improvements
in the severity of their disease (Modified Hoehn and Yahr scale)
compared to 23 percent in the placebo group.
``By commissioning this study, Pharmacia & Upjohn and Boehringer
Ingelheim have made an important contribution to our knowledge of how
this disease affects minority patients and thereby broadened our
understanding of the patients for whom pramipexole may be appropriate
therapy,'' asserted Dr. Tanner. ``It is important that we encourage the
participation of patients from all backgrounds as new treatments are
developed for Parkinson's disease and other conditions.''
Approximately one million people in the U.S. have Parkinson's disease,
with one percent of people over age 60 affected by the condition. The
disease causes tremors, muscle rigidity, slowed motion, shuffling gait
and a loss of facial expression. All of these effects worsen over time.
The U.S. Food and Drug Administration (FDA) approved MIRAPEX as
treatment for the signs and symptoms of idiopathic Parkinson's disease
in 1997. Based on prescription audit data, MIRAPEX is the number-one
prescribed dopamine agonist in the U.S. In studies conducted prior to
approval, the most frequently reported side effects reported by patients
in advanced stages of PD who were treated with pramipexole and levodopa
were postural hypotension, dyskinesias, extrapyramidal syndrome,
insomnia, dizziness and hallucinations.
All PD 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. There have been reports of
patients treated with MIRAPEX falling asleep during activities of daily
living, including operation of a motor vehicle.
Healthcare professionals in the U.S. who have questions about MIRAPEX
can call Pharmacia & Upjohn's Medical and Drug Information number at
800-253-8600, extension 38244. Patients in the U.S. who have questions
about MIRAPEX can call Pharmacia & Upjohn's patient product information
number at 800-432-4702.
Pharmacia & Upjohn Website: http://www.pnu.com.
SOURCE: Pharmacia & Upjohn
Copyright 1994-1999 Yahoo! / Copyright © 1999 PRNewswire
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Judith Richards, London, Ontario, Canada
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