---------------------------------------------------------------------------
New drug for Parkinson's proves effective, study finds
---------------------------------------------------------------------------
ROCHESTER, N.Y. (July 9, 1997 00:39 a.m. EDT) -- A new drug to combat
Parkinson's disease -- the debilitating brain disorder that affects
Muhammad Ali and a million other Americans -- is surprisingly effective and
may cause fewer side effects than similar drugs currently on the market,
says a study to be published Wednesday in the Journal of the American
Medical Association.
It's the first member of the anti-Parkinson's class of drugs known as
dopamine agonists to prove effective alone, without levodopa, in patients
with early Parkinson's.=20
This type of drug has previously only been FDA-approved as an adjunct to
levodopa.
Patients who were treated with pramipexole dihydrochloride see an average
20-percent reduction in the severity of their symptoms, according to the
first large-scale study of the drug's effects on patients in the early
stages of Parkinson's disease.=20
The drug was approved last week by the Food and Drug Administration and
will be available in pharmacies around the nation beginning next week under
the brand name Mirapex, sold by Pharmacia & Upjohn and Boehringer Ingelheim
Pharmaceuticals Inc.
The two companies have worked together since 1991 on the development of the
drug synthesized by Boehringer Ingelheim.=20
The study of pramipexole dihydrochloride's effects on patients at 20
hospitals around the nation, led by researchers at the University of
Rochester, is published in the July 9 Journal of the American Medical
Association.=20
"Pramipexole dihydrochloride is the first of the next generation of an
established class of anti-Parkinson's drugs to be launched," says the
study's medical director, Karl Kieburtz, associate professor of neurology
at Rochester's School of Medicine and Dentistry.=20
"It appears to be more powerful and to be better tolerated by patients than
other such drugs."
About one million adults in North America are afflicted by Parkinson's
disease, in which several hundred thousand cells in a tiny region of the
brain die for unknown reasons.=20
This pea-sized part of the brain produces dopamine, a neurotransmitter
that's key to the control of movement.
Parkinson's, which afflicts adults ranging from ages 40 to 80, results in
uncontrollable tremors and shaky, stiff, and slow movements.
The condition of patients slowly declines over a period of years or even
decades, with the hardest-hit unable even to stand or walk.=20
Current drugs reduce the symptoms, but their effects wane with time.
Pramipexole dihydrochloride is a member of a family of drugs known as
dopamine agonists, which mimic dopamine and stimulate brain cells just as
the natural neurotransmitter would.=20
Dopamine agonists on the market today include bromocriptene (brand name
Parlodel) and pergolide (Permax).
Doctors use the drugs to alleviate symptoms and also to smooth out the
highs and lows of motor control that many Parkinson's sufferers experience
while on levodopa (Sinemet), the most powerful anti-Parkinson's drug now
available.
Adding a powerful new stablemate to the range of drugs already available
will improve doctors' ability to find the best mix for each individual
patient, Kieburtz says.
The drug appears to be more effective than other dopamine agonists in
reducing tremors and movement problems.=20
In addition, unlike current drugs, pramipexole dihydrochloride does not
cause lightheadedness resulting from a noticeable drop in blood pressure
when a patient stands up.=20
Kieburtz says that's probably because the drug targets the specific
dopamine receptor involved in Parkinson's disease more precisely.
"Pramipexole dihydrochloride had a very good tolerability and safety
profile," Kieburtz says.=20
"We thought this drug would be effective, but we were pleasantly surprised
that it works so well. I have many patients who have anxiously waited for
this drug to become available."
Pramipexole dihydrochloride is the first of several next-generation
dopamine agonists being launched by pharmaceutical firms this year.=20
At the study's outset, 264 patients with symptoms of early Parkinson's
disease who were not being treated with levodopa were randomly divided into
five treatment groups.=20
Members of one group received a placebo, while those in the other four
groups received daily doses of pramipexole dihydrochloride.
Physicians measured a patient's condition by monitoring the patient's mood,
motor skills, and ability to perform everyday tasks.=20
Over the 10-week study, patients receiving pramipexole dihydrochloride
improved an average of 20 percent compared to patients taking a placebo.
"Patients with worse symptoms saw even bigger gains, suggesting that the
drug may be useful in treating mild to moderate cases of Parkinson's
disease," Kieburtz says.=20
Physicians have begun a two-year study of 300 patients funded by Pharmacia
& Upjohn and led by the University of Rochester to study the long-term
effects of the drug.
The research was supported by Pharmacia & Upjohn, which supplied the drug,
as well as the National Institutes of Health and the National Parkinson
Foundation.=20
Kieburtz's collaborators in the study included Ira Shoulson, and Michael
McDermott, at the University of Rochester, Stanley Fahn of Columbia
University, Anthony Lang, of The Toronto Hospital, Warren Olanow of Mt.
Sinai Hospital, John Penney, of Massachusetts General Hospital, and G.
Frederick Wooten, of the University of Virginia Health Sciences Center.
At Rochester the study was coordinated through the Department of
Neurology's Clinical Trials Coordination Center and the Division of
Experimental Therapeutics, where physicians are trained to design and
interpret studies of potential new treatments to neurodegenerative diseases.=
=20
By STEVE BRADT, American Reporter Correspondent,=20
copyright 1997, The American Reporter
Copyright =A9 1997 Nando.net
---------------------------------------------------------------------------
[log in to unmask]
=20
