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Patients
starting Parkinson's drug rasagiline earlier
do better...Long-term study suggests drug
may slow progression of movement disorder
Tampa, FL (Jan. 26, 2009) – There is hope that the drug
rasagiline can do what no other medication
for Parkinson's disease now does -- slow the
progression of a devastating degenerative
brain disease that eventually robs people of
their ability to move and function.
Now a new study looking at the long-term effects of
rasagiline (Azilect) on newly diagnosed
patients indicates that people who began the
drug earlier continued to do better than
those for whom treatment was delayed six
months.
The study "Long-term Outcome of Early Versus Delayed
Rasagiline Treatment in Early Parkinson's
Disease" was recently published in the early
online version of the journal Movement
Disorders.
"Patients who received rasagiline right from the beginning
rather than after a six-month delay
experienced less progression of the clinical
signs and symptoms of Parkinson's disease
that interfere with activities of daily
living such as eating, walking and
dressing," said the study's lead author
Robert A. Hauser, MD, director of the
University of South Florida Parkinson's
Disease and Movement Disorders Center.
"This is potentially consistent with a slowing of
underlying disease progression, although
other possible mechanisms also need to be
considered."
The study, sponsored by Teva Pharmaceutical Industries Ltd.
(Israel), Teva Neuroscience, Inc. (USA) and
H. Lundbeck A/S (Denmark), was a long-term
open label extension of the multisite trial
"TVP-1012 (rasagiline) in Early Monotherapy
for Parkinson's Disease Outpatients" study,
known as TEMPO.
In TEMPO, more than 400 untreated patients with early
Parkinson's disease were randomly assigned
to rasagiline for a year (1 mg daily or 2 mg
daily) or to placebo for six months followed
by rasagiline for six months (2 mg daily).
At the end of a year, patients receiving rasagiline from
the start fared better as measured by the
Unified Parkinson's Disease Rating Scale.
They experienced less worsening of motor symptoms, such as
rigidity and tremor, and had fewer problems
with activities of daily living than
patients who began rasagiline six months
later.
The open-label extension study followed more than 300
patients from the TEMPO study for up to 6.5
years.
In this extension study, all patients continued on
rasagiline (1 mg. daily) and could take
other Parkinson's disease medications as
needed.
The researchers found those who started rasagiline right
from the beginning of the TEMPO study
continued to fare better than patients in
the delayed-start group.
Over the course of the entire study, the early-start group
had 16 percent less progression of the signs
and symptoms of Parkinson's disease, and
this greater clinical benefit was observed
even as patients received conventional
Parkinson's disease medications in addition
to rasagiline.
Rasagiline appeared to be well tolerated in this long-term
study.
If the clinical outcomes from the TEMPO and extension study
hold up under further scrutiny, it may
indicate that early initiation of rasagiline
confers a protective effect against disease
progression, Dr. Hauser said.
"If this is the case, it reinforces the importance of
individuals being diagnosed and treated as
soon as possible."
The study authors point out that early initiation of any
drug to relieve symptoms of Parkinson's
disease may lead to a better clinical
outcome compared to delayed administration
-- something that will be elucidated as more
delayed-start studies are performed with
other Parkinson's medications.
###
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Teaching. For more information, visit
www.health.usf.edu
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