JUL 30, 1999, M2 Communications - Vancouver, Canada -- Reports of Parkinson's
disease affecting public figures such as Janet Reno, Michael J. Fox and
Muhammad Ali have increased awareness of the prevalence of the disease and
its impact on patients' lives. Now a landmark study released this week at the
13th International Congress on Parkinson's Disease in Vancouver shows that
SmithKline Beecham's drug Requip (ropinirole hydrochloride) successfully
manages Parkinson's disease and significantly lowers the risk of developing
dyskinesias, involuntary body movements which are often associated with
levodopa, a common Parkinson's disease therapy. The study is the first
five-year, double-blind trial of a dopamine agonist versus levodopa.
The study was designed to measure the incidence of dyskinesias and
efficacy as assessed by activities of daily living. Researchers sought to
evaluate if Requip could successfully manage symptoms in patients with
early-stage Parkinson's disease and delay the need to initiate levodopa
treatment for up to five years. Levodopa has been the "gold standard" of
treatment in Parkinson's disease for the past 35 years; it is used in
approximately 75 percent of patients. Unfortunately, over time Parkinson's
disease progresses and physicians need to increase the dosage and frequency
of levodopa to relieve Parkinson's symptoms. Increasing the dose of levodopa
can cause many patients to experience levodopa-induced side effects such as
irreversible dyskinesias, which can have a negative impact on a patient's
ability to function.
"The study results released this week demonstrate that early stage
Parkinson's disease (Hoehn & Yahr disease stages I-III) can be successfully
managed for up to five years using Requip as first-line treatment," said lead
study author Olivier Rascol, M.D., Ph.D. of the Centre Hospitalier
Universitaire Toulouse, France. "In this study, using Requip and a low dose
of levodopa, when necessary, reduced the risk of developing dyskinesias that
are often associated with levodopa therapy. This is the most compelling data
seen to date in support of early treatment with a second-generation dopamine
agonist, and the results can affect the future management of Parkinson's
disease."
One Woman's Story: From Uncomfortable Dyskinesias to A Life with
Greater Symptom Control
A teacher and avid fan of jigsaw puzzles, gardening and cooking, Helen
Collins lived a busy and fulfilling life until her left hand and leg began to
tremble uncontrollably. In 1980, embarrassed by her irrepressible movements,
Helen went to the doctor. After five years of visits to numerous doctors and
a battery of tests, at the age of 55 Helen was finally diagnosed with
Parkinson's disease. Drained of energy, she found that her favorite
activities such as water exercises and playing bridge became too physically
difficult to perform and she lost interest in doing the things she loved --
socializing, eating out and gardening.
Initially, Helen was placed on levodopa in combination with amantadine
to control her Parkinson's disease. These medications did manage her
symptoms; however, she gradually began to experience uncomfortable motor
complications (e.g., shaking, involuntary movements, dry mouth, a tendency to
grimace and the freezing effect). Twelve years after her diagnosis, Helen's
right side began to display the same symptoms as her left.
In 1998, Helen's doctors re-evaluated her medication and added Requip
and selegiline to her regimen. Since that time, Helen says, "Requip has
helped to control my Parkinson's disease symptoms." With her dyskinesias
occurring less frequently and for shorter spans of time, Helen is back to
doing many of the activities Parkinson's disease forced her to give up.
"Requip lets me be more active," says Helen. "I can drive again and lead a
more normal, better life with Parkinson's disease. I am planning to live
until we find a cure for Parkinson's and will fight back against the disease
and live my life to the fullest," she says.
Requip Effective Long-Term Therapy
In a double-blind, parallel-group study, 268 patients with early
Parkinson's disease were randomized (2:1) to receive either Requip or
levodopa, and were evaluated for five years. The study evaluated the
incidence of dyskinesias. Patients in both the Requip and levodopa groups
whose symptoms did not improve were given supplemental levodopa. The
incidence of dyskinesias experienced during the course of the study and
amount of levodopa added to their treatment regimen were evaluated.
Of those enrolled, 130 patients completed the study (n=85 Requip, n=45
levodopa) and were evaluated. Sixty-four percent of patients on levodopa and
34 percent of patients who received Requip completed the five-year study
without supplemental levodopa therapy. The incidence of dyskinesias in the
Requip and levodopa monotherapy groups was five percent and 36 percent,
respectively. Of the patients who required supplemental levodopa, 20 percent
of patients on Requip with supplemental levodopa developed dyskinesias
compared to 46 percent of levodopa patients who required supplementation.
Patients who received Requip had a significantly lower risk of developing any
dyskinesias compared to patients who received levodopa.
The mean dose of Requip at the end of the five-year study was
16.5mg/day. The mean dose of levodopa supplement for patients who received
Requip was 427mg compared to 753mg for patients in the levodopa group who
required supplementation
"The study provides hope that Parkinson's disease patients treated with
Requip alone or with low doses of adjunctive levodopa can live more active
lives with less risk of developing dyskinesias," said Abraham Lieberman,
M.D., Clinical Director for the National Parkinson Foundation. "The results
strongly support the use of a second-generation dopamine agonist to treat
early-stage Parkinson's disease."
Requip was generally well tolerated. In this study, the adverse events
were similar to those commonly associated with Parkinson's disease
medications. They included nausea, somnolence, insomnia and Parkinsonism
aggravated. All Parkinson's patients should be informed that fainting and low
blood pressure may occur more frequently during initial treatment or with an
increase in dose. Hallucinations can occur at any time during the course of
treatment. Requip may potentiate the dopaminergic side effects of levodopa
and may cause and/or exacerbate pre-existing dyskinesias.
Requip is a second-generation dopamine agonist indicated for the
treatment of the signs and symptoms of both early and advanced stages of
Parkinson's disease and was approved by the U.S. Food and Drug Administration
(FDA) in September 1997.
A Progressive Neurodegenerative Disorder
Parkinson's disease, which affects between 500,000 and one million
Americans, is a chronic and progressive disorder that results from the death
of nerve cells in a critical area of the brain called the substantia nigra.
These nerve cells normally produce dopamine, a chemical messenger that plays
an important role in motor movement control by transmitting signals between
two areas of the brain. Dopamine depletion results in a patient's impaired
ability to control motor movements.
SmithKline Beecham -- one of the world's leading healthcare companies
-- discovers, develops, manufactures, and markets pharmaceuticals and
vaccines, over-the-counter medicines, health-related consumer products, and
clinical laboratory testing services. For company information, visit
SmithKline Beecham on the World Wide Web at www.sb.com.
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