Joe Young -
Try this info:
From: Jennifer Kinscy <[log in to unmask]>
To: Multiple recipients of list PARKINSN
<PARKINSN@lis...
Date: 1/14/98 10:34am
Subject: Requip Information from SmithKline Beecham
Good Morning Listserv Members,
My name is Jennifer Kinscy and I work with SmithKline
Beecham,
manufacturers of Requip. I just wanted to share their latest
news with you.
Please feel free to contact me if you have any questions
about Requip.
Thanks!
Jenny Kinscy,
Media Connection of New York
* * * * * * * * * * *
* *
NEW STUDIES PROVIDE FURTHER EVIDENCE THAT
REQUIP IS AN EFFECTIVE TREATMENT
FOR EARLY PARKINSON'S DISEASE
Additional clinical evidence supports use of Requip early in
disease as
part of comprehensive treatment approach
Philadelphia, PA, January 13, 1998 - Requip (ropinirole
hydrochloride,
SmithKline Beecham) is an effective treatment for early stage
Parkinson's
disease, according to two new studies published this month
in Movement
Disorders. In one study in which patients were treated with
either Requip
or levodopa (L-dopa), Requip was shown to be as effective as
levodopa in
early stage Parkinson's disease (Hoehn & Yahr stages I-II);
levodopa,
however, was more effective in advanced patients (Hoehn &
Yahr stages
II.5-III). In another study, Requip was more efficacious than
bromocriptine. Requip is a second generation dopamine
agonist that was
recently cleared for marketing by the U.S. Food and Drug
Administration
(FDA) for the treatment of the signs and symptoms of
Parkinson's disease,
both as initial therapy and as adjunctive treatment with
levodopa.
"There is a need for Parkinson's disease treatments that can
be used in theearly stages of the disease to control
symptoms and delay the need for
levodopa, a traditionally used Parkinson's disease drug that
is often
associated with motor complications after long term use.
Not only were we
able to avoid giving the patients treated with Requip
additional drugs such
as levodopa, but we also observed sustained improvements
in motor
functioning," said O. Rascol, M.D., department of clinical
pharmacology
and clinical investigation center, faculty of medicine,
University Hospital
in Toulouse, France, and one of the lead study investigators.
Requip Effective in Patients with Early Parkinson's Disease
In a planned six-month interim analysis from an ongoing
five-year,
double-blind, multicenter trial, patients with early Parkinson's
disease
(Hoehn and Yahr stages I-III) were randomized to receive
either Requip
(n=179) or levodopa (n=89). The principal measure of
efficacy was the
percent improvement from baseline in the Unified Parkinson's
Disease Rating
Scale (UPDRS) total motor examination score (Part III).
Efficacy was also
based on the following: 1) percentage of patients who were
considered
responders, defined as at least a 30 percent reduction from
baseline in the
motor score on the UPDRS; 2) percentage of patients
considered to be
improved, defined by a score of 1 (very much improved) or 2
(much improved)
on the Clinical Global Impression (CGI) scale; and 3) the
percentage of
patients who required additional levodopa.
There was no statistically significant difference in the percent
improvement of UPDRS motor score between patients
treated with Requip and
levodopa-treated patients in the earliest stages of
Parkinson's disease
(Hoehn & Yahr stages I-II). In addition, for this same patient
population,
there was no statistically significant difference between the
two treatment
groups in the percentage of patients who were considered to
be improvedbased on the CGI scale. When considering all
patients who entered the
study (Hoehn & Yahr I-III), including those patients with
advanced disease,
there was a significantly greater percentage improvement in
the UPDRS motor
score for levodopa-treated patients compared with those
patients treated
with Requip (44 percent versus 32 percent, respectively).
Few patients in
either treatment group required additional levodopa (4 percent
of
Requip-treated patients and 1 percent of levodopa-treated
patients).
New Study Shows Requip is Significantly Better than
Bromocriptine
In a planned six-month interim analysis from a three-year
international,
multicenter, double-blind comparative clinical trial, patients
were
randomized to receive either Requip (n=168) or bromocriptine
(n=167).
Thirty-three percent of patients received selegiline
concomitantly with
either Requip or bromocriptine.
Of those enrolled, 287 patients were evaluated. Efficacy was
based on the
following: 1) percentage of patients who were considered
responders,
defined as at least a 30 percent reduction from baseline in
the total motor
examination score on the UPDRS; 2) percentage of patients
considered to be
improved, defined by a score of 1 (very much improved) or 2
(much improved)
on the Clinical Global Impression (CGI) scale; and 3) the
percentage of
patients who required additional levodopa.
The overall percent improvement from baseline in UPDRS
motor score in all
treatment groups was 35 percent for the patients treated with
Requip
compared with 27 percent for the bromocriptine-treated
patients. Among
patients who did not receive concomitant selegiline, there
was a
statistically significantly greater percent improvement in total
UPDRS
motor score for Requip-treated patients compared with
bromocriptine-treated
patients (34 percent versus 20 percent, respectively). In
patients who didreceive selegiline concomitantly
improvements were similar (34 percent for
Requip versus 37 percent for bromocriptine).
Overall, there was a significantly greater proportion of
"improvers" in all
treatment groups on the CGI scale in the patients treated
with Requip (48
percent) compared with the bromocriptine group (40 percent).
Of the
patients who did not receive concomitant selegiline, 46
percent of patients
treated with Requip were considered "improvers" versus 30
percent of the
patients treated with bromocriptine; this difference was also
statistically significant. In patients who received selegiline
concomitantly, there was no statistically significant
difference between
the proportion of patients treated with Requip and
bromocriptine-treated
patients (53 percent versus 58 percent, respectively). In
addition, few
patients treated with Requip (7 percent) required
supplemental levodopa
compared with 11 percent of bromocriptine-treated patients.
"These results provide further evidence that newer dopamine
agonists such
as Requip can be used as first-line therapy to effectively
control the
motor symptoms of early Parkinson's disease," said A.D.
Korczyn, M.D.,
department of neurology, faculty of medicine, Tel-Aviv
University ,
Tel-Aviv, Israel. "We are pleased to see that Requip is safe
and effective
in treating patients with less advanced disease and hope that
these results
will encourage physicians to begin therapy with dopamine
agonists earlier."
Requip was generally well-tolerated in both studies. The
most common
adverse event reported was nausea. Other side effects that
occurred less
frequently include involuntary movements, somnolence and
dizziness. All
Parkinson's patients should be informed that syncope or
symptomatic
hypotension may occur more frequently during initial
treatment or with an
increase in dose. Hallucinations can occur at any time
during the course
of treatment with dopamine agonists such as Requip.
A Progressive Neurodegenerative Disorder
Parkinson's disease, which affects between 500,000 and
1,000,000 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
the substantia nigra and another critical area of the brain
called the
striatum. Dopamine depletion results in a patient's impaired
ability to
control motor movements. Requip is a second-generation
dopamine agonist
that has high in-vitro specificity at the d2 and d3 dopamine
receptor
subtypes and works by mimicking the effects of dopamine.
A Leader in Health Care
SmithKline Beecham (NYSE:SBH) -- one of the world's
leading healthcare
companies-discovers, develops, manufactures and markets
pharmaceuticals,
vaccines, over-the-counter medicines and health-related
consumer products,
and provides healthcare services including clinical laboratory
testing,
disease management and pharmaceutical benefit
management.
For company information, visit SmithKline Beecham on the
World Wide Web at
http://www.sb.com.
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