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
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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 the
early 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 improved
based 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 did
receive 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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