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EMBARGOED FOR RELEASE:
THURSDAY, APRIL 30, 1998
(212) 598-3694
9:45 a.m. CST
NEW STUDIES SUGGEST REQUIP MAY PRESERVE DOPAMINERGIC FUNCTION AND PROVIDE
LONG-TERM EFFICACY IN EARLY STAGE PARKINSON'S DISEASE
Data supports use of Requip as first-line therapy
Minneapolis, MN, April 30, 1998 -- According to two new studies presented
today at the 50th annual meeting of the American Academy of Neurology
(AAN) in Minneapolis, Requip (ropinirole hydrochloride, SmithKline
Beecham) alone may preserve dopaminergic function (dopamine activity) in
the specific regions of the brain that regulate movement and provide
long-term symptomatic control in patients with early Parkinson's disease.
The results of a first-of-its-kind pilot study using 18Fluoro-dopa
Positron Emission Tomography (PET) scans suggest that Requip may preserve
dopaminergic function in patients who have had Parkinson's disease for
less than two years. A large-scale, multicenter clinical trial is
currently underway to further test these findings. If similar results are
shown in this study, it may significantly impact future Parkinson's
disease progression studies and could potentially have positive clinical
implications for patients. In another study, Requip was shown to be more
effective than bromocriptine, an older dopamine agonist, in the treatment
of early Parkinson's disease for at least three years. This is exciting
news for the nearly 60,000 people diagnosed with Parkinson's disease each
year.
"Although these findings are preliminary and the numbers are small, these
promising new results suggest that by using Requip alone in the early
stages of Parkinson's disease we may preserve dopaminergic function. This
is particularly important since other commonly used therapies, such as
levodopa, may be associated with unwanted side effects after long-term
use," said David J. Brooks, M.D., Hartnett professor of neurology, MRC
Cyclotron unit, Hammersmith Hospital in England. "If the results of this
18Fluoro-dopa PET scan study are replicated in the large clinical trial,
we may be able to prolong patients ability to perform daily activities and
maintain a normal, active life."
New Study Suggests Requip May Preserve Dopaminergic Function in Early
Stages
In an ongoing five-year, double-blind, multicenter study, patients with
early Parkinson's disease (Hoehn & Yahr* I-III) were randomized to receive
either Requip or levodopa. Of those enrolled, 37 patients were scanned
using 18Fluoro-dopa PET within the first year and then approximately two
years later to measure the gradual decline in basal ganglia (a region of
the brain that is critical in regulating movement) dopaminergic function.
This decline results in the decrease in motor function which is
characteristic of Parkinson's disease. PET scanning, a form of brain
imaging, involves scanning both sides of the brain simultaneously. Images
from both the better (less deteriorated) and worse (more deteriorated)
sides of the brain were analyzed; however, these results focus on an
average of both sides of the brain. The following endpoints were
assessed: 1) mean percent change in putamen (the larger component part of
the corpus striatum, a section of the basal ganglia that receives messages
from other parts of the brain) dopaminergic function in all patients
(Hoehn & Yahr I-III); 2) mean percent change in putamen dopaminergic
function in Parkinson's disease patients with symptoms present for under
two years; and 3) mean percent change in putamen dopaminergic function in
Parkinson's disease patients with symptoms present for more than two
years.
When considering all patients who entered the study (Hoehn & Yahr I-III),
there appeared to be a slower loss of putamen dopaminergic function for
patients treated with Requip compared with those patients treated with
levodopa (13 percent versus 18 percent, respectively). In the subgroup of
patients with Parkinson's disease for less than two years, this difference
became more obvious, the decrease in putamen dopaminergic function was
also less for patients treated with Requip (14 percent) versus
levodopa-treated patients (28 percent). There was no statistically
significant difference between treatment groups for patients with
Parkinson's disease for more than two years.
Overall, patients treated with Requip who have had Parkinson's disease for
less than two years demonstrated the greatest preservation of putamen
dopaminergic function. Although the patient sample size was small, this
pilot study suggests that Requip may preserve dopaminergic function in
early stage Parkinson's patients.
*Parkinson's disease rating system
Requip Effective as Long-Term Therapy in Patients with Early Stage
Parkinson's Disease
In a three-year, international, multicenter, double-blind comparative
clinical trial, Parkinson's 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, 214 patients completed the study (approximately 39 percent
of patients treated with Requip and 33 percent of bromocriptine patients
withdrew from the study). Efficacy was based on the following: 1) mean
Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily
Living (ADL) score (Part II) at completion; 2) improvement in the UPDRS total
motor examination score (Part III); 3)percentage of patients who were
considered responders, defined as those with at least a 30 percent
reduction from baseline in total motor examination score on the UPDRS; 4)
average combined ADL and motor score at endpoint; and 5) the percentage of
patients who required supplemental levodopa therapy.
Among patients who completed the study, patients treated with Requip
demonstrated a statistically significant mean improvement (p=0.009) in the
UPDRS ADL score versus patients treated with bromocriptine. In this same
patient population, patients treated with Requip also showed a greater
mean improvement in UPDRS motor score than patients in the bromocriptine
group (31 percent versus 22 percent, respectively). At the study's
completion, 53 percent of patients treated with Requip were considered
responders compared with 42 percent for the bromocriptine group.
In addition, the average improvement in the combined ADL and motor scores
was statistically significantly greater for patients treated with Requip
(p=0.018) versus bromocriptine-treated patients. Fewer patients treated
with Requip than expected required supplemental levodopa (34 percent
versus 42 percent for bromocriptine). There was a very low incidence of
dyskinesias for both treatment groups (8 percent for Requip versus 7
percent for bromocriptine).
"We are pleased to see that Requip remains effective on a long-term basis
in early stage Parkinson's disease," said Jan Petter Larsen, M.D.,
professor of neurology, Central Hospital of Rogaland in Norway. "This
study clearly shows that using Requip in early disease can sustain motor
function and limit levodopa use for at least three years."
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