At 11:22 07/12/97 EST, MichelMarg wrote:
>My understanding of the therapy is to provide the missing L-Dopa via the
>Sinemet, and Requip can be used as an adjunct agonist interspersed with it. As
>an agonist, it acts as a surrogate L-dopa and increases the effectiveness of
>the drug.
>Requip is not a substitute for L-Dopa!
Here are excerpts from Canadian Press story and a press release...
============================================
TORONTO (CP)<snip>
"We've developed new theories in Parkinsons disease to try to change the
treatment approach and delay the onset of these troublesome side effects," said
Dr. Janis Miyasaki, a Toronto neurologist.
ReQuip is most beneficial to people who are diagnosed with the disease
early. But those who are in the mature stage of the disease can lessen the
dosage of L-dopa by taking ReQuip, Miyasaki said.
"A new treatment approach is to delay the onset of use of levodopa," she
said. "There is evidence in animal studies that exposure to levodopa may prime
the brain to develop these side effects."
=============================================
Philadelphia, PA, September 22, 1997 -- SmithKline Beecham's Requip;
(ropinirole hydrochloride) received marketing clearance today from the U.S.
Food and Drug Administration (FDA) for treatment of the signs and symptoms
of Parkinson's disease, both as initial therapy and as adjunctive treatment
with levodopa. Unlike older dopamine agonists, Requip, which is a second
generation
dopamine agonist, is licensed for use in patients with early Parkinson's
disease (without levodopa) and in patients with advanced Parkinson's disease
(with levodopa).
"Requip allows physicians to delay the use of levodopa, a drug which may
be associated with severe motor fluctuations after long-term use. Now these
physicians can use Requip to control symptoms early in the disease or later in
combination with traditional treatments. This approach will be very valuable in
the management of Parkinson's disease."
<snip>
"It is important to recognize the value of new treatments that can be
used in the early stages of Parkinson's disease," said Emilio Alonso-Mendoza,
executive director, National Parkinson Foundation, Inc. "This may mean that the
disease can be treated effectively over a longer period of time, improving
quality of life for patients and their families.
<snip>
Efficacy in Early Parkinson's Disease
The effects of Requip as initial dopaminergic therapy in patients with
mild to moderate Parkinson's disease were assessed in a double-blind,
randomized, placebo-controlled study. Results were obtained through a
measurement used by physicians to assess the disease status of Parkinson's
disease patients called the Unified Parkinson's Disease Rating Scale (UPDRS).
Physicians measured the overall change they saw in their patients' motor
function. Patients treated with Requip (n=116) demonstrated a significantly
superior improvement in motor score of 24 percent compared to
placebo-treated patients (n=125) who demonstrated a three percent worsening in
motor score after six months. In addition, 33 percent of patients treated with
Requip were rated as either "much improved" or "very much improved" on the
Clinical Global Impressions (CGI) improvement item compared to 12 percent of
patients given placebo.
"This study shows that this new drug can improve motor function early in
the disease and will therefore enable patients to maintain their active
lives," said Dr. Watts.
Efficacy as Adjunctive Therapy With Levodopa
The efficacy of Requip as adjunctive therapy with levodopa in the late
stages of Parkinson's disease was confirmed in a doubleÄblind, randomized study
comparing patients treated with Requip (n=94) to patients treated with placebo
(n=54). Investigators evaluated the number of "responders,"; defined as
patients who were able to achieve: (1) a decrease (compared to baseline) of at
least 20 percent in their levodopa dose, and (2) a decrease of at least 20
percent in the proportion of time awake in the "off" condition (period of time
during the day when patients are particularly immobile).
After six months, 28 percent of patients treated with Requip were
classified as responders versus 11 percent of placebo-treated patients. This
difference was statistically significant. In addition, 49 percent of
Requip-treated patients had their levodopa dose reduced by at least 20 percent
versus 17 percent of placebo-treated patients. This difference was also
statistically significant. The average levodopa dose reduction was 31 percent
for patients treated with Requip. This study demonstrates that the adjunctive
use of Requip with levodopa allows for the reduction of a patient's levodopa
dose, therefore reducing the total amount of levodopa which must be taken
daily. =========================================
Judith Richards
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