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Studies Show Requip Is An Effective Treatment For Early Parkinson's Disease

PHILADELPHIA, PA. -- January 20, 1998 -- SmithKline Beecham's Requip (ropinirole
hydrochloride) 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. Levodopa, however, was more effective in advanced
patients. 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," 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. "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,".

In a planned six-month interim analysis from an ongoing five-year,
double-blind, multicenter trial, patients with early Parkinson's disease
were randomized
to receive either Requip or 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. 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.

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 or bromocriptine. Thirty-three percent
of patients received selegiline concomitantly with either Requip or
bromocriptine.

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.

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 (seven
percent) required supplemental levodopa compared with 11 percent of
bromocriptine-treated patients.

Judith Richards
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