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SmithKline Beecham Parkinson's Disease Press Release - 1/13/98

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). 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.

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. 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.

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