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Previous Volume 342:1484-1491 May 18, 2000 Number 20 Next

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ABSTRACT

Background There is debate about whether the initial treatment for patients with Parkinson's disease should be levodopa or a dopamine agonist.

Methods In this prospective, randomized, double-blind study, we compared the safety and efficacy of the dopamine D2–receptor agonist ropinirole with that of levodopa over a period of five years in 268 patients with early Parkinson's disease. If symptoms were not adequately controlled by the assigned study medication, patients could receive supplementary levodopa, administered in an open-label fashion. The primary outcome measure was the occurrence of dyskinesia.

Results Eighty-five of the 179 patients in the ropinirole group (47 percent) and 45 of the 89 patients in the levodopa group (51 percent) completed all five years of the study. In the ropinirole group, 29 of the 85 patients (34 percent) received no levodopa supplementation. The analysis of the time to dyskinesia showed a significant difference in favor of ropinirole (hazard ratio for remaining free of dyskinesia, 2.82; 95 percent confidence interval, 1.78 to 4.44; P<0.001). At five years, the cumulative incidence of dyskinesia (excluding the three patients who had dyskinesia at base line), regardless of levodopa supplementation, was 20 percent (36 of 177 patients) in the ropinirole group and 45 percent (40 of 88 patients) in the levodopa group. There was no significant difference between the two groups in the mean change in scores for activities of daily living among those who completed the study. Adverse events led to the early withdrawal from the study of 48 of 179 patients in the ropinirole group (27 percent) and 29 of 89 patients in the levodopa group (33 percent). The mean (±SD) daily doses given by the end of the study were 16.5±6.6 mg of ropinirole (plus 427±221 mg of levodopa in patients who received supplementation) and 753±398 mg of levodopa (including supplements).

Conclusions Early Parkinson's disease can be managed successfully for up to five years with a reduced risk of dyskinesia by initiating treatment with ropinirole alone and supplementing it with levodopa if necessary.

Source Information

From the Clinical Investigation Center, Neuropharmacology Unit, INSERM Unité 455, University Hospital, Toulouse, France (O.R.); the Division of Neuroscience, Imperial College School of Medicine, Hammersmith Hospital, London (D.J.B.); the Department of Neurology, Tel Aviv University Medical School, Ramat Aviv, Israel (A.D.K.); the Department of Neurology, General Hospital Middelheim, Born-Bunge Foundation, and University of Antwerp, Antwerp, Belgium (P.P.D.); the Department of Neurology, University of Birmingham, Birmingham, United Kingdom (C.E.C.); and the Department of Medicine (Neurology), University of Toronto and Toronto Western Hospital, Toronto (A.E.L.). Presented at the XIII International Congress on Parkinson's Disease, Vancouver, Canada, July 24–28, 1999.

Address reprint requests to Dr. Rascol at the Service de Pharmacologie Medicale et Clinique, Faculté de Médecine, 37 Allées Jules-Guesde, 31073 Toulouse CEDEX, France, or at rascol{at}cict.fr.

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Ropinirole as Compared with Levodopa in Parkinson's Disease
Hiner B. C., Earnhart M., Yamamoto T., Frucht S., Weiner W. J., Factor S. A., Rascol O., The 056 Study Group
Extract | Full Text  
N Engl J Med 2000; 343:884-885, Sep 21, 2000. Correspondence

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