A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa

Background: There is debate about whether the initial treatment for patient s with Parkinson's disease should be levodopa or a dopamine agonist. Methods: In this prospective, randomized, double-blind study, we compared t he 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 Par kinson's disease. If symptoms were not adequately controlled by the assigne d study medication, patients could receive supplementary levodopa, administ ered in an open-label fashion. The primary outcome measure was the occurren ce of dyskinesia. Results: Eighty-five of the 179 patients in the ropinirole group (47 percen t) and 45 of the 89 patients in the levodopa group (51 percent) completed a ll 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 (haza rd ratio for remaining free of dyskinesia, 2.82; 95 percent confidence inte rval, 1.78 to 4.44; P<0.001). At five years, the cumulative incidence of dy skinesia (excluding the three patients who had dyskinesia at base line), re gardless of levodopa supplementation, was 20 percent (36 of 177 patients) i n the ropinirole group and 45 percent (40 of 88 patients) in the levodopa g roup. There was no significant difference between the two groups in the mea n 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 lev odopa (including supplements). Conclusions: Early Parkinson's disease can be managed successfully for up t o five years with a reduced risk of dyskinesia by initiating treatment with ropinirole alone and supplementing it with levodopa if necessary. (N Engl J Med 2000;342:1484-91.) (C) 2000, Massachusetts Medical Society.