The New England Journal of Medicine -- May 18, 2000 -- Vol. 342, No. 20
http://www.nejm.org/content/2000/0342/0020/1484.asp
A Five-Year Study of the Incidence of Dyskinesia in Patients with Early
Parkinson's Disease Who Were Treated with Ropinirole or Levodopa
Olivier Rascol, David J. Brooks, Amos D. Korczyn, Peter P. De Deyn, Carl
E. Clarke, Anthony E. Lang, for the 056 Study Group
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.
(N Engl J Med 2000;342:1484-91.)
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Copyright © 2000 by the Massachusetts Medical Society.
--
Judith Richards, London, Ontario, Canada
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