Tags

Type your tag names separated by a space and hit enter

A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa.
N Engl J Med. 2000 May 18; 342(20):1484-91.NEJM

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.

Authors+Show Affiliations

Clinical Investigation Center, Neuropharmacology Unit, INSERM Unité 455, University Hospital, Toulouse, France. rascol@cict.frNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

10816186

Citation

Rascol, O, et al. "A Five-year Study of the Incidence of Dyskinesia in Patients With Early Parkinson's Disease Who Were Treated With Ropinirole or Levodopa." The New England Journal of Medicine, vol. 342, no. 20, 2000, pp. 1484-91.
Rascol O, Brooks DJ, Korczyn AD, et al. A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa. N Engl J Med. 2000;342(20):1484-91.
Rascol, O., Brooks, D. J., Korczyn, A. D., De Deyn, P. P., Clarke, C. E., & Lang, A. E. (2000). A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa. The New England Journal of Medicine, 342(20), 1484-91.
Rascol O, et al. A Five-year Study of the Incidence of Dyskinesia in Patients With Early Parkinson's Disease Who Were Treated With Ropinirole or Levodopa. N Engl J Med. 2000 May 18;342(20):1484-91. PubMed PMID: 10816186.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa. AU - Rascol,O, AU - Brooks,D J, AU - Korczyn,A D, AU - De Deyn,P P, AU - Clarke,C E, AU - Lang,A E, PY - 2000/5/18/pubmed PY - 2000/5/29/medline PY - 2000/5/18/entrez SP - 1484 EP - 91 JF - The New England journal of medicine JO - N Engl J Med VL - 342 IS - 20 N2 - 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. SN - 0028-4793 UR - https://www.unboundmedicine.com/medline/citation/10816186/A_five_year_study_of_the_incidence_of_dyskinesia_in_patients_with_early_Parkinson's_disease_who_were_treated_with_ropinirole_or_levodopa_ L2 - https://www.nejm.org/doi/10.1056/NEJM200005183422004?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -