A five-year study of the incidence of dyskinesia in patients with early parkinson's disease who were treated with ropinirole or levodopa
Identifieur interne : 003C16 ( Main/Exploration ); précédent : 003C15; suivant : 003C17A five-year study of the incidence of dyskinesia in patients with early parkinson's disease who were treated with ropinirole or levodopa
Auteurs : O. Rascol [France] ; D. J. Brooks [Royaume-Uni] ; A. D. Korczyn [Israël] ; P. P. De Deyn [Belgique] ; C. E. Clarke [Royaume-Uni] ; A. E. Lang [Canada]Source :
- The New England journal of medicine [ 0028-4793 ] ; 2000.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
- Aged, Agonist, Aminoacid, Antiparkinson Agents (adverse effects), Antiparkinson Agents (therapeutic use), Antiparkinson agent, Chemotherapy, Comparative study, D2 Dopamine receptor, Disease-Free Survival, Dopa, Dopamine agonist, Double blind study, Double-Blind Method, Drug Therapy, Combination, Dyskinesia, Dyskinesia, Drug-Induced (epidemiology), Dyskinesia, Drug-Induced (etiology), Dyskinesia, Drug-Induced (prevention & control), Early, Female, Human, Humans, Incidence, Indoles (adverse effects), Indoles (therapeutic use), Levodopa (adverse effects), Levodopa (therapeutic use), Male, Middle Aged, Parkinson Disease (drug therapy), Parkinson disease, Prevention, Prospective Studies, Randomization, Risk Factors, Ropinirole, Treatment, Treatment efficiency.
- MESH :
- chemical , adverse effects : Antiparkinson Agents, Indoles, Levodopa.
- chemical , therapeutic use : Antiparkinson Agents, Indoles, Levodopa.
- drug therapy : Parkinson Disease.
- epidemiology : Dyskinesia, Drug-Induced.
- etiology : Dyskinesia, Drug-Induced.
- prevention & control : Dyskinesia, Drug-Induced.
- Aged, Disease-Free Survival, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Incidence, Male, Middle Aged, Prospective Studies, Risk Factors.
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.
Affiliations:
- Belgique, Canada, France, Israël, Royaume-Uni
- Angleterre, Grand Londres, Midi-Pyrénées, Midlands de l'Ouest, Occitanie (région administrative), Province d'Anvers, Région flamande
- Anvers, Birmingham, Londres, Toulouse
- Université d'Anvers, Université de Birmingham
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Le document en format XML
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<series><title level="j" type="main">The New England journal of medicine</title>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term>
<term>Agonist</term>
<term>Aminoacid</term>
<term>Antiparkinson Agents (adverse effects)</term>
<term>Antiparkinson Agents (therapeutic use)</term>
<term>Antiparkinson agent</term>
<term>Chemotherapy</term>
<term>Comparative study</term>
<term>D2 Dopamine receptor</term>
<term>Disease-Free Survival</term>
<term>Dopa</term>
<term>Dopamine agonist</term>
<term>Double blind study</term>
<term>Double-Blind Method</term>
<term>Drug Therapy, Combination</term>
<term>Dyskinesia</term>
<term>Dyskinesia, Drug-Induced (epidemiology)</term>
<term>Dyskinesia, Drug-Induced (etiology)</term>
<term>Dyskinesia, Drug-Induced (prevention & control)</term>
<term>Early</term>
<term>Female</term>
<term>Human</term>
<term>Humans</term>
<term>Incidence</term>
<term>Indoles (adverse effects)</term>
<term>Indoles (therapeutic use)</term>
<term>Levodopa (adverse effects)</term>
<term>Levodopa (therapeutic use)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Parkinson Disease (drug therapy)</term>
<term>Parkinson disease</term>
<term>Prevention</term>
<term>Prospective Studies</term>
<term>Randomization</term>
<term>Risk Factors</term>
<term>Ropinirole</term>
<term>Treatment</term>
<term>Treatment efficiency</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiparkinson Agents</term>
<term>Indoles</term>
<term>Levodopa</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term>
<term>Indoles</term>
<term>Levodopa</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term>
</keywords>
<keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Dyskinesia, Drug-Induced</term>
</keywords>
<keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Dyskinesia, Drug-Induced</term>
</keywords>
<keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Dyskinesia, Drug-Induced</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Aged</term>
<term>Disease-Free Survival</term>
<term>Double-Blind Method</term>
<term>Drug Therapy, Combination</term>
<term>Female</term>
<term>Humans</term>
<term>Incidence</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Prospective Studies</term>
<term>Risk Factors</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Parkinson maladie</term>
<term>Homme</term>
<term>Précoce</term>
<term>Randomisation</term>
<term>Etude double insu</term>
<term>Efficacité traitement</term>
<term>Ropinirole</term>
<term>Antiparkinsonien</term>
<term>Agoniste</term>
<term>Récepteur dopaminergique D2</term>
<term>Stimulant dopaminergique</term>
<term>Traitement</term>
<term>Dopa</term>
<term>Chimiothérapie</term>
<term>Prévention</term>
<term>Dyskinésie</term>
<term>Etude comparative</term>
<term>Aminoacide</term>
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<front><div type="abstract" xml:lang="en">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.</div>
</front>
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