Randomized trial of tolcapone versus pergolide as add‐on to levodopa therapy in Parkinson's disease patients with motor fluctuations
Identifieur interne : 004707 ( Main/Exploration ); précédent : 004706; suivant : 004708Randomized trial of tolcapone versus pergolide as add‐on to levodopa therapy in Parkinson's disease patients with motor fluctuations
Auteurs : William Koller [États-Unis] ; Andrew Lees (neurologue) [Royaume-Uni] ; Miroslava Doder [Royaume-Uni] ; Mariese Hely [Australie]Source :
- Movement Disorders [ 0885-3185 ] ; 2001-09.
Descripteurs français
- Pascal (Inist)
- Adulte, Agoniste, Antiparkinsonien, Association médicamenteuse, Catechol O-methyltransferase, Chimiothérapie, Ergot dérivé, Etude comparative, Fluctuation motrice, Inhibiteur enzyme, Lévodopa, Parkinson maladie, Pergolide, Randomisation, Récepteur dopaminergique, Stimulant dopaminergique, Tolcapone, Toxicité, Traitement.
- Wicri :
- topic : Adulte.
English descriptors
- KwdEn :
- Adult, Agonist, Antiparkinson Agents (therapeutic use), Antiparkinson agent, Benzophenones (adverse effects), Benzophenones (therapeutic use), Catechol O-methyltransferase, Chemotherapy, Comparative study, Dopamine agonist, Dopamine receptor, Dose-Response Relationship, Drug, Double-Blind Method, Drug Therapy, Combination, Drug combination, Enzyme inhibitor, Ergot derivatives, Female, Humans, Levodopa, Levodopa (therapeutic use), Male, Middle Aged, Nitrophenols, Parkinson Disease (drug therapy), Parkinson disease, Parkinson's disease, Pergolide, Pergolide (adverse effects), Pergolide (therapeutic use), Quality of Life, Randomization, Tolcapone, Toxicity, Treatment, Treatment Outcome, drug comparison, motor fluctuations, pergolide, tolcapone.
- MESH :
- chemical , adverse effects : Benzophenones, Pergolide.
- chemical , therapeutic use : Antiparkinson Agents, Benzophenones, Levodopa, Pergolide.
- drug therapy : Parkinson Disease.
- Dose-Response Relationship, Drug, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Nitrophenols, Quality of Life, Treatment Outcome.
Abstract
In this 12‐week, randomized, open‐label, blinded‐rater, parallel‐group trial, the efficacy, safety, and tolerability of tolcapone and pergolide were compared in parkinsonian patients with a fluctuating response to levodopa. Patients received tolcapone 100 mg three times daily (t.i.d.), with a possible increase to 200 mg t.i.d., or pergolide titrated to a maximum dose of 5 mg/day by week 9 (mean final dose 2.2 mg/day). The trial involved 203 patients. Efficacy variables that decreased from baseline to week 12 with tolcapone and pergolide included “off” time (reduced by 2–3 hours/day), daily levodopa intake, sickness impact profile scores, Parkinson's disease questionnaire (PDQ)‐39 scores, and Unified Parkinson's Disease Rating Scale (UPDRS) scores. Improvements in efficacy variables were similar with tolcapone and pergolide, with the exception of improvements in quality of life, which were significantly greater with tolcapone; the relative changes in PDQ‐39 score at week 12 were −8.7 and −14.2 (P < 0.05) with pergolide and tolcapone, respectively. Improvements in the investigator's global assessment (IGA) of overall efficacy were recorded in 86% of tolcapone‐treated patients and in 78% of pergolide‐treated patients. The proportion of patients who withdrew because of adverse events was higher in the pergolide group (15%) than in the tolcapone group (5%). Confusion, hypotension, nausea, constipation, abdominal pain, and dyspepsia occurred more frequently with pergolide, whereas diarrhea and urine discoloration occurred more frequently with tolcapone. Tolcapone was better tolerated than pergolide (P < 0.01) according to the IGA of overall tolerability. We conclude that, in this 3‐month study, both tolcapone and pergolide provided improvements in motor fluctuations and allowed reductions in levodopa intake when added to levodopa therapy; intent to treat analysis and a less than maximal dose of pergolide may have biased the results in favor of tolcapone. Tolcapone provided greater improvements in quality of fife, was better tolerated, and had a more favorable adverse‐event profile than pergolide. © 2001 Movement Disorder Society.
Url:
DOI: 10.1002/mds.1175
Affiliations:
- Australie, Royaume-Uni, États-Unis
- Angleterre, Floride, Grand Londres
- Londres, Sydney
- National Hospital for Neurology and Neurosurgery
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Le document en format XML
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term>
<term>Agonist</term>
<term>Antiparkinson Agents (therapeutic use)</term>
<term>Antiparkinson agent</term>
<term>Benzophenones (adverse effects)</term>
<term>Benzophenones (therapeutic use)</term>
<term>Catechol O-methyltransferase</term>
<term>Chemotherapy</term>
<term>Comparative study</term>
<term>Dopamine agonist</term>
<term>Dopamine receptor</term>
<term>Dose-Response Relationship, Drug</term>
<term>Double-Blind Method</term>
<term>Drug Therapy, Combination</term>
<term>Drug combination</term>
<term>Enzyme inhibitor</term>
<term>Ergot derivatives</term>
<term>Female</term>
<term>Humans</term>
<term>Levodopa</term>
<term>Levodopa (therapeutic use)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Nitrophenols</term>
<term>Parkinson Disease (drug therapy)</term>
<term>Parkinson disease</term>
<term>Parkinson's disease</term>
<term>Pergolide</term>
<term>Pergolide (adverse effects)</term>
<term>Pergolide (therapeutic use)</term>
<term>Quality of Life</term>
<term>Randomization</term>
<term>Tolcapone</term>
<term>Toxicity</term>
<term>Treatment</term>
<term>Treatment Outcome</term>
<term>drug comparison</term>
<term>motor fluctuations</term>
<term>pergolide</term>
<term>tolcapone</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Benzophenones</term>
<term>Pergolide</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term>
<term>Benzophenones</term>
<term>Levodopa</term>
<term>Pergolide</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Dose-Response Relationship, Drug</term>
<term>Double-Blind Method</term>
<term>Drug Therapy, Combination</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Nitrophenols</term>
<term>Quality of Life</term>
<term>Treatment Outcome</term>
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<keywords scheme="Pascal" xml:lang="fr"><term>Adulte</term>
<term>Agoniste</term>
<term>Antiparkinsonien</term>
<term>Association médicamenteuse</term>
<term>Catechol O-methyltransferase</term>
<term>Chimiothérapie</term>
<term>Ergot dérivé</term>
<term>Etude comparative</term>
<term>Fluctuation motrice</term>
<term>Inhibiteur enzyme</term>
<term>Lévodopa</term>
<term>Parkinson maladie</term>
<term>Pergolide</term>
<term>Randomisation</term>
<term>Récepteur dopaminergique</term>
<term>Stimulant dopaminergique</term>
<term>Tolcapone</term>
<term>Toxicité</term>
<term>Traitement</term>
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<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Adulte</term>
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<front><div type="abstract" xml:lang="en">In this 12‐week, randomized, open‐label, blinded‐rater, parallel‐group trial, the efficacy, safety, and tolerability of tolcapone and pergolide were compared in parkinsonian patients with a fluctuating response to levodopa. Patients received tolcapone 100 mg three times daily (t.i.d.), with a possible increase to 200 mg t.i.d., or pergolide titrated to a maximum dose of 5 mg/day by week 9 (mean final dose 2.2 mg/day). The trial involved 203 patients. Efficacy variables that decreased from baseline to week 12 with tolcapone and pergolide included “off” time (reduced by 2–3 hours/day), daily levodopa intake, sickness impact profile scores, Parkinson's disease questionnaire (PDQ)‐39 scores, and Unified Parkinson's Disease Rating Scale (UPDRS) scores. Improvements in efficacy variables were similar with tolcapone and pergolide, with the exception of improvements in quality of life, which were significantly greater with tolcapone; the relative changes in PDQ‐39 score at week 12 were −8.7 and −14.2 (P < 0.05) with pergolide and tolcapone, respectively. Improvements in the investigator's global assessment (IGA) of overall efficacy were recorded in 86% of tolcapone‐treated patients and in 78% of pergolide‐treated patients. The proportion of patients who withdrew because of adverse events was higher in the pergolide group (15%) than in the tolcapone group (5%). Confusion, hypotension, nausea, constipation, abdominal pain, and dyspepsia occurred more frequently with pergolide, whereas diarrhea and urine discoloration occurred more frequently with tolcapone. Tolcapone was better tolerated than pergolide (P < 0.01) according to the IGA of overall tolerability. We conclude that, in this 3‐month study, both tolcapone and pergolide provided improvements in motor fluctuations and allowed reductions in levodopa intake when added to levodopa therapy; intent to treat analysis and a less than maximal dose of pergolide may have biased the results in favor of tolcapone. Tolcapone provided greater improvements in quality of fife, was better tolerated, and had a more favorable adverse‐event profile than pergolide. © 2001 Movement Disorder Society.</div>
</front>
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<li>Royaume-Uni</li>
<li>États-Unis</li>
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