Randomized trial of tolcapone versus pergolide as add‐on to levodopa therapy in Parkinson's disease patients with motor fluctuations
Identifieur interne : 000092 ( Istex/Curation ); précédent : 000091; suivant : 000093Randomized 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 [Royaume-Uni] ; Miroslava Doder [Royaume-Uni] ; Mariese Hely [Australie]Source :
- Movement Disorders [ 0885-3185 ] ; 2001-09.
English descriptors
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.
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DOI: 10.1002/mds.1175
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<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Randomized trial of tolcapone versus pergolide as add‐on to levodopa therapy in Parkinson's disease patients with motor fluctuations</title><author><name sortKey="Koller, William" sort="Koller, William" uniqKey="Koller W" first="William" last="Koller">William Koller</name><affiliation wicri:level="2"><mods:affiliation>University of Miami, Miami, Florida</mods:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Floride</region></placeName><wicri:cityArea>University of Miami, Miami</wicri:cityArea></affiliation></author><author><name sortKey="Lees, Andrew" sort="Lees, Andrew" uniqKey="Lees A" first="Andrew" last="Lees">Andrew Lees</name><affiliation wicri:level="1"><mods:affiliation>National Hospital for Neurology and Neurosurgery, London, United Kingdom</mods:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>National Hospital for Neurology and Neurosurgery, London</wicri:regionArea></affiliation></author><author><name sortKey="Doder, Miroslava" sort="Doder, Miroslava" uniqKey="Doder M" first="Miroslava" last="Doder">Miroslava Doder</name><affiliation wicri:level="1"><mods:affiliation>National Hospital for Neurology and Neurosurgery, London, United Kingdom</mods:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>National Hospital for Neurology and Neurosurgery, London</wicri:regionArea></affiliation></author><author><name sortKey="Hely, Mariese" sort="Hely, Mariese" uniqKey="Hely M" first="Mariese" last="Hely">Mariese Hely</name><affiliation wicri:level="1"><mods:affiliation>Westmead Hospital, Sydney, Australia</mods:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Westmead Hospital, Sydney</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:8F05002ECD878E4F188477748156E8ED80B16F9B</idno><date when="2001" year="2001">2001</date><idno type="doi">10.1002/mds.1175</idno><idno type="url">https://api.istex.fr/document/8F05002ECD878E4F188477748156E8ED80B16F9B/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">000092</idno><idno type="wicri:Area/Istex/Curation">000092</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Randomized trial of tolcapone versus pergolide as add‐on to levodopa therapy in Parkinson's disease patients with motor fluctuations</title><author><name sortKey="Koller, William" sort="Koller, William" uniqKey="Koller W" first="William" last="Koller">William Koller</name><affiliation wicri:level="2"><mods:affiliation>University of Miami, Miami, Florida</mods:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Floride</region></placeName><wicri:cityArea>University of Miami, Miami</wicri:cityArea></affiliation></author><author><name sortKey="Lees, Andrew" sort="Lees, Andrew" uniqKey="Lees A" first="Andrew" last="Lees">Andrew Lees</name><affiliation wicri:level="1"><mods:affiliation>National Hospital for Neurology and Neurosurgery, London, United Kingdom</mods:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>National Hospital for Neurology and Neurosurgery, London</wicri:regionArea></affiliation></author><author><name sortKey="Doder, Miroslava" sort="Doder, Miroslava" uniqKey="Doder M" first="Miroslava" last="Doder">Miroslava Doder</name><affiliation wicri:level="1"><mods:affiliation>National Hospital for Neurology and Neurosurgery, London, United Kingdom</mods:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>National Hospital for Neurology and Neurosurgery, London</wicri:regionArea></affiliation></author><author><name sortKey="Hely, Mariese" sort="Hely, Mariese" uniqKey="Hely M" first="Mariese" last="Hely">Mariese Hely</name><affiliation wicri:level="1"><mods:affiliation>Westmead Hospital, Sydney, Australia</mods:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Westmead Hospital, Sydney</wicri:regionArea></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>John Wiley & Sons, Inc.</publisher><pubPlace>New York</pubPlace><date type="published" when="2001-09">2001-09</date><biblScope unit="vol">16</biblScope><biblScope unit="issue">5</biblScope><biblScope unit="page" from="858">858</biblScope><biblScope unit="page" to="866">866</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">8F05002ECD878E4F188477748156E8ED80B16F9B</idno><idno type="DOI">10.1002/mds.1175</idno><idno type="ArticleID">MDS1175</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Parkinson's disease</term><term>drug comparison</term><term>motor fluctuations</term><term>pergolide</term><term>tolcapone</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><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></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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