Randomized trial of tolcapone versus pergolide as add-on to levodopa therapy in Parkinson's disease patients with motor fluctuations
Identifieur interne : 002919 ( PascalFrancis/Checkpoint ); précédent : 002918; suivant : 002920Randomized 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.
Descripteurs français
- Pascal (Inist)
- Parkinson maladie, Lévodopa, Chimiothérapie, Antiparkinsonien, Tolcapone, Inhibiteur enzyme, Catechol O-methyltransferase, Pergolide, Agoniste, Récepteur dopaminergique, Stimulant dopaminergique, Randomisation, Etude comparative, Traitement, Association médicamenteuse, Adulte, Toxicité, Ergot dérivé, Fluctuation motrice.
- Wicri :
- topic : Adulte.
English descriptors
- KwdEn :
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 life, was better tolerated, and had a more favorable adverse-event profile than pergolide.
Affiliations:
- Australie, Royaume-Uni, États-Unis
- Angleterre, Floride, Grand Londres
- Londres, Sydney
- National Hospital for Neurology and Neurosurgery
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uniqKey="Koller W" first="William" last="Koller">William Koller</name><affiliation wicri:level="2"><inist:fA14 i1="01"><s1>University of Miami</s1><s2>Miami, Florida</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region></placeName></affiliation></author><author><name sortKey="Lees, Andrew" sort="Lees, Andrew" uniqKey="Lees A" first="Andrew" last="Lees">Andrew Lees (neurologue)</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>National Hospital for Neurology and Neurosurgery</s1><s2>London</s2><s3>GBR</s3><sZ>2 aut.</sZ><sZ>3 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName><orgName>National Hospital for Neurology and Neurosurgery</orgName></affiliation></author><author><name sortKey="Doder, Miroslava" sort="Doder, Miroslava" uniqKey="Doder M" first="Miroslava" last="Doder">Miroslava Doder</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>National Hospital for Neurology and Neurosurgery</s1><s2>London</s2><s3>GBR</s3><sZ>2 aut.</sZ><sZ>3 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Hely, Mariese" sort="Hely, Mariese" uniqKey="Hely M" first="Mariese" last="Hely">Mariese Hely</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Westmead Hospital</s1><s2>Sydney</s2><s3>AUS</s3><sZ>4 aut.</sZ></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement></placeName></affiliation></author></analytic><series><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno><imprint><date when="2001">2001</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Agonist</term><term>Antiparkinson agent</term><term>Catechol O-methyltransferase</term><term>Chemotherapy</term><term>Comparative study</term><term>Dopamine agonist</term><term>Dopamine receptor</term><term>Drug combination</term><term>Enzyme inhibitor</term><term>Ergot derivatives</term><term>Levodopa</term><term>Parkinson disease</term><term>Pergolide</term><term>Randomization</term><term>Tolcapone</term><term>Toxicity</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Parkinson maladie</term><term>Lévodopa</term><term>Chimiothérapie</term><term>Antiparkinsonien</term><term>Tolcapone</term><term>Inhibiteur enzyme</term><term>Catechol O-methyltransferase</term><term>Pergolide</term><term>Agoniste</term><term>Récepteur dopaminergique</term><term>Stimulant dopaminergique</term><term>Randomisation</term><term>Etude comparative</term><term>Traitement</term><term>Association médicamenteuse</term><term>Adulte</term><term>Toxicité</term><term>Ergot dérivé</term><term>Fluctuation motrice</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Adulte</term></keywords></textClass></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. 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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. 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dopaminérgico</s0><s5>13</s5></fC03><fC03 i1="12" i2="X" l="FRE"><s0>Randomisation</s0><s5>16</s5></fC03><fC03 i1="12" i2="X" l="ENG"><s0>Randomization</s0><s5>16</s5></fC03><fC03 i1="12" i2="X" l="SPA"><s0>Aleatorización</s0><s5>16</s5></fC03><fC03 i1="13" i2="X" l="FRE"><s0>Etude comparative</s0><s5>17</s5></fC03><fC03 i1="13" i2="X" l="ENG"><s0>Comparative study</s0><s5>17</s5></fC03><fC03 i1="13" i2="X" l="SPA"><s0>Estudio comparativo</s0><s5>17</s5></fC03><fC03 i1="14" i2="X" l="FRE"><s0>Traitement</s0><s5>18</s5></fC03><fC03 i1="14" i2="X" l="ENG"><s0>Treatment</s0><s5>18</s5></fC03><fC03 i1="14" i2="X" l="SPA"><s0>Tratamiento</s0><s5>18</s5></fC03><fC03 i1="15" i2="X" l="FRE"><s0>Association médicamenteuse</s0><s5>19</s5></fC03><fC03 i1="15" i2="X" l="ENG"><s0>Drug combination</s0><s5>19</s5></fC03><fC03 i1="15" i2="X" l="SPA"><s0>Asociación medicamentosa</s0><s5>19</s5></fC03><fC03 i1="16" i2="X" l="FRE"><s0>Adulte</s0><s5>20</s5></fC03><fC03 i1="16" i2="X" 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l="SPA"><s0>Transferases</s0><s2>FE</s2></fC07><fC07 i1="03" i2="X" l="FRE"><s0>Enzyme</s0></fC07><fC07 i1="03" i2="X" l="ENG"><s0>Enzyme</s0></fC07><fC07 i1="03" i2="X" l="SPA"><s0>Enzima</s0></fC07><fC07 i1="04" i2="X" l="FRE"><s0>Homme</s0></fC07><fC07 i1="04" i2="X" l="ENG"><s0>Human</s0></fC07><fC07 i1="04" i2="X" l="SPA"><s0>Hombre</s0></fC07><fC07 i1="05" i2="X" l="FRE"><s0>Système nerveux pathologie</s0><s5>37</s5></fC07><fC07 i1="05" i2="X" l="ENG"><s0>Nervous system diseases</s0><s5>37</s5></fC07><fC07 i1="05" i2="X" l="SPA"><s0>Sistema nervioso patología</s0><s5>37</s5></fC07><fC07 i1="06" i2="X" l="FRE"><s0>Système nerveux central pathologie</s0><s5>38</s5></fC07><fC07 i1="06" i2="X" l="ENG"><s0>Central nervous system disease</s0><s5>38</s5></fC07><fC07 i1="06" i2="X" l="SPA"><s0>Sistema nervosio central patología</s0><s5>38</s5></fC07><fC07 i1="07" i2="X" l="FRE"><s0>Encéphale pathologie</s0><s5>39</s5></fC07><fC07 i1="07" i2="X" l="ENG"><s0>Cerebral disorder</s0><s5>39</s5></fC07><fC07 i1="07" i2="X" l="SPA"><s0>Encéfalo patología</s0><s5>39</s5></fC07><fC07 i1="08" i2="X" l="FRE"><s0>Extrapyramidal syndrome</s0><s5>40</s5></fC07><fC07 i1="08" i2="X" l="ENG"><s0>Extrapyramidal syndrome</s0><s5>40</s5></fC07><fC07 i1="08" i2="X" l="SPA"><s0>Extrapiramidal síndrome</s0><s5>40</s5></fC07><fC07 i1="09" i2="X" l="FRE"><s0>Maladie dégénérative</s0><s5>41</s5></fC07><fC07 i1="09" i2="X" l="ENG"><s0>Degenerative disease</s0><s5>41</s5></fC07><fC07 i1="09" i2="X" l="SPA"><s0>Enfermedad degenerativa</s0><s5>41</s5></fC07><fN21><s1>021</s1></fN21></pA></standard></inist><affiliations><list><country><li>Australie</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Floride</li><li>Grand Londres</li></region><settlement><li>Londres</li><li>Sydney</li></settlement><orgName><li>National Hospital for Neurology and Neurosurgery</li></orgName></list><tree><country name="États-Unis"><region name="Floride"><name sortKey="Koller, William" sort="Koller, William" uniqKey="Koller W" first="William" last="Koller">William Koller</name></region></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Lees, Andrew" sort="Lees, Andrew" uniqKey="Lees A" first="Andrew" last="Lees">Andrew Lees (neurologue)</name></region><name sortKey="Doder, Miroslava" sort="Doder, Miroslava" uniqKey="Doder M" first="Miroslava" last="Doder">Miroslava Doder</name></country><country name="Australie"><noRegion><name sortKey="Hely, Mariese" sort="Hely, Mariese" uniqKey="Hely M" first="Mariese" last="Hely">Mariese Hely</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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