Comparison of two dosages of tolcapone added to levodopa in nonfluctuating patients with PD.
Identifieur interne : 005653 ( Main/Exploration ); précédent : 005652; suivant : 005654Comparison of two dosages of tolcapone added to levodopa in nonfluctuating patients with PD.
Auteurs : O. Suchowersky [Canada] ; P. Bailey ; E. Pourcher ; L. Bulger ; G. FacciponteSource :
- Clinical neuropharmacology [ 0362-5664 ]
English descriptors
- KwdEn :
- MESH :
- chemical , administration & dosage : Antiparkinson Agents, Benzophenones.
- chemical , therapeutic use : Levodopa.
- drug therapy : Parkinson Disease.
- Adult, Aged, Cross-Over Studies, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Nitrophenols.
Abstract
The efficacy and safety of two dosages of tolcapone were compared in a 12-week crossover trial involving 118 nonfluctuating patients with PD on a stable dose of levodopa (L-Dopa). At trial onset, all patients received open-label tolcapone 100 mg three times daily for 4 weeks. At week 4, 116 eligible patients entered an 8-week double-blind treatment period and were randomized to receive tolcapone three times daily at either 100 mg (group 1; n = 58) or 200 mg (group 2; n = 58) until week 8, followed by the alternative tolcapone dosage until week 12. Ratings included Unified Parkinson's Disease Rating Scale (UPDRS), Schwab & England, and patient diaries, assessed at baseline and at 4, 8, and 12 weeks. At week 4, the investigator's global assessment (IGA) of efficacy showed improvement in 76% of patients. The mean total daily L-Dopa dose and mean UPDRS scores for subscales II and III decreased significantly (p < 0.001). During the double-blind treatment period, IGA showed improvements at either or both dosages in 61% of patients; further changes in other efficacy variables were minimal and were similar with both tolcapone dosages. The most frequent adverse events were dopaminergic (nausea and dyskinesia); the most frequent nondopaminergic adverse event was diarrhea. The incidence of adverse events during double-blind treatment was slightly higher with tolcapone 200 mg three times daily (33%) than with tolcapone 100 mg three times daily (24%). The authors conclude that tolcapone dosages of 100 mg three times daily and 200 mg three times daily are well tolerated and equally effective in improving function in L-Dopa-treated nonfluctuating patients with PD.
PubMed: 11479392
Affiliations:
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Comparison of two dosages of tolcapone added to levodopa in nonfluctuating patients with PD.</title><author><name sortKey="Suchowersky, O" sort="Suchowersky, O" uniqKey="Suchowersky O" first="O" last="Suchowersky">O. Suchowersky</name><affiliation wicri:level="4"><nlm:affiliation>Department of Clinical Neurosciences, Faculty of Medicine, University of Calgary, Alberta, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Clinical Neurosciences, Faculty of Medicine, University of Calgary, Alberta</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation></author><author><name sortKey="Bailey, P" sort="Bailey, P" uniqKey="Bailey P" first="P" last="Bailey">P. Bailey</name></author><author><name sortKey="Pourcher, E" sort="Pourcher, E" uniqKey="Pourcher E" first="E" last="Pourcher">E. Pourcher</name></author><author><name sortKey="Bulger, L" sort="Bulger, L" uniqKey="Bulger L" first="L" last="Bulger">L. Bulger</name></author><author><name sortKey="Facciponte, G" sort="Facciponte, G" uniqKey="Facciponte G" first="G" last="Facciponte">G. Facciponte</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="????"><PubDate><MedlineDate>2001 Jul-Aug</MedlineDate></PubDate></date><idno type="RBID">pubmed:11479392</idno><idno type="pmid">11479392</idno><idno type="wicri:Area/PubMed/Corpus">001562</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001562</idno><idno type="wicri:Area/PubMed/Curation">001562</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">001562</idno><idno type="wicri:Area/PubMed/Checkpoint">001562</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">001562</idno><idno type="wicri:Area/Ncbi/Merge">000170</idno><idno type="wicri:Area/Ncbi/Curation">000170</idno><idno type="wicri:Area/Ncbi/Checkpoint">000170</idno><idno type="wicri:doubleKey">0362-5664::Suchowersky O:comparison:of:two</idno><idno type="wicri:Area/Main/Merge">006070</idno><idno type="wicri:Area/Main/Curation">005653</idno><idno type="wicri:Area/Main/Exploration">005653</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Comparison of two dosages of tolcapone added to levodopa in nonfluctuating patients with PD.</title><author><name sortKey="Suchowersky, O" sort="Suchowersky, O" uniqKey="Suchowersky O" first="O" last="Suchowersky">O. Suchowersky</name><affiliation wicri:level="4"><nlm:affiliation>Department of Clinical Neurosciences, Faculty of Medicine, University of Calgary, Alberta, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Clinical Neurosciences, Faculty of Medicine, University of Calgary, Alberta</wicri:regionArea><orgName type="university">Université de Calgary</orgName><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName></affiliation></author><author><name sortKey="Bailey, P" sort="Bailey, P" uniqKey="Bailey P" first="P" last="Bailey">P. Bailey</name></author><author><name sortKey="Pourcher, E" sort="Pourcher, E" uniqKey="Pourcher E" first="E" last="Pourcher">E. Pourcher</name></author><author><name sortKey="Bulger, L" sort="Bulger, L" uniqKey="Bulger L" first="L" last="Bulger">L. Bulger</name></author><author><name sortKey="Facciponte, G" sort="Facciponte, G" uniqKey="Facciponte G" first="G" last="Facciponte">G. Facciponte</name></author></analytic><series><title level="j">Clinical neuropharmacology</title><idno type="ISSN">0362-5664</idno></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Antiparkinson Agents (administration & dosage)</term><term>Benzophenones (administration & dosage)</term><term>Cross-Over Studies</term><term>Double-Blind Method</term><term>Drug Therapy, Combination</term><term>Female</term><term>Humans</term><term>Levodopa (therapeutic use)</term><term>Male</term><term>Middle Aged</term><term>Nitrophenols</term><term>Parkinson Disease (drug therapy)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiparkinson Agents</term><term>Benzophenones</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Levodopa</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Cross-Over Studies</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></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The efficacy and safety of two dosages of tolcapone were compared in a 12-week crossover trial involving 118 nonfluctuating patients with PD on a stable dose of levodopa (L-Dopa). At trial onset, all patients received open-label tolcapone 100 mg three times daily for 4 weeks. At week 4, 116 eligible patients entered an 8-week double-blind treatment period and were randomized to receive tolcapone three times daily at either 100 mg (group 1; n = 58) or 200 mg (group 2; n = 58) until week 8, followed by the alternative tolcapone dosage until week 12. Ratings included Unified Parkinson's Disease Rating Scale (UPDRS), Schwab & England, and patient diaries, assessed at baseline and at 4, 8, and 12 weeks. At week 4, the investigator's global assessment (IGA) of efficacy showed improvement in 76% of patients. The mean total daily L-Dopa dose and mean UPDRS scores for subscales II and III decreased significantly (p < 0.001). During the double-blind treatment period, IGA showed improvements at either or both dosages in 61% of patients; further changes in other efficacy variables were minimal and were similar with both tolcapone dosages. The most frequent adverse events were dopaminergic (nausea and dyskinesia); the most frequent nondopaminergic adverse event was diarrhea. The incidence of adverse events during double-blind treatment was slightly higher with tolcapone 200 mg three times daily (33%) than with tolcapone 100 mg three times daily (24%). The authors conclude that tolcapone dosages of 100 mg three times daily and 200 mg three times daily are well tolerated and equally effective in improving function in L-Dopa-treated nonfluctuating patients with PD.</div></front></TEI><affiliations><list><country><li>Canada</li></country><region><li>Alberta</li></region><settlement><li>Calgary</li></settlement><orgName><li>Université de Calgary</li></orgName></list><tree><noCountry><name sortKey="Bailey, P" sort="Bailey, P" uniqKey="Bailey P" first="P" last="Bailey">P. Bailey</name><name sortKey="Bulger, L" sort="Bulger, L" uniqKey="Bulger L" first="L" last="Bulger">L. Bulger</name><name sortKey="Facciponte, G" sort="Facciponte, G" uniqKey="Facciponte G" first="G" last="Facciponte">G. Facciponte</name><name sortKey="Pourcher, E" sort="Pourcher, E" uniqKey="Pourcher E" first="E" last="Pourcher">E. Pourcher</name></noCountry><country name="Canada"><region name="Alberta"><name sortKey="Suchowersky, O" sort="Suchowersky, O" uniqKey="Suchowersky O" first="O" last="Suchowersky">O. Suchowersky</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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