Comparison of two dosages of tolcapone added to levodopa in nonfluctuating patients with PD
Identifieur interne : 003345 ( Main/Exploration ); précédent : 003344; suivant : 003346Comparison of two dosages of tolcapone added to levodopa in nonfluctuating patients with PD
Auteurs : Oksana Suchowersky [États-Unis, Canada] ; Peter Bailey ; E. Pourcher ; Lynne Bulger ; Giovanni FacciponteSource :
- Clinical neuropharmacology [ 0362-5664 ] ; 2001.
Descripteurs français
- Pascal (Inist)
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- topic : Homme.
English descriptors
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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.
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Pourcher</name></author><author><name sortKey="Bulger, Lynne" sort="Bulger, Lynne" uniqKey="Bulger L" first="Lynne" last="Bulger">Lynne Bulger</name></author><author><name sortKey="Facciponte, Giovanni" sort="Facciponte, Giovanni" uniqKey="Facciponte G" first="Giovanni" last="Facciponte">Giovanni Facciponte</name></author></analytic><series><title level="j" type="main">Clinical neuropharmacology</title><title level="j" type="abbreviated">Clin. neuropharmacol.</title><idno type="ISSN">0362-5664</idno><imprint><date when="2001">2001</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Clinical neuropharmacology</title><title level="j" type="abbreviated">Clin. neuropharmacol.</title><idno type="ISSN">0362-5664</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiparkinson agent</term><term>Chemotherapy</term><term>Controlled therapeutic trial</term><term>Drug combination</term><term>Drug interaction</term><term>High dose</term><term>Human</term><term>Levodopa</term><term>Long term</term><term>Low dose</term><term>Multiple dose</term><term>Oral administration</term><term>Parkinson disease</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>Antiparkinsonien</term><term>Tolcapone</term><term>Traitement</term><term>Chimiothérapie</term><term>Homme</term><term>Association médicamenteuse</term><term>Interaction médicamenteuse</term><term>Toxicité</term><term>Long terme</term><term>Essai thérapeutique contrôlé</term><term>Dose répétée</term><term>Dose forte</term><term>Dose faible</term><term>Voie orale</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</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><li>États-Unis</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, Peter" sort="Bailey, Peter" uniqKey="Bailey P" first="Peter" last="Bailey">Peter Bailey</name><name sortKey="Bulger, Lynne" sort="Bulger, Lynne" uniqKey="Bulger L" first="Lynne" last="Bulger">Lynne Bulger</name><name sortKey="Facciponte, Giovanni" sort="Facciponte, Giovanni" uniqKey="Facciponte G" first="Giovanni" last="Facciponte">Giovanni Facciponte</name><name sortKey="Pourcher, E" sort="Pourcher, E" uniqKey="Pourcher E" first="E." last="Pourcher">E. Pourcher</name></noCountry><country name="États-Unis"><region name="Alberta"><name sortKey="Suchowersky, Oksana" sort="Suchowersky, Oksana" uniqKey="Suchowersky O" first="Oksana" last="Suchowersky">Oksana Suchowersky</name></region><name sortKey="Suchowersky, Oksana" sort="Suchowersky, Oksana" uniqKey="Suchowersky O" first="Oksana" last="Suchowersky">Oksana Suchowersky</name></country><country name="Canada"><noRegion><name sortKey="Suchowersky, Oksana" sort="Suchowersky, Oksana" uniqKey="Suchowersky O" first="Oksana" last="Suchowersky">Oksana Suchowersky</name></noRegion><name sortKey="Suchowersky, Oksana" sort="Suchowersky, Oksana" uniqKey="Suchowersky O" first="Oksana" last="Suchowersky">Oksana Suchowersky</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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