Comparison of two dosages of tolcapone added to levodopa in nonfluctuating patients with PD
Identifieur interne : 003345 ( Main/Curation ); 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.
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- Pascal (Inist)
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- topic : Homme.
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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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<affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of Neurological Sciences, Hopital de l'Enfant Jesus</s1>
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<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>
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<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>
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<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>
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