Efficacy and safety of tolcapone in levodopa‐treated Parkinson's disease patients with “wearing‐off” phenomenon: a multicentre, double‐blind, randomized, placebo‐controlled trial
Identifieur interne : 002033 ( Main/Exploration ); précédent : 002032; suivant : 002034Efficacy and safety of tolcapone in levodopa‐treated Parkinson's disease patients with “wearing‐off” phenomenon: a multicentre, double‐blind, randomized, placebo‐controlled trial
Auteurs : V. V. Myllyl [Finlande] ; M. Jackson [Royaume-Uni] ; J. P. Larsen [Norvège] ; H. Baas [Allemagne]Source :
- European Journal of Neurology [ 1351-5101 ] ; 1997-07.
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Abstract
To assess the effect of tolcapone added to levodopa plus benserazide or carbidopa on the “wearing‐off” phenomenon in patients with Parkinson's disease, we undertook a double‐blind, randomized, placebo‐controlled, parallel‐group study of tolcapone 50, 200, or 400 mg three times daily (t.i.d.) for 6 weeks in addition to levodopa therapy. We studied 154 parkinsonian patients, aged 40 years or more, who presented with the “wearing‐off” phenomenon despite “optimal” antiparkinsonian therapy. The main outcome measures were “on”‐ and “off”‐time, Investigator's Global Assessments, Subscales of the Unified Parkinson's Disease Rating Scale, changes in levodopa dosage, and safety and tolerability. Tolcapone was more effective than placebo in reducing the “wearing‐off” phenomenon between baseline and week 6 at all three dosages. Tolcapone 200 mg t.i.d. increased “on”‐time from 37.9% of the waking day to 50.8% (p < 0.01) and reduced “off”‐time from 26.7% of the waking day to 16.4% (p < 0.05). Tolcapone treatment was generally well tolerated at all dosages. Initial exacerbation of adverse dopaminergic effects was controlled by levodopa dosage adjustment; at week 6, the mean total daily levodopa dosage had decreased by 80 mg, from 694 mg at baseline, in the tolcapone 200 mg t.i.d. group (p < 0.01). We conclude that the addition of tolcapone to levodopa plus a decarboxylase inhibitor effectively and safely reduces the “wearing‐off” phenomenon in parkinsonian patients.
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DOI: 10.1111/j.1468-1331.1997.tb00358.x
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