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Table of Contents
Vol. 45, No. 2, 2001
Issue release date: February 2001
Section title: Original Paper
Eur Neurol 2001;45:111–118
(DOI:10.1159/000052104)

Efficacy and Tolerability of Entacapone as Adjunctive Therapy to Levodopa in Patients with Parkinson’s Disease and End-of-Dose Deterioration in Daily Medical Practice: An Open, Multicenter Study

Durif F.a · Devaux I.a · Pere J.-J.b · Delumeau J.-C.c · Bourdeix I.b
aDepartment of Neurology, University Hospital of Clermont-Ferrand, bNovartis Pharma SA, Paris, France; cNovartis Pharma AG, Basel, Switzerland

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Article / Publication Details

First-Page Preview
Abstract of Original Paper

Published online: February 16, 2001
Issue release date: February 2001

Number of Print Pages: 8
Number of Figures: 1
Number of Tables: 5

ISSN: 0014-3022 (Print)
eISSN: 1421-9913 (Online)

For additional information: http://www.karger.com/ENE

Abstract

Entacapone is a potent, reversible and orally active inhibitor of catechol-O-methyltransferase. This open multicenter study evaluated the efficacy, safety and tolerability of entacapone as adjunct therapy to levodopa/dopa decarboxylase inhibitor (≧3 daily doses) in patients with idiopathic Parkinson’s disease and end-of-dose motor fluctuations. The 8-week study included 489 patients under conditions of typical daily medical practice. Patients were treated with a 200-mg fixed dose of entacapone administered with each scheduled dose of levodopa to a maximum of 10 doses per day. Other antiparkinsonian medication should have been stable for at least 1 month. The primary efficacy criteria were: (1) Part II (activities of daily living, ADL) of the Unified Parkinson’s Disease Rating Scale (UPDRS), (2) the reduction of ‘off’ time during the daily waking period as assessed by the percentage of patients improving by at least one category at Item 39 of Part IV of the UPDRS. Secondary outcome measures included: (1) the investigator’s global assessment of change, (2) quality of life (QoL) was assessed using the Parkinson’s Disease Questionnaire (PDQ-39). Adverse events, vital signs and liver enzymes were monitored at weeks 2 and 8. The baseline mean score for ADL was 10.5 (±7.04), which decreased to 8.5 (±6.37) at the end of the study (p < 0.0001). Compared to baseline, 40.8% of patients experienced a reduction in ‘off’ time during the waking period; this improvement was highly significant (p < 0.0001). A reduction in the daily dose of levodopa was observed in 35.8% of patients (mean decrease 209 ± 149 mg). QoL was improved by a mean of 10% in all categories of the PDQ-39 (p < 0.001), except social support and cognition. This improvement was statistically significant (p < 0.001). The dyskinesia score (UPDRS Item 32) was decreased significantly from 2.3 to 2.1 from baseline to end of study (p < 0.001), although 52.7% of patients reported levodopa-induced dyskinesia as an adverse event. There was no case of increased liver enzymes. The study results confirm that the excellent risk/benefit ratio seen in phase III controlled studies can be seen in daily neurological practice. Moreover, the study suggests that the benefits of entacapone are associated with a significant improvement in QoL.

© 2001 S. Karger AG, Basel


Article / Publication Details

First-Page Preview
Abstract of Original Paper

Published online: February 16, 2001
Issue release date: February 2001

Number of Print Pages: 8
Number of Figures: 1
Number of Tables: 5

ISSN: 0014-3022 (Print)
eISSN: 1421-9913 (Online)

For additional information: http://www.karger.com/ENE


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Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.