Efficacy and safety of entacapone in Parkinson's disease patients with suboptimal Levodopa response: a 6‐month randomized placebo‐controlled double‐blind study in Germany and Austria (Celomen study)
Identifieur interne : 001898 ( Main/Exploration ); précédent : 001897; suivant : 001899Efficacy and safety of entacapone in Parkinson's disease patients with suboptimal Levodopa response: a 6‐month randomized placebo‐controlled double‐blind study in Germany and Austria (Celomen study)
Auteurs : Werner Poewe [Autriche] ; G. Deuschl ; A. Gordin [Finlande] ; E. Kultalahti [Finlande] ; M. Leinonen [Finlande]Source :
- Acta Neurologica Scandinavica [ 0001-6314 ] ; 2002-04.
English descriptors
- KwdEn :
Abstract
Objectives– To determine the efficacy and safety of the catechol‐O‐methyltransferase (COMT) inhibitor entacapone, used as an adjunct to levodopa, in Parkinson's disease (PD) patients. Patients and methods– In this parallel group, randomized, double‐blind study, 301 PD patients, the majority with motor fluctuations, received entacapone (200 mg) or placebo with each daily dose of standard or controlled‐release (CR) levodopa. The 24‐week treatment period was followed by 2 weeks of entacapone withdrawal. Efficacy was determined by home diaries (`on' and `off' times), Unified Parkinson's Disease Rating Scale (UPDRS) and changes in levodopa dosage, and safety by adverse‐event inquiry, vital signs, electro cardiography (ECG) and laboratory tests. Results– In the total population, the UPDRS activities of daily living and motor scores were significantly improved (P < 0.05) by entacapone vs placebo. In fluctuating patients, `on' time increased (1.7 h) and `off' time decreased (1.5 h) significantly more with entacapone than with placebo (0.5 and 0.6 h, respectively; P < 0.05), and the daily levodopa dose was reduced by 54 mg with entacapone and increased by 27 mg with placebo (P < 0.05). Entacapone benefit was lost on withdrawal. Entacapone efficacy was comparable between patients using CR and standard levodopa preparations. Increased dyskinesias (entacapone 34%, placebo 26%) and nausea (10 and 5%, respectively), mostly occurring shortly after treatment initiation, were generally managed by reducing the levodopa dose. Diarrhoea (entacapone 8%, placebo 4%) was seldom severe. There were no differences in vital signs, ECG or laboratory results. Conclusion– Entacapone is an effective and safe levodopa extender and enhancer, improving the symptomatic efficacy of levodopa in PD and adding to the patients' benefit.
Url:
DOI: 10.1034/j.1600-0404.2002.1o174.x
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Efficacy and safety of entacapone in Parkinson's disease patients with suboptimal Levodopa response: a 6‐month randomized placebo‐controlled double‐blind study in Germany and Austria (Celomen study)</title><author><name sortKey="Poewe, W H" sort="Poewe, W H" uniqKey="Poewe W" first="W. H." last="Poewe">Werner Poewe</name><affiliation><country>Autriche</country><placeName><settlement type="city">Innsbruck</settlement><region nuts="2" type="region">Tyrol (Land)</region></placeName><orgName type="university">Université de médecine d'Innsbruck</orgName></affiliation></author><author><name sortKey="Deuschl, G" sort="Deuschl, G" uniqKey="Deuschl G" first="G." last="Deuschl">G. Deuschl</name></author><author><name sortKey="Gordin, A" sort="Gordin, A" uniqKey="Gordin A" first="A." last="Gordin">A. Gordin</name></author><author><name sortKey="Kultalahti, E" sort="Kultalahti, E" uniqKey="Kultalahti E" first="E." last="Kultalahti">E. Kultalahti</name></author><author><name sortKey="Leinonen, M" sort="Leinonen, M" uniqKey="Leinonen M" first="M." last="Leinonen">M. Leinonen</name></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:657F6CAB8A17F1EFA272C2DE8858524C5C9FB14B</idno><date when="2002" year="2002">2002</date><idno type="doi">10.1034/j.1600-0404.2002.1o174.x</idno><idno type="url">https://api.istex.fr/document/657F6CAB8A17F1EFA272C2DE8858524C5C9FB14B/fulltext/pdf</idno><idno type="wicri:Area/Main/Corpus">002B71</idno><idno type="wicri:Area/Main/Curation">002804</idno><idno type="wicri:Area/Main/Exploration">001898</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Efficacy and safety of entacapone in Parkinson's disease patients with suboptimal Levodopa response: a 6‐month randomized placebo‐controlled double‐blind study in Germany and Austria (Celomen study)</title><author><name sortKey="Poewe, W H" sort="Poewe, W H" uniqKey="Poewe W" first="W. H." last="Poewe">Werner Poewe</name><affiliation><wicri:noCountry code="subField"></wicri:noCountry><country>Autriche</country><placeName><settlement type="city">Innsbruck</settlement><region nuts="2" type="region">Tyrol (Land)</region></placeName><orgName type="university">Université de médecine d'Innsbruck</orgName></affiliation></author><author><name sortKey="Deuschl, G" sort="Deuschl, G" uniqKey="Deuschl G" first="G." last="Deuschl">G. Deuschl</name><affiliation><wicri:noCountry code="subField"></wicri:noCountry></affiliation></author><author><name sortKey="Gordin, A" sort="Gordin, A" uniqKey="Gordin A" first="A." last="Gordin">A. Gordin</name><affiliation wicri:level="1"><country xml:lang="fr">Finlande</country><wicri:regionArea>Research Center, Orion Pharma, Espoo</wicri:regionArea><wicri:noRegion>Espoo</wicri:noRegion></affiliation></author><author><name sortKey="Kultalahti, E" sort="Kultalahti, E" uniqKey="Kultalahti E" first="E." last="Kultalahti">E. Kultalahti</name><affiliation wicri:level="1"><country xml:lang="fr">Finlande</country><wicri:regionArea>Research Center, Orion Pharma, Espoo</wicri:regionArea><wicri:noRegion>Espoo</wicri:noRegion></affiliation></author><author><name sortKey="Leinonen, M" sort="Leinonen, M" uniqKey="Leinonen M" first="M." last="Leinonen">M. Leinonen</name><affiliation wicri:level="1"><country xml:lang="fr">Finlande</country><wicri:regionArea>Research Center, Orion Pharma, Espoo</wicri:regionArea><wicri:noRegion>Espoo</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j">Acta Neurologica Scandinavica</title><idno type="ISSN">0001-6314</idno><idno type="eISSN">1600-0404</idno><imprint><publisher>Blackwell Publishing</publisher><pubPlace>Oxford, UK</pubPlace><date type="published" when="2002-04">2002-04</date><biblScope unit="volume">105</biblScope><biblScope unit="issue">4</biblScope><biblScope unit="page" from="245">245</biblScope><biblScope unit="page" to="255">255</biblScope></imprint><idno type="ISSN">0001-6314</idno></series><idno type="istex">657F6CAB8A17F1EFA272C2DE8858524C5C9FB14B</idno><idno type="DOI">10.1034/j.1600-0404.2002.1o174.x</idno><idno type="ArticleID">ANE1O174</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0001-6314</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>COMT</term><term>Parkinson's disease</term><term>entacapone</term><term>levodopa</term><term>safety</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Objectives– To determine the efficacy and safety of the catechol‐O‐methyltransferase (COMT) inhibitor entacapone, used as an adjunct to levodopa, in Parkinson's disease (PD) patients. Patients and methods– In this parallel group, randomized, double‐blind study, 301 PD patients, the majority with motor fluctuations, received entacapone (200 mg) or placebo with each daily dose of standard or controlled‐release (CR) levodopa. The 24‐week treatment period was followed by 2 weeks of entacapone withdrawal. Efficacy was determined by home diaries (`on' and `off' times), Unified Parkinson's Disease Rating Scale (UPDRS) and changes in levodopa dosage, and safety by adverse‐event inquiry, vital signs, electro cardiography (ECG) and laboratory tests. Results– In the total population, the UPDRS activities of daily living and motor scores were significantly improved (P < 0.05) by entacapone vs placebo. In fluctuating patients, `on' time increased (1.7 h) and `off' time decreased (1.5 h) significantly more with entacapone than with placebo (0.5 and 0.6 h, respectively; P < 0.05), and the daily levodopa dose was reduced by 54 mg with entacapone and increased by 27 mg with placebo (P < 0.05). Entacapone benefit was lost on withdrawal. Entacapone efficacy was comparable between patients using CR and standard levodopa preparations. Increased dyskinesias (entacapone 34%, placebo 26%) and nausea (10 and 5%, respectively), mostly occurring shortly after treatment initiation, were generally managed by reducing the levodopa dose. Diarrhoea (entacapone 8%, placebo 4%) was seldom severe. There were no differences in vital signs, ECG or laboratory results. Conclusion– Entacapone is an effective and safe levodopa extender and enhancer, improving the symptomatic efficacy of levodopa in PD and adding to the patients' benefit.</div></front></TEI><affiliations><list><country><li>Autriche</li><li>Finlande</li></country><region><li>Tyrol (Land)</li></region><settlement><li>Innsbruck</li></settlement><orgName><li>Université de médecine d'Innsbruck</li></orgName></list><tree><noCountry><name sortKey="Deuschl, G" sort="Deuschl, G" uniqKey="Deuschl G" first="G." last="Deuschl">G. Deuschl</name></noCountry><country name="Autriche"><region name="Tyrol (Land)"><name sortKey="Poewe, W H" sort="Poewe, W H" uniqKey="Poewe W" first="W. H." last="Poewe">Werner Poewe</name></region></country><country name="Finlande"><noRegion><name sortKey="Gordin, A" sort="Gordin, A" uniqKey="Gordin A" first="A." last="Gordin">A. Gordin</name></noRegion><name sortKey="Kultalahti, E" sort="Kultalahti, E" uniqKey="Kultalahti E" first="E." last="Kultalahti">E. Kultalahti</name><name sortKey="Leinonen, M" sort="Leinonen, M" uniqKey="Leinonen M" first="M." last="Leinonen">M. Leinonen</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Sante/explor/ParkinsonV1/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001898 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 001898 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Sante
|area= ParkinsonV1
|flux= Main
|étape= Exploration
|type= RBID
|clé= ISTEX:657F6CAB8A17F1EFA272C2DE8858524C5C9FB14B
|texte= Efficacy and safety of entacapone in Parkinson's disease patients with suboptimal Levodopa response: a 6‐month randomized placebo‐controlled double‐blind study in Germany and Austria (Celomen study)
}}
| This area was generated with Dilib version V0.6.23. |  |