Early versus delayed initiation of entacapone in levodopa‐treated patients with Parkinson’s disease: a long‐term, retrospective analysis
Identifieur interne : 000F09 ( Main/Corpus ); précédent : 000F08; suivant : 000F10Early versus delayed initiation of entacapone in levodopa‐treated patients with Parkinson’s disease: a long‐term, retrospective analysis
Auteurs : H. Nissinen ; M. Kuoppam Ki ; M. Leinonen ; A. H. SchapiraSource :
- European Journal of Neurology [ 1351-5101 ] ; 2009-12.
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Abstract
Background: We analysed data from three clinical trials in Parkinson’s disease (PD) patients with wearing‐off to determine whether early enhancement of levodopa therapy with entacapone can lead to better long‐term outcomes than delayed entacapone treatment. Methods: Post‐hoc analysis of pooled data from three randomized, double‐blind, placebo‐controlled studies and their long‐term, open‐label extension phases. In all three studies, patients on levodopa/dopa‐decarboxylase inhibitor (DDCI) were first randomized to entacapone (‘early‐start’ group) or placebo (‘delayed‐start’ group) for the initial 6‐month double‐blind phase, after which all patients received open‐label levodopa/DDCI and entacapone treatment for up to 5 years. Results: A total of 488 PD patients with wearing‐off were included in the analysis. A statistically significant benefit of early initiation of levodopa/DDCI and entacapone was found, with an improvement in Unified Parkinson’s Disease Rating Scale Part III (motor) score of −1.66 (95% confidence intervals [−3.01, −0.31]) points compared with the delayed‐start treatment group (P < 0.05). Levodopa/DDCI and entacapone therapy was well tolerated. There was no excess of dyskinesia in the early‐start group. Conclusions: These data suggest that early rather than delayed addition of entacapone to levodopa/DDCI in PD patients with wearing‐off provides a modest clinical benefit over levodopa/DDCI that is maintained for up to 5 years.
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DOI: 10.1111/j.1468-1331.2009.02726.x
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ISTEX:16F213EBB8D3A357753F7CF40F76BADFB5C62FE5Le document en format XML
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Schapira</name><affiliation><mods:affiliation>University Department of Clinical Neurosciences, Institute of Neurology, University College London, National Hospital for Neurology and Neurosurgery and Royal Free Hospital, London, UK</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:16F213EBB8D3A357753F7CF40F76BADFB5C62FE5</idno><date when="2009" year="2009">2009</date><idno type="doi">10.1111/j.1468-1331.2009.02726.x</idno><idno type="url">https://api.istex.fr/document/16F213EBB8D3A357753F7CF40F76BADFB5C62FE5/fulltext/pdf</idno><idno type="wicri:Area/Main/Corpus">000F09</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Early versus delayed initiation of entacapone in levodopa‐treated patients with Parkinson’s disease: a long‐term, retrospective analysis</title><author><name sortKey="Nissinen, H" sort="Nissinen, H" uniqKey="Nissinen H" first="H." last="Nissinen">H. Nissinen</name><affiliation><mods:affiliation>Orion Pharma, Espoo, Finland</mods:affiliation></affiliation></author><author><name sortKey="Kuoppam Ki, M" sort="Kuoppam Ki, M" uniqKey="Kuoppam Ki M" first="M." last="Kuoppam Ki">M. Kuoppam Ki</name><affiliation><mods:affiliation>Orion Pharma, Turku, Finland</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Neurology, Turku University Hospital, University of Turku, Turku, Finland</mods:affiliation></affiliation></author><author><name sortKey="Leinonen, M" sort="Leinonen, M" uniqKey="Leinonen M" first="M." last="Leinonen">M. Leinonen</name><affiliation><mods:affiliation>4Pharma AB, Kista, Sweden</mods:affiliation></affiliation></author><author><name sortKey="Schapira, A H" sort="Schapira, A H" uniqKey="Schapira A" first="A. H." last="Schapira">A. H. Schapira</name><affiliation><mods:affiliation>University Department of Clinical Neurosciences, Institute of Neurology, University College London, National Hospital for Neurology and Neurosurgery and Royal Free Hospital, London, UK</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">European Journal of Neurology</title><idno type="ISSN">1351-5101</idno><idno type="eISSN">1468-1331</idno><imprint><publisher>Blackwell Publishing Ltd</publisher><pubPlace>Oxford, UK</pubPlace><date type="published" when="2009-12">2009-12</date><biblScope unit="volume">16</biblScope><biblScope unit="issue">12</biblScope><biblScope unit="page" from="1305">1305</biblScope><biblScope unit="page" to="1311">1311</biblScope></imprint><idno type="ISSN">1351-5101</idno></series><idno type="istex">16F213EBB8D3A357753F7CF40F76BADFB5C62FE5</idno><idno type="DOI">10.1111/j.1468-1331.2009.02726.x</idno><idno type="ArticleID">ENE2726</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1351-5101</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Parkinson’s disease</term><term>entacapone</term><term>levodopa</term><term>wearing‐off</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background: We analysed data from three clinical trials in Parkinson’s disease (PD) patients with wearing‐off to determine whether early enhancement of levodopa therapy with entacapone can lead to better long‐term outcomes than delayed entacapone treatment. Methods: Post‐hoc analysis of pooled data from three randomized, double‐blind, placebo‐controlled studies and their long‐term, open‐label extension phases. In all three studies, patients on levodopa/dopa‐decarboxylase inhibitor (DDCI) were first randomized to entacapone (‘early‐start’ group) or placebo (‘delayed‐start’ group) for the initial 6‐month double‐blind phase, after which all patients received open‐label levodopa/DDCI and entacapone treatment for up to 5 years. Results: A total of 488 PD patients with wearing‐off were included in the analysis. A statistically significant benefit of early initiation of levodopa/DDCI and entacapone was found, with an improvement in Unified Parkinson’s Disease Rating Scale Part III (motor) score of −1.66 (95% confidence intervals [−3.01, −0.31]) points compared with the delayed‐start treatment group (P < 0.05). Levodopa/DDCI and entacapone therapy was well tolerated. There was no excess of dyskinesia in the early‐start group. Conclusions: These data suggest that early rather than delayed addition of entacapone to levodopa/DDCI in PD patients with wearing‐off provides a modest clinical benefit over levodopa/DDCI that is maintained for up to 5 years.</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>H. Nissinen</name><affiliations><json:string>Orion Pharma, Espoo, Finland</json:string></affiliations></json:item><json:item><name>M. Kuoppamäki</name><affiliations><json:string>Orion Pharma, Turku, Finland</json:string><json:string>Department of Neurology, Turku University Hospital, University of Turku, Turku, Finland</json:string></affiliations></json:item><json:item><name>M. Leinonen</name><affiliations><json:string>4Pharma AB, Kista, Sweden</json:string></affiliations></json:item><json:item><name>A. H. Schapira</name><affiliations><json:string>University Department of Clinical Neurosciences, Institute of Neurology, University College London, National Hospital for Neurology and Neurosurgery and Royal Free Hospital, London, UK</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>entacapone</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>levodopa</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Parkinson’s disease</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>wearing‐off</value></json:item></subject><articleId><json:string>ENE2726</json:string></articleId><language><json:string>eng</json:string></language><abstract>Background: We analysed data from three clinical trials in Parkinson’s disease (PD) patients with wearing‐off to determine whether early enhancement of levodopa therapy with entacapone can lead to better long‐term outcomes than delayed entacapone treatment. Methods: Post‐hoc analysis of pooled data from three randomized, double‐blind, placebo‐controlled studies and their long‐term, open‐label extension phases. In all three studies, patients on levodopa/dopa‐decarboxylase inhibitor (DDCI) were first randomized to entacapone (‘early‐start’ group) or placebo (‘delayed‐start’ group) for the initial 6‐month double‐blind phase, after which all patients received open‐label levodopa/DDCI and entacapone treatment for up to 5 years. Results: A total of 488 PD patients with wearing‐off were included in the analysis. A statistically significant benefit of early initiation of levodopa/DDCI and entacapone was found, with an improvement in Unified Parkinson’s Disease Rating Scale Part III (motor) score of −1.66 (95% confidence intervals [−3.01, −0.31]) points compared with the delayed‐start treatment group (P > 0.05). Levodopa/DDCI and entacapone therapy was well tolerated. There was no excess of dyskinesia in the early‐start group. 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H.</forename><surname>Schapira</surname></persName><affiliation>University Department of Clinical Neurosciences, Institute of Neurology, University College London, National Hospital for Neurology and Neurosurgery and Royal Free Hospital, London, UK</affiliation></author></analytic><monogr><title level="j">European Journal of Neurology</title><idno type="pISSN">1351-5101</idno><idno type="eISSN">1468-1331</idno><idno type="DOI">10.1111/(ISSN)1468-1331</idno><imprint><publisher>Blackwell Publishing Ltd</publisher><pubPlace>Oxford, UK</pubPlace><date type="published" when="2009-12"></date><biblScope unit="volume">16</biblScope><biblScope unit="issue">12</biblScope><biblScope unit="page" from="1305">1305</biblScope><biblScope unit="page" to="1311">1311</biblScope></imprint></monogr><idno type="istex">16F213EBB8D3A357753F7CF40F76BADFB5C62FE5</idno><idno type="DOI">10.1111/j.1468-1331.2009.02726.x</idno><idno type="ArticleID">ENE2726</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2009</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Background: We analysed data from three clinical trials in Parkinson’s disease (PD) patients with wearing‐off to determine whether early enhancement of levodopa therapy with entacapone can lead to better long‐term outcomes than delayed entacapone treatment. Methods: Post‐hoc analysis of pooled data from three randomized, double‐blind, placebo‐controlled studies and their long‐term, open‐label extension phases. In all three studies, patients on levodopa/dopa‐decarboxylase inhibitor (DDCI) were first randomized to entacapone (‘early‐start’ group) or placebo (‘delayed‐start’ group) for the initial 6‐month double‐blind phase, after which all patients received open‐label levodopa/DDCI and entacapone treatment for up to 5 years. Results: A total of 488 PD patients with wearing‐off were included in the analysis. A statistically significant benefit of early initiation of levodopa/DDCI and entacapone was found, with an improvement in Unified Parkinson’s Disease Rating Scale Part III (motor) score of −1.66 (95% confidence intervals [−3.01, −0.31]) points compared with the delayed‐start treatment group (P < 0.05). Levodopa/DDCI and entacapone therapy was well tolerated. There was no excess of dyskinesia in the early‐start group. Conclusions: These data suggest that early rather than delayed addition of entacapone to levodopa/DDCI in PD patients with wearing‐off provides a modest clinical benefit over levodopa/DDCI that is maintained for up to 5 years.</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>entacapone</term></item><item><term>levodopa</term></item><item><term>Parkinson’s disease</term></item><item><term>wearing‐off</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2009-12">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/16F213EBB8D3A357753F7CF40F76BADFB5C62FE5/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>Blackwell Publishing Ltd</publisherName><publisherLoc>Oxford, UK</publisherLoc></publisherInfo><doi origin="wiley" registered="yes">10.1111/(ISSN)1468-1331</doi><issn type="print">1351-5101</issn><issn type="electronic">1468-1331</issn><idGroup><id type="product" value="ENE"></id><id type="publisherDivision" value="ST"></id></idGroup><titleGroup><title type="main" sort="EUROPEAN JOURNAL OF NEUROLOGY">European Journal of Neurology</title></titleGroup></publicationMeta><publicationMeta level="part" position="12012"><doi origin="wiley">10.1111/ene.2009.16.issue-12</doi><numberingGroup><numbering type="journalVolume" number="16">16</numbering><numbering type="journalIssue" number="12">12</numbering></numberingGroup><coverDate startDate="2009-12">December 2009</coverDate></publicationMeta><publicationMeta level="unit" type="article" position="9" status="forIssue"><doi origin="wiley">10.1111/j.1468-1331.2009.02726.x</doi><idGroup><id type="unit" value="ENE2726"></id></idGroup><countGroup><count type="pageTotal" number="7"></count></countGroup><titleGroup><title type="tocHeading1">Original Articles</title></titleGroup><copyright>© 2009 The Author(s). Journal compilation © 2009 EFNS</copyright><eventGroup><event type="firstOnline" date="2009-06-30"></event><event type="publishedOnlineFinalForm" date="2009-11-17"></event><event type="xmlConverted" agent="Converter:BPG_TO_WML3G version:2.3.2 mode:FullText source:FullText result:FullText" date="2010-03-06"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.8.8" date="2014-01-24"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.1.7 mode:FullText,remove_FC" date="2014-10-16"></event></eventGroup><numberingGroup><numbering type="pageFirst" number="1305">1305</numbering><numbering type="pageLast" number="1311">1311</numbering></numberingGroup><correspondenceTo>Helena Nissinen, MD, Orion Corporation Orion Pharma, Orionintie 1, PO Box 65, FI‐02101 Espoo, Finland (tel.: +358 10 426 4806; fax: +358 10 426 3815; e‐mail: <email>helena.nissinen@orionpharma.com</email>).</correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:ENE.ENE2726.pdf"></link></linkGroup></publicationMeta><contentMeta><unparsedEditorialHistory>Received 16 January 2009 Accepted 19 May 2009</unparsedEditorialHistory><countGroup><count type="figureTotal" number="2"></count><count type="tableTotal" number="3"></count></countGroup><titleGroup><title type="main">Early versus delayed initiation of entacapone in levodopa‐treated patients with Parkinson’s disease: a long‐term, retrospective analysis</title><title type="shortAuthors">H. Nissinen <i>et al.</i></title><title type="short">Early versus delayed initiation of entacapone in Parkinson’s disease</title></titleGroup><creators><creator creatorRole="author" xml:id="cr1" affiliationRef="#a1"><personName><givenNames>H.</givenNames><familyName>Nissinen</familyName></personName></creator><creator creatorRole="author" xml:id="cr2" affiliationRef="#a2 #a3"><personName><givenNames>M.</givenNames><familyName>Kuoppamäki</familyName></personName></creator><creator creatorRole="author" xml:id="cr3" affiliationRef="#a4"><personName><givenNames>M.</givenNames><familyName>Leinonen</familyName></personName></creator><creator creatorRole="author" xml:id="cr4" affiliationRef="#a5"><personName><givenNames>A. H. </givenNames><familyName>Schapira</familyName></personName></creator></creators><affiliationGroup><affiliation xml:id="a1" countryCode="FI"><unparsedAffiliation>Orion Pharma, Espoo, Finland</unparsedAffiliation></affiliation><affiliation xml:id="a2" countryCode="FI"><unparsedAffiliation>Orion Pharma, Turku, Finland</unparsedAffiliation></affiliation><affiliation xml:id="a3" countryCode="FI"><unparsedAffiliation>Department of Neurology, Turku University Hospital, University of Turku, Turku, Finland</unparsedAffiliation></affiliation><affiliation xml:id="a4" countryCode="SE"><unparsedAffiliation>4Pharma AB, Kista, Sweden</unparsedAffiliation></affiliation><affiliation xml:id="a5" countryCode="GB"><unparsedAffiliation>University Department of Clinical Neurosciences, Institute of Neurology, University College London, National Hospital for Neurology and Neurosurgery and Royal Free Hospital, London, UK</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en"><keyword xml:id="k1">entacapone</keyword><keyword xml:id="k2">levodopa</keyword><keyword xml:id="k3">Parkinson’s disease</keyword><keyword xml:id="k4">wearing‐off</keyword></keywordGroup><abstractGroup><abstract type="main" xml:lang="en"><p><b>Background: </b> We analysed data from three clinical trials in Parkinson’s disease (PD) patients with wearing‐off to determine whether early enhancement of levodopa therapy with entacapone can lead to better long‐term outcomes than delayed entacapone treatment.</p><p><b>Methods: </b> <i>Post‐hoc</i> analysis of pooled data from three randomized, double‐blind, placebo‐controlled studies and their long‐term, open‐label extension phases. In all three studies, patients on levodopa/dopa‐decarboxylase inhibitor (DDCI) were first randomized to entacapone (‘early‐start’ group) or placebo (‘delayed‐start’ group) for the initial 6‐month double‐blind phase, after which all patients received open‐label levodopa/DDCI and entacapone treatment for up to 5 years.</p><p><b>Results: </b> A total of 488 PD patients with wearing‐off were included in the analysis. A statistically significant benefit of early initiation of levodopa/DDCI and entacapone was found, with an improvement in Unified Parkinson’s Disease Rating Scale Part III (motor) score of −1.66 (95% confidence intervals [−3.01, −0.31]) points compared with the delayed‐start treatment group (<i>P</i> < 0.05). Levodopa/DDCI and entacapone therapy was well tolerated. There was no excess of dyskinesia in the early‐start group.</p><p><b>Conclusions: </b> These data suggest that early rather than delayed addition of entacapone to levodopa/DDCI in PD patients with wearing‐off provides a modest clinical benefit over levodopa/DDCI that is maintained for up to 5 years.</p></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Early versus delayed initiation of entacapone in levodopa‐treated patients with Parkinson’s disease: a long‐term, retrospective analysis</title></titleInfo><titleInfo type="abbreviated"><title>Early versus delayed initiation of entacapone in Parkinson’s disease</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Early versus delayed initiation of entacapone in levodopa‐treated patients with Parkinson’s disease: a long‐term, retrospective analysis</title></titleInfo><name type="personal"><namePart type="given">H.</namePart><namePart type="family">Nissinen</namePart><affiliation>Orion Pharma, Espoo, Finland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M.</namePart><namePart type="family">Kuoppamäki</namePart><affiliation>Orion Pharma, Turku, Finland</affiliation><affiliation>Department of Neurology, Turku University Hospital, University of Turku, Turku, Finland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M.</namePart><namePart type="family">Leinonen</namePart><affiliation>4Pharma AB, Kista, Sweden</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A. H.</namePart><namePart type="family">Schapira</namePart><affiliation>University Department of Clinical Neurosciences, Institute of Neurology, University College London, National Hospital for Neurology and Neurosurgery and Royal Free Hospital, London, UK</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article"></genre><originInfo><publisher>Blackwell Publishing Ltd</publisher><place><placeTerm type="text">Oxford, UK</placeTerm></place><dateIssued encoding="w3cdtf">2009-12</dateIssued><edition>Received 16 January 2009 Accepted 19 May 2009</edition><copyrightDate encoding="w3cdtf">2009</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType><extent unit="figures">2</extent><extent unit="tables">3</extent></physicalDescription><abstract lang="en">Background: We analysed data from three clinical trials in Parkinson’s disease (PD) patients with wearing‐off to determine whether early enhancement of levodopa therapy with entacapone can lead to better long‐term outcomes than delayed entacapone treatment. Methods: Post‐hoc analysis of pooled data from three randomized, double‐blind, placebo‐controlled studies and their long‐term, open‐label extension phases. In all three studies, patients on levodopa/dopa‐decarboxylase inhibitor (DDCI) were first randomized to entacapone (‘early‐start’ group) or placebo (‘delayed‐start’ group) for the initial 6‐month double‐blind phase, after which all patients received open‐label levodopa/DDCI and entacapone treatment for up to 5 years. Results: A total of 488 PD patients with wearing‐off were included in the analysis. A statistically significant benefit of early initiation of levodopa/DDCI and entacapone was found, with an improvement in Unified Parkinson’s Disease Rating Scale Part III (motor) score of −1.66 (95% confidence intervals [−3.01, −0.31]) points compared with the delayed‐start treatment group (P < 0.05). Levodopa/DDCI and entacapone therapy was well tolerated. There was no excess of dyskinesia in the early‐start group. Conclusions: These data suggest that early rather than delayed addition of entacapone to levodopa/DDCI in PD patients with wearing‐off provides a modest clinical benefit over levodopa/DDCI that is maintained for up to 5 years.</abstract><subject lang="en"><genre>Keywords</genre><topic>entacapone</topic><topic>levodopa</topic><topic>Parkinson’s disease</topic><topic>wearing‐off</topic></subject><relatedItem type="host"><titleInfo><title>European Journal of Neurology</title></titleInfo><genre type="Journal">journal</genre><identifier type="ISSN">1351-5101</identifier><identifier type="eISSN">1468-1331</identifier><identifier type="DOI">10.1111/(ISSN)1468-1331</identifier><identifier type="PublisherID">ENE</identifier><part><date>2009</date><detail type="volume"><caption>vol.</caption><number>16</number></detail><detail type="issue"><caption>no.</caption><number>12</number></detail><extent unit="pages"><start>1305</start><end>1311</end><total>7</total></extent></part></relatedItem><identifier type="istex">16F213EBB8D3A357753F7CF40F76BADFB5C62FE5</identifier><identifier type="DOI">10.1111/j.1468-1331.2009.02726.x</identifier><identifier type="ArticleID">ENE2726</identifier><accessCondition type="use and reproduction" contentType="copyright">© 2009 The Author(s). 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