Double‐blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease
Identifieur interne : 000452 ( Main/Corpus ); précédent : 000451; suivant : 000453Double‐blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease
Auteurs : Robert A. Hauser ; Michel Panisset ; Giovanni Abbruzzese ; Linda Mancione ; Nalina Dronamraju ; Algirdas KakariekaSource :
- Movement Disorders [ 0885-3185 ] ; 2009-03-15.
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Abstract
We performed a 39‐week, randomized, double‐blind, multicenter study to compare the efficacy, safety, and tolerability of levodopa/carbidopa/entacapone (LCE, Stalevo) with levodopa/carbidopa (LC, Sinemet IR) in patients with early Parkinson's disease (PD). Four hundred twenty‐three patients with early PD warranting levodopa were randomly assigned to treatment with LCE 100/25/200 or LC 100/25 three‐times daily. The adjusted mean difference in total Unified Parkinson's disease Rating Scale (UPDRS) Parts II and III between groups using the analysis of covariance model (prespecified primary outcome measure) was 1.7 (standard error = 0.84) points favoring LCE (P = 0.045). Significantly greater improvement with LCE compared with LC was also observed in UPDRS Part II activities of daily living (ADL) scores (P = 0.025), Schwab and England ADL scores (blinded rater, P = 0.003; subject, P = 0.006) and subject‐reported Clinical Global Impression (CGI) scores (P = 0.047). There was no significant difference in UPDRS Part III or investigator‐rated CGI scores. Wearing‐off was observed in 29 (13.9%) subjects in the LCE group and 43 (20.0%) in the LC group (P = 0.099). Dyskinesia was observed in 11 (5.3%) subjects in the LCE group and 16 (7.4%) in the LC group (P = 0.367). Nausea and diarrhea were reported more frequently in the LCE group. LCE provided greater symptomatic benefit than LC and did not increase motor complications. © 2008 Movement Disorder Society
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DOI: 10.1002/mds.22343
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Hauser</name><affiliation><mods:affiliation>Parkinson's Disease and Movement Disorders Center of Excellence, University of South Florida, Tampa, FL, USA</mods:affiliation></affiliation></author><author><name sortKey="Panisset, Michel" sort="Panisset, Michel" uniqKey="Panisset M" first="Michel" last="Panisset">Michel Panisset</name><affiliation><mods:affiliation>André‐Barbeau Movement Disorders Unit, Department of Medicine (Neurology), University of Montreal, Quebec, Canada</mods:affiliation></affiliation></author><author><name sortKey="Abbruzzese, Giovanni" sort="Abbruzzese, Giovanni" uniqKey="Abbruzzese G" first="Giovanni" last="Abbruzzese">Giovanni Abbruzzese</name><affiliation><mods:affiliation>Department of Neurological Sciences, Movement Disorder Unit, University of Genoa, Genoa, Italy</mods:affiliation></affiliation></author><author><name sortKey="Mancione, Linda" sort="Mancione, Linda" uniqKey="Mancione L" first="Linda" last="Mancione">Linda Mancione</name><affiliation><mods:affiliation>Novartis Pharmaceuticals, East Hanover, NJ, USA</mods:affiliation></affiliation></author><author><name sortKey="Dronamraju, Nalina" sort="Dronamraju, Nalina" uniqKey="Dronamraju N" first="Nalina" last="Dronamraju">Nalina Dronamraju</name><affiliation><mods:affiliation>Novartis Pharmaceuticals, East Hanover, NJ, USA</mods:affiliation></affiliation></author><author><name sortKey="Kakarieka, Algirdas" sort="Kakarieka, Algirdas" uniqKey="Kakarieka A" first="Algirdas" last="Kakarieka">Algirdas Kakarieka</name><affiliation><mods:affiliation>Novartis Pharma AG, Basel, Switzerland</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:040A5F110A6A28ADFF13CCEDF4A94E8B38A8CF05</idno><date when="2009" year="2009">2009</date><idno type="doi">10.1002/mds.22343</idno><idno type="url">https://api.istex.fr/document/040A5F110A6A28ADFF13CCEDF4A94E8B38A8CF05/fulltext/pdf</idno><idno type="wicri:Area/Main/Corpus">000452</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Double‐blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease</title><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name><affiliation><mods:affiliation>Parkinson's Disease and Movement Disorders Center of Excellence, University of South Florida, Tampa, FL, USA</mods:affiliation></affiliation></author><author><name sortKey="Panisset, Michel" sort="Panisset, Michel" uniqKey="Panisset M" first="Michel" last="Panisset">Michel Panisset</name><affiliation><mods:affiliation>André‐Barbeau Movement Disorders Unit, Department of Medicine (Neurology), University of Montreal, Quebec, Canada</mods:affiliation></affiliation></author><author><name sortKey="Abbruzzese, Giovanni" sort="Abbruzzese, Giovanni" uniqKey="Abbruzzese G" first="Giovanni" last="Abbruzzese">Giovanni Abbruzzese</name><affiliation><mods:affiliation>Department of Neurological Sciences, Movement Disorder Unit, University of Genoa, Genoa, Italy</mods:affiliation></affiliation></author><author><name sortKey="Mancione, Linda" sort="Mancione, Linda" uniqKey="Mancione L" first="Linda" last="Mancione">Linda Mancione</name><affiliation><mods:affiliation>Novartis Pharmaceuticals, East Hanover, NJ, USA</mods:affiliation></affiliation></author><author><name sortKey="Dronamraju, Nalina" sort="Dronamraju, Nalina" uniqKey="Dronamraju N" first="Nalina" last="Dronamraju">Nalina Dronamraju</name><affiliation><mods:affiliation>Novartis Pharmaceuticals, East Hanover, NJ, USA</mods:affiliation></affiliation></author><author><name sortKey="Kakarieka, Algirdas" sort="Kakarieka, Algirdas" uniqKey="Kakarieka A" first="Algirdas" last="Kakarieka">Algirdas Kakarieka</name><affiliation><mods:affiliation>Novartis Pharma AG, Basel, Switzerland</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2009-03-15">2009-03-15</date><biblScope unit="volume">24</biblScope><biblScope unit="issue">4</biblScope><biblScope unit="page" from="541">541</biblScope><biblScope unit="page" to="550">550</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">040A5F110A6A28ADFF13CCEDF4A94E8B38A8CF05</idno><idno type="DOI">10.1002/mds.22343</idno><idno type="ArticleID">MDS22343</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Parkinson's disease</term><term>Stalevo</term><term>UPDRS</term><term>entacapone</term><term>levodopa</term><term>treatment</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">We performed a 39‐week, randomized, double‐blind, multicenter study to compare the efficacy, safety, and tolerability of levodopa/carbidopa/entacapone (LCE, Stalevo) with levodopa/carbidopa (LC, Sinemet IR) in patients with early Parkinson's disease (PD). Four hundred twenty‐three patients with early PD warranting levodopa were randomly assigned to treatment with LCE 100/25/200 or LC 100/25 three‐times daily. The adjusted mean difference in total Unified Parkinson's disease Rating Scale (UPDRS) Parts II and III between groups using the analysis of covariance model (prespecified primary outcome measure) was 1.7 (standard error = 0.84) points favoring LCE (P = 0.045). Significantly greater improvement with LCE compared with LC was also observed in UPDRS Part II activities of daily living (ADL) scores (P = 0.025), Schwab and England ADL scores (blinded rater, P = 0.003; subject, P = 0.006) and subject‐reported Clinical Global Impression (CGI) scores (P = 0.047). There was no significant difference in UPDRS Part III or investigator‐rated CGI scores. Wearing‐off was observed in 29 (13.9%) subjects in the LCE group and 43 (20.0%) in the LC group (P = 0.099). Dyskinesia was observed in 11 (5.3%) subjects in the LCE group and 16 (7.4%) in the LC group (P = 0.367). Nausea and diarrhea were reported more frequently in the LCE group. LCE provided greater symptomatic benefit than LC and did not increase motor complications. © 2008 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Robert A. Hauser MD</name><affiliations><json:string>Parkinson's Disease and Movement Disorders Center of Excellence, University of South Florida, Tampa, FL, USA</json:string></affiliations></json:item><json:item><name>Michel Panisset MD</name><affiliations><json:string>André‐Barbeau Movement Disorders Unit, Department of Medicine (Neurology), University of Montreal, Quebec, Canada</json:string></affiliations></json:item><json:item><name>Giovanni Abbruzzese MD</name><affiliations><json:string>Department of Neurological Sciences, Movement Disorder Unit, University of Genoa, Genoa, Italy</json:string></affiliations></json:item><json:item><name>Linda Mancione BA</name><affiliations><json:string>Novartis Pharmaceuticals, East Hanover, NJ, USA</json:string></affiliations></json:item><json:item><name>Nalina Dronamraju PhD</name><affiliations><json:string>Novartis Pharmaceuticals, East Hanover, NJ, USA</json:string></affiliations></json:item><json:item><name>Algirdas Kakarieka MD</name><affiliations><json:string>Novartis Pharma AG, Basel, Switzerland</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>Stalevo</value></json:item><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>treatment</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>UPDRS</value></json:item></subject><articleId><json:string>MDS22343</json:string></articleId><language><json:string>eng</json:string></language><abstract>We performed a 39‐week, randomized, double‐blind, multicenter study to compare the efficacy, safety, and tolerability of levodopa/carbidopa/entacapone (LCE, Stalevo) with levodopa/carbidopa (LC, Sinemet IR) in patients with early Parkinson's disease (PD). Four hundred twenty‐three patients with early PD warranting levodopa were randomly assigned to treatment with LCE 100/25/200 or LC 100/25 three‐times daily. The adjusted mean difference in total Unified Parkinson's disease Rating Scale (UPDRS) Parts II and III between groups using the analysis of covariance model (prespecified primary outcome measure) was 1.7 (standard error = 0.84) points favoring LCE (P = 0.045). Significantly greater improvement with LCE compared with LC was also observed in UPDRS Part II activities of daily living (ADL) scores (P = 0.025), Schwab and England ADL scores (blinded rater, P = 0.003; subject, P = 0.006) and subject‐reported Clinical Global Impression (CGI) scores (P = 0.047). There was no significant difference in UPDRS Part III or investigator‐rated CGI scores. Wearing‐off was observed in 29 (13.9%) subjects in the LCE group and 43 (20.0%) in the LC group (P = 0.099). Dyskinesia was observed in 11 (5.3%) subjects in the LCE group and 16 (7.4%) in the LC group (P = 0.367). Nausea and diarrhea were reported more frequently in the LCE group. LCE provided greater symptomatic benefit than LC and did not increase motor complications. © 2008 Movement Disorder Society</abstract><qualityIndicators><score>7.7</score><pdfVersion>1.3</pdfVersion><pdfPageSize>612 x 810 pts</pdfPageSize><refBibsNative>true</refBibsNative><keywordCount>6</keywordCount><abstractCharCount>1468</abstractCharCount><pdfWordCount>5003</pdfWordCount><pdfCharCount>33525</pdfCharCount><pdfPageCount>10</pdfPageCount><abstractWordCount>225</abstractWordCount></qualityIndicators><title>Double‐blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease</title><corporate><json:item><name>on behalf of the FIRST‐STEP Study Group</name></json:item></corporate><genre><json:string>article</json:string></genre><host><volume>24</volume><publisherId><json:string>MDS</json:string></publisherId><pages><total>10</total><last>550</last><first>541</first></pages><issn><json:string>0885-3185</json:string></issn><issue>4</issue><subject><json:item><value>Research Article</value></json:item></subject><genre><json:string>Journal</json:string></genre><language><json:string>unknown</json:string></language><eissn><json:string>1531-8257</json:string></eissn><title>Movement Disorders</title><doi><json:string>10.1002/(ISSN)1531-8257</json:string></doi></host><publicationDate>2009</publicationDate><copyrightDate>2009</copyrightDate><doi><json:string>10.1002/mds.22343</json:string></doi><id>040A5F110A6A28ADFF13CCEDF4A94E8B38A8CF05</id><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/040A5F110A6A28ADFF13CCEDF4A94E8B38A8CF05/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/040A5F110A6A28ADFF13CCEDF4A94E8B38A8CF05/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/040A5F110A6A28ADFF13CCEDF4A94E8B38A8CF05/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Double‐blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><availability><p>WILEY</p></availability><date>2009</date></publicationStmt><notesStmt><note type="content">*Disclosures: No compensation was provided to Drs Hauser, Panisset, or Abbruzzese for their work on this manuscript. Drs Hauser, Panisset, and Abbruzzese's institutions received compensation from Novartis for their sites' conduct of the study. Drs Hauser, Panisset, and Abbruzzese have received honoraria and consulting fees from Novartis and Orion Pharma. Linda Mancione, Nalina Dronamraju, and Algirdas Kakarieka are employees of Novartis. Non‐Sponsor Disclosures: Dr Hauser has received honoraria or consulting fees from Bayer Schering Pharma AG, Bertek, Boehringer Ingelheim, Centopharm, Eisai, Genzyme, GlaxoSmithKline, Impax, Kyowa Pharmaceutical, Merck KGA, Ortho McNeil, Pfizer, Prestwick, Schwarz Pharma, Schering, Solvay, Teva Neuroscience, Valeant and Vernalis. Dr Panisset has received honoraria or consulting fees from Teva, Allergan, UCB‐Perdue, Prestwick, Smith‐Kline Beecham and Solvay. Dr Abbruzzese has received honoraria or consulting fees from Boehringer Ingelheim and Wyeth Lederle. The authors have confirmed that their work complies with the Journal's Editorial policy on ghost‐writing. (Movement Disorders Vol. 20., No. 12, 2005, p. 1536)</note><note type="content">*Members of FIRST‐STEP Study Group are listed in the Appendix.</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Double‐blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease</title><author><orgName>on behalf of the FIRST‐STEP Study Group</orgName></author><author><persName><forename type="first">Robert A.</forename><surname>Hauser</surname></persName><roleName type="degree">MD</roleName><note type="correspondence"><p>Correspondence: Parkinson's Disease and Movement Disorders Center, University of South Florida, 4 Columbia Drive, Suite 410, Tampa, FL 33606</p></note><affiliation>Parkinson's Disease and Movement Disorders Center of Excellence, University of South Florida, Tampa, FL, USA</affiliation></author><author><persName><forename type="first">Michel</forename><surname>Panisset</surname></persName><roleName type="degree">MD</roleName><affiliation>André‐Barbeau Movement Disorders Unit, Department of Medicine (Neurology), University of Montreal, Quebec, Canada</affiliation></author><author><persName><forename type="first">Giovanni</forename><surname>Abbruzzese</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurological Sciences, Movement Disorder Unit, University of Genoa, Genoa, Italy</affiliation></author><author><persName><forename type="first">Linda</forename><surname>Mancione</surname></persName><roleName type="degree">BA</roleName><affiliation>Novartis Pharmaceuticals, East Hanover, NJ, USA</affiliation></author><author><persName><forename type="first">Nalina</forename><surname>Dronamraju</surname></persName><roleName type="degree">PhD</roleName><affiliation>Novartis Pharmaceuticals, East Hanover, NJ, USA</affiliation></author><author><persName><forename type="first">Algirdas</forename><surname>Kakarieka</surname></persName><roleName type="degree">MD</roleName><affiliation>Novartis Pharma AG, Basel, Switzerland</affiliation></author></analytic><monogr><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="pISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><idno type="DOI">10.1002/(ISSN)1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2009-03-15"></date><biblScope unit="volume">24</biblScope><biblScope unit="issue">4</biblScope><biblScope unit="page" from="541">541</biblScope><biblScope unit="page" to="550">550</biblScope></imprint></monogr><idno type="istex">040A5F110A6A28ADFF13CCEDF4A94E8B38A8CF05</idno><idno type="DOI">10.1002/mds.22343</idno><idno type="ArticleID">MDS22343</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2009</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>We performed a 39‐week, randomized, double‐blind, multicenter study to compare the efficacy, safety, and tolerability of levodopa/carbidopa/entacapone (LCE, Stalevo) with levodopa/carbidopa (LC, Sinemet IR) in patients with early Parkinson's disease (PD). Four hundred twenty‐three patients with early PD warranting levodopa were randomly assigned to treatment with LCE 100/25/200 or LC 100/25 three‐times daily. The adjusted mean difference in total Unified Parkinson's disease Rating Scale (UPDRS) Parts II and III between groups using the analysis of covariance model (prespecified primary outcome measure) was 1.7 (standard error = 0.84) points favoring LCE (P = 0.045). Significantly greater improvement with LCE compared with LC was also observed in UPDRS Part II activities of daily living (ADL) scores (P = 0.025), Schwab and England ADL scores (blinded rater, P = 0.003; subject, P = 0.006) and subject‐reported Clinical Global Impression (CGI) scores (P = 0.047). There was no significant difference in UPDRS Part III or investigator‐rated CGI scores. Wearing‐off was observed in 29 (13.9%) subjects in the LCE group and 43 (20.0%) in the LC group (P = 0.099). Dyskinesia was observed in 11 (5.3%) subjects in the LCE group and 16 (7.4%) in the LC group (P = 0.367). Nausea and diarrhea were reported more frequently in the LCE group. LCE provided greater symptomatic benefit than LC and did not increase motor complications. © 2008 Movement Disorder Society</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>Stalevo</term></item><item><term>entacapone</term></item><item><term>levodopa</term></item><item><term>Parkinson's disease</term></item><item><term>treatment</term></item><item><term>UPDRS</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>article category</head><item><term>Research Article</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2008-05-31">Received</change><change when="2008-09-10">Registration</change><change when="2009-03-15">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/040A5F110A6A28ADFF13CCEDF4A94E8B38A8CF05/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>Wiley Subscription Services, Inc., A Wiley Company</publisherName><publisherLoc>Hoboken</publisherLoc></publisherInfo><doi registered="yes">10.1002/(ISSN)1531-8257</doi><issn type="print">0885-3185</issn><issn type="electronic">1531-8257</issn><idGroup><id type="product" value="MDS"></id></idGroup><titleGroup><title type="main" xml:lang="en" sort="MOVEMENT DISORDERS">Movement Disorders</title><title type="short">Mov. 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xml:id="au2" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Michel</givenNames><familyName>Panisset</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Giovanni</givenNames><familyName>Abbruzzese</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af4"><personName><givenNames>Linda</givenNames><familyName>Mancione</familyName><degrees>BA</degrees></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af4"><personName><givenNames>Nalina</givenNames><familyName>Dronamraju</familyName><degrees>PhD</degrees></personName></creator><creator xml:id="au6" creatorRole="author" affiliationRef="#af5"><personName><givenNames>Algirdas</givenNames><familyName>Kakarieka</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au7" creatorRole="author"><groupName>on behalf of the FIRST‐STEP Study Group</groupName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="US" type="organization"><unparsedAffiliation>Parkinson's Disease and Movement Disorders Center of Excellence, University of South Florida, Tampa, FL, USA</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="CA" type="organization"><unparsedAffiliation>André‐Barbeau Movement Disorders Unit, Department of Medicine (Neurology), University of Montreal, Quebec, Canada</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="IT" type="organization"><unparsedAffiliation>Department of Neurological Sciences, Movement Disorder Unit, University of Genoa, Genoa, Italy</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="US" type="organization"><unparsedAffiliation>Novartis Pharmaceuticals, East Hanover, NJ, USA</unparsedAffiliation></affiliation><affiliation xml:id="af5" countryCode="CH" type="organization"><unparsedAffiliation>Novartis Pharma AG, Basel, Switzerland</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">Stalevo</keyword><keyword xml:id="kwd2">entacapone</keyword><keyword xml:id="kwd3">levodopa</keyword><keyword xml:id="kwd4">Parkinson's disease</keyword><keyword xml:id="kwd5">treatment</keyword><keyword xml:id="kwd6">UPDRS</keyword></keywordGroup><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>We performed a 39‐week, randomized, double‐blind, multicenter study to compare the efficacy, safety, and tolerability of levodopa/carbidopa/entacapone (LCE, Stalevo) with levodopa/carbidopa (LC, Sinemet IR) in patients with early Parkinson's disease (PD). Four hundred twenty‐three patients with early PD warranting levodopa were randomly assigned to treatment with LCE 100/25/200 or LC 100/25 three‐times daily. The adjusted mean difference in total Unified Parkinson's disease Rating Scale (UPDRS) Parts II and III between groups using the analysis of covariance model (prespecified primary outcome measure) was 1.7 (standard error = 0.84) points favoring LCE (<i>P</i> = 0.045). Significantly greater improvement with LCE compared with LC was also observed in UPDRS Part II activities of daily living (ADL) scores (<i>P</i> = 0.025), Schwab and England ADL scores (blinded rater, <i>P</i> = 0.003; subject, <i>P</i> = 0.006) and subject‐reported Clinical Global Impression (CGI) scores (<i>P</i> = 0.047). There was no significant difference in UPDRS Part III or investigator‐rated CGI scores. Wearing‐off was observed in 29 (13.9%) subjects in the LCE group and 43 (20.0%) in the LC group (<i>P</i> = 0.099). Dyskinesia was observed in 11 (5.3%) subjects in the LCE group and 16 (7.4%) in the LC group (<i>P</i> = 0.367). Nausea and diarrhea were reported more frequently in the LCE group. LCE provided greater symptomatic benefit than LC and did not increase motor complications. © 2008 Movement Disorder Society</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn1"><p>Disclosures: No compensation was provided to Drs Hauser, Panisset, or Abbruzzese for their work on this manuscript. Drs Hauser, Panisset, and Abbruzzese's institutions received compensation from Novartis for their sites' conduct of the study. Drs Hauser, Panisset, and Abbruzzese have received honoraria and consulting fees from Novartis and Orion Pharma. Linda Mancione, Nalina Dronamraju, and Algirdas Kakarieka are employees of Novartis. Non‐Sponsor Disclosures: Dr Hauser has received honoraria or consulting fees from Bayer Schering Pharma AG, Bertek, Boehringer Ingelheim, Centopharm, Eisai, Genzyme, GlaxoSmithKline, Impax, Kyowa Pharmaceutical, Merck KGA, Ortho McNeil, Pfizer, Prestwick, Schwarz Pharma, Schering, Solvay, Teva Neuroscience, Valeant and Vernalis. Dr Panisset has received honoraria or consulting fees from Teva, Allergan, UCB‐Perdue, Prestwick, Smith‐Kline Beecham and Solvay. Dr Abbruzzese has received honoraria or consulting fees from Boehringer Ingelheim and Wyeth Lederle. The authors have confirmed that their work complies with the Journal's Editorial policy on ghost‐writing. (Movement Disorders Vol. 20., No. 12, 2005, p. 1536)</p></note><note xml:id="fn2"><p>Members of FIRST‐STEP Study Group are listed in the <link href="#app1">Appendix</link>.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Double‐blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Levodopa/Carbidopa/Entacapone in Early PD</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Double‐blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease</title></titleInfo><name type="personal"><namePart type="given">Robert A.</namePart><namePart type="family">Hauser</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Parkinson's Disease and Movement Disorders Center of Excellence, University of South Florida, Tampa, FL, USA</affiliation><description>Correspondence: Parkinson's Disease and Movement Disorders Center, University of South Florida, 4 Columbia Drive, Suite 410, Tampa, FL 33606</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Michel</namePart><namePart type="family">Panisset</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>André‐Barbeau Movement Disorders Unit, Department of Medicine (Neurology), University of Montreal, Quebec, Canada</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Giovanni</namePart><namePart type="family">Abbruzzese</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurological Sciences, Movement Disorder Unit, University of Genoa, Genoa, Italy</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Linda</namePart><namePart type="family">Mancione</namePart><namePart type="termsOfAddress">BA</namePart><affiliation>Novartis Pharmaceuticals, East Hanover, NJ, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Nalina</namePart><namePart type="family">Dronamraju</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Novartis Pharmaceuticals, East Hanover, NJ, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Algirdas</namePart><namePart type="family">Kakarieka</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Novartis Pharma AG, Basel, Switzerland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="corporate"><namePart>on behalf of the FIRST‐STEP Study Group</namePart><description>Parkinson's Disease and Movement Disorders Center of Excellence, University of South Florida, Tampa, FL, USAAndré‐Barbeau Movement Disorders Unit, Department of Medicine (Neurology), University of Montreal, Quebec, CanadaDepartment of Neurological Sciences, Movement Disorder Unit, University of Genoa, Genoa, ItalyNovartis Pharmaceuticals, East Hanover, NJ, USANovartis Pharma AG, Basel, Switzerland</description></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article"></genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">2009-03-15</dateIssued><dateCaptured encoding="w3cdtf">2008-05-31</dateCaptured><dateValid encoding="w3cdtf">2008-09-10</dateValid><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">3</extent><extent unit="tables">4</extent><extent unit="references">28</extent><extent unit="words">6945</extent></physicalDescription><abstract lang="en">We performed a 39‐week, randomized, double‐blind, multicenter study to compare the efficacy, safety, and tolerability of levodopa/carbidopa/entacapone (LCE, Stalevo) with levodopa/carbidopa (LC, Sinemet IR) in patients with early Parkinson's disease (PD). Four hundred twenty‐three patients with early PD warranting levodopa were randomly assigned to treatment with LCE 100/25/200 or LC 100/25 three‐times daily. The adjusted mean difference in total Unified Parkinson's disease Rating Scale (UPDRS) Parts II and III between groups using the analysis of covariance model (prespecified primary outcome measure) was 1.7 (standard error = 0.84) points favoring LCE (P = 0.045). Significantly greater improvement with LCE compared with LC was also observed in UPDRS Part II activities of daily living (ADL) scores (P = 0.025), Schwab and England ADL scores (blinded rater, P = 0.003; subject, P = 0.006) and subject‐reported Clinical Global Impression (CGI) scores (P = 0.047). There was no significant difference in UPDRS Part III or investigator‐rated CGI scores. Wearing‐off was observed in 29 (13.9%) subjects in the LCE group and 43 (20.0%) in the LC group (P = 0.099). Dyskinesia was observed in 11 (5.3%) subjects in the LCE group and 16 (7.4%) in the LC group (P = 0.367). Nausea and diarrhea were reported more frequently in the LCE group. LCE provided greater symptomatic benefit than LC and did not increase motor complications. © 2008 Movement Disorder Society</abstract><note type="content">*Disclosures: No compensation was provided to Drs Hauser, Panisset, or Abbruzzese for their work on this manuscript. Drs Hauser, Panisset, and Abbruzzese's institutions received compensation from Novartis for their sites' conduct of the study. Drs Hauser, Panisset, and Abbruzzese have received honoraria and consulting fees from Novartis and Orion Pharma. Linda Mancione, Nalina Dronamraju, and Algirdas Kakarieka are employees of Novartis. Non‐Sponsor Disclosures: Dr Hauser has received honoraria or consulting fees from Bayer Schering Pharma AG, Bertek, Boehringer Ingelheim, Centopharm, Eisai, Genzyme, GlaxoSmithKline, Impax, Kyowa Pharmaceutical, Merck KGA, Ortho McNeil, Pfizer, Prestwick, Schwarz Pharma, Schering, Solvay, Teva Neuroscience, Valeant and Vernalis. Dr Panisset has received honoraria or consulting fees from Teva, Allergan, UCB‐Perdue, Prestwick, Smith‐Kline Beecham and Solvay. Dr Abbruzzese has received honoraria or consulting fees from Boehringer Ingelheim and Wyeth Lederle. The authors have confirmed that their work complies with the Journal's Editorial policy on ghost‐writing. (Movement Disorders Vol. 20., No. 12, 2005, p. 1536)</note><note type="content">*Members of FIRST‐STEP Study Group are listed in the Appendix.</note><subject lang="en"><genre>Keywords</genre><topic>Stalevo</topic><topic>entacapone</topic><topic>levodopa</topic><topic>Parkinson's disease</topic><topic>treatment</topic><topic>UPDRS</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title></titleInfo><titleInfo type="abbreviated"><title>Mov. Disord.</title></titleInfo><genre type="Journal">journal</genre><subject><genre>article category</genre><topic>Research Article</topic></subject><identifier type="ISSN">0885-3185</identifier><identifier type="eISSN">1531-8257</identifier><identifier type="DOI">10.1002/(ISSN)1531-8257</identifier><identifier type="PublisherID">MDS</identifier><part><date>2009</date><detail type="volume"><caption>vol.</caption><number>24</number></detail><detail type="issue"><caption>no.</caption><number>4</number></detail><extent unit="pages"><start>541</start><end>550</end><total>10</total></extent></part></relatedItem><identifier type="istex">040A5F110A6A28ADFF13CCEDF4A94E8B38A8CF05</identifier><identifier type="DOI">10.1002/mds.22343</identifier><identifier type="ArticleID">MDS22343</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2008 Movement Disorder Society</accessCondition><recordInfo><recordContentSource>WILEY</recordContentSource><recordOrigin>Wiley Subscription Services, Inc., A Wiley Company</recordOrigin></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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