Long‐term outcome of early versus delayed rasagiline treatment in early Parkinson's disease
Identifieur interne : 000327 ( Istex/Corpus ); précédent : 000326; suivant : 000328Long‐term outcome of early versus delayed rasagiline treatment in early Parkinson's disease
Auteurs : Robert A. Hauser ; Mark F. Lew ; Howard I. Hurtig ; William G. Ondo ; Joanne Wojcieszek ; Cheryl J. Fitzer-AttasSource :
- Movement Disorders [ 0885-3185 ] ; 2009-03-15.
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- KwdEn :
Abstract
The purpose of this study to compare the long‐term clinical outcome of early versus delayed rasagiline treatment in early Parkinson's disease (PD). Subjects (N = 404) were randomly assigned to initial treatment with rasagiline (early‐start group) or placebo for 6 months followed by rasagiline (delayed‐start group) in the TEMPO study. Subjects who chose to participate in an open‐label extension (N = 306) continued to receive rasagiline as well as other PD medications as needed. Average (±SD) duration in the study was 3.6 ± 2.1 years; 177 subjects received rasagiline for ≥5.0 years. Over the entire 6.5‐year follow‐up period, the adjusted mean difference in change from baseline in total UPDRS scores was 2.5 units (SE 1.1; P = 0.021) or 16% (SE 5.7; P = 0.006) in favor of the early‐start versus delayed‐start rasagiline group. Although the interaction between treatment and time was significant, values for the early‐start group were better than the delayed‐start group across all time points. Significantly less worsening (percent change) in total UPDRS scores was observed in the early‐start group at the time points 0.5, 1.5, 2.0, 3.0, 4.5, 5.0, and 5.5 years (P < 0.05). Compared to delayed start, early initiation of rasagiline provided long‐term clinical benefit, even in the face of treatment with other dopaminergic agents. This might reflect enduring benefits due to neuroprotection or effects on compensatory mechanisms in early PD. © 2008 Movement Disorder Society
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DOI: 10.1002/mds.22402
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ISTEX:5B1103AD18D631B83CB2914DC8D246159F83891DLe document en format XML
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Ondo</name><affiliation><mods:affiliation>Department of Neurology, Baylor College of Medicine, Houston, Texas, USA</mods:affiliation></affiliation></author><author><name sortKey="Wojcieszek, Joanne" sort="Wojcieszek, Joanne" uniqKey="Wojcieszek J" first="Joanne" last="Wojcieszek">Joanne Wojcieszek</name><affiliation><mods:affiliation>Department of Neurology, Indiana University School of Medicine, Indianapolis, Indiana, USA</mods:affiliation></affiliation></author><author><name sortKey="Fitzer Ttas, Cheryl J" sort="Fitzer Ttas, Cheryl J" uniqKey="Fitzer Ttas C" first="Cheryl J." last="Fitzer-Attas">Cheryl J. Fitzer-Attas</name><affiliation><mods:affiliation>Teva Pharmaceutical Industries Ltd, Petach Tikva, Israel</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="vol">24</biblScope><biblScope unit="issue">4</biblScope><biblScope unit="page" from="564">564</biblScope><biblScope unit="page" to="573">573</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">5B1103AD18D631B83CB2914DC8D246159F83891D</idno><idno type="DOI">10.1002/mds.22402</idno><idno type="ArticleID">MDS22402</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>MAO‐B inhibitor</term><term>Parkinson's disease</term><term>disease modification</term><term>neuroprotection</term><term>rasagiline</term><term>treatment</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The purpose of this study to compare the long‐term clinical outcome of early versus delayed rasagiline treatment in early Parkinson's disease (PD). Subjects (N = 404) were randomly assigned to initial treatment with rasagiline (early‐start group) or placebo for 6 months followed by rasagiline (delayed‐start group) in the TEMPO study. Subjects who chose to participate in an open‐label extension (N = 306) continued to receive rasagiline as well as other PD medications as needed. Average (±SD) duration in the study was 3.6 ± 2.1 years; 177 subjects received rasagiline for ≥5.0 years. Over the entire 6.5‐year follow‐up period, the adjusted mean difference in change from baseline in total UPDRS scores was 2.5 units (SE 1.1; P = 0.021) or 16% (SE 5.7; P = 0.006) in favor of the early‐start versus delayed‐start rasagiline group. Although the interaction between treatment and time was significant, values for the early‐start group were better than the delayed‐start group across all time points. Significantly less worsening (percent change) in total UPDRS scores was observed in the early‐start group at the time points 0.5, 1.5, 2.0, 3.0, 4.5, 5.0, and 5.5 years (P < 0.05). Compared to delayed start, early initiation of rasagiline provided long‐term clinical benefit, even in the face of treatment with other dopaminergic agents. This might reflect enduring benefits due to neuroprotection or effects on compensatory mechanisms in early PD. © 2008 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Robert A. Hauser MD</name><affiliations><json:string>Parkinsons's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USA</json:string></affiliations></json:item><json:item><name>Mark F. Lew MD</name><affiliations><json:string>Department of Neurology, Keck/University of Southern California School of Medicine, Los Angeles, California, USA</json:string></affiliations></json:item><json:item><name>Howard I. Hurtig MD</name><affiliations><json:string>Department of Neurology, Pennsylvania Hospital, University of Pennsylvania Health System, Philadelphia, Pennsylvania, USA</json:string></affiliations></json:item><json:item><name>William G. Ondo MD</name><affiliations><json:string>Department of Neurology, Baylor College of Medicine, Houston, Texas, USA</json:string></affiliations></json:item><json:item><name>Joanne Wojcieszek MD</name><affiliations><json:string>Department of Neurology, Indiana University School of Medicine, Indianapolis, Indiana, USA</json:string></affiliations></json:item><json:item><name>Cheryl J. Fitzer‐Attas PhD</name><affiliations><json:string>Teva Pharmaceutical Industries Ltd, Petach Tikva, Israel</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>rasagiline</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>neuroprotection</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>disease modification</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>MAO‐B inhibitor</value></json:item></subject><language><json:string>eng</json:string></language><abstract>The purpose of this study to compare the long‐term clinical outcome of early versus delayed rasagiline treatment in early Parkinson's disease (PD). Subjects (N = 404) were randomly assigned to initial treatment with rasagiline (early‐start group) or placebo for 6 months followed by rasagiline (delayed‐start group) in the TEMPO study. Subjects who chose to participate in an open‐label extension (N = 306) continued to receive rasagiline as well as other PD medications as needed. Average (±SD) duration in the study was 3.6 ± 2.1 years; 177 subjects received rasagiline for ≥5.0 years. Over the entire 6.5‐year follow‐up period, the adjusted mean difference in change from baseline in total UPDRS scores was 2.5 units (SE 1.1; P = 0.021) or 16% (SE 5.7; P = 0.006) in favor of the early‐start versus delayed‐start rasagiline group. Although the interaction between treatment and time was significant, values for the early‐start group were better than the delayed‐start group across all time points. Significantly less worsening (percent change) in total UPDRS scores was observed in the early‐start group at the time points 0.5, 1.5, 2.0, 3.0, 4.5, 5.0, and 5.5 years (P > 0.05). Compared to delayed start, early initiation of rasagiline provided long‐term clinical benefit, even in the face of treatment with other dopaminergic agents. This might reflect enduring benefits due to neuroprotection or effects on compensatory mechanisms in early PD. © 2008 Movement Disorder Society</abstract><qualityIndicators><score>7.784</score><pdfVersion>1.3</pdfVersion><pdfPageSize>612 x 810 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractCharCount>1482</abstractCharCount><pdfWordCount>5209</pdfWordCount><pdfCharCount>34224</pdfCharCount><pdfPageCount>10</pdfPageCount><abstractWordCount>232</abstractWordCount></qualityIndicators><title>Long‐term outcome of early versus delayed rasagiline treatment in early Parkinson's disease</title><corporate><json:item><name></name><affiliations><json:string>Parkinsons's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USA</json:string><json:string>Department of Neurology, Keck/University of Southern California School of Medicine, Los Angeles, California, USA</json:string><json:string>Department of Neurology, Pennsylvania Hospital, University of Pennsylvania Health System, Philadelphia, Pennsylvania, USA</json:string><json:string>Department of Neurology, Baylor College of Medicine, Houston, Texas, USA</json:string><json:string>Department of Neurology, Indiana University School of Medicine, Indianapolis, Indiana, USA</json:string><json:string>Teva Pharmaceutical Industries Ltd, Petach Tikva, Israel</json:string></affiliations></json:item></corporate><genre><json:string>Serial article</json:string></genre><host><volume>24</volume><pages><total>10</total><last>573</last><first>564</first></pages><issn><json:string>0885-3185</json:string></issn><issue>4</issue><subject><json:item><value>Research Article</value></json:item></subject><genre></genre><language><json:string>unknown</json:string></language><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.22402</json:string></doi><id>5B1103AD18D631B83CB2914DC8D246159F83891D</id><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/5B1103AD18D631B83CB2914DC8D246159F83891D/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/5B1103AD18D631B83CB2914DC8D246159F83891D/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/5B1103AD18D631B83CB2914DC8D246159F83891D/fulltext/tei"><teiHeader type="text"><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Long‐term outcome of early versus delayed rasagiline treatment 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 Subscription Services, Inc., A Wiley Company</p></availability><date>2009</date></publicationStmt><notesStmt><note type="content">*Disclosures: Drs. Hauser, Lew, Hurtig, Ondo, and Wojcieszek's institutions received compensation from Teva Pharmaceuticals, Inc. and Teva Neuroscience, Inc. for their sites' conduct of the study. Drs. Hauser, Lew, Wojcieszek, and Ondo have received honoraria and consulting fees from Teva Pharmaceutical Industries, Inc. and/or Teva Neuroscience, Inc. Dr. Fitzer‐Attas is an employee of Teva Pharmaceutical Industries, Ltd.</note><note type="content">*Non‐sponsor disclosures: Dr. Hauser has received honoraria or consulting fees from Bayer Schering Pharma AG, Bertek, Boehringer Ingelheim, Centopharm, Eisai Ltd, Genzyme, GlaxoSmithKline, Impax, Kyowa Pharmaceutical, Merck KgaA, Novartis, Ortho McNeil, Pfizer, Prestwick, Schwarz Pharma, Schering, Solvay, Teva Neuroscience, Valeant, and Vernalis. Dr Lew has received honoraria or consulting fees from Boehringer‐Ingelheim, GSK, Allergan, Solstice, Novartis, Teva, Valeant, UCB, Bayer, BI, Kyowa,Schwarz Pharma,Ipsen, Prestwick, Vernalis. He has received research funding from Teva, BI, GSK, Kyowa, Solstice, Novartis, Schwarz Pharma/UCB, Ipsen, NIH, Eisai, Mentor, Solvay, Schering Plough. Dr. Wojcieszek has received honoraria from Schwartz Pharma and Valeant. Dr. Ondo has received honoraria or consulting fees from Bayer Schering Pharma AG, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Prestwick, UCB Pharma, Solvay, Teva Neuroscience, Valeant, Allergan, and Vernalis.</note><note>Teva Pharmaceutical Industries, Ltd.</note><note>Teva Neuroscience, Inc. (USA)</note><note>H. Lundbeck A/S</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Long‐term outcome of early versus delayed rasagiline treatment in early Parkinson's disease</title><author><orgName>on behalf of the TEMPO Open‐label Study Group</orgName><affiliation>Parkinsons's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USA</affiliation><affiliation>Department of Neurology, Keck/University of Southern California School of Medicine, Los Angeles, California, USA</affiliation><affiliation>Department of Neurology, Pennsylvania Hospital, University of Pennsylvania Health System, Philadelphia, Pennsylvania, USA</affiliation><affiliation>Department of Neurology, Baylor College of Medicine, Houston, Texas, USA</affiliation><affiliation>Department of Neurology, Indiana University School of Medicine, Indianapolis, Indiana, USA</affiliation><affiliation>Teva Pharmaceutical Industries Ltd, Petach Tikva, Israel</affiliation></author><author><persName><forename type="first">Robert A.</forename><surname>Hauser</surname><roleName type="degree">MD</roleName></persName><note type="correspondence"><p>Correspondence: Parkinson's Disease and Movement Disorders Center, University of South Florida, 4 Columbia Drive, Suite 410, Tampa, FL 33606, USA</p></note><affiliation>Parkinsons's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USA</affiliation></author><author><persName><forename type="first">Mark F.</forename><surname>Lew</surname><roleName type="degree">MD</roleName></persName><affiliation>Department of Neurology, Keck/University of Southern California School of Medicine, Los Angeles, California, USA</affiliation></author><author><persName><forename type="first">Howard I.</forename><surname>Hurtig</surname><roleName type="degree">MD</roleName></persName><affiliation>Department of Neurology, Pennsylvania Hospital, University of Pennsylvania Health System, Philadelphia, Pennsylvania, USA</affiliation></author><author><persName><forename type="first">William G.</forename><surname>Ondo</surname><roleName type="degree">MD</roleName></persName><affiliation>Department of Neurology, Baylor College of Medicine, Houston, Texas, USA</affiliation></author><author><persName><forename type="first">Joanne</forename><surname>Wojcieszek</surname><roleName type="degree">MD</roleName></persName><affiliation>Department of Neurology, Indiana University School of Medicine, Indianapolis, Indiana, USA</affiliation></author><author><persName><forename type="first">Cheryl J.</forename><surname>Fitzer‐Attas</surname><roleName type="degree">PhD</roleName></persName><affiliation>Teva Pharmaceutical Industries Ltd, Petach Tikva, Israel</affiliation></author></analytic><monogr><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. 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Subjects (N = 404) were randomly assigned to initial treatment with rasagiline (early‐start group) or placebo for 6 months followed by rasagiline (delayed‐start group) in the TEMPO study. Subjects who chose to participate in an open‐label extension (N = 306) continued to receive rasagiline as well as other PD medications as needed. Average (±SD) duration in the study was 3.6 ± 2.1 years; 177 subjects received rasagiline for ≥5.0 years. Over the entire 6.5‐year follow‐up period, the adjusted mean difference in change from baseline in total UPDRS scores was 2.5 units (SE 1.1; P = 0.021) or 16% (SE 5.7; P = 0.006) in favor of the early‐start versus delayed‐start rasagiline group. Although the interaction between treatment and time was significant, values for the early‐start group were better than the delayed‐start group across all time points. Significantly less worsening (percent change) in total UPDRS scores was observed in the early‐start group at the time points 0.5, 1.5, 2.0, 3.0, 4.5, 5.0, and 5.5 years (P < 0.05). Compared to delayed start, early initiation of rasagiline provided long‐term clinical benefit, even in the face of treatment with other dopaminergic agents. This might reflect enduring benefits due to neuroprotection or effects on compensatory mechanisms in early PD. © 2008 Movement Disorder Society</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>rasagiline</term></item><item><term>Parkinson's disease</term></item><item><term>treatment</term></item><item><term>neuroprotection</term></item><item><term>disease modification</term></item><item><term>MAO‐B inhibitor</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="2008-04-27">Received</change><change when="2008-10-24">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/5B1103AD18D631B83CB2914DC8D246159F83891D/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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elementName="appendix">APPENDIX</objectName></objectNameGroup><linkGroup><link type="toTypesetVersion" href="file:MDS.MDS22402.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="2"></count><count type="tableTotal" number="3"></count><count type="referenceTotal" number="23"></count><count type="wordTotal" number="6668"></count></countGroup><titleGroup><title type="main" xml:lang="en">Long‐term outcome of early versus delayed rasagiline treatment in early Parkinson's disease<link href="#fn1"></link> <link href="#fn2"></link></title><title type="short" xml:lang="en">Early vs. Delayed Rasagiline in Parkinson's Disease</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes"><personName><givenNames>Robert A.</givenNames><familyName>Hauser</familyName><degrees>MD</degrees></personName><contactDetails><email>rhauser@health.usf.edu</email></contactDetails></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Mark F.</givenNames><familyName>Lew</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Howard I.</givenNames><familyName>Hurtig</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af4"><personName><givenNames>William G.</givenNames><familyName>Ondo</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af5"><personName><givenNames>Joanne</givenNames><familyName>Wojcieszek</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au6" creatorRole="author" affiliationRef="#af6"><personName><givenNames>Cheryl J.</givenNames><familyName>Fitzer‐Attas</familyName><degrees>PhD</degrees></personName></creator><creator xml:id="au7" creatorRole="author" noteRef="#fn4"><groupName>on behalf of the TEMPO Open‐label Study Group </groupName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="US" type="organization"><unparsedAffiliation>Parkinsons's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USA</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, Keck/University of Southern California School of Medicine, Los Angeles, California, USA</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, Pennsylvania Hospital, University of Pennsylvania Health System, Philadelphia, Pennsylvania, USA</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, Baylor College of Medicine, Houston, Texas, USA</unparsedAffiliation></affiliation><affiliation xml:id="af5" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, Indiana University School of Medicine, Indianapolis, Indiana, USA</unparsedAffiliation></affiliation><affiliation xml:id="af6" countryCode="IL" type="organization"><unparsedAffiliation>Teva Pharmaceutical Industries Ltd, Petach Tikva, Israel</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">rasagiline</keyword><keyword xml:id="kwd2">Parkinson's disease</keyword><keyword xml:id="kwd3">treatment</keyword><keyword xml:id="kwd4">neuroprotection</keyword><keyword xml:id="kwd5">disease modification</keyword><keyword xml:id="kwd6">MAO‐B inhibitor</keyword></keywordGroup><fundingInfo><fundingAgency>Teva Pharmaceutical Industries, Ltd.</fundingAgency></fundingInfo><fundingInfo><fundingAgency>Teva Neuroscience, Inc. (USA)</fundingAgency></fundingInfo><fundingInfo><fundingAgency>H. Lundbeck A/S</fundingAgency></fundingInfo><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>The purpose of this study to compare the long‐term clinical outcome of early versus delayed rasagiline treatment in early Parkinson's disease (PD). Subjects (N = 404) were randomly assigned to initial treatment with rasagiline (early‐start group) or placebo for 6 months followed by rasagiline (delayed‐start group) in the TEMPO study. Subjects who chose to participate in an open‐label extension (N = 306) continued to receive rasagiline as well as other PD medications as needed. Average (±SD) duration in the study was 3.6 ± 2.1 years; 177 subjects received rasagiline for ≥5.0 years. Over the entire 6.5‐year follow‐up period, the adjusted mean difference in change from baseline in total UPDRS scores was 2.5 units (SE 1.1; <i>P</i> = 0.021) or 16% (SE 5.7; <i>P</i> = 0.006) in favor of the early‐start versus delayed‐start rasagiline group. Although the interaction between treatment and time was significant, values for the early‐start group were better than the delayed‐start group across all time points. Significantly less worsening (percent change) in total UPDRS scores was observed in the early‐start group at the time points 0.5, 1.5, 2.0, 3.0, 4.5, 5.0, and 5.5 years (<i>P</i> < 0.05). Compared to delayed start, early initiation of rasagiline provided long‐term clinical benefit, even in the face of treatment with other dopaminergic agents. This might reflect enduring benefits due to neuroprotection or effects on compensatory mechanisms in early PD. © 2008 Movement Disorder Society</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn1"><p>Disclosures: Drs. Hauser, Lew, Hurtig, Ondo, and Wojcieszek's institutions received compensation from Teva Pharmaceuticals, Inc. and Teva Neuroscience, Inc. for their sites' conduct of the study. Drs. Hauser, Lew, Wojcieszek, and Ondo have received honoraria and consulting fees from Teva Pharmaceutical Industries, Inc. and/or Teva Neuroscience, Inc. Dr. Fitzer‐Attas is an employee of Teva Pharmaceutical Industries, Ltd.</p></note><note xml:id="fn2"><p>Non‐sponsor disclosures: Dr. Hauser has received honoraria or consulting fees from Bayer Schering Pharma AG, Bertek, Boehringer Ingelheim, Centopharm, Eisai Ltd, Genzyme, GlaxoSmithKline, Impax, Kyowa Pharmaceutical, Merck KgaA, Novartis, Ortho McNeil, Pfizer, Prestwick, Schwarz Pharma, Schering, Solvay, Teva Neuroscience, Valeant, and Vernalis. Dr Lew has received honoraria or consulting fees from Boehringer‐Ingelheim, GSK, Allergan, Solstice, Novartis, Teva, Valeant, UCB, Bayer, BI, Kyowa,Schwarz Pharma,Ipsen, Prestwick, Vernalis. He has received research funding from Teva, BI, GSK, Kyowa, Solstice, Novartis, Schwarz Pharma/UCB, Ipsen, NIH, Eisai, Mentor, Solvay, Schering Plough. Dr. Wojcieszek has received honoraria from Schwartz Pharma and Valeant. Dr. Ondo has received honoraria or consulting fees from Bayer Schering Pharma AG, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Prestwick, UCB Pharma, Solvay, Teva Neuroscience, Valeant, Allergan, and Vernalis.</p></note><note xml:id="fn4"><p>Members of “TEMPO Open‐label Study Group” are listed as an <link href="#app1">Appendix</link>.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><!--Version 0.6 générée le 3-12-2015--><mods version="3.6"><titleInfo lang="en"><title>Long‐term outcome of early versus delayed rasagiline treatment in early Parkinson's disease</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Early vs. Delayed Rasagiline in Parkinson's Disease</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Long‐term outcome of early versus delayed rasagiline treatment 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>Parkinsons's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USA</affiliation><description>Correspondence: Parkinson's Disease and Movement Disorders Center, University of South Florida, 4 Columbia Drive, Suite 410, Tampa, FL 33606, USA</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Mark F.</namePart><namePart type="family">Lew</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Keck/University of Southern California School of Medicine, Los Angeles, California, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Howard I.</namePart><namePart type="family">Hurtig</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Pennsylvania Hospital, University of Pennsylvania Health System, Philadelphia, Pennsylvania, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">William G.</namePart><namePart type="family">Ondo</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Baylor College of Medicine, Houston, Texas, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Joanne</namePart><namePart type="family">Wojcieszek</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Indiana University School of Medicine, Indianapolis, Indiana, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Cheryl J.</namePart><namePart type="family">Fitzer‐Attas</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Teva Pharmaceutical Industries Ltd, Petach Tikva, Israel</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="corporate"><namePart>on behalf of the TEMPO Open‐label Study Group</namePart><affiliation>Parkinsons's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USA</affiliation><affiliation>Department of Neurology, Keck/University of Southern California School of Medicine, Los Angeles, California, USA</affiliation><affiliation>Department of Neurology, Pennsylvania Hospital, University of Pennsylvania Health System, Philadelphia, Pennsylvania, USA</affiliation><affiliation>Department of Neurology, Baylor College of Medicine, Houston, Texas, USA</affiliation><affiliation>Department of Neurology, Indiana University School of Medicine, Indianapolis, Indiana, USA</affiliation><affiliation>Teva Pharmaceutical Industries Ltd, Petach Tikva, Israel</affiliation><description>Parkinsons's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USADepartment of Neurology, Keck/University of Southern California School of Medicine, Los Angeles, California, USADepartment of Neurology, Pennsylvania Hospital, University of Pennsylvania Health System, Philadelphia, Pennsylvania, USADepartment of Neurology, Baylor College of Medicine, Houston, Texas, USADepartment of Neurology, Indiana University School of Medicine, Indianapolis, Indiana, USATeva Pharmaceutical Industries Ltd, Petach Tikva, Israel</description></name><typeOfResource>text</typeOfResource><genre authority="originalCategForm">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">2008-04-27</dateCaptured><dateValid encoding="w3cdtf">2008-10-24</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">2</extent><extent unit="tables">3</extent><extent unit="references">23</extent><extent unit="words">6668</extent></physicalDescription><abstract lang="en">The purpose of this study to compare the long‐term clinical outcome of early versus delayed rasagiline treatment in early Parkinson's disease (PD). Subjects (N = 404) were randomly assigned to initial treatment with rasagiline (early‐start group) or placebo for 6 months followed by rasagiline (delayed‐start group) in the TEMPO study. Subjects who chose to participate in an open‐label extension (N = 306) continued to receive rasagiline as well as other PD medications as needed. Average (±SD) duration in the study was 3.6 ± 2.1 years; 177 subjects received rasagiline for ≥5.0 years. Over the entire 6.5‐year follow‐up period, the adjusted mean difference in change from baseline in total UPDRS scores was 2.5 units (SE 1.1; P = 0.021) or 16% (SE 5.7; P = 0.006) in favor of the early‐start versus delayed‐start rasagiline group. Although the interaction between treatment and time was significant, values for the early‐start group were better than the delayed‐start group across all time points. Significantly less worsening (percent change) in total UPDRS scores was observed in the early‐start group at the time points 0.5, 1.5, 2.0, 3.0, 4.5, 5.0, and 5.5 years (P < 0.05). Compared to delayed start, early initiation of rasagiline provided long‐term clinical benefit, even in the face of treatment with other dopaminergic agents. This might reflect enduring benefits due to neuroprotection or effects on compensatory mechanisms in early PD. © 2008 Movement Disorder Society</abstract><note type="content">*Disclosures: Drs. Hauser, Lew, Hurtig, Ondo, and Wojcieszek's institutions received compensation from Teva Pharmaceuticals, Inc. and Teva Neuroscience, Inc. for their sites' conduct of the study. Drs. Hauser, Lew, Wojcieszek, and Ondo have received honoraria and consulting fees from Teva Pharmaceutical Industries, Inc. and/or Teva Neuroscience, Inc. Dr. Fitzer‐Attas is an employee of Teva Pharmaceutical Industries, Ltd.</note><note type="content">*Non‐sponsor disclosures: Dr. Hauser has received honoraria or consulting fees from Bayer Schering Pharma AG, Bertek, Boehringer Ingelheim, Centopharm, Eisai Ltd, Genzyme, GlaxoSmithKline, Impax, Kyowa Pharmaceutical, Merck KgaA, Novartis, Ortho McNeil, Pfizer, Prestwick, Schwarz Pharma, Schering, Solvay, Teva Neuroscience, Valeant, and Vernalis. Dr Lew has received honoraria or consulting fees from Boehringer‐Ingelheim, GSK, Allergan, Solstice, Novartis, Teva, Valeant, UCB, Bayer, BI, Kyowa,Schwarz Pharma,Ipsen, Prestwick, Vernalis. He has received research funding from Teva, BI, GSK, Kyowa, Solstice, Novartis, Schwarz Pharma/UCB, Ipsen, NIH, Eisai, Mentor, Solvay, Schering Plough. Dr. Wojcieszek has received honoraria from Schwartz Pharma and Valeant. Dr. Ondo has received honoraria or consulting fees from Bayer Schering Pharma AG, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Prestwick, UCB Pharma, Solvay, Teva Neuroscience, Valeant, Allergan, and Vernalis.</note><note type="funding">Teva Pharmaceutical Industries, Ltd.</note><note type="funding">Teva Neuroscience, Inc. (USA)</note><note type="funding">H. Lundbeck A/S</note><subject lang="en"><genre>Keywords</genre><topic>rasagiline</topic><topic>Parkinson's disease</topic><topic>treatment</topic><topic>neuroprotection</topic><topic>disease modification</topic><topic>MAO‐B inhibitor</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title></titleInfo><titleInfo type="abbreviated"><title>Mov. Disord.</title></titleInfo><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>564</start><end>573</end><total>10</total></extent></part></relatedItem><identifier type="istex">5B1103AD18D631B83CB2914DC8D246159F83891D</identifier><identifier type="DOI">10.1002/mds.22402</identifier><identifier type="ArticleID">MDS22402</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2008 Movement Disorder Society</accessCondition><recordInfo><recordOrigin>Wiley Subscription Services, Inc., A Wiley Company</recordOrigin><recordContentSource>WILEY</recordContentSource></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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