Placebo influences on dyskinesia in Parkinson's disease
Identifieur interne : 000342 ( Istex/Corpus ); précédent : 000341; suivant : 000343Placebo influences on dyskinesia in Parkinson's disease
Auteurs : Christopher G. Goetz ; Eugene Laska ; Christine Hicking ; Philippe Damier ; Thomas Müller ; John Nutt ; C. Warren Olanow ; Olivier Rascol ; Hermann RussSource :
- Movement Disorders [ 0885-3185 ] ; 2008-04-15.
English descriptors
Abstract
Clinical features that are prognostic indicators of placebo response among dyskinetic Parkinson's disease patients were determined. Placebo‐associated improvements occur in Parkinsonism, but responses in dyskinesia have not been studied. Placebo data from two multicenter studies with identical design comparing sarizotan to placebo for treating dyskinesia were accessed. Sarizotan (2 mg/day) failed to improve dyskinesia compared with placebo, but both treatments improved dyskinesia compared with baseline. Stepwise regression identified baseline characteristics that influenced dyskinesia response to placebo, and these factors were entered into a logistic regression model to quantify their influence on placebo‐related dyskinesia improvements and worsening. Because placebo‐associated improvements in Parkinsonism have been attributed to heightened dopaminergic activity, we also examined the association between changes in Parkinsonism and dyskinesia. Four hundred eighty‐four subjects received placebo treatment; 178 met criteria for placebo‐associated dyskinesia improvement and 37 for dyskinesia worsening. Older age, lower baseline Parkinsonism score, and lower total daily levodopa doses were associated with placebo‐associated improvement, whereas lower baseline dyskinesia score was associated with placebo‐associated worsening. Placebo‐associated dyskinesia changes were not correlated with Parkinsonism changes, and all effects in the sarizotan group were statistically explained by the placebo‐effect regression model. Dyskinesias are affected by placebo treatment. The absence of correlation between placebo‐induced changes in dyskinesia and Parkinsonism argues against a dopaminergic activation mechanism to explain placebo‐associated improvements in dyskinesia. The magnitude and variance of placebo‐related changes and the factors that influence them can be helpful in the design of future clinical trials of antidyskinetic agents. © 2007 Movement Disorder Society
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DOI: 10.1002/mds.21897
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ISTEX:26A53AAFCA642D9FC0D0DC629121E408271C161ELe document en format XML
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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="2008-04-15">2008-04-15</date><biblScope unit="vol">23</biblScope><biblScope unit="issue">5</biblScope><biblScope unit="page" from="700">700</biblScope><biblScope unit="page" to="707">707</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">26A53AAFCA642D9FC0D0DC629121E408271C161E</idno><idno type="DOI">10.1002/mds.21897</idno><idno type="ArticleID">MDS21897</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>dyskinesias</term><term>placebo</term><term>randomized clinical trials</term><term>sarizotan</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Clinical features that are prognostic indicators of placebo response among dyskinetic Parkinson's disease patients were determined. 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Older age, lower baseline Parkinsonism score, and lower total daily levodopa doses were associated with placebo‐associated improvement, whereas lower baseline dyskinesia score was associated with placebo‐associated worsening. Placebo‐associated dyskinesia changes were not correlated with Parkinsonism changes, and all effects in the sarizotan group were statistically explained by the placebo‐effect regression model. Dyskinesias are affected by placebo treatment. The absence of correlation between placebo‐induced changes in dyskinesia and Parkinsonism argues against a dopaminergic activation mechanism to explain placebo‐associated improvements in dyskinesia. The magnitude and variance of placebo‐related changes and the factors that influence them can be helpful in the design of future clinical trials of antidyskinetic agents. © 2007 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Christopher G. Goetz MD</name><affiliations><json:string>Rush University Medical Center, Chicago, Illinois, USA</json:string></affiliations></json:item><json:item><name>Eugene Laska PhD</name><affiliations><json:string>New York University School of Medicine, New York, New York, USA</json:string><json:string>Nathan Kline Institute, Orangeburg, New York, USA</json:string></affiliations></json:item><json:item><name>Christine Hicking Dipl Stat</name><affiliations><json:string>Merck KGaA, Darmstadt, Germany</json:string></affiliations></json:item><json:item><name>Philippe Damier MD, PhD</name><affiliations><json:string>Centre Hospitalo‐universitaire de Nantes, Centre d'Investigation Clinique, Nantes, France</json:string></affiliations></json:item><json:item><name>Thomas Müller MD</name><affiliations><json:string>Ruhr University, Bochum, Germany</json:string></affiliations></json:item><json:item><name>John Nutt MD</name><affiliations><json:string>Oregon Health Sciences University, Portland, Oregon, USA</json:string></affiliations></json:item><json:item><name>C. Warren Olanow MD</name><affiliations><json:string>Mount Sinai School of Medicine New York, New York, USA</json:string></affiliations></json:item><json:item><name>Olivier Rascol MD, PhD</name><affiliations><json:string>Toulouse University Hospital, INSERM Clinical Investigation Center, Toulouse, France</json:string></affiliations></json:item><json:item><name>Hermann Russ MD, PhD</name><affiliations><json:string>Merck KGaA, Darmstadt, Germany</json:string></affiliations></json:item></author><subject><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>placebo</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>dyskinesias</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>sarizotan</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>randomized clinical trials</value></json:item></subject><language><json:string>eng</json:string></language><abstract>Clinical features that are prognostic indicators of placebo response among dyskinetic Parkinson's disease patients were determined. Placebo‐associated improvements occur in Parkinsonism, but responses in dyskinesia have not been studied. Placebo data from two multicenter studies with identical design comparing sarizotan to placebo for treating dyskinesia were accessed. Sarizotan (2 mg/day) failed to improve dyskinesia compared with placebo, but both treatments improved dyskinesia compared with baseline. Stepwise regression identified baseline characteristics that influenced dyskinesia response to placebo, and these factors were entered into a logistic regression model to quantify their influence on placebo‐related dyskinesia improvements and worsening. Because placebo‐associated improvements in Parkinsonism have been attributed to heightened dopaminergic activity, we also examined the association between changes in Parkinsonism and dyskinesia. Four hundred eighty‐four subjects received placebo treatment; 178 met criteria for placebo‐associated dyskinesia improvement and 37 for dyskinesia worsening. Older age, lower baseline Parkinsonism score, and lower total daily levodopa doses were associated with placebo‐associated improvement, whereas lower baseline dyskinesia score was associated with placebo‐associated worsening. Placebo‐associated dyskinesia changes were not correlated with Parkinsonism changes, and all effects in the sarizotan group were statistically explained by the placebo‐effect regression model. Dyskinesias are affected by placebo treatment. The absence of correlation between placebo‐induced changes in dyskinesia and Parkinsonism argues against a dopaminergic activation mechanism to explain placebo‐associated improvements in dyskinesia. The magnitude and variance of placebo‐related changes and the factors that influence them can be helpful in the design of future clinical trials of antidyskinetic agents. © 2007 Movement Disorder Society</abstract><qualityIndicators><score>7.766</score><pdfVersion>1.3</pdfVersion><pdfPageSize>594 x 792 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractCharCount>1984</abstractCharCount><pdfWordCount>4778</pdfWordCount><pdfCharCount>31848</pdfCharCount><pdfPageCount>8</pdfPageCount><abstractWordCount>249</abstractWordCount></qualityIndicators><title>Placebo influences on dyskinesia in Parkinson's disease</title><genre><json:string>Serial article</json:string></genre><host><volume>23</volume><pages><total>8</total><last>707</last><first>700</first></pages><issn><json:string>0885-3185</json:string></issn><issue>5</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>2008</publicationDate><copyrightDate>2008</copyrightDate><doi><json:string>10.1002/mds.21897</json:string></doi><id>26A53AAFCA642D9FC0D0DC629121E408271C161E</id><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/26A53AAFCA642D9FC0D0DC629121E408271C161E/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/26A53AAFCA642D9FC0D0DC629121E408271C161E/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/26A53AAFCA642D9FC0D0DC629121E408271C161E/fulltext/tei"><teiHeader type="text"><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Placebo influences on dyskinesia in 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>2008</date></publicationStmt><notesStmt><note type="content">*The authors have confirmed with the Editor that their work complies with the Journal's Editorial policy on ghost‐writing (Movement Disorders, 2005, 20:1536). All authors had full access to the data and confirm the accuracy of the analysis.</note><note>NINOS - No. R21 NSO48594;</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Placebo influences on dyskinesia in Parkinson's disease</title><author><persName><forename type="first">Christopher G.</forename><surname>Goetz</surname><roleName type="degree">MD</roleName></persName><note type="correspondence"><p>Correspondence: Rush University Medical Center, Suite 755, 1725 West Harrison Street, Chicago, IL</p></note><affiliation>Rush University Medical Center, Chicago, Illinois, USA</affiliation></author><author><persName><forename type="first">Eugene</forename><surname>Laska</surname><roleName type="degree">PhD</roleName></persName><affiliation>New York University School of Medicine, New York, New York, USA</affiliation><affiliation>Nathan Kline Institute, Orangeburg, New York, USA</affiliation></author><author><persName><forename type="first">Christine</forename><surname>Hicking</surname><roleName type="degree">Dipl Stat</roleName></persName><affiliation>Merck KGaA, Darmstadt, Germany</affiliation></author><author><persName><forename type="first">Philippe</forename><surname>Damier</surname><roleName type="degree">MD, PhD</roleName></persName><affiliation>Centre Hospitalo‐universitaire de Nantes, Centre d'Investigation Clinique, Nantes, France</affiliation></author><author><persName><forename type="first">Thomas</forename><surname>Müller</surname><roleName type="degree">MD</roleName></persName><affiliation>Ruhr University, Bochum, Germany</affiliation></author><author><persName><forename type="first">John</forename><surname>Nutt</surname><roleName type="degree">MD</roleName></persName><affiliation>Oregon Health Sciences University, Portland, Oregon, USA</affiliation></author><author><persName><forename type="first">C.</forename><surname>Warren Olanow</surname><roleName type="degree">MD</roleName></persName><affiliation>Mount Sinai School of Medicine New York, New York, USA</affiliation></author><author><persName><forename type="first">Olivier</forename><surname>Rascol</surname><roleName type="degree">MD, PhD</roleName></persName><affiliation>Toulouse University Hospital, INSERM Clinical Investigation Center, Toulouse, France</affiliation></author><author><persName><forename type="first">Hermann</forename><surname>Russ</surname><roleName type="degree">MD, PhD</roleName></persName><affiliation>Merck KGaA, Darmstadt, Germany</affiliation></author></analytic><monogr><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. 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Placebo‐associated improvements occur in Parkinsonism, but responses in dyskinesia have not been studied. Placebo data from two multicenter studies with identical design comparing sarizotan to placebo for treating dyskinesia were accessed. Sarizotan (2 mg/day) failed to improve dyskinesia compared with placebo, but both treatments improved dyskinesia compared with baseline. Stepwise regression identified baseline characteristics that influenced dyskinesia response to placebo, and these factors were entered into a logistic regression model to quantify their influence on placebo‐related dyskinesia improvements and worsening. Because placebo‐associated improvements in Parkinsonism have been attributed to heightened dopaminergic activity, we also examined the association between changes in Parkinsonism and dyskinesia. Four hundred eighty‐four subjects received placebo treatment; 178 met criteria for placebo‐associated dyskinesia improvement and 37 for dyskinesia worsening. Older age, lower baseline Parkinsonism score, and lower total daily levodopa doses were associated with placebo‐associated improvement, whereas lower baseline dyskinesia score was associated with placebo‐associated worsening. Placebo‐associated dyskinesia changes were not correlated with Parkinsonism changes, and all effects in the sarizotan group were statistically explained by the placebo‐effect regression model. Dyskinesias are affected by placebo treatment. The absence of correlation between placebo‐induced changes in dyskinesia and Parkinsonism argues against a dopaminergic activation mechanism to explain placebo‐associated improvements in dyskinesia. The magnitude and variance of placebo‐related changes and the factors that influence them can be helpful in the design of future clinical trials of antidyskinetic agents. © 2007 Movement Disorder Society</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>Parkinson's disease</term></item><item><term>placebo</term></item><item><term>dyskinesias</term></item><item><term>sarizotan</term></item><item><term>randomized clinical trials</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="2007-06-22">Received</change><change when="2007-11-11">Registration</change><change when="2008-04-15">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/26A53AAFCA642D9FC0D0DC629121E408271C161E/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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href="file:MDS.MDS21897.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="0"></count><count type="tableTotal" number="3"></count><count type="referenceTotal" number="21"></count><count type="wordTotal" number="5444"></count></countGroup><titleGroup><title type="main" xml:lang="en">Placebo influences on dyskinesia in Parkinson's disease<link href="#fn1"></link></title><title type="short" xml:lang="en">Placebo Influences on Dyskinesia</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes"><personName><givenNames>Christopher G.</givenNames><familyName>Goetz</familyName><degrees>MD</degrees></personName><contactDetails><email>cgoetz@rush.edu</email></contactDetails></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af2 #af3"><personName><givenNames>Eugene</givenNames><familyName>Laska</familyName><degrees>PhD</degrees></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af4"><personName><givenNames>Christine</givenNames><familyName>Hicking</familyName><degrees>Dipl Stat</degrees></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af5"><personName><givenNames>Philippe</givenNames><familyName>Damier</familyName><degrees>MD, PhD</degrees></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af6"><personName><givenNames>Thomas</givenNames><familyName>Müller</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au6" creatorRole="author" affiliationRef="#af7"><personName><givenNames>John</givenNames><familyName>Nutt</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au7" creatorRole="author" affiliationRef="#af8"><personName><givenNames>C.</givenNames><familyName>Warren Olanow</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au8" creatorRole="author" affiliationRef="#af9"><personName><givenNames>Olivier</givenNames><familyName>Rascol</familyName><degrees>MD, PhD</degrees></personName></creator><creator xml:id="au9" creatorRole="author" affiliationRef="#af4"><personName><givenNames>Hermann</givenNames><familyName>Russ</familyName><degrees>MD, PhD</degrees></personName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="US" type="organization"><unparsedAffiliation>Rush University Medical Center, Chicago, Illinois, USA</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="US" type="organization"><unparsedAffiliation>New York University School of Medicine, New York, New York, USA</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="US" type="organization"><unparsedAffiliation>Nathan Kline Institute, Orangeburg, New York, USA</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="DE" type="organization"><unparsedAffiliation>Merck KGaA, Darmstadt, Germany</unparsedAffiliation></affiliation><affiliation xml:id="af5" countryCode="FR" type="organization"><unparsedAffiliation>Centre Hospitalo‐universitaire de Nantes, Centre d'Investigation Clinique, Nantes, France</unparsedAffiliation></affiliation><affiliation xml:id="af6" countryCode="DE" type="organization"><unparsedAffiliation>Ruhr University, Bochum, Germany</unparsedAffiliation></affiliation><affiliation xml:id="af7" countryCode="US" type="organization"><unparsedAffiliation>Oregon Health Sciences University, Portland, Oregon, USA</unparsedAffiliation></affiliation><affiliation xml:id="af8" countryCode="US" type="organization"><unparsedAffiliation>Mount Sinai School of Medicine New York, New York, USA</unparsedAffiliation></affiliation><affiliation xml:id="af9" countryCode="FR" type="organization"><unparsedAffiliation>Toulouse University Hospital, INSERM Clinical Investigation Center, Toulouse, France</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">Parkinson's disease</keyword><keyword xml:id="kwd2">placebo</keyword><keyword xml:id="kwd3">dyskinesias</keyword><keyword xml:id="kwd4">sarizotan</keyword><keyword xml:id="kwd5">randomized clinical trials</keyword></keywordGroup><fundingInfo><fundingAgency>NINOS</fundingAgency><fundingNumber>R21 NSO48594</fundingNumber></fundingInfo><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>Clinical features that are prognostic indicators of placebo response among dyskinetic Parkinson's disease patients were determined. Placebo‐associated improvements occur in Parkinsonism, but responses in dyskinesia have not been studied. Placebo data from two multicenter studies with identical design comparing sarizotan to placebo for treating dyskinesia were accessed. Sarizotan (2 mg/day) failed to improve dyskinesia compared with placebo, but both treatments improved dyskinesia compared with baseline. Stepwise regression identified baseline characteristics that influenced dyskinesia response to placebo, and these factors were entered into a logistic regression model to quantify their influence on placebo‐related dyskinesia improvements and worsening. Because placebo‐associated improvements in Parkinsonism have been attributed to heightened dopaminergic activity, we also examined the association between changes in Parkinsonism and dyskinesia. Four hundred eighty‐four subjects received placebo treatment; 178 met criteria for placebo‐associated dyskinesia improvement and 37 for dyskinesia worsening. Older age, lower baseline Parkinsonism score, and lower total daily levodopa doses were associated with placebo‐associated improvement, whereas lower baseline dyskinesia score was associated with placebo‐associated worsening. Placebo‐associated dyskinesia changes were not correlated with Parkinsonism changes, and all effects in the sarizotan group were statistically explained by the placebo‐effect regression model. Dyskinesias are affected by placebo treatment. The absence of correlation between placebo‐induced changes in dyskinesia and Parkinsonism argues against a dopaminergic activation mechanism to explain placebo‐associated improvements in dyskinesia. The magnitude and variance of placebo‐related changes and the factors that influence them can be helpful in the design of future clinical trials of antidyskinetic agents. © 2007 Movement Disorder Society</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn1"><p>The authors have confirmed with the Editor that their work complies with the Journal's Editorial policy on ghost‐writing (Movement Disorders, 2005, 20:1536). All authors had full access to the data and confirm the accuracy of the analysis.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><!--Version 0.6 générée le 4-12-2015--><mods version="3.6"><titleInfo lang="en"><title>Placebo influences on dyskinesia in Parkinson's disease</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Placebo Influences on Dyskinesia</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Placebo influences on dyskinesia in Parkinson's disease</title></titleInfo><name type="personal"><namePart type="given">Christopher G.</namePart><namePart type="family">Goetz</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Rush University Medical Center, Chicago, Illinois, USA</affiliation><description>Correspondence: Rush University Medical Center, Suite 755, 1725 West Harrison Street, Chicago, IL</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Eugene</namePart><namePart type="family">Laska</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>New York University School of Medicine, New York, New York, USA</affiliation><affiliation>Nathan Kline Institute, Orangeburg, New York, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Christine</namePart><namePart type="family">Hicking</namePart><namePart type="termsOfAddress">Dipl Stat</namePart><affiliation>Merck KGaA, Darmstadt, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Philippe</namePart><namePart type="family">Damier</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>Centre Hospitalo‐universitaire de Nantes, Centre d'Investigation Clinique, Nantes, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Thomas</namePart><namePart type="family">Müller</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Ruhr University, Bochum, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">John</namePart><namePart type="family">Nutt</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Oregon Health Sciences University, Portland, Oregon, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C.</namePart><namePart type="family">Warren Olanow</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Mount Sinai School of Medicine New York, New York, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Olivier</namePart><namePart type="family">Rascol</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>Toulouse University Hospital, INSERM Clinical Investigation Center, Toulouse, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Hermann</namePart><namePart type="family">Russ</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>Merck KGaA, Darmstadt, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></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">2008-04-15</dateIssued><dateCaptured encoding="w3cdtf">2007-06-22</dateCaptured><dateValid encoding="w3cdtf">2007-11-11</dateValid><copyrightDate encoding="w3cdtf">2008</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="tables">3</extent><extent unit="references">21</extent><extent unit="words">5444</extent></physicalDescription><abstract lang="en">Clinical features that are prognostic indicators of placebo response among dyskinetic Parkinson's disease patients were determined. Placebo‐associated improvements occur in Parkinsonism, but responses in dyskinesia have not been studied. Placebo data from two multicenter studies with identical design comparing sarizotan to placebo for treating dyskinesia were accessed. Sarizotan (2 mg/day) failed to improve dyskinesia compared with placebo, but both treatments improved dyskinesia compared with baseline. Stepwise regression identified baseline characteristics that influenced dyskinesia response to placebo, and these factors were entered into a logistic regression model to quantify their influence on placebo‐related dyskinesia improvements and worsening. Because placebo‐associated improvements in Parkinsonism have been attributed to heightened dopaminergic activity, we also examined the association between changes in Parkinsonism and dyskinesia. Four hundred eighty‐four subjects received placebo treatment; 178 met criteria for placebo‐associated dyskinesia improvement and 37 for dyskinesia worsening. Older age, lower baseline Parkinsonism score, and lower total daily levodopa doses were associated with placebo‐associated improvement, whereas lower baseline dyskinesia score was associated with placebo‐associated worsening. Placebo‐associated dyskinesia changes were not correlated with Parkinsonism changes, and all effects in the sarizotan group were statistically explained by the placebo‐effect regression model. Dyskinesias are affected by placebo treatment. The absence of correlation between placebo‐induced changes in dyskinesia and Parkinsonism argues against a dopaminergic activation mechanism to explain placebo‐associated improvements in dyskinesia. The magnitude and variance of placebo‐related changes and the factors that influence them can be helpful in the design of future clinical trials of antidyskinetic agents. © 2007 Movement Disorder Society</abstract><note type="content">*The authors have confirmed with the Editor that their work complies with the Journal's Editorial policy on ghost‐writing (Movement Disorders, 2005, 20:1536). All authors had full access to the data and confirm the accuracy of the analysis.</note><note type="funding">NINOS - No. R21 NSO48594; </note><subject lang="en"><genre>Keywords</genre><topic>Parkinson's disease</topic><topic>placebo</topic><topic>dyskinesias</topic><topic>sarizotan</topic><topic>randomized clinical trials</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>2008</date><detail type="volume"><caption>vol.</caption><number>23</number></detail><detail type="issue"><caption>no.</caption><number>5</number></detail><extent unit="pages"><start>700</start><end>707</end><total>8</total></extent></part></relatedItem><identifier type="istex">26A53AAFCA642D9FC0D0DC629121E408271C161E</identifier><identifier type="DOI">10.1002/mds.21897</identifier><identifier type="ArticleID">MDS21897</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2007 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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