Rasagiline improves quality of life in patients with early Parkinson's disease
Identifieur interne : 000832 ( Istex/Corpus ); précédent : 000831; suivant : 000833Rasagiline improves quality of life in patients with early Parkinson's disease
Auteurs : Kevin M. Biglan ; Steven Schwid ; Shirley Eberly ; Karen Blindauer ; Stanley Fahn ; Tamar Goren ; Karl Kieburtz ; David Oakes ; Sandra Plumb ; Andrew Siderowf ; Matthew Stern ; Ira ShoulsonSource :
- Movement Disorders [ 0885-3185 ] ; 2006-05.
English descriptors
- KwdEn :
Abstract
The objective of this study was to determine the effects of rasagiline as monotherapy on quality of life (QOL) in patients with early Parkinson's disease (PD). Rasagiline, a potent, second‐generation, irreversible, selective monoamine oxidase B inhibitor improves PD symptoms in patients with early PD. Patients with early untreated PD were randomly assigned to once‐daily rasagiline 1 mg/day, rasagiline 2 mg/day, or placebo in a 6‐month, double‐blind trial (n = 404). At the end of 6 months, patients entered the preplanned, active‐treatment phase in which those receiving 1 mg/day and 2 mg/day of rasagiline continued on their previously assigned dosages and those receiving placebo switched to rasagiline 2 mg/day, while maintaining blinding to treatment assignments. QOL was measured with the Parkinson's Disease Quality of Life questionnaire (PDQUALIF) at 0, 14, 26, and 52 weeks after randomization. Analysis of the change in PDQUALIF scores from baseline to 6 months showed adjusted treatment effects (with 95% confidence interval) favoring rasagiline over placebo of −2.91 units (−5.19, −0.64, P = 0.01) for the 1 mg/day group and −2.74 units (−5.02, −0.45, P = 0.02) for the 2 mg/day. Subscore analysis attributed most of this benefit to the self‐image/sexuality domain. At 12 months (n = 266), with all groups receiving rasagiline for at least 6 months, no significant differences in PDQUALIF scores were seen between groups. Rasagiline improved QOL compared with placebo. This QOL improvement appears to be accounted for primarily by the symptomatic benefit of rasagiline. © 2006 Movement Disorder Society
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DOI: 10.1002/mds.20764
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Biglan</name><affiliation><mods:affiliation>Department of Neurology, Johns Hopkins University, Baltimore, Maryland, USA</mods:affiliation></affiliation></author><author><name sortKey="Schwid, Steven" sort="Schwid, Steven" uniqKey="Schwid S" first="Steven" last="Schwid">Steven Schwid</name><affiliation><mods:affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</mods:affiliation></affiliation></author><author><name sortKey="Eberly, Shirley" sort="Eberly, Shirley" uniqKey="Eberly S" first="Shirley" last="Eberly">Shirley Eberly</name><affiliation><mods:affiliation>Department of Biostatistics, University of Rochester, New York, USA</mods:affiliation></affiliation></author><author><name sortKey="Blindauer, Karen" sort="Blindauer, Karen" uniqKey="Blindauer K" first="Karen" last="Blindauer">Karen Blindauer</name><affiliation><mods:affiliation>Department of Neurology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA</mods:affiliation></affiliation></author><author><name sortKey="Fahn, Stanley" sort="Fahn, Stanley" uniqKey="Fahn S" first="Stanley" last="Fahn">Stanley Fahn</name><affiliation><mods:affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</mods:affiliation></affiliation></author><author><name sortKey="Goren, Tamar" sort="Goren, Tamar" uniqKey="Goren T" first="Tamar" last="Goren">Tamar Goren</name><affiliation><mods:affiliation>Teva Pharmaceutical Industries, Ltd., Netanya, Israel</mods:affiliation></affiliation></author><author><name sortKey="Kieburtz, Karl" sort="Kieburtz, Karl" uniqKey="Kieburtz K" first="Karl" last="Kieburtz">Karl Kieburtz</name><affiliation><mods:affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</mods:affiliation></affiliation></author><author><name sortKey="Oakes, David" sort="Oakes, David" uniqKey="Oakes D" first="David" last="Oakes">David Oakes</name><affiliation><mods:affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Biostatistics, University of Rochester, New York, USA</mods:affiliation></affiliation></author><author><name sortKey="Plumb, Sandra" sort="Plumb, Sandra" uniqKey="Plumb S" first="Sandra" last="Plumb">Sandra Plumb</name><affiliation><mods:affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</mods:affiliation></affiliation></author><author><name sortKey="Siderowf, Andrew" sort="Siderowf, Andrew" uniqKey="Siderowf A" first="Andrew" last="Siderowf">Andrew Siderowf</name><affiliation><mods:affiliation>Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA</mods:affiliation></affiliation></author><author><name sortKey="Stern, Matthew" sort="Stern, Matthew" uniqKey="Stern M" first="Matthew" last="Stern">Matthew Stern</name><affiliation><mods:affiliation>Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA</mods:affiliation></affiliation></author><author><name sortKey="Shoulson, Ira" sort="Shoulson, Ira" uniqKey="Shoulson I" first="Ira" last="Shoulson">Ira Shoulson</name><affiliation><mods:affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:FAC4E07EB855AFF17AC19C92C821D2EA53FF80D0</idno><date when="2006" year="2006">2006</date><idno type="doi">10.1002/mds.20764</idno><idno type="url">https://api.istex.fr/document/FAC4E07EB855AFF17AC19C92C821D2EA53FF80D0/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">000832</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Rasagiline improves quality of life in patients with early Parkinson's disease</title><author><name sortKey="Biglan, Kevin M" sort="Biglan, Kevin M" uniqKey="Biglan K" first="Kevin M." last="Biglan">Kevin M. Biglan</name><affiliation><mods:affiliation>Department of Neurology, Johns Hopkins University, Baltimore, Maryland, USA</mods:affiliation></affiliation></author><author><name sortKey="Schwid, Steven" sort="Schwid, Steven" uniqKey="Schwid S" first="Steven" last="Schwid">Steven Schwid</name><affiliation><mods:affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</mods:affiliation></affiliation></author><author><name sortKey="Eberly, Shirley" sort="Eberly, Shirley" uniqKey="Eberly S" first="Shirley" last="Eberly">Shirley Eberly</name><affiliation><mods:affiliation>Department of Biostatistics, University of Rochester, New York, USA</mods:affiliation></affiliation></author><author><name sortKey="Blindauer, Karen" sort="Blindauer, Karen" uniqKey="Blindauer K" first="Karen" last="Blindauer">Karen Blindauer</name><affiliation><mods:affiliation>Department of Neurology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA</mods:affiliation></affiliation></author><author><name sortKey="Fahn, Stanley" sort="Fahn, Stanley" uniqKey="Fahn S" first="Stanley" last="Fahn">Stanley Fahn</name><affiliation><mods:affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</mods:affiliation></affiliation></author><author><name sortKey="Goren, Tamar" sort="Goren, Tamar" uniqKey="Goren T" first="Tamar" last="Goren">Tamar Goren</name><affiliation><mods:affiliation>Teva Pharmaceutical Industries, Ltd., Netanya, Israel</mods:affiliation></affiliation></author><author><name sortKey="Kieburtz, Karl" sort="Kieburtz, Karl" uniqKey="Kieburtz K" first="Karl" last="Kieburtz">Karl Kieburtz</name><affiliation><mods:affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</mods:affiliation></affiliation></author><author><name sortKey="Oakes, David" sort="Oakes, David" uniqKey="Oakes D" first="David" last="Oakes">David Oakes</name><affiliation><mods:affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Biostatistics, University of Rochester, New York, USA</mods:affiliation></affiliation></author><author><name sortKey="Plumb, Sandra" sort="Plumb, Sandra" uniqKey="Plumb S" first="Sandra" last="Plumb">Sandra Plumb</name><affiliation><mods:affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</mods:affiliation></affiliation></author><author><name sortKey="Siderowf, Andrew" sort="Siderowf, Andrew" uniqKey="Siderowf A" first="Andrew" last="Siderowf">Andrew Siderowf</name><affiliation><mods:affiliation>Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA</mods:affiliation></affiliation></author><author><name sortKey="Stern, Matthew" sort="Stern, Matthew" uniqKey="Stern M" first="Matthew" last="Stern">Matthew Stern</name><affiliation><mods:affiliation>Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA</mods:affiliation></affiliation></author><author><name sortKey="Shoulson, Ira" sort="Shoulson, Ira" uniqKey="Shoulson I" first="Ira" last="Shoulson">Ira Shoulson</name><affiliation><mods:affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="sub">Official Journal of the Movement Disorder Society</title><title level="j" type="abbrev">Mov. 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Rasagiline, a potent, second‐generation, irreversible, selective monoamine oxidase B inhibitor improves PD symptoms in patients with early PD. Patients with early untreated PD were randomly assigned to once‐daily rasagiline 1 mg/day, rasagiline 2 mg/day, or placebo in a 6‐month, double‐blind trial (n = 404). At the end of 6 months, patients entered the preplanned, active‐treatment phase in which those receiving 1 mg/day and 2 mg/day of rasagiline continued on their previously assigned dosages and those receiving placebo switched to rasagiline 2 mg/day, while maintaining blinding to treatment assignments. QOL was measured with the Parkinson's Disease Quality of Life questionnaire (PDQUALIF) at 0, 14, 26, and 52 weeks after randomization. Analysis of the change in PDQUALIF scores from baseline to 6 months showed adjusted treatment effects (with 95% confidence interval) favoring rasagiline over placebo of −2.91 units (−5.19, −0.64, P = 0.01) for the 1 mg/day group and −2.74 units (−5.02, −0.45, P = 0.02) for the 2 mg/day. Subscore analysis attributed most of this benefit to the self‐image/sexuality domain. At 12 months (n = 266), with all groups receiving rasagiline for at least 6 months, no significant differences in PDQUALIF scores were seen between groups. Rasagiline improved QOL compared with placebo. This QOL improvement appears to be accounted for primarily by the symptomatic benefit of rasagiline. © 2006 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Kevin M. Biglan MD, MPH</name><affiliations><json:string>Department of Neurology, Johns Hopkins University, Baltimore, Maryland, USA</json:string></affiliations></json:item><json:item><name>Steven Schwid MD</name><affiliations><json:string>Department of Neurology, University of Rochester, Rochester, New York, USA</json:string></affiliations></json:item><json:item><name>Shirley Eberly MS</name><affiliations><json:string>Department of Biostatistics, University of Rochester, New York, USA</json:string></affiliations></json:item><json:item><name>Karen Blindauer MD</name><affiliations><json:string>Department of Neurology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA</json:string></affiliations></json:item><json:item><name>Stanley Fahn MD</name><affiliations><json:string>Department of Neurology, University of Rochester, Rochester, New York, USA</json:string></affiliations></json:item><json:item><name>Tamar Goren PhD</name><affiliations><json:string>Teva Pharmaceutical Industries, Ltd., Netanya, Israel</json:string></affiliations></json:item><json:item><name>Karl Kieburtz MD, MPH</name><affiliations><json:string>Department of Neurology, University of Rochester, Rochester, New York, USA</json:string></affiliations></json:item><json:item><name>David Oakes PhD</name><affiliations><json:string>Department of Neurology, University of Rochester, Rochester, New York, USA</json:string><json:string>Department of Biostatistics, University of Rochester, New York, USA</json:string></affiliations></json:item><json:item><name>Sandra Plumb BS</name><affiliations><json:string>Department of Neurology, University of Rochester, Rochester, New York, USA</json:string></affiliations></json:item><json:item><name>Andrew Siderowf MD</name><affiliations><json:string>Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA</json:string></affiliations></json:item><json:item><name>Matthew Stern MD</name><affiliations><json:string>Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA</json:string></affiliations></json:item><json:item><name>Ira Shoulson MD</name><affiliations><json:string>Department of Neurology, University of Rochester, Rochester, New York, USA</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>rasagiline</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>quality of life</value></json:item></subject><language><json:string>eng</json:string></language><abstract>The objective of this study was to determine the effects of rasagiline as monotherapy on quality of life (QOL) in patients with early Parkinson's disease (PD). Rasagiline, a potent, second‐generation, irreversible, selective monoamine oxidase B inhibitor improves PD symptoms in patients with early PD. Patients with early untreated PD were randomly assigned to once‐daily rasagiline 1 mg/day, rasagiline 2 mg/day, or placebo in a 6‐month, double‐blind trial (n = 404). At the end of 6 months, patients entered the preplanned, active‐treatment phase in which those receiving 1 mg/day and 2 mg/day of rasagiline continued on their previously assigned dosages and those receiving placebo switched to rasagiline 2 mg/day, while maintaining blinding to treatment assignments. QOL was measured with the Parkinson's Disease Quality of Life questionnaire (PDQUALIF) at 0, 14, 26, and 52 weeks after randomization. Analysis of the change in PDQUALIF scores from baseline to 6 months showed adjusted treatment effects (with 95% confidence interval) favoring rasagiline over placebo of −2.91 units (−5.19, −0.64, P = 0.01) for the 1 mg/day group and −2.74 units (−5.02, −0.45, P = 0.02) for the 2 mg/day. Subscore analysis attributed most of this benefit to the self‐image/sexuality domain. At 12 months (n = 266), with all groups receiving rasagiline for at least 6 months, no significant differences in PDQUALIF scores were seen between groups. Rasagiline improved QOL compared with placebo. 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(Netanya, Israel)</note><note>H. Lundbeck A/S (Copenhagen, Denmark)</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Rasagiline improves quality of life in patients with early Parkinson's disease</title><author><persName><forename type="first">Kevin M.</forename><surname>Biglan</surname><roleName type="degree">MD, MPH</roleName></persName><note type="correspondence"><p>Correspondence: Johns Hopkins School of Medicine, Johns Hopkins Outpatient Center, 601 N Caroline Street, Baltimore, MD 21287</p></note><affiliation>Department of Neurology, Johns Hopkins University, Baltimore, Maryland, USA</affiliation></author><author><persName><forename type="first">Steven</forename><surname>Schwid</surname><roleName type="degree">MD</roleName></persName><affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</affiliation></author><author><persName><forename type="first">Shirley</forename><surname>Eberly</surname><roleName type="degree">MS</roleName></persName><affiliation>Department of Biostatistics, University of Rochester, New York, USA</affiliation></author><author><persName><forename type="first">Karen</forename><surname>Blindauer</surname><roleName type="degree">MD</roleName></persName><affiliation>Department of Neurology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA</affiliation></author><author><persName><forename type="first">Stanley</forename><surname>Fahn</surname><roleName type="degree">MD</roleName></persName><affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</affiliation></author><author><persName><forename type="first">Tamar</forename><surname>Goren</surname><roleName type="degree">PhD</roleName></persName><affiliation>Teva Pharmaceutical Industries, Ltd., Netanya, Israel</affiliation></author><author><persName><forename type="first">Karl</forename><surname>Kieburtz</surname><roleName type="degree">MD, MPH</roleName></persName><affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</affiliation></author><author><persName><forename type="first">David</forename><surname>Oakes</surname><roleName type="degree">PhD</roleName></persName><affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</affiliation><affiliation>Department of Biostatistics, University of Rochester, New York, USA</affiliation></author><author><persName><forename type="first">Sandra</forename><surname>Plumb</surname><roleName type="degree">BS</roleName></persName><affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</affiliation></author><author><persName><forename type="first">Andrew</forename><surname>Siderowf</surname><roleName type="degree">MD</roleName></persName><affiliation>Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA</affiliation></author><author><persName><forename type="first">Matthew</forename><surname>Stern</surname><roleName type="degree">MD</roleName></persName><affiliation>Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA</affiliation></author><author><persName><forename type="first">Ira</forename><surname>Shoulson</surname><roleName type="degree">MD</roleName></persName><affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</affiliation></author></analytic><monogr><title level="j">Movement Disorders</title><title level="j" type="sub">Official Journal of the Movement Disorder Society</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="2006-05"></date><biblScope unit="vol">21</biblScope><biblScope unit="issue">5</biblScope><biblScope unit="page" from="616">616</biblScope><biblScope unit="page" to="623">623</biblScope></imprint></monogr><idno type="istex">FAC4E07EB855AFF17AC19C92C821D2EA53FF80D0</idno><idno type="DOI">10.1002/mds.20764</idno><idno type="ArticleID">MDS20764</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2006</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>The objective of this study was to determine the effects of rasagiline as monotherapy on quality of life (QOL) in patients with early Parkinson's disease (PD). Rasagiline, a potent, second‐generation, irreversible, selective monoamine oxidase B inhibitor improves PD symptoms in patients with early PD. Patients with early untreated PD were randomly assigned to once‐daily rasagiline 1 mg/day, rasagiline 2 mg/day, or placebo in a 6‐month, double‐blind trial (n = 404). At the end of 6 months, patients entered the preplanned, active‐treatment phase in which those receiving 1 mg/day and 2 mg/day of rasagiline continued on their previously assigned dosages and those receiving placebo switched to rasagiline 2 mg/day, while maintaining blinding to treatment assignments. QOL was measured with the Parkinson's Disease Quality of Life questionnaire (PDQUALIF) at 0, 14, 26, and 52 weeks after randomization. Analysis of the change in PDQUALIF scores from baseline to 6 months showed adjusted treatment effects (with 95% confidence interval) favoring rasagiline over placebo of −2.91 units (−5.19, −0.64, P = 0.01) for the 1 mg/day group and −2.74 units (−5.02, −0.45, P = 0.02) for the 2 mg/day. Subscore analysis attributed most of this benefit to the self‐image/sexuality domain. At 12 months (n = 266), with all groups receiving rasagiline for at least 6 months, no significant differences in PDQUALIF scores were seen between groups. Rasagiline improved QOL compared with placebo. This QOL improvement appears to be accounted for primarily by the symptomatic benefit of rasagiline. © 2006 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>rasagiline</term></item><item><term>quality of life</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="2004-08-13">Received</change><change when="2005-08-09">Registration</change><change when="2006-05">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/FAC4E07EB855AFF17AC19C92C821D2EA53FF80D0/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="subtitle">Official Journal of the Movement Disorder Society</title><title type="short">Mov. 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date="2005-08-09"></event><event type="publishedOnlineEarlyUnpaginated" date="2006-01-31"></event><event type="firstOnline" date="2006-01-31"></event><event type="publishedOnlineFinalForm" date="2006-05-04"></event><event type="xmlConverted" agent="Converter:JWSART34_TO_WML3G version:2.3.2 mode:FullText source:FullText result:FullText" date="2010-03-09"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.8.8" date="2014-02-02"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.1.7 mode:FullText,remove_FC" date="2014-10-31"></event></eventGroup><numberingGroup><numbering type="pageFirst">616</numbering><numbering type="pageLast">623</numbering></numberingGroup><correspondenceTo>Johns Hopkins School of Medicine, Johns Hopkins Outpatient Center, 601 N Caroline Street, Baltimore, MD 21287</correspondenceTo><objectNameGroup><objectName elementName="appendix">APPENDIX</objectName></objectNameGroup><linkGroup><link type="toTypesetVersion" href="file:MDS.MDS20764.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="3"></count><count type="tableTotal" number="3"></count><count type="referenceTotal" number="20"></count><count type="wordTotal" number="4882"></count></countGroup><titleGroup><title type="main" xml:lang="en">Rasagiline improves quality of life in patients with early Parkinson's disease</title><title type="short" xml:lang="en">Rasagiline and Quality of Life</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes"><personName><givenNames>Kevin M.</givenNames><familyName>Biglan</familyName><degrees>MD, MPH</degrees></personName><contactDetails><email>kbiglan1@jhmi.edu</email></contactDetails></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Steven</givenNames><familyName>Schwid</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Shirley</givenNames><familyName>Eberly</familyName><degrees>MS</degrees></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af4"><personName><givenNames>Karen</givenNames><familyName>Blindauer</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af5"><personName><givenNames>Stanley</givenNames><familyName>Fahn</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au6" creatorRole="author" affiliationRef="#af6"><personName><givenNames>Tamar</givenNames><familyName>Goren</familyName><degrees>PhD</degrees></personName></creator><creator xml:id="au7" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Karl</givenNames><familyName>Kieburtz</familyName><degrees>MD, MPH</degrees></personName></creator><creator xml:id="au8" creatorRole="author" affiliationRef="#af2 #af3"><personName><givenNames>David</givenNames><familyName>Oakes</familyName><degrees>PhD</degrees></personName></creator><creator xml:id="au9" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Sandra</givenNames><familyName>Plumb</familyName><degrees>BS</degrees></personName></creator><creator xml:id="au10" creatorRole="author" affiliationRef="#af7"><personName><givenNames>Andrew</givenNames><familyName>Siderowf</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au11" creatorRole="author" affiliationRef="#af7"><personName><givenNames>Matthew</givenNames><familyName>Stern</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au12" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Ira</givenNames><familyName>Shoulson</familyName><degrees>MD</degrees></personName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, Johns Hopkins University, Baltimore, Maryland, USA</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="US" type="organization"><unparsedAffiliation>Department of Biostatistics, University of Rochester, New York, USA</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA</unparsedAffiliation></affiliation><affiliation xml:id="af5" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</unparsedAffiliation></affiliation><affiliation xml:id="af6" countryCode="IL" type="organization"><unparsedAffiliation>Teva Pharmaceutical Industries, Ltd., Netanya, Israel</unparsedAffiliation></affiliation><affiliation xml:id="af7" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">Parkinson's disease</keyword><keyword xml:id="kwd2">rasagiline</keyword><keyword xml:id="kwd3">quality of life</keyword></keywordGroup><fundingInfo><fundingAgency>Teva Pharmaceutical Industries, Ltd. (Netanya, Israel)</fundingAgency></fundingInfo><fundingInfo><fundingAgency>H. Lundbeck A/S (Copenhagen, Denmark)</fundingAgency></fundingInfo><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>The objective of this study was to determine the effects of rasagiline as monotherapy on quality of life (QOL) in patients with early Parkinson's disease (PD). Rasagiline, a potent, second‐generation, irreversible, selective monoamine oxidase B inhibitor improves PD symptoms in patients with early PD. Patients with early untreated PD were randomly assigned to once‐daily rasagiline 1 mg/day, rasagiline 2 mg/day, or placebo in a 6‐month, double‐blind trial (n = 404). At the end of 6 months, patients entered the preplanned, active‐treatment phase in which those receiving 1 mg/day and 2 mg/day of rasagiline continued on their previously assigned dosages and those receiving placebo switched to rasagiline 2 mg/day, while maintaining blinding to treatment assignments. QOL was measured with the Parkinson's Disease Quality of Life questionnaire (PDQUALIF) at 0, 14, 26, and 52 weeks after randomization. Analysis of the change in PDQUALIF scores from baseline to 6 months showed adjusted treatment effects (with 95% confidence interval) favoring rasagiline over placebo of −2.91 units (−5.19, −0.64, <i>P</i> = 0.01) for the 1 mg/day group and −2.74 units (−5.02, −0.45, <i>P</i> = 0.02) for the 2 mg/day. Subscore analysis attributed most of this benefit to the self‐image/sexuality domain. At 12 months (n = 266), with all groups receiving rasagiline for at least 6 months, no significant differences in PDQUALIF scores were seen between groups. Rasagiline improved QOL compared with placebo. This QOL improvement appears to be accounted for primarily by the symptomatic benefit of rasagiline. © 2006 Movement Disorder Society</p></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><!--Version 0.6 générée le 3-12-2015--><mods version="3.6"><titleInfo lang="en"><title>Rasagiline improves quality of life in patients with early Parkinson's disease</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Rasagiline and Quality of Life</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Rasagiline improves quality of life in patients with early Parkinson's disease</title></titleInfo><name type="personal"><namePart type="given">Kevin M.</namePart><namePart type="family">Biglan</namePart><namePart type="termsOfAddress">MD, MPH</namePart><affiliation>Department of Neurology, Johns Hopkins University, Baltimore, Maryland, USA</affiliation><description>Correspondence: Johns Hopkins School of Medicine, Johns Hopkins Outpatient Center, 601 N Caroline Street, Baltimore, MD 21287</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Steven</namePart><namePart type="family">Schwid</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Shirley</namePart><namePart type="family">Eberly</namePart><namePart type="termsOfAddress">MS</namePart><affiliation>Department of Biostatistics, University of Rochester, New York, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Karen</namePart><namePart type="family">Blindauer</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Stanley</namePart><namePart type="family">Fahn</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Tamar</namePart><namePart type="family">Goren</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Teva Pharmaceutical Industries, Ltd., Netanya, Israel</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Karl</namePart><namePart type="family">Kieburtz</namePart><namePart type="termsOfAddress">MD, MPH</namePart><affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">David</namePart><namePart type="family">Oakes</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</affiliation><affiliation>Department of Biostatistics, University of Rochester, New York, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Sandra</namePart><namePart type="family">Plumb</namePart><namePart type="termsOfAddress">BS</namePart><affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Andrew</namePart><namePart type="family">Siderowf</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Matthew</namePart><namePart type="family">Stern</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Ira</namePart><namePart type="family">Shoulson</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</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">2006-05</dateIssued><dateCaptured encoding="w3cdtf">2004-08-13</dateCaptured><dateValid encoding="w3cdtf">2005-08-09</dateValid><copyrightDate encoding="w3cdtf">2006</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">3</extent><extent unit="references">20</extent><extent unit="words">4882</extent></physicalDescription><abstract lang="en">The objective of this study was to determine the effects of rasagiline as monotherapy on quality of life (QOL) in patients with early Parkinson's disease (PD). Rasagiline, a potent, second‐generation, irreversible, selective monoamine oxidase B inhibitor improves PD symptoms in patients with early PD. Patients with early untreated PD were randomly assigned to once‐daily rasagiline 1 mg/day, rasagiline 2 mg/day, or placebo in a 6‐month, double‐blind trial (n = 404). At the end of 6 months, patients entered the preplanned, active‐treatment phase in which those receiving 1 mg/day and 2 mg/day of rasagiline continued on their previously assigned dosages and those receiving placebo switched to rasagiline 2 mg/day, while maintaining blinding to treatment assignments. QOL was measured with the Parkinson's Disease Quality of Life questionnaire (PDQUALIF) at 0, 14, 26, and 52 weeks after randomization. Analysis of the change in PDQUALIF scores from baseline to 6 months showed adjusted treatment effects (with 95% confidence interval) favoring rasagiline over placebo of −2.91 units (−5.19, −0.64, P = 0.01) for the 1 mg/day group and −2.74 units (−5.02, −0.45, P = 0.02) for the 2 mg/day. Subscore analysis attributed most of this benefit to the self‐image/sexuality domain. At 12 months (n = 266), with all groups receiving rasagiline for at least 6 months, no significant differences in PDQUALIF scores were seen between groups. Rasagiline improved QOL compared with placebo. This QOL improvement appears to be accounted for primarily by the symptomatic benefit of rasagiline. © 2006 Movement Disorder Society</abstract><note type="funding">Teva Pharmaceutical Industries, Ltd. (Netanya, Israel)</note><note type="funding">H. Lundbeck A/S (Copenhagen, Denmark)</note><subject lang="en"><genre>Keywords</genre><topic>Parkinson's disease</topic><topic>rasagiline</topic><topic>quality of life</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title><subTitle>Official Journal of the Movement Disorder Society</subTitle></titleInfo><titleInfo type="abbreviated"><title>Mov. 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