Effect of rasagiline as adjunct therapy to levodopa on severity of OFF in Parkinson’s disease
Identifieur interne : 000948 ( Main/Corpus ); précédent : 000947; suivant : 000949Effect of rasagiline as adjunct therapy to levodopa on severity of OFF in Parkinson’s disease
Auteurs : F. Stocchi ; J. M. RabeySource :
- European Journal of Neurology [ 1351-5101 ] ; 2011-12.
English descriptors
- KwdEn :
Abstract
Background: The LARGO study demonstrated that rasagiline 1 mg/day as adjunct to levodopa significantly reduces OFF time to the same magnitude as adjunct entacapone. This substudy of LARGO aimed to assess the effect of rasagiline and entacapone on the motor symptoms of PD during the practically defined OFF state. Methods: LARGO was a randomized, double‐blind, multicenter trial that assessed the efficacy and safety of rasagiline (1 mg/day), entacapone (200 mg with each levodopa dose), and placebo in 687 levodopa‐treated PD patients with motor fluctuations. A substudy of LARGO measured UPDRS motor scores in the practically defined OFF state in 32 rasagiline, 36 entacapone, and 37 placebo patients. Results: Treatment with rasagiline produced a significant improvement over placebo of 5.64 units in UPDRS motor OFF score (P = 0.013 vs. placebo). By contrast, the effect of adjunct entacapone was not significant (P = 0.14 vs. placebo). Whereas rasagiline also showed a trend in reducing the UPDRS‐ADL OFF score (P = 0.058 vs. placebo), no such trend was noted for entacapone (P = 0.26 vs. placebo). Retrospective analysis, using the Bonferroni correction, of UPDRS motor subdomains further revealed that rasagiline, but not entacapone, significantly improved bradykinesia (P < 0.001) and showed trends for improvements in facial expression, speech, and axial impairment during OFF time. Conclusions: This study provides the first objectively measured evidence that adjunct rasagiline 1 mg/day is effective in reducing the severity of motor symptoms in the OFF state. This suggests a continuous effect of rasagiline 1 mg/day throughout the day and night and is consistent with its extended duration of therapeutic action.
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DOI: 10.1111/j.1468-1331.2011.03512.x
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ISTEX:72E14E1C2570C09CB28605C9016874A376D1CE91Le document en format XML
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This substudy of LARGO aimed to assess the effect of rasagiline and entacapone on the motor symptoms of PD during the practically defined OFF state. Methods: LARGO was a randomized, double‐blind, multicenter trial that assessed the efficacy and safety of rasagiline (1 mg/day), entacapone (200 mg with each levodopa dose), and placebo in 687 levodopa‐treated PD patients with motor fluctuations. A substudy of LARGO measured UPDRS motor scores in the practically defined OFF state in 32 rasagiline, 36 entacapone, and 37 placebo patients. Results: Treatment with rasagiline produced a significant improvement over placebo of 5.64 units in UPDRS motor OFF score (P = 0.013 vs. placebo). By contrast, the effect of adjunct entacapone was not significant (P = 0.14 vs. placebo). Whereas rasagiline also showed a trend in reducing the UPDRS‐ADL OFF score (P = 0.058 vs. placebo), no such trend was noted for entacapone (P = 0.26 vs. placebo). Retrospective analysis, using the Bonferroni correction, of UPDRS motor subdomains further revealed that rasagiline, but not entacapone, significantly improved bradykinesia (P < 0.001) and showed trends for improvements in facial expression, speech, and axial impairment during OFF time. Conclusions: This study provides the first objectively measured evidence that adjunct rasagiline 1 mg/day is effective in reducing the severity of motor symptoms in the OFF state. This suggests a continuous effect of rasagiline 1 mg/day throughout the day and night and is consistent with its extended duration of therapeutic action.</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>F. Stocchi</name><affiliations><json:string>Institute of Neurology, IRCCS San Raffaele, Pisana, Rome, Italy</json:string></affiliations></json:item><json:item><name>J. M. 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M.</forename><surname>Rabey</surname></persName><affiliation>Department of Neurology, Assaf Harofeh Medical Center, Zerifin, Affiliated to Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel</affiliation></author></analytic><monogr><title level="j">European Journal of Neurology</title><idno type="pISSN">1351-5101</idno><idno type="eISSN">1468-1331</idno><idno type="DOI">10.1111/(ISSN)1468-1331</idno><imprint><publisher>Blackwell Publishing Ltd</publisher><pubPlace>Oxford, UK</pubPlace><date type="published" when="2011-12"></date><biblScope unit="volume">18</biblScope><biblScope unit="issue">12</biblScope><biblScope unit="page" from="1373">1373</biblScope><biblScope unit="page" to="1378">1378</biblScope></imprint></monogr><idno type="istex">72E14E1C2570C09CB28605C9016874A376D1CE91</idno><idno type="DOI">10.1111/j.1468-1331.2011.03512.x</idno><idno type="ArticleID">ENE3512</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2011</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Background: The LARGO study demonstrated that rasagiline 1 mg/day as adjunct to levodopa significantly reduces OFF time to the same magnitude as adjunct entacapone. This substudy of LARGO aimed to assess the effect of rasagiline and entacapone on the motor symptoms of PD during the practically defined OFF state. Methods: LARGO was a randomized, double‐blind, multicenter trial that assessed the efficacy and safety of rasagiline (1 mg/day), entacapone (200 mg with each levodopa dose), and placebo in 687 levodopa‐treated PD patients with motor fluctuations. A substudy of LARGO measured UPDRS motor scores in the practically defined OFF state in 32 rasagiline, 36 entacapone, and 37 placebo patients. Results: Treatment with rasagiline produced a significant improvement over placebo of 5.64 units in UPDRS motor OFF score (P = 0.013 vs. placebo). By contrast, the effect of adjunct entacapone was not significant (P = 0.14 vs. placebo). Whereas rasagiline also showed a trend in reducing the UPDRS‐ADL OFF score (P = 0.058 vs. placebo), no such trend was noted for entacapone (P = 0.26 vs. placebo). Retrospective analysis, using the Bonferroni correction, of UPDRS motor subdomains further revealed that rasagiline, but not entacapone, significantly improved bradykinesia (P < 0.001) and showed trends for improvements in facial expression, speech, and axial impairment during OFF time. Conclusions: This study provides the first objectively measured evidence that adjunct rasagiline 1 mg/day is effective in reducing the severity of motor symptoms in the OFF state. This suggests a continuous effect of rasagiline 1 mg/day throughout the day and night and is consistent with its extended duration of therapeutic action.</p></abstract><abstract style="short"><p>Click here for the corresponding questions to this CME article.</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>entacapone</term></item><item><term>motor control</term></item><item><term>Parkinson’s disease</term></item><item><term>rasagiline</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>article category</head><item><term>CME ARTICLE</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2011-12">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/72E14E1C2570C09CB28605C9016874A376D1CE91/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>Blackwell Publishing Ltd</publisherName><publisherLoc>Oxford, UK</publisherLoc></publisherInfo><doi origin="wiley" registered="yes">10.1111/(ISSN)1468-1331</doi><issn type="print">1351-5101</issn><issn type="electronic">1468-1331</issn><idGroup><id type="product" value="ENE"></id><id type="publisherDivision" value="ST"></id></idGroup><titleGroup><title type="main" sort="EUROPEAN JOURNAL OF NEUROLOGY">European Journal of Neurology</title></titleGroup></publicationMeta><publicationMeta level="part" position="12112"><doi origin="wiley">10.1111/ene.2011.18.issue-12</doi><numberingGroup><numbering type="journalVolume" number="18">18</numbering><numbering type="journalIssue" number="12">12</numbering></numberingGroup><coverDate startDate="2011-12">December 2011</coverDate></publicationMeta><publicationMeta level="unit" type="article" position="2" status="forIssue"><doi origin="wiley">10.1111/j.1468-1331.2011.03512.x</doi><idGroup><id type="unit" value="ENE3512"></id></idGroup><countGroup><count type="pageTotal" number="6"></count></countGroup><titleGroup><title type="tocHeading1">CME Article</title><title type="articleCategory">CME ARTICLE</title></titleGroup><copyright>© 2011 The Author(s). European Journal of Neurology © 2011 EFNS</copyright><eventGroup><event type="xmlConverted" agent="Converter:BPG_TO_WML3G version:3.0 mode:FullText" date="2011-11-18"></event><event type="publishedOnlineEarlyUnpaginated" date="2011-09-06"></event><event type="firstOnline" date="2011-09-06"></event><event type="publishedOnlineFinalForm" date="2011-11-18"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.8.8" date="2014-01-24"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.1.7 mode:FullText,remove_FC" date="2014-10-16"></event></eventGroup><numberingGroup><numbering type="pageFirst" number="1373">1373</numbering><numbering type="pageLast" number="1378">1378</numbering></numberingGroup><correspondenceTo>F. Stocchi, Department of Neurology, Institute for Research and Medical Care IRCCS San Raffaele, Via della Pisana 235, 00163 Rome, Italy (tel.: +390666058456; fax: +390666058458; e‐mail: <email>fabrizio.stocchi@sanraffaele.it</email>).</correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:ENE.ENE3512.pdf"></link></linkGroup></publicationMeta><contentMeta><unparsedEditorialHistory>Received 4 May 2011 Accepted 12 July 2011</unparsedEditorialHistory><countGroup><count type="figureTotal" number="1"></count><count type="tableTotal" number="3"></count></countGroup><titleGroup><title type="main">Effect of rasagiline as adjunct therapy to levodopa on severity of OFF in Parkinson’s disease</title><title type="shortAuthors">F. Stocchi and J. M. Rabey</title><title type="short">Rasagiline as adjunct to levodopa on severity of OFF</title></titleGroup><creators><creator creatorRole="author" xml:id="cr1" affiliationRef="#a1"><personName><givenNames>F.</givenNames><familyName>Stocchi</familyName></personName></creator><creator creatorRole="author" xml:id="cr2" affiliationRef="#a2"><personName><givenNames>J. M.</givenNames><familyName>Rabey</familyName></personName></creator></creators><affiliationGroup><affiliation xml:id="a1" countryCode="IT"><unparsedAffiliation>Institute of Neurology, IRCCS San Raffaele, Pisana, Rome, Italy</unparsedAffiliation></affiliation><affiliation xml:id="a2" countryCode="IL"><unparsedAffiliation>Department of Neurology, Assaf Harofeh Medical Center, Zerifin, Affiliated to Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en"><keyword xml:id="k1">entacapone</keyword><keyword xml:id="k2">motor control</keyword><keyword xml:id="k3">Parkinson’s disease</keyword><keyword xml:id="k4">rasagiline</keyword></keywordGroup><abstractGroup><abstract type="main" xml:lang="en"><p><b>Background: </b> The LARGO study demonstrated that rasagiline 1 mg/day as adjunct to levodopa significantly reduces OFF time to the same magnitude as adjunct entacapone. This substudy of LARGO aimed to assess the effect of rasagiline and entacapone on the motor symptoms of PD during the practically defined OFF state.</p><p><b>Methods: </b> LARGO was a randomized, double‐blind, multicenter trial that assessed the efficacy and safety of rasagiline (1 mg/day), entacapone (200 mg with each levodopa dose), and placebo in 687 levodopa‐treated PD patients with motor fluctuations. A substudy of LARGO measured UPDRS motor scores in the practically defined OFF state in 32 rasagiline, 36 entacapone, and 37 placebo patients.</p><p><b>Results: </b> Treatment with rasagiline produced a significant improvement over placebo of 5.64 units in UPDRS motor OFF score (<i>P </i>= 0.013 vs. placebo). By contrast, the effect of adjunct entacapone was not significant (<i>P </i>= 0.14 vs. placebo). Whereas rasagiline also showed a trend in reducing the UPDRS‐ADL OFF score (<i>P </i>= 0.058 vs. placebo), no such trend was noted for entacapone (<i>P </i>= 0.26 vs. placebo). Retrospective analysis, using the Bonferroni correction, of UPDRS motor subdomains further revealed that rasagiline, but not entacapone, significantly improved bradykinesia (<i>P </i>< 0.001) and showed trends for improvements in facial expression, speech, and axial impairment during OFF time.</p><p><b>Conclusions: </b> This study provides the first objectively measured evidence that adjunct rasagiline 1 mg/day is effective in reducing the severity of motor symptoms in the OFF state. This suggests a continuous effect of rasagiline 1 mg/day throughout the day and night and is consistent with its extended duration of therapeutic action.</p></abstract><abstract type="short"><p>Click <url href="http://www.efns.org/EFNSContinuing-Medical-Education-online.301.0.html">here</url> for the corresponding questions to this CME article.</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="n-fnt-1"><p>This work was corporately managed by Teva Pharmaceutical Industries, and sponsored by Teva Pharmaceutical Industries, and H Lundbeck A/S. Dr. Stocchi reports consulting fees from Teva, Lundbeck, GlaxoSmithKline, Boehringer Ingleheim, Newron, Merck Serono, Novartis, Impax, Schering Plough, Chiesi pharma and UCB. Dr Rabey was an investigator in a clinical multicenter study and received institutional support from Teva Pharmaceutical Industries Ltd for this study.</p></note><note xml:id="fn2"><p><b>This is a Continuing Medical Education article, and can be found with corresponding questions on the Internet at </b><url href="http://www.efns.org/EFNS Continuing-Medical-Education-online.301.0.html">http://www.efns.org/EFNS Continuing‐Medical‐Education‐online.301.0.html</url><b>.</b> Certificates for correctly answering the questions will be issued by the EFNS.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Effect of rasagiline as adjunct therapy to levodopa on severity of OFF in Parkinson’s disease</title></titleInfo><titleInfo type="abbreviated"><title>Rasagiline as adjunct to levodopa on severity of OFF</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Effect of rasagiline as adjunct therapy to levodopa on severity of OFF in Parkinson’s disease</title></titleInfo><name type="personal"><namePart type="given">F.</namePart><namePart type="family">Stocchi</namePart><affiliation>Institute of Neurology, IRCCS San Raffaele, Pisana, Rome, Italy</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J. M.</namePart><namePart type="family">Rabey</namePart><affiliation>Department of Neurology, Assaf Harofeh Medical Center, Zerifin, Affiliated to Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article"></genre><originInfo><publisher>Blackwell Publishing Ltd</publisher><place><placeTerm type="text">Oxford, UK</placeTerm></place><dateIssued encoding="w3cdtf">2011-12</dateIssued><edition>Received 4 May 2011 Accepted 12 July 2011</edition><copyrightDate encoding="w3cdtf">2011</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">1</extent><extent unit="tables">3</extent></physicalDescription><abstract lang="en">Background: The LARGO study demonstrated that rasagiline 1 mg/day as adjunct to levodopa significantly reduces OFF time to the same magnitude as adjunct entacapone. This substudy of LARGO aimed to assess the effect of rasagiline and entacapone on the motor symptoms of PD during the practically defined OFF state. Methods: LARGO was a randomized, double‐blind, multicenter trial that assessed the efficacy and safety of rasagiline (1 mg/day), entacapone (200 mg with each levodopa dose), and placebo in 687 levodopa‐treated PD patients with motor fluctuations. A substudy of LARGO measured UPDRS motor scores in the practically defined OFF state in 32 rasagiline, 36 entacapone, and 37 placebo patients. Results: Treatment with rasagiline produced a significant improvement over placebo of 5.64 units in UPDRS motor OFF score (P = 0.013 vs. placebo). By contrast, the effect of adjunct entacapone was not significant (P = 0.14 vs. placebo). Whereas rasagiline also showed a trend in reducing the UPDRS‐ADL OFF score (P = 0.058 vs. placebo), no such trend was noted for entacapone (P = 0.26 vs. placebo). Retrospective analysis, using the Bonferroni correction, of UPDRS motor subdomains further revealed that rasagiline, but not entacapone, significantly improved bradykinesia (P < 0.001) and showed trends for improvements in facial expression, speech, and axial impairment during OFF time. Conclusions: This study provides the first objectively measured evidence that adjunct rasagiline 1 mg/day is effective in reducing the severity of motor symptoms in the OFF state. This suggests a continuous effect of rasagiline 1 mg/day throughout the day and night and is consistent with its extended duration of therapeutic action.</abstract><abstract type="short">Click here for the corresponding questions to this CME article.</abstract><subject lang="en"><genre>Keywords</genre><topic>entacapone</topic><topic>motor control</topic><topic>Parkinson’s disease</topic><topic>rasagiline</topic></subject><relatedItem type="host"><titleInfo><title>European Journal of Neurology</title></titleInfo><genre type="Journal">journal</genre><subject><genre>article category</genre><topic>CME ARTICLE</topic></subject><identifier type="ISSN">1351-5101</identifier><identifier type="eISSN">1468-1331</identifier><identifier type="DOI">10.1111/(ISSN)1468-1331</identifier><identifier type="PublisherID">ENE</identifier><part><date>2011</date><detail type="volume"><caption>vol.</caption><number>18</number></detail><detail type="issue"><caption>no.</caption><number>12</number></detail><extent unit="pages"><start>1373</start><end>1378</end><total>6</total></extent></part></relatedItem><identifier type="istex">72E14E1C2570C09CB28605C9016874A376D1CE91</identifier><identifier type="DOI">10.1111/j.1468-1331.2011.03512.x</identifier><identifier type="ArticleID">ENE3512</identifier><accessCondition type="use and reproduction" contentType="copyright">© 2011 The Author(s). 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