Efficacy and tolerability of entacapone versus cabergoline in parkinsonian patients suffering from wearing‐off
Identifieur interne : 000F74 ( Istex/Corpus ); précédent : 000F73; suivant : 000F75Efficacy and tolerability of entacapone versus cabergoline in parkinsonian patients suffering from wearing‐off
Auteurs : Günther Deuschl ; Antanas Vaitkus ; Gabriele-Cornelia Fox ; Torsten Roscher ; Dieter Schremmer ; Ariel GordinSource :
- Movement Disorders [ 0885-3185 ] ; 2007-08-15.
English descriptors
Abstract
In this 12‐wk, multi‐center, randomized, open‐label, rater‐blinded study, efficacy and tolerability of Entacapone (ENT) or Cabergoline (CBG) in conjunction with levodopa were compared in 161 older Parkinson's disease patients with wearing‐off. Patients received either ENT, 3 to 5 times daily, or CBG, titrated according to requirements to a maximum of 6 mg/d. A significant decrease of nearly 2 hours in the daily OFF‐time (primary efficacy variable) was recorded in both treatment groups. The non‐inferiority test failed despite a trend in favor of ENT. Reduction in OFF‐time occurred faster in the ENT compared to the CBG treated patients. A decrease of ∼20% was detected in parts II and III of the UPDRS, with no differences between the groups. Forty‐three percent of the patients in the ENT group reported dyskinesias at baseline, and 35% at the final visit. The corresponding figures in the CBG group were 46% and 43%. Quality of life, measured by PDQ‐39, increased substantially with both ENT and CBG. The mean daily dosage at the final visit was 698 mg for ENT (plus 447 mg levodopa) and 3.45 mg for CBG (plus 475 mg levodopa). Adverse events (AE), leading to discontinuation, were reported in 8.5% of the ENT and 13.9% of the CBG treated patients. Nausea was the most common AE in each group, corresponding figures being 7.3% with ENT and 25.3% with CBG (P = 0.0024). A probable or possible causal relationship with ENT was reported in 41% and with CBG in 64% of the AE. Among these, only one serious AE (dehydration) was recorded with each treatment group. ENT and CBG reduced the patient's motor complications effectively and to a similar degree. The clinical benefit was more quickly apparent with ENT, which also showed a more favorable AE profile than CBG. © 2007 Movement Disorder Society
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DOI: 10.1002/mds.21473
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Patients received either ENT, 3 to 5 times daily, or CBG, titrated according to requirements to a maximum of 6 mg/d. A significant decrease of nearly 2 hours in the daily OFF‐time (primary efficacy variable) was recorded in both treatment groups. The non‐inferiority test failed despite a trend in favor of ENT. Reduction in OFF‐time occurred faster in the ENT compared to the CBG treated patients. A decrease of ∼20% was detected in parts II and III of the UPDRS, with no differences between the groups. Forty‐three percent of the patients in the ENT group reported dyskinesias at baseline, and 35% at the final visit. The corresponding figures in the CBG group were 46% and 43%. Quality of life, measured by PDQ‐39, increased substantially with both ENT and CBG. The mean daily dosage at the final visit was 698 mg for ENT (plus 447 mg levodopa) and 3.45 mg for CBG (plus 475 mg levodopa). Adverse events (AE), leading to discontinuation, were reported in 8.5% of the ENT and 13.9% of the CBG treated patients. Nausea was the most common AE in each group, corresponding figures being 7.3% with ENT and 25.3% with CBG (P = 0.0024). A probable or possible causal relationship with ENT was reported in 41% and with CBG in 64% of the AE. Among these, only one serious AE (dehydration) was recorded with each treatment group. ENT and CBG reduced the patient's motor complications effectively and to a similar degree. The clinical benefit was more quickly apparent with ENT, which also showed a more favorable AE profile than CBG. © 2007 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Günther Deuschl MD</name><affiliations><json:string>Department of Neurology, Christian‐Albrechts‐Universität, Kiel, Germany</json:string></affiliations></json:item><json:item><name>Antanas Vaitkus MD, PhD</name><affiliations><json:string>Department of Neurology, Kaunas Medical University, Kaunas, Lithuania</json:string></affiliations></json:item><json:item><name>Gabriele‐Cornelia Fox PhD</name><affiliations><json:string>Medical Department, Orion Pharma, Hamburg/Espoo, Germany/Finland</json:string></affiliations></json:item><json:item><name>Torsten Roscher MD</name><affiliations><json:string>Medical Department, Orion Pharma, Hamburg/Espoo, Germany/Finland</json:string></affiliations></json:item><json:item><name>Dieter Schremmer PhD</name><affiliations><json:string>Department of Biometrics, GKM, München, Germany</json:string></affiliations></json:item><json:item><name>Ariel Gordin MD</name><affiliations><json:string>Medical Department, Orion Pharma, Hamburg/Espoo, Germany/Finland</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>COMT inhibition</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Entacapone</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Cabergoline</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>clinical trial</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>wearing‐off</value></json:item></subject><language><json:string>eng</json:string></language><abstract>In this 12‐wk, multi‐center, randomized, open‐label, rater‐blinded study, efficacy and tolerability of Entacapone (ENT) or Cabergoline (CBG) in conjunction with levodopa were compared in 161 older Parkinson's disease patients with wearing‐off. Patients received either ENT, 3 to 5 times daily, or CBG, titrated according to requirements to a maximum of 6 mg/d. A significant decrease of nearly 2 hours in the daily OFF‐time (primary efficacy variable) was recorded in both treatment groups. The non‐inferiority test failed despite a trend in favor of ENT. Reduction in OFF‐time occurred faster in the ENT compared to the CBG treated patients. A decrease of ∼20% was detected in parts II and III of the UPDRS, with no differences between the groups. Forty‐three percent of the patients in the ENT group reported dyskinesias at baseline, and 35% at the final visit. The corresponding figures in the CBG group were 46% and 43%. Quality of life, measured by PDQ‐39, increased substantially with both ENT and CBG. The mean daily dosage at the final visit was 698 mg for ENT (plus 447 mg levodopa) and 3.45 mg for CBG (plus 475 mg levodopa). Adverse events (AE), leading to discontinuation, were reported in 8.5% of the ENT and 13.9% of the CBG treated patients. Nausea was the most common AE in each group, corresponding figures being 7.3% with ENT and 25.3% with CBG (P = 0.0024). A probable or possible causal relationship with ENT was reported in 41% and with CBG in 64% of the AE. Among these, only one serious AE (dehydration) was recorded with each treatment group. ENT and CBG reduced the patient's motor complications effectively and to a similar degree. The clinical benefit was more quickly apparent with ENT, which also showed a more favorable AE profile than CBG. © 2007 Movement Disorder Society</abstract><qualityIndicators><score>6.647</score><pdfVersion>1.3</pdfVersion><pdfPageSize>594 x 792 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractCharCount>1803</abstractCharCount><pdfWordCount>3647</pdfWordCount><pdfCharCount>22524</pdfCharCount><pdfPageCount>6</pdfPageCount><abstractWordCount>299</abstractWordCount></qualityIndicators><title>Efficacy and tolerability of entacapone versus cabergoline in parkinsonian patients suffering from wearing‐off</title><genre><json:string>Serial article</json:string></genre><host><volume>22</volume><pages><total>6</total><last>1555</last><first>1550</first></pages><issn><json:string>0885-3185</json:string></issn><issue>11</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>2007</publicationDate><copyrightDate>2007</copyrightDate><doi><json:string>10.1002/mds.21473</json:string></doi><id>03604EDF2C723CCF8974422A855C42649A8AA539</id><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/03604EDF2C723CCF8974422A855C42649A8AA539/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/03604EDF2C723CCF8974422A855C42649A8AA539/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/03604EDF2C723CCF8974422A855C42649A8AA539/fulltext/tei"><teiHeader type="text"><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Efficacy and tolerability of entacapone versus cabergoline in parkinsonian patients suffering from wearing‐off</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>2007</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(12):1536). All authors had full access to the data and confirm the accuracy for the analysis. G. Deuschl and A. Vaitkus received no payment for manuscript preparation. G.‐C. Fox is an employee of Orion Pharma GmbH.</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Efficacy and tolerability of entacapone versus cabergoline in parkinsonian patients suffering from wearing‐off</title><author><persName><forename type="first">Günther</forename><surname>Deuschl</surname><roleName type="degree">MD</roleName></persName><note type="correspondence"><p>Correspondence: Department of Neurology, Universitätsklinikum Schleswig‐Holstein, Campus Kiel,Christian‐Albrechts‐Universität, Kiel, Germany</p></note><affiliation>Department of Neurology, Christian‐Albrechts‐Universität, Kiel, Germany</affiliation></author><author><persName><forename type="first">Antanas</forename><surname>Vaitkus</surname><roleName type="degree">MD, PhD</roleName></persName><affiliation>Department of Neurology, Kaunas Medical University, Kaunas, Lithuania</affiliation></author><author><persName><forename type="first">Gabriele‐Cornelia</forename><surname>Fox</surname><roleName type="degree">PhD</roleName></persName><affiliation>Medical Department, Orion Pharma, Hamburg/Espoo, Germany/Finland</affiliation></author><author><persName><forename type="first">Torsten</forename><surname>Roscher</surname><roleName type="degree">MD</roleName></persName><affiliation>Medical Department, Orion Pharma, Hamburg/Espoo, Germany/Finland</affiliation></author><author><persName><forename type="first">Dieter</forename><surname>Schremmer</surname><roleName type="degree">PhD</roleName></persName><affiliation>Department of Biometrics, GKM, München, Germany</affiliation></author><author><persName><forename type="first">Ariel</forename><surname>Gordin</surname><roleName type="degree">MD</roleName></persName><affiliation>Medical Department, Orion Pharma, Hamburg/Espoo, Germany/Finland</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. 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Patients received either ENT, 3 to 5 times daily, or CBG, titrated according to requirements to a maximum of 6 mg/d. A significant decrease of nearly 2 hours in the daily OFF‐time (primary efficacy variable) was recorded in both treatment groups. The non‐inferiority test failed despite a trend in favor of ENT. Reduction in OFF‐time occurred faster in the ENT compared to the CBG treated patients. A decrease of ∼20% was detected in parts II and III of the UPDRS, with no differences between the groups. Forty‐three percent of the patients in the ENT group reported dyskinesias at baseline, and 35% at the final visit. The corresponding figures in the CBG group were 46% and 43%. Quality of life, measured by PDQ‐39, increased substantially with both ENT and CBG. The mean daily dosage at the final visit was 698 mg for ENT (plus 447 mg levodopa) and 3.45 mg for CBG (plus 475 mg levodopa). Adverse events (AE), leading to discontinuation, were reported in 8.5% of the ENT and 13.9% of the CBG treated patients. Nausea was the most common AE in each group, corresponding figures being 7.3% with ENT and 25.3% with CBG (P = 0.0024). A probable or possible causal relationship with ENT was reported in 41% and with CBG in 64% of the AE. Among these, only one serious AE (dehydration) was recorded with each treatment group. ENT and CBG reduced the patient's motor complications effectively and to a similar degree. 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type="organization"><unparsedAffiliation>Department of Neurology, Christian‐Albrechts‐Universität, Kiel, Germany</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="LT" type="organization"><unparsedAffiliation>Department of Neurology, Kaunas Medical University, Kaunas, Lithuania</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="DE" type="organization"><unparsedAffiliation>Medical Department, Orion Pharma, Hamburg/Espoo, Germany/Finland</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="DE" type="organization"><unparsedAffiliation>Department of Biometrics, GKM, München, Germany</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">COMT inhibition</keyword><keyword xml:id="kwd2">Entacapone</keyword><keyword xml:id="kwd3">Cabergoline</keyword><keyword xml:id="kwd4">Parkinson's disease</keyword><keyword xml:id="kwd5">clinical trial</keyword><keyword xml:id="kwd6">wearing‐off</keyword></keywordGroup><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>In this 12‐wk, multi‐center, randomized, open‐label, rater‐blinded study, efficacy and tolerability of Entacapone (ENT) or Cabergoline (CBG) in conjunction with levodopa were compared in 161 older Parkinson's disease patients with wearing‐off. Patients received either ENT, 3 to 5 times daily, or CBG, titrated according to requirements to a maximum of 6 mg/d. A significant decrease of nearly 2 hours in the daily OFF‐time (primary efficacy variable) was recorded in both treatment groups. The non‐inferiority test failed despite a trend in favor of ENT. Reduction in OFF‐time occurred faster in the ENT compared to the CBG treated patients. A decrease of ∼20% was detected in parts II and III of the UPDRS, with no differences between the groups. Forty‐three percent of the patients in the ENT group reported dyskinesias at baseline, and 35% at the final visit. The corresponding figures in the CBG group were 46% and 43%. Quality of life, measured by PDQ‐39, increased substantially with both ENT and CBG. The mean daily dosage at the final visit was 698 mg for ENT (plus 447 mg levodopa) and 3.45 mg for CBG (plus 475 mg levodopa). Adverse events (AE), leading to discontinuation, were reported in 8.5% of the ENT and 13.9% of the CBG treated patients. Nausea was the most common AE in each group, corresponding figures being 7.3% with ENT and 25.3% with CBG (<i>P</i> = 0.0024). A probable or possible causal relationship with ENT was reported in 41% and with CBG in 64% of the AE. Among these, only one serious AE (dehydration) was recorded with each treatment group. ENT and CBG reduced the patient's motor complications effectively and to a similar degree. The clinical benefit was more quickly apparent with ENT, which also showed a more favorable AE profile than CBG. © 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(12):1536). All authors had full access to the data and confirm the accuracy for the analysis. G. Deuschl and A. Vaitkus received no payment for manuscript preparation. G.‐C. Fox is an employee of Orion Pharma GmbH.</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>Efficacy and tolerability of entacapone versus cabergoline in parkinsonian patients suffering from wearing‐off</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Entacapone Versus Cabergoline</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Efficacy and tolerability of entacapone versus cabergoline in parkinsonian patients suffering from wearing‐off</title></titleInfo><name type="personal"><namePart type="given">Günther</namePart><namePart type="family">Deuschl</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Christian‐Albrechts‐Universität, Kiel, Germany</affiliation><description>Correspondence: Department of Neurology, Universitätsklinikum Schleswig‐Holstein, Campus Kiel,Christian‐Albrechts‐Universität, Kiel, Germany</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Antanas</namePart><namePart type="family">Vaitkus</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>Department of Neurology, Kaunas Medical University, Kaunas, Lithuania</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Gabriele‐Cornelia</namePart><namePart type="family">Fox</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Medical Department, Orion Pharma, Hamburg/Espoo, Germany/Finland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Torsten</namePart><namePart type="family">Roscher</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Medical Department, Orion Pharma, Hamburg/Espoo, Germany/Finland</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Dieter</namePart><namePart type="family">Schremmer</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Department of Biometrics, GKM, München, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Ariel</namePart><namePart type="family">Gordin</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Medical Department, Orion Pharma, Hamburg/Espoo, Germany/Finland</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">2007-08-15</dateIssued><dateCaptured encoding="w3cdtf">2006-11-24</dateCaptured><dateValid encoding="w3cdtf">2007-02-20</dateValid><copyrightDate encoding="w3cdtf">2007</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">4</extent><extent unit="references">21</extent><extent unit="words">4294</extent></physicalDescription><abstract lang="en">In this 12‐wk, multi‐center, randomized, open‐label, rater‐blinded study, efficacy and tolerability of Entacapone (ENT) or Cabergoline (CBG) in conjunction with levodopa were compared in 161 older Parkinson's disease patients with wearing‐off. Patients received either ENT, 3 to 5 times daily, or CBG, titrated according to requirements to a maximum of 6 mg/d. A significant decrease of nearly 2 hours in the daily OFF‐time (primary efficacy variable) was recorded in both treatment groups. The non‐inferiority test failed despite a trend in favor of ENT. Reduction in OFF‐time occurred faster in the ENT compared to the CBG treated patients. A decrease of ∼20% was detected in parts II and III of the UPDRS, with no differences between the groups. Forty‐three percent of the patients in the ENT group reported dyskinesias at baseline, and 35% at the final visit. The corresponding figures in the CBG group were 46% and 43%. Quality of life, measured by PDQ‐39, increased substantially with both ENT and CBG. The mean daily dosage at the final visit was 698 mg for ENT (plus 447 mg levodopa) and 3.45 mg for CBG (plus 475 mg levodopa). Adverse events (AE), leading to discontinuation, were reported in 8.5% of the ENT and 13.9% of the CBG treated patients. Nausea was the most common AE in each group, corresponding figures being 7.3% with ENT and 25.3% with CBG (P = 0.0024). A probable or possible causal relationship with ENT was reported in 41% and with CBG in 64% of the AE. Among these, only one serious AE (dehydration) was recorded with each treatment group. ENT and CBG reduced the patient's motor complications effectively and to a similar degree. The clinical benefit was more quickly apparent with ENT, which also showed a more favorable AE profile than CBG. © 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(12):1536). All authors had full access to the data and confirm the accuracy for the analysis. G. Deuschl and A. Vaitkus received no payment for manuscript preparation. G.‐C. Fox is an employee of Orion Pharma GmbH.</note><subject lang="en"><genre>Keywords</genre><topic>COMT inhibition</topic><topic>Entacapone</topic><topic>Cabergoline</topic><topic>Parkinson's disease</topic><topic>clinical trial</topic><topic>wearing‐off</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. 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>2007</date><detail type="volume"><caption>vol.</caption><number>22</number></detail><detail type="issue"><caption>no.</caption><number>11</number></detail><extent unit="pages"><start>1550</start><end>1555</end><total>6</total></extent></part></relatedItem><identifier type="istex">03604EDF2C723CCF8974422A855C42649A8AA539</identifier><identifier type="DOI">10.1002/mds.21473</identifier><identifier type="ArticleID">MDS21473</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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