Placebo‐controlled, double‐blind dose‐finding study of entacapone in fluctuating parkinsonian patients
Identifieur interne : 001E20 ( Istex/Corpus ); précédent : 001E19; suivant : 001E21Placebo‐controlled, double‐blind dose‐finding study of entacapone in fluctuating parkinsonian patients
Auteurs : Yoshikuni Mizuno ; Ichiro Kanazawa ; Sadako Kuno ; Nobuo Yanagisawa ; Mitsutoshi Yamamoto ; Tomoyoshi KondoSource :
- Movement Disorders [ 0885-3185 ] ; 2007-01.
English descriptors
Abstract
We conducted a multicenter randomized, placebo‐controlled double‐blind parallel‐group study in Japanese Parkinson's disease (PD) patients with wearing‐off motor fluctuations to determine the clinical efficacy and safety of entacapone as an adjunct to concomitant treatment with levodopa and a dopa decarboxylase inhibitor (DCI). We randomized 341 patients to receive entacapone 100 or 200 mg or placebo per dose of levodopa/DCI for 8 weeks. The primary efficacy variable was on time change while awake, determined by patients' diaries. Mean baseline on time in each group was approximately 8 hours. Mean on time change at final assessment was 1.4 hours each for entacapone 100‐mg and 200‐mg groups and by 0.5 hours for the placebo group (P < 0.05). The two entacapone doses were equally efficacious. Adverse events occurred in 79 patients (69.9%) in placebo, 82 (72.6%) in 100 mg, and 98 (86.0%) in 200 mg. The most common adverse event with entacapone was an increase in dyskinesias. The overall safety profile was satisfactory in both entacapone groups. In conclusion, both entacapone 100 and 200 mg were equally effective in increasing on time of PD patients with wearing‐off fluctuations, although the safety and tolerability profile appeared more favorable for the 100‐mg dose. © 2006 Movement Disorder Society
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DOI: 10.1002/mds.21218
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ISTEX:4541E5DBBD6525DA6DCA9215596100387273860DLe document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Placebo‐controlled, double‐blind dose‐finding study of entacapone in fluctuating parkinsonian patients</title><author><name sortKey="Mizuno, Yoshikuni" sort="Mizuno, Yoshikuni" uniqKey="Mizuno Y" first="Yoshikuni" last="Mizuno">Yoshikuni Mizuno</name><affiliation><mods:affiliation>Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan</mods:affiliation></affiliation></author><author><name sortKey="Kanazawa, Ichiro" sort="Kanazawa, Ichiro" uniqKey="Kanazawa I" first="Ichiro" last="Kanazawa">Ichiro Kanazawa</name><affiliation><mods:affiliation>National Center of Neurology and Psychiatry, Tokyo, Japan</mods:affiliation></affiliation></author><author><name sortKey="Kuno, Sadako" sort="Kuno, Sadako" uniqKey="Kuno S" first="Sadako" last="Kuno">Sadako Kuno</name><affiliation><mods:affiliation>National Center of Neurology and Psychiatry, Tokyo, Japan</mods:affiliation></affiliation></author><author><name sortKey="Yanagisawa, Nobuo" sort="Yanagisawa, Nobuo" uniqKey="Yanagisawa N" first="Nobuo" last="Yanagisawa">Nobuo Yanagisawa</name><affiliation><mods:affiliation>Kanto Rosai Hospital, Kanagawa, Japan</mods:affiliation></affiliation></author><author><name sortKey="Yamamoto, Mitsutoshi" sort="Yamamoto, Mitsutoshi" uniqKey="Yamamoto M" first="Mitsutoshi" last="Yamamoto">Mitsutoshi Yamamoto</name><affiliation><mods:affiliation>Department of Neurology, Kagawa Prefectural Central Hospital, Kagawa, Japan</mods:affiliation></affiliation></author><author><name sortKey="Kondo, Tomoyoshi" sort="Kondo, Tomoyoshi" uniqKey="Kondo T" first="Tomoyoshi" last="Kondo">Tomoyoshi Kondo</name><affiliation><mods:affiliation>Department of Neurology, Wakayama Medical College, Wakayama, Japan</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:4541E5DBBD6525DA6DCA9215596100387273860D</idno><date when="2007" year="2007">2007</date><idno type="doi">10.1002/mds.21218</idno><idno type="url">https://api.istex.fr/document/4541E5DBBD6525DA6DCA9215596100387273860D/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">001E20</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Placebo‐controlled, double‐blind dose‐finding study of entacapone in fluctuating parkinsonian patients</title><author><name sortKey="Mizuno, Yoshikuni" sort="Mizuno, Yoshikuni" uniqKey="Mizuno Y" first="Yoshikuni" last="Mizuno">Yoshikuni Mizuno</name><affiliation><mods:affiliation>Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan</mods:affiliation></affiliation></author><author><name sortKey="Kanazawa, Ichiro" sort="Kanazawa, Ichiro" uniqKey="Kanazawa I" first="Ichiro" last="Kanazawa">Ichiro Kanazawa</name><affiliation><mods:affiliation>National Center of Neurology and Psychiatry, Tokyo, Japan</mods:affiliation></affiliation></author><author><name sortKey="Kuno, Sadako" sort="Kuno, Sadako" uniqKey="Kuno S" first="Sadako" last="Kuno">Sadako Kuno</name><affiliation><mods:affiliation>National Center of Neurology and Psychiatry, Tokyo, Japan</mods:affiliation></affiliation></author><author><name sortKey="Yanagisawa, Nobuo" sort="Yanagisawa, Nobuo" uniqKey="Yanagisawa N" first="Nobuo" last="Yanagisawa">Nobuo Yanagisawa</name><affiliation><mods:affiliation>Kanto Rosai Hospital, Kanagawa, Japan</mods:affiliation></affiliation></author><author><name sortKey="Yamamoto, Mitsutoshi" sort="Yamamoto, Mitsutoshi" uniqKey="Yamamoto M" first="Mitsutoshi" last="Yamamoto">Mitsutoshi Yamamoto</name><affiliation><mods:affiliation>Department of Neurology, Kagawa Prefectural Central Hospital, Kagawa, Japan</mods:affiliation></affiliation></author><author><name sortKey="Kondo, Tomoyoshi" sort="Kondo, Tomoyoshi" uniqKey="Kondo T" first="Tomoyoshi" last="Kondo">Tomoyoshi Kondo</name><affiliation><mods:affiliation>Department of Neurology, Wakayama Medical College, Wakayama, Japan</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2007-01">2007-01</date><biblScope unit="vol">22</biblScope><biblScope unit="issue">1</biblScope><biblScope unit="page" from="75">75</biblScope><biblScope unit="page" to="80">80</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">4541E5DBBD6525DA6DCA9215596100387273860D</idno><idno type="DOI">10.1002/mds.21218</idno><idno type="ArticleID">MDS21218</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>COMT inhibitor</term><term>Parkinson's disease</term><term>entacapone</term><term>treatment</term><term>wearing‐off fluctuation</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">We conducted a multicenter randomized, placebo‐controlled double‐blind parallel‐group study in Japanese Parkinson's disease (PD) patients with wearing‐off motor fluctuations to determine the clinical efficacy and safety of entacapone as an adjunct to concomitant treatment with levodopa and a dopa decarboxylase inhibitor (DCI). We randomized 341 patients to receive entacapone 100 or 200 mg or placebo per dose of levodopa/DCI for 8 weeks. The primary efficacy variable was on time change while awake, determined by patients' diaries. Mean baseline on time in each group was approximately 8 hours. Mean on time change at final assessment was 1.4 hours each for entacapone 100‐mg and 200‐mg groups and by 0.5 hours for the placebo group (P < 0.05). The two entacapone doses were equally efficacious. Adverse events occurred in 79 patients (69.9%) in placebo, 82 (72.6%) in 100 mg, and 98 (86.0%) in 200 mg. The most common adverse event with entacapone was an increase in dyskinesias. The overall safety profile was satisfactory in both entacapone groups. In conclusion, both entacapone 100 and 200 mg were equally effective in increasing on time of PD patients with wearing‐off fluctuations, although the safety and tolerability profile appeared more favorable for the 100‐mg dose. © 2006 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Yoshikuni Mizuno MD</name><affiliations><json:string>Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan</json:string></affiliations></json:item><json:item><name>Ichiro Kanazawa MD</name><affiliations><json:string>National Center of Neurology and Psychiatry, Tokyo, Japan</json:string></affiliations></json:item><json:item><name>Sadako Kuno MD</name><affiliations><json:string>National Center of Neurology and Psychiatry, Tokyo, Japan</json:string></affiliations></json:item><json:item><name>Nobuo Yanagisawa MD</name><affiliations><json:string>Kanto Rosai Hospital, Kanagawa, Japan</json:string></affiliations></json:item><json:item><name>Mitsutoshi Yamamoto MD</name><affiliations><json:string>Department of Neurology, Kagawa Prefectural Central Hospital, Kagawa, Japan</json:string></affiliations></json:item><json:item><name>Tomoyoshi Kondo MD</name><affiliations><json:string>Department of Neurology, Wakayama Medical College, Wakayama, Japan</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>entacapone</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Parkinson's disease</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>treatment</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>wearing‐off fluctuation</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>COMT inhibitor</value></json:item></subject><language><json:string>eng</json:string></language><abstract>We conducted a multicenter randomized, placebo‐controlled double‐blind parallel‐group study in Japanese Parkinson's disease (PD) patients with wearing‐off motor fluctuations to determine the clinical efficacy and safety of entacapone as an adjunct to concomitant treatment with levodopa and a dopa decarboxylase inhibitor (DCI). We randomized 341 patients to receive entacapone 100 or 200 mg or placebo per dose of levodopa/DCI for 8 weeks. The primary efficacy variable was on time change while awake, determined by patients' diaries. Mean baseline on time in each group was approximately 8 hours. Mean on time change at final assessment was 1.4 hours each for entacapone 100‐mg and 200‐mg groups and by 0.5 hours for the placebo group (P > 0.05). The two entacapone doses were equally efficacious. Adverse events occurred in 79 patients (69.9%) in placebo, 82 (72.6%) in 100 mg, and 98 (86.0%) in 200 mg. The most common adverse event with entacapone was an increase in dyskinesias. The overall safety profile was satisfactory in both entacapone groups. In conclusion, both entacapone 100 and 200 mg were equally effective in increasing on time of PD patients with wearing‐off fluctuations, although the safety and tolerability profile appeared more favorable for the 100‐mg dose. © 2006 Movement Disorder Society</abstract><qualityIndicators><score>5.505</score><pdfVersion>1.3</pdfVersion><pdfPageSize>594 x 792 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractCharCount>1315</abstractCharCount><pdfWordCount>3069</pdfWordCount><pdfCharCount>19538</pdfCharCount><pdfPageCount>6</pdfPageCount><abstractWordCount>203</abstractWordCount></qualityIndicators><title>Placebo‐controlled, double‐blind dose‐finding study of entacapone in fluctuating parkinsonian patients</title><corporate><json:item><name></name></json:item></corporate><genre><json:string>Serial article</json:string></genre><host><volume>22</volume><pages><total>6</total><last>80</last><first>75</first></pages><issn><json:string>0885-3185</json:string></issn><issue>1</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.21218</json:string></doi><id>4541E5DBBD6525DA6DCA9215596100387273860D</id><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/4541E5DBBD6525DA6DCA9215596100387273860D/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/4541E5DBBD6525DA6DCA9215596100387273860D/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/4541E5DBBD6525DA6DCA9215596100387273860D/fulltext/tei"><teiHeader type="text"><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Placebo‐controlled, double‐blind dose‐finding study of entacapone in fluctuating parkinsonian patients</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 of this study received neither financial compensation nor other beneficial consideration for the writing of this manuscript. In addition, all authors listed herein were actively involved in both the research described in this study and the writing of the manuscript presented for consideration.</note><note>Novartis Pharma</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Placebo‐controlled, double‐blind dose‐finding study of entacapone in fluctuating parkinsonian patients</title><author><orgName>Japanese Parkinson–Entacapone Study Group</orgName></author><author><persName><forename type="first">Yoshikuni</forename><surname>Mizuno</surname><roleName type="degree">MD</roleName></persName><note type="correspondence"><p>Correspondence: Department of Neurology, Juntendo University School of Medicine, 2‐1‐1 Hongo, Bunkyo, Tokyo 113‐8421, Japan</p></note><affiliation>Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan</affiliation></author><author><persName><forename type="first">Ichiro</forename><surname>Kanazawa</surname><roleName type="degree">MD</roleName></persName><affiliation>National Center of Neurology and Psychiatry, Tokyo, Japan</affiliation></author><author><persName><forename type="first">Sadako</forename><surname>Kuno</surname><roleName type="degree">MD</roleName></persName><affiliation>National Center of Neurology and Psychiatry, Tokyo, Japan</affiliation></author><author><persName><forename type="first">Nobuo</forename><surname>Yanagisawa</surname><roleName type="degree">MD</roleName></persName><affiliation>Kanto Rosai Hospital, Kanagawa, Japan</affiliation></author><author><persName><forename type="first">Mitsutoshi</forename><surname>Yamamoto</surname><roleName type="degree">MD</roleName></persName><affiliation>Department of Neurology, Kagawa Prefectural Central Hospital, Kagawa, Japan</affiliation></author><author><persName><forename type="first">Tomoyoshi</forename><surname>Kondo</surname><roleName type="degree">MD</roleName></persName><affiliation>Department of Neurology, Wakayama Medical College, Wakayama, Japan</affiliation></author></analytic><monogr><title level="j">Movement Disorders</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="2007-01"></date><biblScope unit="vol">22</biblScope><biblScope unit="issue">1</biblScope><biblScope unit="page" from="75">75</biblScope><biblScope unit="page" to="80">80</biblScope></imprint></monogr><idno type="istex">4541E5DBBD6525DA6DCA9215596100387273860D</idno><idno type="DOI">10.1002/mds.21218</idno><idno type="ArticleID">MDS21218</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2007</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>We conducted a multicenter randomized, placebo‐controlled double‐blind parallel‐group study in Japanese Parkinson's disease (PD) patients with wearing‐off motor fluctuations to determine the clinical efficacy and safety of entacapone as an adjunct to concomitant treatment with levodopa and a dopa decarboxylase inhibitor (DCI). We randomized 341 patients to receive entacapone 100 or 200 mg or placebo per dose of levodopa/DCI for 8 weeks. The primary efficacy variable was on time change while awake, determined by patients' diaries. Mean baseline on time in each group was approximately 8 hours. Mean on time change at final assessment was 1.4 hours each for entacapone 100‐mg and 200‐mg groups and by 0.5 hours for the placebo group (P < 0.05). The two entacapone doses were equally efficacious. Adverse events occurred in 79 patients (69.9%) in placebo, 82 (72.6%) in 100 mg, and 98 (86.0%) in 200 mg. The most common adverse event with entacapone was an increase in dyskinesias. The overall safety profile was satisfactory in both entacapone groups. In conclusion, both entacapone 100 and 200 mg were equally effective in increasing on time of PD patients with wearing‐off fluctuations, although the safety and tolerability profile appeared more favorable for the 100‐mg dose. © 2006 Movement Disorder Society</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>entacapone</term></item><item><term>Parkinson's disease</term></item><item><term>treatment</term></item><item><term>wearing‐off fluctuation</term></item><item><term>COMT inhibitor</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>Article category</head><item><term>Research Article</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2006-02-19">Received</change><change when="2006-07-31">Registration</change><change when="2007-01">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/4541E5DBBD6525DA6DCA9215596100387273860D/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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xml:lang="en" type="author"><keyword xml:id="kwd1">entacapone</keyword><keyword xml:id="kwd2">Parkinson's disease</keyword><keyword xml:id="kwd3">treatment</keyword><keyword xml:id="kwd4">wearing‐off fluctuation</keyword><keyword xml:id="kwd5">COMT inhibitor</keyword></keywordGroup><fundingInfo><fundingAgency>Novartis Pharma</fundingAgency></fundingInfo><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>We conducted a multicenter randomized, placebo‐controlled double‐blind parallel‐group study in Japanese Parkinson's disease (PD) patients with wearing‐off motor fluctuations to determine the clinical efficacy and safety of entacapone as an adjunct to concomitant treatment with levodopa and a dopa decarboxylase inhibitor (DCI). We randomized 341 patients to receive entacapone 100 or 200 mg or placebo per dose of levodopa/DCI for 8 weeks. The primary efficacy variable was <i>on</i> time change while awake, determined by patients' diaries. Mean baseline <i>on</i> time in each group was approximately 8 hours. Mean <i>on</i> time change at final assessment was 1.4 hours each for entacapone 100‐mg and 200‐mg groups and by 0.5 hours for the placebo group (<i>P</i> < 0.05). The two entacapone doses were equally efficacious. Adverse events occurred in 79 patients (69.9%) in placebo, 82 (72.6%) in 100 mg, and 98 (86.0%) in 200 mg. The most common adverse event with entacapone was an increase in dyskinesias. The overall safety profile was satisfactory in both entacapone groups. In conclusion, both entacapone 100 and 200 mg were equally effective in increasing <i>on</i> time of PD patients with wearing‐off fluctuations, although the safety and tolerability profile appeared more favorable for the 100‐mg dose. © 2006 Movement Disorder Society</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn1"><p>The authors of this study received neither financial compensation nor other beneficial consideration for the writing of this manuscript. In addition, all authors listed herein were actively involved in both the research described in this study and the writing of the manuscript presented for consideration.</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>Placebo‐controlled, double‐blind dose‐finding study of entacapone in fluctuating parkinsonian patients</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Entacapone in Advanced Parkinson's Disease</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Placebo‐controlled, double‐blind dose‐finding study of entacapone in fluctuating parkinsonian patients</title></titleInfo><name type="personal"><namePart type="given">Yoshikuni</namePart><namePart type="family">Mizuno</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan</affiliation><description>Correspondence: Department of Neurology, Juntendo University School of Medicine, 2‐1‐1 Hongo, Bunkyo, Tokyo 113‐8421, Japan</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Ichiro</namePart><namePart type="family">Kanazawa</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>National Center of Neurology and Psychiatry, Tokyo, Japan</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Sadako</namePart><namePart type="family">Kuno</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>National Center of Neurology and Psychiatry, Tokyo, Japan</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Nobuo</namePart><namePart type="family">Yanagisawa</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Kanto Rosai Hospital, Kanagawa, Japan</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Mitsutoshi</namePart><namePart type="family">Yamamoto</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Kagawa Prefectural Central Hospital, Kagawa, Japan</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Tomoyoshi</namePart><namePart type="family">Kondo</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Wakayama Medical College, Wakayama, Japan</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="corporate"><namePart>Japanese Parkinson–Entacapone Study Group</namePart><description>Department of Neurology, Juntendo University School of Medicine, Tokyo, JapanNational Center of Neurology and Psychiatry, Tokyo, JapanKanto Rosai Hospital, Kanagawa, JapanDepartment of Neurology, Kagawa Prefectural Central Hospital, Kagawa, JapanDepartment of Neurology, Wakayama Medical College, Wakayama, Japan</description></name><typeOfResource>text</typeOfResource><genre authority="originalCategForm">article</genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">2007-01</dateIssued><dateCaptured encoding="w3cdtf">2006-02-19</dateCaptured><dateValid encoding="w3cdtf">2006-07-31</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="tables">4</extent><extent unit="references">12</extent><extent unit="words">3660</extent></physicalDescription><abstract lang="en">We conducted a multicenter randomized, placebo‐controlled double‐blind parallel‐group study in Japanese Parkinson's disease (PD) patients with wearing‐off motor fluctuations to determine the clinical efficacy and safety of entacapone as an adjunct to concomitant treatment with levodopa and a dopa decarboxylase inhibitor (DCI). We randomized 341 patients to receive entacapone 100 or 200 mg or placebo per dose of levodopa/DCI for 8 weeks. The primary efficacy variable was on time change while awake, determined by patients' diaries. Mean baseline on time in each group was approximately 8 hours. Mean on time change at final assessment was 1.4 hours each for entacapone 100‐mg and 200‐mg groups and by 0.5 hours for the placebo group (P < 0.05). The two entacapone doses were equally efficacious. Adverse events occurred in 79 patients (69.9%) in placebo, 82 (72.6%) in 100 mg, and 98 (86.0%) in 200 mg. The most common adverse event with entacapone was an increase in dyskinesias. The overall safety profile was satisfactory in both entacapone groups. In conclusion, both entacapone 100 and 200 mg were equally effective in increasing on time of PD patients with wearing‐off fluctuations, although the safety and tolerability profile appeared more favorable for the 100‐mg dose. © 2006 Movement Disorder Society</abstract><note type="content">*The authors of this study received neither financial compensation nor other beneficial consideration for the writing of this manuscript. In addition, all authors listed herein were actively involved in both the research described in this study and the writing of the manuscript presented for consideration.</note><note type="funding">Novartis Pharma</note><subject lang="en"><genre>Keywords</genre><topic>entacapone</topic><topic>Parkinson's disease</topic><topic>treatment</topic><topic>wearing‐off fluctuation</topic><topic>COMT inhibitor</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title></titleInfo><titleInfo type="abbreviated"><title>Mov. Disord.</title></titleInfo><subject><genre>article category</genre><topic>Research Article</topic></subject><identifier type="ISSN">0885-3185</identifier><identifier type="eISSN">1531-8257</identifier><identifier type="DOI">10.1002/(ISSN)1531-8257</identifier><identifier type="PublisherID">MDS</identifier><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>22</number></detail><detail type="issue"><caption>no.</caption><number>1</number></detail><extent unit="pages"><start>75</start><end>80</end><total>6</total></extent></part></relatedItem><identifier type="istex">4541E5DBBD6525DA6DCA9215596100387273860D</identifier><identifier type="DOI">10.1002/mds.21218</identifier><identifier type="ArticleID">MDS21218</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2006 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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