Rotigotine transdermal patch in early Parkinson's disease: A randomized, double‐blind, controlled study versus placebo and ropinirole
Identifieur interne : 000D77 ( Main/Corpus ); précédent : 000D76; suivant : 000D78Rotigotine transdermal patch in early Parkinson's disease: A randomized, double‐blind, controlled study versus placebo and ropinirole
Auteurs : Nir Giladi ; Babak Boroojerdi ; Amos D. Korczyn ; David J. Burn ; Carl E. Clarke ; Anthony H. V. SchapiraSource :
- Movement Disorders [ 0885-3185 ] ; 2007-12-15.
English descriptors
Abstract
Rotigotine is a new, non‐ergot dopamine agonist formulated in a transdermal delivery system. The present study was to investigate the efficacy and safety of the rotigotine transdermal patch in the treatment of early Parkinson's disease. Patients (n = 561) were randomized to rotigotine, ropinirole, or placebo. The titration period was up to 13 weeks, and there was a minimum dose‐maintenance period of 24 weeks for ropinirole and 33 weeks for rotigotine. The primary endpoint was the proportion of patients with a minimum of 20% decrease in the combined Unified Parkinson's Disease Rating Scale Part II and Part III scores. The responder rate in the rotigotine group was significantly higher than in the placebo group (52% vs. 30%, P < 0.0001). Transdermal rotigotine at doses ≤8 mg/24 h did not show noninferiority to ropinirole at doses ≤24 mg/day. In a post‐hoc subgroup analysis, rotigotine ≤8 mg/24 hours had a similar efficacy to ropinirole at doses ≤12 mg/day. The rotigotine transdermal patch was well tolerated. The most common adverse events were application‐site reactions, nausea, and somnolence. Application‐site reactions were predominantly mild or moderate in intensity. In conclusion, the rotigotine transdermal patch represents an effective and safe option for the treatment of patients with early Parkinson's disease.
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DOI: 10.1002/mds.21741
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ISTEX:3DFAF358B00233168B68C32114FE9602AA742627Le document en format XML
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Korczyn</name><affiliation><mods:affiliation>Chair of Neurology, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel</mods:affiliation></affiliation></author><author><name sortKey="Burn, David J" sort="Burn, David J" uniqKey="Burn D" first="David J." last="Burn">David J. Burn</name><affiliation><mods:affiliation>Department of Neurology, City Hospital Birmingham and University Birmingham, United Kingdom</mods:affiliation></affiliation></author><author><name sortKey="Clarke, Carl E" sort="Clarke, Carl E" uniqKey="Clarke C" first="Carl E." last="Clarke">Carl E. Clarke</name><affiliation><mods:affiliation>Department of Neurology, City Hospital NHS Trust, Birmingham, United Kingdom</mods:affiliation></affiliation></author><author><name sortKey="Schapira, Anthony H V" sort="Schapira, Anthony H V" uniqKey="Schapira A" first="Anthony H. V." last="Schapira">Anthony H. V. 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Korczyn</name><affiliation><mods:affiliation>Chair of Neurology, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel</mods:affiliation></affiliation></author><author><name sortKey="Burn, David J" sort="Burn, David J" uniqKey="Burn D" first="David J." last="Burn">David J. Burn</name><affiliation><mods:affiliation>Department of Neurology, City Hospital Birmingham and University Birmingham, United Kingdom</mods:affiliation></affiliation></author><author><name sortKey="Clarke, Carl E" sort="Clarke, Carl E" uniqKey="Clarke C" first="Carl E." last="Clarke">Carl E. Clarke</name><affiliation><mods:affiliation>Department of Neurology, City Hospital NHS Trust, Birmingham, United Kingdom</mods:affiliation></affiliation></author><author><name sortKey="Schapira, Anthony H V" sort="Schapira, Anthony H V" uniqKey="Schapira A" first="Anthony H. V." last="Schapira">Anthony H. V. 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The present study was to investigate the efficacy and safety of the rotigotine transdermal patch in the treatment of early Parkinson's disease. Patients (n = 561) were randomized to rotigotine, ropinirole, or placebo. The titration period was up to 13 weeks, and there was a minimum dose‐maintenance period of 24 weeks for ropinirole and 33 weeks for rotigotine. The primary endpoint was the proportion of patients with a minimum of 20% decrease in the combined Unified Parkinson's Disease Rating Scale Part II and Part III scores. The responder rate in the rotigotine group was significantly higher than in the placebo group (52% vs. 30%, P < 0.0001). Transdermal rotigotine at doses ≤8 mg/24 h did not show noninferiority to ropinirole at doses ≤24 mg/day. In a post‐hoc subgroup analysis, rotigotine ≤8 mg/24 hours had a similar efficacy to ropinirole at doses ≤12 mg/day. The rotigotine transdermal patch was well tolerated. The most common adverse events were application‐site reactions, nausea, and somnolence. Application‐site reactions were predominantly mild or moderate in intensity. In conclusion, the rotigotine transdermal patch represents an effective and safe option for the treatment of patients with early Parkinson's disease.</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Nir Giladi MD</name><affiliations><json:string>Movement Disorders Unit, Department of Neurology, Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel</json:string></affiliations></json:item><json:item><name>Babak Boroojerdi MD</name><affiliations><json:string>SCHWARZ PHARMA AG, Monheim, Germany</json:string></affiliations></json:item><json:item><name>Amos D. Korczyn MD</name><affiliations><json:string>Chair of Neurology, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel</json:string></affiliations></json:item><json:item><name>David J. Burn MD</name><affiliations><json:string>Department of Neurology, City Hospital Birmingham and University Birmingham, United Kingdom</json:string></affiliations></json:item><json:item><name>Carl E. Clarke MD</name><affiliations><json:string>Department of Neurology, City Hospital NHS Trust, Birmingham, United Kingdom</json:string></affiliations></json:item><json:item><name>Anthony H.V. Schapira MD</name><affiliations><json:string>Department of Clinical Neurosciences, Institute of Neurology, London, United Kingdom</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>dopamine agonist</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>rotigotine</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>transdermal patch</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>therapy</value></json:item></subject><articleId><json:string>MDS21741</json:string></articleId><language><json:string>eng</json:string></language><abstract>Rotigotine is a new, non‐ergot dopamine agonist formulated in a transdermal delivery system. The present study was to investigate the efficacy and safety of the rotigotine transdermal patch in the treatment of early Parkinson's disease. Patients (n = 561) were randomized to rotigotine, ropinirole, or placebo. The titration period was up to 13 weeks, and there was a minimum dose‐maintenance period of 24 weeks for ropinirole and 33 weeks for rotigotine. The primary endpoint was the proportion of patients with a minimum of 20% decrease in the combined Unified Parkinson's Disease Rating Scale Part II and Part III scores. The responder rate in the rotigotine group was significantly higher than in the placebo group (52% vs. 30%, P > 0.0001). Transdermal rotigotine at doses ≤8 mg/24 h did not show noninferiority to ropinirole at doses ≤24 mg/day. In a post‐hoc subgroup analysis, rotigotine ≤8 mg/24 hours had a similar efficacy to ropinirole at doses ≤12 mg/day. The rotigotine transdermal patch was well tolerated. The most common adverse events were application‐site reactions, nausea, and somnolence. Application‐site reactions were predominantly mild or moderate in intensity. In conclusion, the rotigotine transdermal patch represents an effective and safe option for the treatment of patients with early Parkinson's disease.</abstract><qualityIndicators><score>6.158</score><pdfVersion>1.3</pdfVersion><pdfPageSize>594 x 792 pts</pdfPageSize><refBibsNative>true</refBibsNative><keywordCount>5</keywordCount><abstractCharCount>1336</abstractCharCount><pdfWordCount>3710</pdfWordCount><pdfCharCount>24864</pdfCharCount><pdfPageCount>7</pdfPageCount><abstractWordCount>204</abstractWordCount></qualityIndicators><title>Rotigotine transdermal patch in early Parkinson's disease: A randomized, double‐blind, controlled study versus placebo and ropinirole</title><corporate><json:item><name>SP513 investigators</name></json:item></corporate><genre><json:string>article</json:string></genre><host><volume>22</volume><publisherId><json:string>MDS</json:string></publisherId><pages><total>8</total><last>2404</last><first>2398</first></pages><issn><json:string>0885-3185</json:string></issn><issue>16</issue><subject><json:item><value>Research Article</value></json:item></subject><genre><json:string>Journal</json:string></genre><language><json:string>unknown</json:string></language><eissn><json:string>1531-8257</json:string></eissn><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.21741</json:string></doi><id>3DFAF358B00233168B68C32114FE9602AA742627</id><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/3DFAF358B00233168B68C32114FE9602AA742627/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/3DFAF358B00233168B68C32114FE9602AA742627/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/3DFAF358B00233168B68C32114FE9602AA742627/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Rotigotine transdermal patch in early Parkinson's disease: A randomized, double‐blind, controlled study versus placebo and ropinirole</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><availability><p>WILEY</p></availability><date>2007</date></publicationStmt><notesStmt><note type="content">*Members of the SP513 investigators are listed as an Appendix</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Rotigotine transdermal patch in early Parkinson's disease: A randomized, double‐blind, controlled study versus placebo and ropinirole</title><author><orgName>SP513 investigators</orgName></author><author><persName><forename type="first">Nir</forename><surname>Giladi</surname></persName><roleName type="degree">MD</roleName><note type="correspondence"><p>Correspondence: Movement Disorders Unit, Tel‐Aviv Parkinson Center, Department of Neurology, Tel Aviv Sourasky Medical Center, 6 Weizman Street, Tel Aviv, Israel 64239</p></note><affiliation>Movement Disorders Unit, Department of Neurology, Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel</affiliation></author><author><persName><forename type="first">Babak</forename><surname>Boroojerdi</surname></persName><roleName type="degree">MD</roleName><affiliation>SCHWARZ PHARMA AG, Monheim, Germany</affiliation></author><author><persName><forename type="first">Amos D.</forename><surname>Korczyn</surname></persName><roleName type="degree">MD</roleName><affiliation>Chair of Neurology, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel</affiliation></author><author><persName><forename type="first">David J.</forename><surname>Burn</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, City Hospital Birmingham and University Birmingham, United Kingdom</affiliation></author><author><persName><forename type="first">Carl E.</forename><surname>Clarke</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, City Hospital NHS Trust, Birmingham, United Kingdom</affiliation></author><author><persName><forename type="first">Anthony H.V.</forename><surname>Schapira</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Clinical Neurosciences, Institute of Neurology, London, United Kingdom</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="2007-12-15"></date><biblScope unit="volume">22</biblScope><biblScope unit="issue">16</biblScope><biblScope unit="page" from="2398">2398</biblScope><biblScope unit="page" to="2404">2404</biblScope></imprint></monogr><idno type="istex">3DFAF358B00233168B68C32114FE9602AA742627</idno><idno type="DOI">10.1002/mds.21741</idno><idno type="ArticleID">MDS21741</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2007</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Rotigotine is a new, non‐ergot dopamine agonist formulated in a transdermal delivery system. The present study was to investigate the efficacy and safety of the rotigotine transdermal patch in the treatment of early Parkinson's disease. Patients (n = 561) were randomized to rotigotine, ropinirole, or placebo. The titration period was up to 13 weeks, and there was a minimum dose‐maintenance period of 24 weeks for ropinirole and 33 weeks for rotigotine. The primary endpoint was the proportion of patients with a minimum of 20% decrease in the combined Unified Parkinson's Disease Rating Scale Part II and Part III scores. The responder rate in the rotigotine group was significantly higher than in the placebo group (52% vs. 30%, P < 0.0001). Transdermal rotigotine at doses ≤8 mg/24 h did not show noninferiority to ropinirole at doses ≤24 mg/day. In a post‐hoc subgroup analysis, rotigotine ≤8 mg/24 hours had a similar efficacy to ropinirole at doses ≤12 mg/day. The rotigotine transdermal patch was well tolerated. The most common adverse events were application‐site reactions, nausea, and somnolence. Application‐site reactions were predominantly mild or moderate in intensity. In conclusion, the rotigotine transdermal patch represents an effective and safe option for the treatment of patients with early Parkinson's disease.</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>dopamine agonist</term></item><item><term>Parkinson's disease</term></item><item><term>rotigotine</term></item><item><term>transdermal patch</term></item><item><term>therapy</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>article category</head><item><term>Research Article</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2007-05-03">Received</change><change when="2007-08-21">Registration</change><change when="2007-12-15">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/3DFAF358B00233168B68C32114FE9602AA742627/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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elementName="appendix">APPENDIX</objectName></objectNameGroup><linkGroup><link type="toTypesetVersion" href="file:MDS.MDS21741.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="3"></count><count type="tableTotal" number="2"></count><count type="referenceTotal" number="27"></count><count type="wordTotal" number="4145"></count></countGroup><titleGroup><title type="main" xml:lang="en">Rotigotine transdermal patch in early Parkinson's disease: A randomized, double‐blind, controlled study versus placebo and ropinirole<link href="#fn1"></link></title><title type="short" xml:lang="en">Rotigotine Transdermal Patch in PD</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes"><personName><givenNames>Nir</givenNames><familyName>Giladi</familyName><degrees>MD</degrees></personName><contactDetails><email>nirg@tasmc.health.gov.il</email></contactDetails></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Babak</givenNames><familyName>Boroojerdi</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Amos D.</givenNames><familyName>Korczyn</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af4"><personName><givenNames>David J.</givenNames><familyName>Burn</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af5"><personName><givenNames>Carl E.</givenNames><familyName>Clarke</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au6" creatorRole="author" affiliationRef="#af6"><personName><givenNames>Anthony H.V.</givenNames><familyName>Schapira</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au7" creatorRole="author"><groupName>SP513 investigators</groupName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="IL" type="organization"><unparsedAffiliation>Movement Disorders Unit, Department of Neurology, Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="DE" type="organization"><unparsedAffiliation>SCHWARZ PHARMA AG, Monheim, Germany</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="IL" type="organization"><unparsedAffiliation>Chair of Neurology, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="GB" type="organization"><unparsedAffiliation>Department of Neurology, City Hospital Birmingham and University Birmingham, United Kingdom</unparsedAffiliation></affiliation><affiliation xml:id="af5" countryCode="GB" type="organization"><unparsedAffiliation>Department of Neurology, City Hospital NHS Trust, Birmingham, United Kingdom</unparsedAffiliation></affiliation><affiliation xml:id="af6" countryCode="GB" type="organization"><unparsedAffiliation>Department of Clinical Neurosciences, Institute of Neurology, London, United Kingdom</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">dopamine agonist</keyword><keyword xml:id="kwd2">Parkinson's disease</keyword><keyword xml:id="kwd3">rotigotine</keyword><keyword xml:id="kwd4">transdermal patch</keyword><keyword xml:id="kwd5">therapy</keyword></keywordGroup><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>Rotigotine is a new, non‐ergot dopamine agonist formulated in a transdermal delivery system. The present study was to investigate the efficacy and safety of the rotigotine transdermal patch in the treatment of early Parkinson's disease. Patients (n = 561) were randomized to rotigotine, ropinirole, or placebo. The titration period was up to 13 weeks, and there was a minimum dose‐maintenance period of 24 weeks for ropinirole and 33 weeks for rotigotine. The primary endpoint was the proportion of patients with a minimum of 20% decrease in the combined Unified Parkinson's Disease Rating Scale Part II and Part III scores. The responder rate in the rotigotine group was significantly higher than in the placebo group (52% vs. 30%, <i>P</i> < 0.0001). Transdermal rotigotine at doses ≤8 mg/24 h did not show noninferiority to ropinirole at doses ≤24 mg/day. In a post‐hoc subgroup analysis, rotigotine ≤8 mg/24 hours had a similar efficacy to ropinirole at doses ≤12 mg/day. The rotigotine transdermal patch was well tolerated. The most common adverse events were application‐site reactions, nausea, and somnolence. Application‐site reactions were predominantly mild or moderate in intensity. In conclusion, the rotigotine transdermal patch represents an effective and safe option for the treatment of patients with early Parkinson's disease.</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn1"><p>Members of the SP513 investigators are listed as an <link href="#app1">Appendix</link></p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Rotigotine transdermal patch in early Parkinson's disease: A randomized, double‐blind, controlled study versus placebo and ropinirole</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Rotigotine Transdermal Patch in PD</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Rotigotine transdermal patch in early Parkinson's disease: A randomized, double‐blind, controlled study versus placebo and ropinirole</title></titleInfo><name type="personal"><namePart type="given">Nir</namePart><namePart type="family">Giladi</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Movement Disorders Unit, Department of Neurology, Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel</affiliation><description>Correspondence: Movement Disorders Unit, Tel‐Aviv Parkinson Center, Department of Neurology, Tel Aviv Sourasky Medical Center, 6 Weizman Street, Tel Aviv, Israel 64239</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Babak</namePart><namePart type="family">Boroojerdi</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>SCHWARZ PHARMA AG, Monheim, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Amos D.</namePart><namePart type="family">Korczyn</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Chair of Neurology, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">David J.</namePart><namePart type="family">Burn</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, City Hospital Birmingham and University Birmingham, United Kingdom</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Carl E.</namePart><namePart type="family">Clarke</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, City Hospital NHS Trust, Birmingham, United Kingdom</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Anthony H.V.</namePart><namePart type="family">Schapira</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Clinical Neurosciences, Institute of Neurology, London, United Kingdom</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="corporate"><namePart>SP513 investigators</namePart><description>Movement Disorders Unit, Department of Neurology, Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, IsraelSCHWARZ PHARMA AG, Monheim, GermanyChair of Neurology, Sackler School of Medicine, Tel Aviv University, Tel Aviv, IsraelDepartment of Neurology, City Hospital Birmingham and University Birmingham, United KingdomDepartment of Neurology, City Hospital NHS Trust, Birmingham, United KingdomDepartment of Clinical Neurosciences, Institute of Neurology, London, United Kingdom</description></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article"></genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">2007-12-15</dateIssued><dateCaptured encoding="w3cdtf">2007-05-03</dateCaptured><dateValid encoding="w3cdtf">2007-08-21</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">3</extent><extent unit="tables">2</extent><extent unit="references">27</extent><extent unit="words">4145</extent></physicalDescription><abstract lang="en">Rotigotine is a new, non‐ergot dopamine agonist formulated in a transdermal delivery system. The present study was to investigate the efficacy and safety of the rotigotine transdermal patch in the treatment of early Parkinson's disease. Patients (n = 561) were randomized to rotigotine, ropinirole, or placebo. The titration period was up to 13 weeks, and there was a minimum dose‐maintenance period of 24 weeks for ropinirole and 33 weeks for rotigotine. The primary endpoint was the proportion of patients with a minimum of 20% decrease in the combined Unified Parkinson's Disease Rating Scale Part II and Part III scores. The responder rate in the rotigotine group was significantly higher than in the placebo group (52% vs. 30%, P < 0.0001). Transdermal rotigotine at doses ≤8 mg/24 h did not show noninferiority to ropinirole at doses ≤24 mg/day. In a post‐hoc subgroup analysis, rotigotine ≤8 mg/24 hours had a similar efficacy to ropinirole at doses ≤12 mg/day. The rotigotine transdermal patch was well tolerated. The most common adverse events were application‐site reactions, nausea, and somnolence. Application‐site reactions were predominantly mild or moderate in intensity. In conclusion, the rotigotine transdermal patch represents an effective and safe option for the treatment of patients with early Parkinson's disease.</abstract><note type="content">*Members of the SP513 investigators are listed as an Appendix</note><subject lang="en"><genre>Keywords</genre><topic>dopamine agonist</topic><topic>Parkinson's disease</topic><topic>rotigotine</topic><topic>transdermal patch</topic><topic>therapy</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title></titleInfo><titleInfo type="abbreviated"><title>Mov. Disord.</title></titleInfo><genre type="Journal">journal</genre><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>16</number></detail><extent unit="pages"><start>2398</start><end>2404</end><total>8</total></extent></part></relatedItem><identifier type="istex">3DFAF358B00233168B68C32114FE9602AA742627</identifier><identifier type="DOI">10.1002/mds.21741</identifier><identifier type="ArticleID">MDS21741</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2007 Movement Disorder Society</accessCondition><recordInfo><recordContentSource>WILEY</recordContentSource><recordOrigin>Wiley Subscription Services, Inc., A Wiley Company</recordOrigin></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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