Effects of long-term treatment with rotigotine transdermal system on dyskinesia in patients with early-stage Parkinson's disease.
Identifieur interne : 000036 ( PubMed/Checkpoint ); précédent : 000035; suivant : 000037Effects of long-term treatment with rotigotine transdermal system on dyskinesia in patients with early-stage Parkinson's disease.
Auteurs : Nir Giladi [Israël] ; Liesbet Ghys [Belgique] ; Erwin Surmann [Allemagne] ; Babak Boroojerdi [États-Unis] ; Joseph Jankovic [États-Unis]Source :
- Parkinsonism & related disorders ; 2014.
English descriptors
- KwdEn :
- Administration, Cutaneous, Adult, Age Factors, Aged, Aged, 80 and over, Antiparkinson Agents (administration & dosage), Disability Evaluation, Dose-Response Relationship, Drug, Double-Blind Method, Dyskinesias (diagnosis), Dyskinesias (epidemiology), Dyskinesias (etiology), Female, Humans, Kaplan-Meier Estimate, Levodopa (therapeutic use), Longitudinal Studies, Male, Middle Aged, Parkinson Disease (drug therapy), Sex Factors, Tetrahydronaphthalenes (administration & dosage), Thiophenes (administration & dosage).
- MESH :
- chemical , administration & dosage : Antiparkinson Agents, Tetrahydronaphthalenes, Thiophenes.
- diagnosis : Dyskinesias.
- drug therapy : Parkinson Disease.
- epidemiology : Dyskinesias.
- etiology : Dyskinesias.
- chemical , therapeutic use : Levodopa.
- Administration, Cutaneous, Adult, Age Factors, Aged, Aged, 80 and over, Disability Evaluation, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Kaplan-Meier Estimate, Longitudinal Studies, Male, Middle Aged, Sex Factors.
Abstract
In two 6-month, double-blind, placebo-controlled studies, rotigotine transdermal system was well-tolerated and efficacious monotherapy in early-stage PD. This post hoc analysis of the long-term open-label extensions (NCT00594165; NCT00599196) of these studies assessed incidence and severity of dyskinesia in participants treated with rotigotine, with or without concomitant levodopa, for up to 6 years.
DOI: 10.1016/j.parkreldis.2014.09.016
PubMed: 25444083
Affiliations:
- Allemagne, Belgique, Israël, États-Unis
- Caroline du Nord, Région de Bruxelles-Capitale, Texas
- Bruxelles, Houston
- Baylor College of Medicine
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Electronic address: nirg@tlvmc.gov.il.</nlm:affiliation><country xml:lang="fr">Israël</country><wicri:regionArea>Department of Neurology, Tel-Aviv University, Tel-Aviv, Israel; Sago School of Neuroscience, Tel-Aviv University, Tel-Aviv</wicri:regionArea><wicri:noRegion>Tel-Aviv</wicri:noRegion></affiliation></author><author><name sortKey="Ghys, Liesbet" sort="Ghys, Liesbet" uniqKey="Ghys L" first="Liesbet" last="Ghys">Liesbet Ghys</name><affiliation wicri:level="3"><nlm:affiliation>UCB Pharma, Brussels, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>UCB Pharma, Brussels</wicri:regionArea><placeName><settlement type="city">Bruxelles</settlement><region nuts="2">Région de Bruxelles-Capitale</region></placeName></affiliation></author><author><name sortKey="Surmann, Erwin" sort="Surmann, Erwin" uniqKey="Surmann E" first="Erwin" last="Surmann">Erwin Surmann</name><affiliation wicri:level="1"><nlm:affiliation>UCB Pharma, Monheim am Rhein, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>UCB Pharma, Monheim am Rhein</wicri:regionArea><wicri:noRegion>Monheim am Rhein</wicri:noRegion><wicri:noRegion>Monheim am Rhein</wicri:noRegion><wicri:noRegion>Monheim am Rhein</wicri:noRegion></affiliation></author><author><name sortKey="Boroojerdi, Babak" sort="Boroojerdi, Babak" uniqKey="Boroojerdi B" first="Babak" last="Boroojerdi">Babak Boroojerdi</name><affiliation wicri:level="2"><nlm:affiliation>UCB Biosciences Inc., Raleigh, NC, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>UCB Biosciences Inc., Raleigh, NC</wicri:regionArea><placeName><region type="state">Caroline du Nord</region></placeName></affiliation></author><author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name><affiliation wicri:level="2"><nlm:affiliation>Parkinson's Disease Center and Movement Disorders Clinic, Baylor College of Medicine, Department of Neurology, Houston, TX, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Parkinson's Disease Center and Movement Disorders Clinic, Baylor College of Medicine, Department of Neurology, Houston, TX</wicri:regionArea><placeName><region type="state">Texas</region></placeName><placeName><settlement type="city">Houston</settlement><region type="state">Texas</region></placeName><orgName type="university" n="3">Baylor College of Medicine</orgName></affiliation></author></analytic><series><title level="j">Parkinsonism & related disorders</title><idno type="e-ISSN">1873-5126</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Cutaneous</term><term>Adult</term><term>Age Factors</term><term>Aged</term><term>Aged, 80 and over</term><term>Antiparkinson Agents (administration & dosage)</term><term>Disability Evaluation</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Dyskinesias (diagnosis)</term><term>Dyskinesias (epidemiology)</term><term>Dyskinesias (etiology)</term><term>Female</term><term>Humans</term><term>Kaplan-Meier Estimate</term><term>Levodopa (therapeutic use)</term><term>Longitudinal Studies</term><term>Male</term><term>Middle Aged</term><term>Parkinson Disease (drug therapy)</term><term>Sex Factors</term><term>Tetrahydronaphthalenes (administration & dosage)</term><term>Thiophenes (administration & dosage)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiparkinson Agents</term><term>Tetrahydronaphthalenes</term><term>Thiophenes</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Dyskinesias</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Dyskinesias</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Dyskinesias</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Levodopa</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Cutaneous</term><term>Adult</term><term>Age Factors</term><term>Aged</term><term>Aged, 80 and over</term><term>Disability Evaluation</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Kaplan-Meier Estimate</term><term>Longitudinal Studies</term><term>Male</term><term>Middle Aged</term><term>Sex Factors</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">In two 6-month, double-blind, placebo-controlled studies, rotigotine transdermal system was well-tolerated and efficacious monotherapy in early-stage PD. This post hoc analysis of the long-term open-label extensions (NCT00594165; NCT00599196) of these studies assessed incidence and severity of dyskinesia in participants treated with rotigotine, with or without concomitant levodopa, for up to 6 years.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">25444083</PMID><DateCreated><Year>2014</Year><Month>12</Month><Day>02</Day></DateCreated><DateCompleted><Year>2015</Year><Month>08</Month><Day>19</Day></DateCompleted><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-5126</ISSN><JournalIssue CitedMedium="Internet"><Volume>20</Volume><Issue>12</Issue><PubDate><Year>2014</Year><Month>Dec</Month></PubDate></JournalIssue><Title>Parkinsonism & related disorders</Title><ISOAbbreviation>Parkinsonism Relat. Disord.</ISOAbbreviation></Journal><ArticleTitle>Effects of long-term treatment with rotigotine transdermal system on dyskinesia in patients with early-stage Parkinson's disease.</ArticleTitle><Pagination><MedlinePgn>1345-51</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.parkreldis.2014.09.016</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S1353-8020(14)00338-1</ELocationID><Abstract><AbstractText Label="PURPOSE" NlmCategory="OBJECTIVE">In two 6-month, double-blind, placebo-controlled studies, rotigotine transdermal system was well-tolerated and efficacious monotherapy in early-stage PD. This post hoc analysis of the long-term open-label extensions (NCT00594165; NCT00599196) of these studies assessed incidence and severity of dyskinesia in participants treated with rotigotine, with or without concomitant levodopa, for up to 6 years.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Open-label rotigotine was titrated to optimal dose (≤16 mg/24 h). Concomitant levodopa was permitted. Dyskinesia data, recorded using the Unified Parkinson's Disease Rating Scale Part IV, were pooled from the two open-label studies.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Of 596 participants who received open-label rotigotine, 299 (50%) remained at trial closure; no patient discontinued due to dyskinesia. In the two studies, median exposure to rotigotine was 1910 days (∼5 years, 3 months), and 1564.5 days (∼4 years, 3 months). During up to 6 years of open-label rotigotine, 423/596 (71%) received levodopa. Dyskinesias were reported in 115/596 (19%) participants, 90/115 (78%) of who developed dyskinesia after levodopa was added; 25 reported dyskinesia in the absence of levodopa (includes patients who never received open-label levodopa, and those who reported dyskinesia before starting concomitant levodopa). Dyskinesia severity data were available for 107 of the 115 participants. In 56/107 (52%) participants, dyskinesia was considered 'not disabling' for all occurrences; the worst-case severity was 'mildly disabling' for 33/107 (31%), and 'moderately' or 'severely disabling' for 18/107 (17%; 3% of total participants).</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">During treatment with rotigotine in patients with PD for up to 6 years the incidence of dyskinesia was low, and the dyskinesia was generally 'not disabling' or 'mildly disabling'.</AbstractText><CopyrightInformation>Copyright © 2014 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Giladi</LastName><ForeName>Nir</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Department of Neurology, Tel-Aviv University, Tel-Aviv, Israel; Sago School of Neuroscience, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: nirg@tlvmc.gov.il.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ghys</LastName><ForeName>Liesbet</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>UCB Pharma, Brussels, Belgium.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Surmann</LastName><ForeName>Erwin</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>UCB Pharma, Monheim am Rhein, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Boroojerdi</LastName><ForeName>Babak</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>UCB Biosciences Inc., Raleigh, NC, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jankovic</LastName><ForeName>Joseph</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Parkinson's Disease Center and Movement Disorders Clinic, Baylor College of Medicine, Department of Neurology, Houston, TX, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2014</Year><Month>09</Month><Day>28</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Parkinsonism Relat Disord</MedlineTA><NlmUniqueID>9513583</NlmUniqueID><ISSNLinking>1353-8020</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000978">Antiparkinson Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D013764">Tetrahydronaphthalenes</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D013876">Thiophenes</NameOfSubstance></Chemical><Chemical><RegistryNumber>46627O600J</RegistryNumber><NameOfSubstance UI="D007980">Levodopa</NameOfSubstance></Chemical><Chemical><RegistryNumber>92206-54-7</RegistryNumber><NameOfSubstance UI="C047508">N 0437</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000279">Administration, Cutaneous</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000328">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000367">Age Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000368">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000369">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000978">Antiparkinson Agents</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000008">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004185">Disability Evaluation</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004305">Dose-Response Relationship, Drug</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004311">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D020820">Dyskinesias</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000175">diagnosis</QualifierName><QualifierName MajorTopicYN="N" UI="Q000453">epidemiology</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000209">etiology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005260">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D053208">Kaplan-Meier Estimate</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D007980">Levodopa</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008137">Longitudinal Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008297">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008875">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D010300">Parkinson Disease</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012737">Sex Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D013764">Tetrahydronaphthalenes</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000008">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D013876">Thiophenes</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000008">administration & dosage</QualifierName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Dyskinesia</Keyword><Keyword MajorTopicYN="N">Levodopa</Keyword><Keyword MajorTopicYN="N">Parkinson's disease</Keyword><Keyword MajorTopicYN="N">Rotigotine</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2013</Year><Month>5</Month><Day>21</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2014</Year><Month>9</Month><Day>4</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2014</Year><Month>9</Month><Day>8</Day></PubMedPubDate><PubMedPubDate PubStatus="aheadofprint"><Year>2014</Year><Month>9</Month><Day>28</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2014</Year><Month>12</Month><Day>3</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2014</Year><Month>12</Month><Day>3</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2015</Year><Month>8</Month><Day>20</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">25444083</ArticleId><ArticleId IdType="pii">S1353-8020(14)00338-1</ArticleId><ArticleId IdType="doi">10.1016/j.parkreldis.2014.09.016</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Allemagne</li><li>Belgique</li><li>Israël</li><li>États-Unis</li></country><region><li>Caroline du Nord</li><li>Région de Bruxelles-Capitale</li><li>Texas</li></region><settlement><li>Bruxelles</li><li>Houston</li></settlement><orgName><li>Baylor College of Medicine</li></orgName></list><tree><country name="Israël"><noRegion><name sortKey="Giladi, Nir" sort="Giladi, Nir" uniqKey="Giladi N" first="Nir" last="Giladi">Nir Giladi</name></noRegion></country><country name="Belgique"><region name="Région de Bruxelles-Capitale"><name sortKey="Ghys, Liesbet" sort="Ghys, Liesbet" uniqKey="Ghys L" first="Liesbet" last="Ghys">Liesbet Ghys</name></region></country><country name="Allemagne"><noRegion><name sortKey="Surmann, Erwin" sort="Surmann, Erwin" uniqKey="Surmann E" first="Erwin" last="Surmann">Erwin Surmann</name></noRegion></country><country name="États-Unis"><region name="Caroline du Nord"><name sortKey="Boroojerdi, Babak" sort="Boroojerdi, Babak" uniqKey="Boroojerdi B" first="Babak" last="Boroojerdi">Babak Boroojerdi</name></region><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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