A double-blind, delayed-start trial of rasagiline in Parkinson's disease.
Identifieur interne : 000106 ( PubMed/Corpus ); précédent : 000105; suivant : 000107A double-blind, delayed-start trial of rasagiline in Parkinson's disease.
Auteurs : C Olanow ; Olivier Rascol ; Robert Hauser ; Paul. Feigin ; Joseph Jankovic ; Anthony Lang ; William Langston ; Eldad Melamed ; Werner Poewe ; Fabrizio Stocchi ; Eduardo TolosaSource :
- The New England journal of medicine ; 2009.
English descriptors
- KwdEn :
- Adult, Aged, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Indans (administration & dosage), Indans (adverse effects), Male, Middle Aged, Monoamine Oxidase Inhibitors (administration & dosage), Monoamine Oxidase Inhibitors (adverse effects), Neuroprotective Agents (administration & dosage), Neuroprotective Agents (adverse effects), Parkinson Disease (classification), Parkinson Disease (drug therapy), Research Design, Severity of Illness Index.
- MESH :
- chemical , administration & dosage : Indans, Monoamine Oxidase Inhibitors, Neuroprotective Agents.
- chemical , adverse effects : Indans, Monoamine Oxidase Inhibitors, Neuroprotective Agents.
- classification : Parkinson Disease.
- drug therapy : Parkinson Disease.
- Adult, Aged, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Research Design, Severity of Illness Index.
Abstract
A therapy that slows disease progression is the major unmet need in Parkinson's disease.
DOI: 10.1056/NEJMoa0809335
PubMed: 19776408
Links to Exploration step
pubmed:19776408Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">A double-blind, delayed-start trial of rasagiline in Parkinson's disease.</title><author><name sortKey="Olanow, C Warren" sort="Olanow, C Warren" uniqKey="Olanow C" first="C" last="Olanow">C Olanow</name><affiliation><nlm:affiliation>Department of Neurology and Neuroscience, Mount Sinai School of Medicine, New York, NY 10029, USA. warren.olanow@mssm.edu</nlm:affiliation></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name></author><author><name sortKey="Hauser, Robert" sort="Hauser, Robert" uniqKey="Hauser R" first="Robert" last="Hauser">Robert Hauser</name></author><author><name sortKey="Feigin, Paul D" sort="Feigin, Paul D" uniqKey="Feigin P" first="Paul" last="Feigin">Paul. Feigin</name></author><author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name></author><author><name sortKey="Lang, Anthony" sort="Lang, Anthony" uniqKey="Lang A" first="Anthony" last="Lang">Anthony Lang</name></author><author><name sortKey="Langston, William" sort="Langston, William" uniqKey="Langston W" first="William" last="Langston">William Langston</name></author><author><name sortKey="Melamed, Eldad" sort="Melamed, Eldad" uniqKey="Melamed E" first="Eldad" last="Melamed">Eldad Melamed</name></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name></author><author><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name></author><author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2009">2009</date><idno type="doi">10.1056/NEJMoa0809335</idno><idno type="RBID">pubmed:19776408</idno><idno type="pmid">19776408</idno><idno type="wicri:Area/PubMed/Corpus">000106</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">A double-blind, delayed-start trial of rasagiline in Parkinson's disease.</title><author><name sortKey="Olanow, C Warren" sort="Olanow, C Warren" uniqKey="Olanow C" first="C" last="Olanow">C Olanow</name><affiliation><nlm:affiliation>Department of Neurology and Neuroscience, Mount Sinai School of Medicine, New York, NY 10029, USA. warren.olanow@mssm.edu</nlm:affiliation></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name></author><author><name sortKey="Hauser, Robert" sort="Hauser, Robert" uniqKey="Hauser R" first="Robert" last="Hauser">Robert Hauser</name></author><author><name sortKey="Feigin, Paul D" sort="Feigin, Paul D" uniqKey="Feigin P" first="Paul" last="Feigin">Paul. Feigin</name></author><author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name></author><author><name sortKey="Lang, Anthony" sort="Lang, Anthony" uniqKey="Lang A" first="Anthony" last="Lang">Anthony Lang</name></author><author><name sortKey="Langston, William" sort="Langston, William" uniqKey="Langston W" first="William" last="Langston">William Langston</name></author><author><name sortKey="Melamed, Eldad" sort="Melamed, Eldad" uniqKey="Melamed E" first="Eldad" last="Melamed">Eldad Melamed</name></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name></author><author><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name></author><author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name></author></analytic><series><title level="j">The New England journal of medicine</title><idno type="e-ISSN">1533-4406</idno><imprint><date when="2009" type="published">2009</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Female</term><term>Humans</term><term>Indans (administration & dosage)</term><term>Indans (adverse effects)</term><term>Male</term><term>Middle Aged</term><term>Monoamine Oxidase Inhibitors (administration & dosage)</term><term>Monoamine Oxidase Inhibitors (adverse effects)</term><term>Neuroprotective Agents (administration & dosage)</term><term>Neuroprotective Agents (adverse effects)</term><term>Parkinson Disease (classification)</term><term>Parkinson Disease (drug therapy)</term><term>Research Design</term><term>Severity of Illness Index</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Indans</term><term>Monoamine Oxidase Inhibitors</term><term>Neuroprotective Agents</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Indans</term><term>Monoamine Oxidase Inhibitors</term><term>Neuroprotective Agents</term></keywords><keywords scheme="MESH" qualifier="classification" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Research Design</term><term>Severity of Illness Index</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">A therapy that slows disease progression is the major unmet need in Parkinson's disease.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">19776408</PMID><DateCreated><Year>2009</Year><Month>09</Month><Day>24</Day></DateCreated><DateCompleted><Year>2009</Year><Month>10</Month><Day>02</Day></DateCompleted><DateRevised><Year>2012</Year><Month>11</Month><Day>15</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1533-4406</ISSN><JournalIssue CitedMedium="Internet"><Volume>361</Volume><Issue>13</Issue><PubDate><Year>2009</Year><Month>Sep</Month><Day>24</Day></PubDate></JournalIssue><Title>The New England journal of medicine</Title><ISOAbbreviation>N. Engl. J. Med.</ISOAbbreviation></Journal><ArticleTitle>A double-blind, delayed-start trial of rasagiline in Parkinson's disease.</ArticleTitle><Pagination><MedlinePgn>1268-78</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1056/NEJMoa0809335</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">A therapy that slows disease progression is the major unmet need in Parkinson's disease.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">In this double-blind trial, we examined the possibility that rasagiline has disease-modifying effects in Parkinson's disease. A total of 1176 subjects with untreated Parkinson's disease were randomly assigned to receive rasagiline (at a dose of either 1 mg or 2 mg per day) for 72 weeks (the early-start group) or placebo for 36 weeks followed by rasagiline (at a dose of either 1 mg or 2 mg per day) for 36 weeks (the delayed-start group). To determine a positive result with either dose, the early-start treatment group had to meet each of three hierarchical end points of the primary analysis based on the Unified Parkinson's Disease Rating Scale (UPDRS, a 176-point scale, with higher numbers indicating more severe disease): superiority to placebo in the rate of change in the UPDRS score between weeks 12 and 36, superiority to delayed-start treatment in the change in the score between baseline and week 72, and noninferiority to delayed-start treatment in the rate of change in the score between weeks 48 and 72.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Early-start treatment with rasagiline at a dose of 1 mg per day met all end points in the primary analysis: a smaller mean (+/-SE) increase (rate of worsening) in the UPDRS score between weeks 12 and 36 (0.09+/-0.02 points per week in the early-start group vs. 0.14+/-0.01 points per week in the placebo group, P=0.01), less worsening in the score between baseline and week 72 (2.82+/-0.53 points in the early-start group vs. 4.52+/-0.56 points in the delayed-start group, P=0.02), and noninferiority between the two groups with respect to the rate of change in the UPDRS score between weeks 48 and 72 (0.085+/-0.02 points per week in the early-start group vs. 0.085+/-0.02 points per week in the delayed-start group, P<0.001). All three end points were not met with rasagiline at a dose of 2 mg per day, since the change in the UPDRS score between baseline and week 72 was not significantly different in the two groups (3.47+/-0.50 points in the early-start group and 3.11+/-0.50 points in the delayed-start group, P=0.60).</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Early treatment with rasagiline at a dose of 1 mg per day provided benefits that were consistent with a possible disease-modifying effect, but early treatment with rasagiline at a dose of 2 mg per day did not. Because the two doses were associated with different outcomes, the study results must be interpreted with caution. (ClinicalTrials.gov number, NCT00256204.)</AbstractText><CopyrightInformation>2009 Massachusetts Medical Society</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Olanow</LastName><ForeName>C Warren</ForeName><Initials>CW</Initials><AffiliationInfo><Affiliation>Department of Neurology and Neuroscience, Mount Sinai School of Medicine, New York, NY 10029, USA. warren.olanow@mssm.edu</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rascol</LastName><ForeName>Olivier</ForeName><Initials>O</Initials></Author><Author ValidYN="Y"><LastName>Hauser</LastName><ForeName>Robert</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Feigin</LastName><ForeName>Paul D</ForeName><Initials>PD</Initials></Author><Author ValidYN="Y"><LastName>Jankovic</LastName><ForeName>Joseph</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Lang</LastName><ForeName>Anthony</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Langston</LastName><ForeName>William</ForeName><Initials>W</Initials></Author><Author ValidYN="Y"><LastName>Melamed</LastName><ForeName>Eldad</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><LastName>Poewe</LastName><ForeName>Werner</ForeName><Initials>W</Initials></Author><Author ValidYN="Y"><LastName>Stocchi</LastName><ForeName>Fabrizio</ForeName><Initials>F</Initials></Author><Author ValidYN="Y"><LastName>Tolosa</LastName><ForeName>Eduardo</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><CollectiveName>ADAGIO Study Investigators</CollectiveName></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00256204</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>N Engl J Med</MedlineTA><NlmUniqueID>0255562</NlmUniqueID><ISSNLinking>0028-4793</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007189">Indans</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D008996">Monoamine Oxidase Inhibitors</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D018696">Neuroprotective Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>003N66TS6T</RegistryNumber><NameOfSubstance UI="C031967">rasagiline</NameOfSubstance></Chemical></ChemicalList><CitationSubset>AIM</CitationSubset><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="CommentIn"><RefSource>Curr Neurol Neurosci Rep. 2010 Nov;10(6):413-6</RefSource><PMID Version="1">20711692</PMID></CommentsCorrections><CommentsCorrections RefType="CommentIn"><RefSource>J Neurol. 2009 Dec;256(12):2111-4</RefSource><PMID Version="1">19921300</PMID></CommentsCorrections><CommentsCorrections RefType="CommentIn"><RefSource>N Engl J Med. 2010 Feb 18;362(7):657-8; author reply 658-9</RefSource><PMID Version="1">20164492</PMID></CommentsCorrections><CommentsCorrections RefType="CommentIn"><RefSource>N Engl J Med. 2010 Feb 18;362(7):658; author reply 658-9</RefSource><PMID Version="1">20187261</PMID></CommentsCorrections><CommentsCorrections RefType="ErratumIn"><RefSource>N Engl J Med. 2011 May 12;364(19):1882</RefSource></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000328">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000368">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" 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