A double-blind, delayed-start trial of rasagiline in Parkinson's disease.
Identifieur interne : 000259 ( Ncbi/Merge ); précédent : 000258; suivant : 000260A double-blind, delayed-start trial of rasagiline in Parkinson's disease.
Auteurs : C Olanow [États-Unis] ; Olivier Rascol ; Robert Hauser ; Paul. Feigin ; Joseph Jankovic [États-Unis] ; 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
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pubmed:19776408Le document en format XML
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<series><title level="j">The New England journal of medicine</title>
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<term>Humans</term>
<term>Indans (administration & dosage)</term>
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<term>Research Design</term>
<term>Severity of Illness Index</term>
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<front><div type="abstract" xml:lang="en">A therapy that slows disease progression is the major unmet need in Parkinson's disease.</div>
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<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>
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<Title>The New England journal of medicine</Title>
<ISOAbbreviation>N. Engl. J. Med.</ISOAbbreviation>
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<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>
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<Author ValidYN="Y"><LastName>Rascol</LastName>
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<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>
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<MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000328">Adult</DescriptorName>
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<MeshHeading><DescriptorName MajorTopicYN="N" UI="D000368">Aged</DescriptorName>
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<QualifierName MajorTopicYN="Y" UI="Q000008">administration & dosage</QualifierName>
<QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName>
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<MeshHeading><DescriptorName MajorTopicYN="N" UI="D008996">Monoamine Oxidase Inhibitors</DescriptorName>
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<QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName>
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<QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName>
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