A double-blind, delayed-start trial of rasagiline in Parkinson's disease (the ADAGIO study): prespecified and post-hoc analyses of the need for additional therapies, changes in UPDRS scores, and non-motor outcomes.
Identifieur interne : 000072 ( PubMed/Corpus ); précédent : 000071; suivant : 000073A double-blind, delayed-start trial of rasagiline in Parkinson's disease (the ADAGIO study): prespecified and post-hoc analyses of the need for additional therapies, changes in UPDRS scores, and non-motor outcomes.
Auteurs : Olivier Rascol ; Cheryl. Fitzer ; Robert Hauser ; Joseph Jankovic ; Anthony Lang ; J Langston ; Eldad Melamed ; Werner Poewe ; Fabrizio Stocchi ; Eduardo Tolosa ; Eli Eyal ; Yoni. Weiss ; C OlanowSource :
- The Lancet. Neurology ; 2011.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Antiparkinson Agents (therapeutic use), Double-Blind Method, Female, Humans, Indans (therapeutic use), Male, Middle Aged, Parkinson Disease (diagnosis), Parkinson Disease (drug therapy), Parkinson Disease (epidemiology), Severity of Illness Index, Time Factors, Treatment Outcome.
- MESH :
- chemical , therapeutic use : Antiparkinson Agents, Indans.
- diagnosis : Parkinson Disease.
- drug therapy : Parkinson Disease.
- epidemiology : Parkinson Disease.
- Adult, Aged, Aged, 80 and over, Double-Blind Method, Female, Humans, Male, Middle Aged, Severity of Illness Index, Time Factors, Treatment Outcome.
Abstract
The ADAGIO study investigated whether rasagiline has disease-modifying effects in Parkinson's disease. Rasagiline 1 mg per day, but not 2 mg per day, was shown to be efficacious in the primary analysis. Here, we report additional secondary and post-hoc analyses of the ADAGIO study.
DOI: 10.1016/S1474-4422(11)70073-4
PubMed: 21482191
Links to Exploration step
pubmed:21482191Le document en format XML
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<author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name>
<affiliation><nlm:affiliation>Department of Clinical Pharmacology, Faculty of Medicine, Toulouse, France. rascol@cict.fr</nlm:affiliation>
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<author><name sortKey="Fitzer Attas, Cheryl J" sort="Fitzer Attas, Cheryl J" uniqKey="Fitzer Attas C" first="Cheryl" last="Fitzer">Cheryl. Fitzer</name>
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<author><name sortKey="Hauser, Robert" sort="Hauser, Robert" uniqKey="Hauser R" first="Robert" last="Hauser">Robert Hauser</name>
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<author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name>
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<author><name sortKey="Lang, Anthony" sort="Lang, Anthony" uniqKey="Lang A" first="Anthony" last="Lang">Anthony Lang</name>
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<author><name sortKey="Langston, J William" sort="Langston, J William" uniqKey="Langston J" first="J" last="Langston">J Langston</name>
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<author><name sortKey="Melamed, Eldad" sort="Melamed, Eldad" uniqKey="Melamed E" first="Eldad" last="Melamed">Eldad Melamed</name>
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<author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name>
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<author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name>
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<author><name sortKey="Weiss, Yoni M" sort="Weiss, Yoni M" uniqKey="Weiss Y" first="Yoni" last="Weiss">Yoni. Weiss</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">A double-blind, delayed-start trial of rasagiline in Parkinson's disease (the ADAGIO study): prespecified and post-hoc analyses of the need for additional therapies, changes in UPDRS scores, and non-motor outcomes.</title>
<author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name>
<affiliation><nlm:affiliation>Department of Clinical Pharmacology, Faculty of Medicine, Toulouse, France. rascol@cict.fr</nlm:affiliation>
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<author><name sortKey="Fitzer Attas, Cheryl J" sort="Fitzer Attas, Cheryl J" uniqKey="Fitzer Attas C" first="Cheryl" last="Fitzer">Cheryl. Fitzer</name>
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<author><name sortKey="Hauser, Robert" sort="Hauser, Robert" uniqKey="Hauser R" first="Robert" last="Hauser">Robert Hauser</name>
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<author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name>
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<series><title level="j">The Lancet. Neurology</title>
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<term>Double-Blind Method</term>
<term>Female</term>
<term>Humans</term>
<term>Indans (therapeutic use)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Parkinson Disease (diagnosis)</term>
<term>Parkinson Disease (drug therapy)</term>
<term>Parkinson Disease (epidemiology)</term>
<term>Severity of Illness Index</term>
<term>Time Factors</term>
<term>Treatment Outcome</term>
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<term>Aged, 80 and over</term>
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<term>Humans</term>
<term>Male</term>
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<front><div type="abstract" xml:lang="en">The ADAGIO study investigated whether rasagiline has disease-modifying effects in Parkinson's disease. Rasagiline 1 mg per day, but not 2 mg per day, was shown to be efficacious in the primary analysis. Here, we report additional secondary and post-hoc analyses of the ADAGIO study.</div>
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<pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">21482191</PMID>
<DateCreated><Year>2011</Year>
<Month>04</Month>
<Day>22</Day>
</DateCreated>
<DateCompleted><Year>2011</Year>
<Month>06</Month>
<Day>20</Day>
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<DateRevised><Year>2014</Year>
<Month>08</Month>
<Day>15</Day>
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<JournalIssue CitedMedium="Internet"><Volume>10</Volume>
<Issue>5</Issue>
<PubDate><Year>2011</Year>
<Month>May</Month>
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<Title>The Lancet. Neurology</Title>
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<ArticleTitle>A double-blind, delayed-start trial of rasagiline in Parkinson's disease (the ADAGIO study): prespecified and post-hoc analyses of the need for additional therapies, changes in UPDRS scores, and non-motor outcomes.</ArticleTitle>
<Pagination><MedlinePgn>415-23</MedlinePgn>
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<ELocationID EIdType="doi" ValidYN="Y">10.1016/S1474-4422(11)70073-4</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">The ADAGIO study investigated whether rasagiline has disease-modifying effects in Parkinson's disease. Rasagiline 1 mg per day, but not 2 mg per day, was shown to be efficacious in the primary analysis. Here, we report additional secondary and post-hoc analyses of the ADAGIO study.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">ADAGIO was a placebo-controlled, double-blind, multicentre, delayed-start study, in which 1176 patients with untreated early Parkinson's disease were randomly assigned to receive rasagiline 1 mg or 2 mg per day for 72 weeks (early-start groups) or placebo for 36 weeks followed by rasagiline 1 mg or 2 mg per day for 36 weeks (delayed-start groups). We assessed the need for additional antiparkinsonian therapy and changes in non-motor experiences of daily living and fatigue scales (prespecified outcomes) and changes in unified Parkinson's disease rating scale (UPDRS) scores and subscores in placebo and active groups (post-hoc outcomes). The ADAGIO study is registered with ClinicalTrials.gov, number NCT00256204.</AbstractText>
<AbstractText Label="FINDINGS" NlmCategory="RESULTS">The need for additional antiparkinsonian therapy was reduced with rasagiline 1 mg (25 of 288 [9%] patients) and 2 mg (26 of 293 [9%]) versus placebo (108 of 593 [18%]; odds ratio for 1 mg rasagiline vs placebo 0·41, 95% CI 0·25-0·65, p=0·0002; 2 mg rasagiline vs placebo 0·41, 0·26-0·64, p=0·0001). At week 36, both doses significantly improved UPDRS motor subscores compared with placebo (1 mg rasagiline mean difference -1·88 [SE 0·35]; 2 mg rasagiline -2·18 [0·35]; both p<0·0001) and activities of daily living subscores (ADL; 1 mg rasagiline -0·86 [0·18]; 2 mg rasagiline -0·88 [0·18]; both p<0·0001), and 1 mg rasagiline significantly improved UPDRS mentation subscore (-0·22 [0·08]; p=0·004). At week 72, the only significant difference between early-start and delayed-start groups was for ADL subscore with the 1 mg dose (-0·62 [0·29]; p=0·035). When assessed for the effect on non-motor symptoms at week 36, both doses showed benefits on the Parkinson fatigue scale versus placebo (1 mg rasagiline mean difference -0·14 [SE 0·05], p=0·0032; 2 mg rasagiline -0·19 [0·05], p<0·0001), and the 1 mg dose showed benefits on the scale for non-motor experiences of daily living compared with placebo (mean difference -0·33 [0·17]; p=0·049). The rate of progression of total UPDRS score for patients in the placebo group was 4·3 points [SE 0·3] over 36 weeks, with extrapolation to about 6 units per year. In the placebo group, patients with the lowest quartile of baseline UPDRS scores (≤14; n=160) progressed more slowly than did those with highest scores (>25·5; n=145; mean difference -3·46 [SE 0·77]; p<0·0001).</AbstractText>
<AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">These findings show that rasagiline delayed the need for symptomatic antiparkinsonian drugs and emphasise the contribution of the UPDRS ADL in the response of the rasagiline 1 mg per day early-start versus delayed-start group. The rate of UPDRS deterioration was less than was anticipated from previous studies and correlated with baseline severity. Understanding of the pattern of UPDRS deterioration is essential to assess disease modification.</AbstractText>
<AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Teva Pharmaceutical Industries and H Lundbeck A/S.</AbstractText>
<CopyrightInformation>Copyright © 2011 Elsevier Ltd. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Rascol</LastName>
<ForeName>Olivier</ForeName>
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<Author ValidYN="Y"><LastName>Langston</LastName>
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<Author ValidYN="Y"><LastName>Melamed</LastName>
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<Author ValidYN="Y"><LastName>Tolosa</LastName>
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