Rasagiline as an adjunct to levodopa in patients with Parkinson's disease and motor fluctuations (LARGO, Lasting effect in Adjunct therapy with Rasagiline Given Once daily, study): a randomised, double-blind, parallel-group trial.
Identifieur interne : 000506 ( Ncbi/Merge ); précédent : 000505; suivant : 000507Rasagiline as an adjunct to levodopa in patients with Parkinson's disease and motor fluctuations (LARGO, Lasting effect in Adjunct therapy with Rasagiline Given Once daily, study): a randomised, double-blind, parallel-group trial.
Auteurs : O. Rascol [France] ; D J Brooks ; E. Melamed ; W. Oertel ; Werner Poewe ; F. Stocchi ; E. TolosaSource :
- Lancet (London, England) [ 1474-547X ]
English descriptors
- KwdEn :
- Administration, Oral, Aged, Antiparkinson Agents (administration & dosage), Antiparkinson Agents (adverse effects), Catechol O-Methyltransferase Inhibitors, Catechols (administration & dosage), Catechols (adverse effects), Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Dyskinesia, Drug-Induced (etiology), Dyskinesia, Drug-Induced (prevention & control), Enzyme Inhibitors (administration & dosage), Enzyme Inhibitors (adverse effects), Humans, Indans (administration & dosage), Indans (adverse effects), Levodopa (administration & dosage), Levodopa (adverse effects), Monoamine Oxidase Inhibitors (administration & dosage), Monoamine Oxidase Inhibitors (adverse effects), Nitriles, Parkinson Disease (drug therapy).
- MESH :
- chemical , administration & dosage : Antiparkinson Agents, Catechols, Enzyme Inhibitors, Indans, Levodopa, Monoamine Oxidase Inhibitors.
- chemical , adverse effects : Antiparkinson Agents, Catechols, Enzyme Inhibitors, Indans, Levodopa, Monoamine Oxidase Inhibitors.
- drug therapy : Parkinson Disease.
- etiology : Dyskinesia, Drug-Induced.
- prevention & control : Dyskinesia, Drug-Induced.
- Administration, Oral, Aged, Catechol O-Methyltransferase Inhibitors, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Humans, Nitriles.
Abstract
Rasagiline mesylate is a novel drug for Parkinson's disease with selective, irreversible monoamine oxidase B (MAO-B) inhibitor activity, and is effective as monotherapy in early disease. This study investigated rasagiline efficacy and safety in levodopa-treated patients with Parkinson's disease and motor fluctuations.
DOI: 10.1016/S0140-6736(05)71083-7
PubMed: 15766996
Links toward previous steps (curation, corpus...)
- to stream PubMed, to step Corpus: 000F59
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- to stream PubMed, to step Checkpoint: 000F19
Links to Exploration step
pubmed:15766996Le document en format XML
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<term>Catechol O-Methyltransferase Inhibitors</term>
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<front><div type="abstract" xml:lang="en">Rasagiline mesylate is a novel drug for Parkinson's disease with selective, irreversible monoamine oxidase B (MAO-B) inhibitor activity, and is effective as monotherapy in early disease. This study investigated rasagiline efficacy and safety in levodopa-treated patients with Parkinson's disease and motor fluctuations.</div>
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<Month>03</Month>
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<Day>08</Day>
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<Day>16</Day>
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<Issue>9463</Issue>
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<ArticleTitle>Rasagiline as an adjunct to levodopa in patients with Parkinson's disease and motor fluctuations (LARGO, Lasting effect in Adjunct therapy with Rasagiline Given Once daily, study): a randomised, double-blind, parallel-group trial.</ArticleTitle>
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<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Rasagiline mesylate is a novel drug for Parkinson's disease with selective, irreversible monoamine oxidase B (MAO-B) inhibitor activity, and is effective as monotherapy in early disease. This study investigated rasagiline efficacy and safety in levodopa-treated patients with Parkinson's disease and motor fluctuations.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">In an 18-week, double-blind, multicentre (74 hospitals and academic centres in Israel, Argentina, and Europe) trial, 687 outpatients were randomly assigned to oral rasagiline (231 individuals; 1 mg once daily), entacapone (227; 200 mg with every levodopa dose), or placebo (229). Primary outcome was change in total daily off-time (intention-to-treat population). Other measures included the clinical global improvement (CGI) score and unified Parkinson's disease rating scale (UPDRS) scores. Analysis was by intention to treat.</AbstractText>
<AbstractText Label="FINDINGS" NlmCategory="RESULTS">88 (13%) patients who were assigned treatment did not complete the study (23 rasagiline, 30 entacapone, 35 placebo), mainly because of withdrawal of consent (n=34) and adverse events (n=34). Both rasagiline and entacapone reduced mean daily off-time (-1.18 h rasagiline and -1.2 h entacapone vs placebo -0.4 h; p=0.0001, p<0.0001, respectively) and increased daily on-time without troublesome dyskinesia (0.85 h vs placebo 0.03 h; p=0.0005 for both). We recorded significant mean improvements in CGI scores (-0.86 rasagiline and -0.72 entacapone vs -0.37 placebo; p<0.0001, p=0.0002, respectively). Changes in UPDRS scores also significantly improved for activities of daily living during off-time (-1.71 and -1.38 vs placebo; p<0.0001, p=0.0006, respectively) and motor function during on-time (-2.94 and -2.73 vs placebo; both p<0.0001). Frequency of adverse events was similar for all treatments.</AbstractText>
<AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Once-daily rasagiline reduces mean daily off-time and improves symptoms of Parkinson's disease in levodopa-treated patients with motor fluctuations, an effect similar to that of entacapone.</AbstractText>
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