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.
Abstract | BACKGROUND: 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. FINDINGS: 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. INTERPRETATION:
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Authors | O Rascol, D J Brooks, E Melamed, W Oertel, W Poewe, F Stocchi, E Tolosa, LARGO study group |
Journal | Lancet (London, England)
(Lancet)
2005 Mar 12-18
Vol. 365
Issue 9463
Pg. 947-54
ISSN: 1474-547X [Electronic] England |
PMID | 15766996
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antiparkinson Agents
- Catechol O-Methyltransferase Inhibitors
- Catechols
- Enzyme Inhibitors
- Indans
- Monoamine Oxidase Inhibitors
- Nitriles
- rasagiline
- Levodopa
- entacapone
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Topics |
- Administration, Oral
- Aged
- Antiparkinson Agents
(administration & dosage, adverse effects)
- Catechol O-Methyltransferase Inhibitors
- Catechols
(administration & dosage, adverse effects)
- Double-Blind Method
- Drug Administration Schedule
- Drug Therapy, Combination
- Dyskinesia, Drug-Induced
(etiology, prevention & control)
- Enzyme Inhibitors
(administration & dosage, adverse effects)
- Humans
- Indans
(administration & dosage, adverse effects)
- Levodopa
(administration & dosage, adverse effects)
- Monoamine Oxidase Inhibitors
(administration & dosage, adverse effects)
- Nitriles
- Parkinson Disease
(drug therapy)
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