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.
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| Title: | 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. |
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| Authors: | Rascol, O, Brooks, D.J., Melamed, E., Oertel, W., Poewe, W., Stocchi, F., Tolosa, E. |
| Source: | Lancet. 3/12/2005, Vol. 365 Issue 9463, p947-954. 8p. 1 Diagram, 4 Charts, 3 Graphs. |
| Subjects: | Parkinson's disease, Dopa, Phenylalanine, Catecholamines, Brain diseases, Monoamine oxidase, Amine oxidase |
| Abstract: | 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. 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 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. [ABSTRACT FROM AUTHOR] |
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| Database: | Psychology and Behavioral Sciences Collection |
| FullText | Links: – Type: pdflink Text: Availability: 0 |
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| Header | DbId: pbh DbLabel: Psychology and Behavioral Sciences Collection An: 16373305 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: 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. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Rascol%2C+O%22">Rascol, O</searchLink><br /><searchLink fieldCode="AR" term="%22Brooks%2C+D%2EJ%2E%22">Brooks, D.J.</searchLink><br /><searchLink fieldCode="AR" term="%22Melamed%2C+E%2E%22">Melamed, E.</searchLink><br /><searchLink fieldCode="AR" term="%22Oertel%2C+W%2E%22">Oertel, W.</searchLink><br /><searchLink fieldCode="AR" term="%22Poewe%2C+W%2E%22">Poewe, W.</searchLink><br /><searchLink fieldCode="AR" term="%22Stocchi%2C+F%2E%22">Stocchi, F.</searchLink><br /><searchLink fieldCode="AR" term="%22Tolosa%2C+E%2E%22">Tolosa, E.</searchLink> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Lancet%22">Lancet</searchLink>. 3/12/2005, Vol. 365 Issue 9463, p947-954. 8p. 1 Diagram, 4 Charts, 3 Graphs. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22Parkinson's+disease%22">Parkinson's disease</searchLink><br /><searchLink fieldCode="DE" term="%22Dopa%22">Dopa</searchLink><br /><searchLink fieldCode="DE" term="%22Phenylalanine%22">Phenylalanine</searchLink><br /><searchLink fieldCode="DE" term="%22Catecholamines%22">Catecholamines</searchLink><br /><searchLink fieldCode="DE" term="%22Brain+diseases%22">Brain diseases</searchLink><br /><searchLink fieldCode="DE" term="%22Monoamine+oxidase%22">Monoamine oxidase</searchLink><br /><searchLink fieldCode="DE" term="%22Amine+oxidase%22">Amine oxidase</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: 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. 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 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. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Lancet is the property of Lancet and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1016/S0140-6736(05)71083-7 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 8 StartPage: 947 Subjects: – SubjectFull: Parkinson's disease Type: general – SubjectFull: Dopa Type: general – SubjectFull: Phenylalanine Type: general – SubjectFull: Catecholamines Type: general – SubjectFull: Brain diseases Type: general – SubjectFull: Monoamine oxidase Type: general – SubjectFull: Amine oxidase Type: general Titles: – TitleFull: 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. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Rascol, O – PersonEntity: Name: NameFull: Brooks, D.J. – PersonEntity: Name: NameFull: Melamed, E. – PersonEntity: Name: NameFull: Oertel, W. – PersonEntity: Name: NameFull: Poewe, W. – PersonEntity: Name: NameFull: Stocchi, F. – PersonEntity: Name: NameFull: Tolosa, E. IsPartOfRelationships: – BibEntity: Dates: – D: 12 M: 03 Text: 3/12/2005 Type: published Y: 2005 Identifiers: – Type: issn-print Value: 01406736 Numbering: – Type: volume Value: 365 – Type: issue Value: 9463 Titles: – TitleFull: Lancet Type: main |
| ResultId | 1 |
