Efficacy and safety of entacapone in Parkinson's disease patients with suboptimal Levodopa response: a 6-month randomized placebo-controlled double-blind study in Germany and Austria (Celomen study).
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| Title: | Efficacy and safety of entacapone in Parkinson's disease patients with suboptimal Levodopa response: a 6-month randomized placebo-controlled double-blind study in Germany and Austria (Celomen study). |
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| Authors: | Poewe, W. H, Deuschl, G, Gordin, A, Kultalahti, E.-R, Leinonen, M |
| Source: | Acta Neurologica Scandinavica. Apr2002, Vol. 105 Issue 4, p245-255. 11p. 1 Diagram, 5 Charts, 5 Graphs. |
| Subjects: | Methyltransferases, Entacapone, Parkinson's disease, Chemical inhibitors |
| Geographic Terms: | Europe |
| Abstract: | Objectives – To determine the efficacy and safety of the catechol-O -methyltransferase (COMT) inhibitor entacapone, used as an adjunct to levodopa, in Parkinson's disease (PD) patients. Patients and methods – In this parallel group, randomized, double-blind study, 301 PD patients, the majority with motor fluctuations, received entacapone (200 mg) or placebo with each daily dose of standard or controlled-release (CR) levodopa. The 24-week treatment period was followed by 2 weeks of entacapone withdrawal. Efficacy was determined by home diaries (`on' and `off' times), Unified Parkinson's Disease Rating Scale (UPDRS) and changes in levodopa dosage, and safety by adverse-event inquiry, vital signs, electro cardiography (ECG) and laboratory tests. Results – In the total population, the UPDRS activities of daily living and motor scores were significantly improved (P < 0.05) by entacapone vs placebo. In fluctuating patients, `on' time increased (1.7 h) and `off' time decreased (1.5 h) significantly more with entacapone than with placebo (0.5 and 0.6 h, respectively; P < 0.05), and the daily levodopa dose was reduced by 54 mg with entacapone and increased by 27 mg with placebo (P < 0.05). Entacapone benefit was lost on withdrawal. Entacapone efficacy was comparable between patients using CR and standard levodopa preparations. Increased dyskinesias (entacapone 34%, placebo 26%) and nausea (10 and 5%, respectively), mostly occurring shortly after treatment initiation, were generally managed by reducing the levodopa dose. Diarrhoea (entacapone 8%, placebo 4%) was seldom severe. There were no differences in vital signs, ECG or laboratory results. Conclusion – Entacapone is an effective and safe levodopa extender and enhancer, improving the symptomatic efficacy of levodopa in PD and adding to the patients' benefit. [ABSTRACT FROM AUTHOR] |
| Copyright of Acta Neurologica Scandinavica is the property of Wiley-Blackwell 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. (Copyright applies to all Abstracts.) | |
| 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: 6439749 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Efficacy and safety of entacapone in Parkinson's disease patients with suboptimal Levodopa response: a 6-month randomized placebo-controlled double-blind study in Germany and Austria (Celomen study). – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Poewe%2C+W%2E+H%22">Poewe, W. H</searchLink><br /><searchLink fieldCode="AR" term="%22Deuschl%2C+G%22">Deuschl, G</searchLink><br /><searchLink fieldCode="AR" term="%22Gordin%2C+A%22">Gordin, A</searchLink><br /><searchLink fieldCode="AR" term="%22Kultalahti%2C+E%2E-R%22">Kultalahti, E.-R</searchLink><br /><searchLink fieldCode="AR" term="%22Leinonen%2C+M%22">Leinonen, M</searchLink> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Acta+Neurologica+Scandinavica%22">Acta Neurologica Scandinavica</searchLink>. Apr2002, Vol. 105 Issue 4, p245-255. 11p. 1 Diagram, 5 Charts, 5 Graphs. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22Methyltransferases%22">Methyltransferases</searchLink><br /><searchLink fieldCode="DE" term="%22Entacapone%22">Entacapone</searchLink><br /><searchLink fieldCode="DE" term="%22Parkinson's+disease%22">Parkinson's disease</searchLink><br /><searchLink fieldCode="DE" term="%22Chemical+inhibitors%22">Chemical inhibitors</searchLink> – Name: SubjectGeographic Label: Geographic Terms Group: Su Data: <searchLink fieldCode="DE" term="%22Europe%22">Europe</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Objectives – To determine the efficacy and safety of the catechol-O -methyltransferase (COMT) inhibitor entacapone, used as an adjunct to levodopa, in Parkinson's disease (PD) patients. Patients and methods – In this parallel group, randomized, double-blind study, 301 PD patients, the majority with motor fluctuations, received entacapone (200 mg) or placebo with each daily dose of standard or controlled-release (CR) levodopa. The 24-week treatment period was followed by 2 weeks of entacapone withdrawal. Efficacy was determined by home diaries (`on' and `off' times), Unified Parkinson's Disease Rating Scale (UPDRS) and changes in levodopa dosage, and safety by adverse-event inquiry, vital signs, electro cardiography (ECG) and laboratory tests. Results – In the total population, the UPDRS activities of daily living and motor scores were significantly improved (P < 0.05) by entacapone vs placebo. In fluctuating patients, `on' time increased (1.7 h) and `off' time decreased (1.5 h) significantly more with entacapone than with placebo (0.5 and 0.6 h, respectively; P < 0.05), and the daily levodopa dose was reduced by 54 mg with entacapone and increased by 27 mg with placebo (P < 0.05). Entacapone benefit was lost on withdrawal. Entacapone efficacy was comparable between patients using CR and standard levodopa preparations. Increased dyskinesias (entacapone 34%, placebo 26%) and nausea (10 and 5%, respectively), mostly occurring shortly after treatment initiation, were generally managed by reducing the levodopa dose. Diarrhoea (entacapone 8%, placebo 4%) was seldom severe. There were no differences in vital signs, ECG or laboratory results. Conclusion – Entacapone is an effective and safe levodopa extender and enhancer, improving the symptomatic efficacy of levodopa in PD and adding to the patients' benefit. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Acta Neurologica Scandinavica is the property of Wiley-Blackwell 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: 10.1034/j.1600-0404.2002.1o174.x Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 11 StartPage: 245 Subjects: – SubjectFull: Methyltransferases Type: general – SubjectFull: Entacapone Type: general – SubjectFull: Parkinson's disease Type: general – SubjectFull: Chemical inhibitors Type: general – SubjectFull: Europe Type: general Titles: – TitleFull: Efficacy and safety of entacapone in Parkinson's disease patients with suboptimal Levodopa response: a 6-month randomized placebo-controlled double-blind study in Germany and Austria (Celomen study). Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Poewe, W. H – PersonEntity: Name: NameFull: Deuschl, G – PersonEntity: Name: NameFull: Gordin, A – PersonEntity: Name: NameFull: Kultalahti, E.-R – PersonEntity: Name: NameFull: Leinonen, M IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 04 Text: Apr2002 Type: published Y: 2002 Identifiers: – Type: issn-print Value: 00016314 Numbering: – Type: volume Value: 105 – Type: issue Value: 4 Titles: – TitleFull: Acta Neurologica Scandinavica Type: main |
| ResultId | 1 |
