Long‐term efficacy of opicapone in fluctuating Parkinson's disease patients: a pooled analysis of data from two phase 3 clinical trials and their open‐label extensions.
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| Title: | Long‐term efficacy of opicapone in fluctuating Parkinson's disease patients: a pooled analysis of data from two phase 3 clinical trials and their open‐label extensions. |
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| Authors: | Ferreira, J. J., Lees, A., Rocha, J.‐F., Poewe, W., Rascol, O., Soares‐da‐Silva, P. |
| Source: | European Journal of Neurology. Jul2019, Vol. 26 Issue 7, p953-960. 8p. 1 Diagram, 2 Charts, 2 Graphs. |
| Subjects: | Parkinson's disease, Data analysis, Clinical trials |
| Abstract: | Background and purpose: The aim was to evaluate the efficacy of the catechol‐O‐methyltransferase inhibitor opicapone (25 and 50 mg) as adjunct therapy to levodopa in a pooled population of Parkinson's disease patients who participated in the pivotal double‐blind trials of opicapone and their 1‐year open‐label extensions. Methods: Data (placebo, opicapone 25 mg and opicapone 50 mg) from the BIPARK‐1 and BIPARK‐2 double‐blind and open‐label studies were combined. The studies had similar designs, eligibility criteria and assessment methods. The primary efficacy variable in both double‐blind studies was the change from baseline in absolute OFF time based on patient diaries. Results: Double‐blind treatment with opicapone (25 and 50 mg) significantly reduced absolute daily OFF time from a baseline of 6.1–6.6 h. The mean (and 95% confidence interval) treatment effect versus placebo was −35.1 (−62.1, −8.2) min (P = 0.0106) for the 25 mg dose and −58.1 (−84.5, −31.7) min (P < 0.0001) for the 50 mg dose. Reductions in OFF time were mirrored by significant increases in ON time without troublesome dyskinesia (P < 0.05 and P < 0.0001 for the 25 and 50 mg doses, respectively). No significant differences were observed for ON time with troublesome dyskinesia. Patient diary results from the open‐label phase indicated a maintenance of effect for patients previously treated with opicapone 50 mg. The group previously treated with the 25 mg dose benefitted with further optimization of therapy during the open‐label phase, whilst switching from placebo to opicapone led to significant reductions in OFF time and increased ON time. Conclusions: Over at least 1 year of open‐label therapy, opicapone consistently reduced OFF time and increased ON time without increasing the frequency of troublesome dyskinesia. [ABSTRACT FROM AUTHOR] |
| Copyright of European Journal of Neurology 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 |
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| Header | DbId: pbh DbLabel: Psychology and Behavioral Sciences Collection An: 136821635 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Long‐term efficacy of opicapone in fluctuating Parkinson's disease patients: a pooled analysis of data from two phase 3 clinical trials and their open‐label extensions. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Ferreira%2C+J%2E+J%2E%22">Ferreira, J. J.</searchLink><br /><searchLink fieldCode="AR" term="%22Lees%2C+A%2E%22">Lees, A.</searchLink><br /><searchLink fieldCode="AR" term="%22Rocha%2C+J%2E‐F%2E%22">Rocha, J.‐F.</searchLink><br /><searchLink fieldCode="AR" term="%22Poewe%2C+W%2E%22">Poewe, W.</searchLink><br /><searchLink fieldCode="AR" term="%22Rascol%2C+O%2E%22">Rascol, O.</searchLink><br /><searchLink fieldCode="AR" term="%22Soares‐da‐Silva%2C+P%2E%22">Soares‐da‐Silva, P.</searchLink> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22European+Journal+of+Neurology%22">European Journal of Neurology</searchLink>. Jul2019, Vol. 26 Issue 7, p953-960. 8p. 1 Diagram, 2 Charts, 2 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="%22Data+analysis%22">Data analysis</searchLink><br /><searchLink fieldCode="DE" term="%22Clinical+trials%22">Clinical trials</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Background and purpose: The aim was to evaluate the efficacy of the catechol‐O‐methyltransferase inhibitor opicapone (25 and 50 mg) as adjunct therapy to levodopa in a pooled population of Parkinson's disease patients who participated in the pivotal double‐blind trials of opicapone and their 1‐year open‐label extensions. Methods: Data (placebo, opicapone 25 mg and opicapone 50 mg) from the BIPARK‐1 and BIPARK‐2 double‐blind and open‐label studies were combined. The studies had similar designs, eligibility criteria and assessment methods. The primary efficacy variable in both double‐blind studies was the change from baseline in absolute OFF time based on patient diaries. Results: Double‐blind treatment with opicapone (25 and 50 mg) significantly reduced absolute daily OFF time from a baseline of 6.1–6.6 h. The mean (and 95% confidence interval) treatment effect versus placebo was −35.1 (−62.1, −8.2) min (P = 0.0106) for the 25 mg dose and −58.1 (−84.5, −31.7) min (P < 0.0001) for the 50 mg dose. Reductions in OFF time were mirrored by significant increases in ON time without troublesome dyskinesia (P < 0.05 and P < 0.0001 for the 25 and 50 mg doses, respectively). No significant differences were observed for ON time with troublesome dyskinesia. Patient diary results from the open‐label phase indicated a maintenance of effect for patients previously treated with opicapone 50 mg. The group previously treated with the 25 mg dose benefitted with further optimization of therapy during the open‐label phase, whilst switching from placebo to opicapone led to significant reductions in OFF time and increased ON time. Conclusions: Over at least 1 year of open‐label therapy, opicapone consistently reduced OFF time and increased ON time without increasing the frequency of troublesome dyskinesia. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of European Journal of Neurology 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: 10.1111/ene.13914 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 8 StartPage: 953 Subjects: – SubjectFull: Parkinson's disease Type: general – SubjectFull: Data analysis Type: general – SubjectFull: Clinical trials Type: general Titles: – TitleFull: Long‐term efficacy of opicapone in fluctuating Parkinson's disease patients: a pooled analysis of data from two phase 3 clinical trials and their open‐label extensions. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Ferreira, J. J. – PersonEntity: Name: NameFull: Lees, A. – PersonEntity: Name: NameFull: Rocha, J.‐F. – PersonEntity: Name: NameFull: Poewe, W. – PersonEntity: Name: NameFull: Rascol, O. – PersonEntity: Name: NameFull: Soares‐da‐Silva, P. IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 07 Text: Jul2019 Type: published Y: 2019 Identifiers: – Type: issn-print Value: 13515101 Numbering: – Type: volume Value: 26 – Type: issue Value: 7 Titles: – TitleFull: European Journal of Neurology Type: main |
| ResultId | 1 |
