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The Added Benefit of Opicapone When Used Early in Parkinson's Disease Patients With Levodopa-Induced Motor Fluctuations: A Post-hoc Analysis of BIPARK-I and -II
Introduction: Opicapone (OPC) was efficacious in reducing OFF-time in two pivotal trials in patients with Parkinson's disease (PD) and end-of-dose motor fluctuations (BIPARK-I and -II). Post-hoc analyses of these trials evaluated the efficacy of OPC following pre-defined segmentation of the wid...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Frontiers Media S.A.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8603564/ https://www.ncbi.nlm.nih.gov/pubmed/34803891 http://dx.doi.org/10.3389/fneur.2021.754016 |
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author | Rocha, José-Francisco Ebersbach, Georg Lees, Andrew Tolosa, Eduardo Ferreira, Joaquim J. Poewe, Werner Rascol, Olivier Stocchi, Fabrizio Antonini, Angelo Magalhães, Diogo Gama, Helena Soares-da-Silva, Patrício |
author_facet | Rocha, José-Francisco Ebersbach, Georg Lees, Andrew Tolosa, Eduardo Ferreira, Joaquim J. Poewe, Werner Rascol, Olivier Stocchi, Fabrizio Antonini, Angelo Magalhães, Diogo Gama, Helena Soares-da-Silva, Patrício |
author_sort | Rocha, José-Francisco |
collection | PubMed |
description | Introduction: Opicapone (OPC) was efficacious in reducing OFF-time in two pivotal trials in patients with Parkinson's disease (PD) and end-of-dose motor fluctuations (BIPARK-I and -II). Post-hoc analyses of these trials evaluated the efficacy of OPC following pre-defined segmentation of the wide spectrum of motor fluctuations in PD. Methods: Data from matching treatment arms in BIPARK-I and -II were combined for the placebo (PLC) and OPC 50-mg groups, and exploratory post-hoc analyses were performed to investigate the efficacy of OPC 50 mg vs. PLC in subgroups of patients who were in “earlier” vs. “later” stages of both their disease course (e.g., duration of PD <6 years vs. ≥6 years) and levodopa treatment pathway (e.g., number of daily levodopa intakes <4 vs. ≥4). Efficacy variables included changes from baseline in absolute OFF-time and total ON-time. Results: The Full Analysis Set included 517 patients (PLC, n = 255; OPC 50 mg, n = 262). OPC 50 mg was significantly more effective than PLC in reducing OFF-time and increasing ON-time in the majority of subgroup analyses (p < 0.05). Moreover, patients in “earlier” stages of both their disease course and levodopa treatment pathway experienced numerically greater efficacy when using OPC 50 mg, in comparison with those in “later” stages. Conclusion: OPC 50 mg was efficacious over the whole trajectory of motor fluctuation evolution in PD patients. There was also a signal for enhanced efficacy in patients who were earlier vs. later in their disease course and levodopa treatment pathway. |
format | Online Article Text |
id | pubmed-8603564 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-86035642021-11-20 The Added Benefit of Opicapone When Used Early in Parkinson's Disease Patients With Levodopa-Induced Motor Fluctuations: A Post-hoc Analysis of BIPARK-I and -II Rocha, José-Francisco Ebersbach, Georg Lees, Andrew Tolosa, Eduardo Ferreira, Joaquim J. Poewe, Werner Rascol, Olivier Stocchi, Fabrizio Antonini, Angelo Magalhães, Diogo Gama, Helena Soares-da-Silva, Patrício Front Neurol Neurology Introduction: Opicapone (OPC) was efficacious in reducing OFF-time in two pivotal trials in patients with Parkinson's disease (PD) and end-of-dose motor fluctuations (BIPARK-I and -II). Post-hoc analyses of these trials evaluated the efficacy of OPC following pre-defined segmentation of the wide spectrum of motor fluctuations in PD. Methods: Data from matching treatment arms in BIPARK-I and -II were combined for the placebo (PLC) and OPC 50-mg groups, and exploratory post-hoc analyses were performed to investigate the efficacy of OPC 50 mg vs. PLC in subgroups of patients who were in “earlier” vs. “later” stages of both their disease course (e.g., duration of PD <6 years vs. ≥6 years) and levodopa treatment pathway (e.g., number of daily levodopa intakes <4 vs. ≥4). Efficacy variables included changes from baseline in absolute OFF-time and total ON-time. Results: The Full Analysis Set included 517 patients (PLC, n = 255; OPC 50 mg, n = 262). OPC 50 mg was significantly more effective than PLC in reducing OFF-time and increasing ON-time in the majority of subgroup analyses (p < 0.05). Moreover, patients in “earlier” stages of both their disease course and levodopa treatment pathway experienced numerically greater efficacy when using OPC 50 mg, in comparison with those in “later” stages. Conclusion: OPC 50 mg was efficacious over the whole trajectory of motor fluctuation evolution in PD patients. There was also a signal for enhanced efficacy in patients who were earlier vs. later in their disease course and levodopa treatment pathway. Frontiers Media S.A. 2021-11-05 /pmc/articles/PMC8603564/ /pubmed/34803891 http://dx.doi.org/10.3389/fneur.2021.754016 Text en Copyright © 2021 Rocha, Ebersbach, Lees, Tolosa, Ferreira, Poewe, Rascol, Stocchi, Antonini, Magalhães, Gama and Soares-da-Silva. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Neurology Rocha, José-Francisco Ebersbach, Georg Lees, Andrew Tolosa, Eduardo Ferreira, Joaquim J. Poewe, Werner Rascol, Olivier Stocchi, Fabrizio Antonini, Angelo Magalhães, Diogo Gama, Helena Soares-da-Silva, Patrício The Added Benefit of Opicapone When Used Early in Parkinson's Disease Patients With Levodopa-Induced Motor Fluctuations: A Post-hoc Analysis of BIPARK-I and -II |
title | The Added Benefit of Opicapone When Used Early in Parkinson's Disease Patients With Levodopa-Induced Motor Fluctuations: A Post-hoc Analysis of BIPARK-I and -II |
title_full | The Added Benefit of Opicapone When Used Early in Parkinson's Disease Patients With Levodopa-Induced Motor Fluctuations: A Post-hoc Analysis of BIPARK-I and -II |
title_fullStr | The Added Benefit of Opicapone When Used Early in Parkinson's Disease Patients With Levodopa-Induced Motor Fluctuations: A Post-hoc Analysis of BIPARK-I and -II |
title_full_unstemmed | The Added Benefit of Opicapone When Used Early in Parkinson's Disease Patients With Levodopa-Induced Motor Fluctuations: A Post-hoc Analysis of BIPARK-I and -II |
title_short | The Added Benefit of Opicapone When Used Early in Parkinson's Disease Patients With Levodopa-Induced Motor Fluctuations: A Post-hoc Analysis of BIPARK-I and -II |
title_sort | added benefit of opicapone when used early in parkinson's disease patients with levodopa-induced motor fluctuations: a post-hoc analysis of bipark-i and -ii |
topic | Neurology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8603564/ https://www.ncbi.nlm.nih.gov/pubmed/34803891 http://dx.doi.org/10.3389/fneur.2021.754016 |
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