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...
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Frontiers Media S.A.
2021
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oai:doaj.org-article:202fb31b049d40719834b2f73826e9882021-11-05T15:30:31ZThe 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 -II1664-229510.3389/fneur.2021.754016https://doaj.org/article/202fb31b049d40719834b2f73826e9882021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fneur.2021.754016/fullhttps://doaj.org/toc/1664-2295Introduction: 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.José-Francisco RochaGeorg EbersbachAndrew LeesEduardo TolosaJoaquim J. FerreiraWerner PoeweOlivier RascolFabrizio StocchiAngelo AntoniniDiogo MagalhãesHelena GamaPatrício Soares-da-SilvaFrontiers Media S.A.articlecatechol-O-methyltransferase inhibitorlevodopamotor fluctuationsopicaponeParkinson's diseasewearing-offNeurology. Diseases of the nervous systemRC346-429ENFrontiers in Neurology, Vol 12 (2021) |
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catechol-O-methyltransferase inhibitor levodopa motor fluctuations opicapone Parkinson's disease wearing-off Neurology. Diseases of the nervous system RC346-429 |
| spellingShingle |
catechol-O-methyltransferase inhibitor levodopa motor fluctuations opicapone Parkinson's disease wearing-off Neurology. Diseases of the nervous system RC346-429 José-Francisco Rocha Georg Ebersbach Andrew Lees Eduardo Tolosa Joaquim J. Ferreira Werner Poewe Olivier Rascol Fabrizio Stocchi Angelo Antonini Diogo Magalhães Helena Gama Patrício Soares-da-Silva 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 |
| 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 |
article |
| author |
José-Francisco Rocha Georg Ebersbach Andrew Lees Eduardo Tolosa Joaquim J. Ferreira Werner Poewe Olivier Rascol Fabrizio Stocchi Angelo Antonini Diogo Magalhães Helena Gama Patrício Soares-da-Silva |
| author_facet |
José-Francisco Rocha Georg Ebersbach Andrew Lees Eduardo Tolosa Joaquim J. Ferreira Werner Poewe Olivier Rascol Fabrizio Stocchi Angelo Antonini Diogo Magalhães Helena Gama Patrício Soares-da-Silva |
| author_sort |
José-Francisco Rocha |
| 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_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_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_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 |
| publisher |
Frontiers Media S.A. |
| publishDate |
2021 |
| url |
https://doaj.org/article/202fb31b049d40719834b2f73826e988 |
| work_keys_str_mv |
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