Lipid profile with eslicarbazepine acetate and carbamazepine monotherapy in adult patients with newly diagnosed focal seizures: post hoc analysis of a phase III trial and open-label extension study

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• dc.contributor.author Trinka, Eugen
• dc.contributor.author Rocamora Zúñiga, Rodrigo Alberto
• dc.contributor.author Chaves, João
• dc.contributor.author Koepp, Mathias J.
• dc.contributor.author Rüegg, Stephan
• dc.contributor.author Holtkamp, Martin
• dc.contributor.author Moreira, Joana
• dc.contributor.author Fonseca, Miguel M.
• dc.contributor.author Castilla-Fernández, Guillermo
• dc.contributor.author Ikedo, Fábio
• dc.date.accessioned 2025-07-21T06:00:56Z
• dc.date.available 2025-07-21T06:00:56Z
• dc.date.issued 2023
• dc.description.abstract Background: Antiseizure medications can have negative effects on plasma lipid levels. Objectives: To evaluate plasma lipid changes in patients with newly diagnosed focal epilepsy treated with eslicarbazepine acetate (ESL) or controlled-release carbamazepine (CBZ-CR) monotherapy during a phase III, randomized, double-blind (DB) trial and 2 years of ESL treatment in an open-label extension (OLE). Design: Post hoc analysis of a phase III trial and OLE study. Methods: Proportions of patients with elevated levels of total cholesterol and low-density lipoprotein (LDL) cholesterol were assessed at DB baseline, OLE baseline (last visit of DB trial), and end of OLE. Results: A total of 184 patients received ESL monotherapy during the OLE: 96 received ESL monotherapy in the DB trial and 88 patients received CBZ-CR monotherapy. The proportions of patients with elevated total cholesterol and LDL cholesterol increased significantly during the DB trial in those treated with CBZ-CR monotherapy [total cholesterol, +14.9% (p < 0.001); LDL cholesterol, +11.5% (p = 0.012)] but decreased significantly after switching to ESL monotherapy in the OLE [total cholesterol, -15.3% (p = 0.008); LDL cholesterol, -11.1% (p = 0.021)]. No significant changes were observed in those treated with ESL monotherapy during the DB trial and OLE. At the end of the DB trial, between-group differences (ESL-CBZ-CR) in the proportions of patients with elevated total and LDL cholesterol were -13.6% (p = 0.037) and -12.3% (p = 0.061), respectively; at the end of the OLE, these between-group differences were -6.0% (p = 0.360) and -0.6% (p = 1.000), respectively. Conclusion: A lower proportion of patients with newly diagnosed focal epilepsy had increased levels of total and LDL cholesterol, compared to baseline, following monotherapy with ESL versus CBZ-CR; after switching from CBZ-CR to ESL, the proportions of patients with increased levels decreased significantly. Registration: ClinicalTrials.gov NCT01162460/NCT02484001; EudraCT 2009-011135-13/2015-001243-36.
• dc.format.mimetype application/pdf
• dc.identifier.citation Trinka E, Rocamora R, Chaves J, Koepp MJ, Rüegg S, Holtkamp M, et al. Lipid profile with eslicarbazepine acetate and carbamazepine monotherapy in adult patients with newly diagnosed focal seizures: post hoc analysis of a phase III trial and open-label extension study. Ther Adv Neurol Disord. 2023 Sep 4;16:17562864231193530. DOI: 10.1177/17562864231193530
• dc.identifier.doi http://dx.doi.org/10.1177/17562864231193530
• dc.identifier.issn 1756-2856
• dc.identifier.uri http://hdl.handle.net/10230/70956
• dc.language.iso eng
• dc.publisher SAGE Publications
• dc.relation.ispartof Ther Adv Neurol Disord. 2023 Sep 4;16:17562864231193530
• dc.rights © The Author(s), 2023. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by-nc/4.0/
• dc.subject.keyword Cardiovascular risk
• dc.subject.keyword Cholesterol
• dc.subject.keyword Focal epilepsy
• dc.subject.keyword Focal seizures
• dc.subject.keyword Hypercholesterolemia
• dc.subject.keyword Lipid parameters
• dc.subject.keyword Triglycerides
• dc.title Lipid profile with eslicarbazepine acetate and carbamazepine monotherapy in adult patients with newly diagnosed focal seizures: post hoc analysis of a phase III trial and open-label extension study
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion