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.

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.
Competing Interests: ET reports personal fees from EVER Pharma, Marinus, Arvelle, Angelini, Argenx, Medtronic, Bial-Portela & Cª, NewBridge, GL Pharma, GlaxoSmithKline, Boehringer Ingelheim, LivaNova, Eisai, UCB, Biogen, Sanofi, Jazz Pharmaceuticals, and Actavis. His institution received grants from Biogen, UCB Pharma, Eisai, Red Bull, Merck, Bayer, the European Union, FWF Osterreichischer Fond zur Wissenschaftsforderung, Bundesministerium für Wissenschaft und Forschung, and Jubiläumsfond der Österreichischen Nationalbank. RR is a consultant for Eisai, Bial, UCB, GlaxoSmithKline and Shire, and receives grant and research support from Bial, Eisai, and UCB. JC has received speaker’s honoraria and/or consultancy fees from Bial and Eisai and was granted with a Tecnifar Bursary. MJK reports personal fees as speaker or consultant from Arvelle, BIAL, Eisai, GW Pharmaceuticals, Novartis and UCB Pharma. He holds stocks for Prevep. MJK or his institution received grants from UCB Pharma, Eisai, Arvelle/Angelini, the European Union, Wellcome Trust and Medical Research Council. SR received unconditional research grants from UCB-pharma, honoraria from serving on the scientific advisory boards of Arvelle/Angelini, Bial, Eisai, GW/Jazz Pharmaceuticals, and UCB Pharma, and from serving as a consultant for Arvelle/Angelini, Eisai, Jazz Pharmaceuticals, Pfizer, Novartis, Sandoz, and UCB Pharma. He does not hold any stocks of any pharmaceutical industries or manufacturers of medical devices. He received funding from UCB Pharma, and the Swiss National Science Foundation. MH received speaker’s honoraria and/or consultancy fees from Angelini/Arvelle, Bial, Desitin, Eisai, GW Pharmaceuticals/Jazz, Neuraxpharm, UCB, and Zogenix with the last 3 years. JM, MMF and GCF are current employees of Bial – Portela & Cª, S.A. FI was an employee of Bial – Portela & Cª, S.A. at the time this study was conducted but is currently employed at Neuroscience Clinical Development, Biopharmaceuticals R&D, AstraZeneca, Cambridge, UK.
(© The Author(s), 2023.)