Markers of bone and lipid metabolism with eslicarbazepine acetate monotherapy

Mintzer, Scott; Constantino, Tawnya; Gidal, Barry E.; Bhargava, Parul; Grinnell, Todd; Blum, David

doi:10.1016/j.eplepsyres.2019.106216

Cited by 3 publications

(8 citation statements)

References 19 publications

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“…Nevertheless, the results are consistent with those of previous studies. 6,[19][20][21]24 Since the sample size was small, it was not possible to conduct meaningful analyses of mean changes in lipid parameters, due to high variability in the TherapeuTic advances in neurological disorders Volume 16…”

Section: Discussionmentioning

confidence: 99%

“…10 The findings of the current study are consistent with previous reports. 6,[19][20][21]24 A single-center, observational, retrospective cohort study assessed the effects of ESL on lipid metabolism in 108 patients (without having newly diagnosed focal seizures, and including patients with add-on ASMs) over a median duration of 23.1 months (range 3-41 months), and, in the overall population, mean total cholesterol levels decreased significantly during follow-up, changing from previous increased levels (>200 mg/dL) to normal levels (<200 mg/dL) during treatment. 20 The proportion of patients with hypercholesterolemia also decreased during ESL treatment, although this change was not statistically significant.…”

Section: Discussionmentioning

confidence: 99%

“… 6 In a similar post hoc analysis of pooled data from two phase III conversion to ESL monotherapy studies, lipid parameters were assessed at baseline, Week 18, and Month 12, and analyzed in terms of the use of enzyme-inducing ASMs at baseline. 24 The most frequently used enzyme-inducing ASMs were CBZ (77%) and phenytoin (24%). 24 Patients converting from enzyme-inducing ASMs had higher levels of total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides at baseline, compared with those converting from non-enzyme-inducing ASMs (significantly higher for total cholesterol and HDL cholesterol).…”

Section: Discussionmentioning

confidence: 99%

“… 24 The most frequently used enzyme-inducing ASMs were CBZ (77%) and phenytoin (24%). 24 Patients converting from enzyme-inducing ASMs had higher levels of total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides at baseline, compared with those converting from non-enzyme-inducing ASMs (significantly higher for total cholesterol and HDL cholesterol). 24 After converting to ESL monotherapy, plasma levels of total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides decreased in patients converting from enzyme-inducing ASMs and increased in those converting from non-enzyme-inducing ASMs, reaching very similar values that were intermediate between the baseline values for the subgroups of patients converting from enzyme-inducing and non-enzyme-inducing ASMs.…”

Section: Discussionmentioning

confidence: 99%

“…19 In comparison, ESL is a less potent enzyme inducer than CBZ, and patients who have switched from CBZ to ESL have experienced improvements in lipid parameters. 6,[19][20][21][22][23][24][25][26] This post hoc analysis evaluated changes in plasma lipid parameters for patients treated with ESL or CBZ-CR monotherapy during a randomized DB trial comparing CBZ-CR with ESL for newly diagnosed epilepsy, 3 and during the following 2 consecutive years of ESL treatment in an openlabel extension (OLE) study. 27…”

Section: Introductionmentioning

confidence: 99%

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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

Trinka,

Rocamora,

Chaves

et al. 2023

Ther Adv Neurol Disord

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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.

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