Evaluate the lipid changes in adult patients with newly diagnosed focal-onset seizures(FOS) treated during double-blind(DB) study with eslicarbazepine acetate (ESL) or controlled-release carbamazepine(CBZ-CR) monotherapy, and after a 2-year open-label extension(OLE) study of ESL.

Post-hoc analysis in 184 newly diagnosed adults with FOS from a phase III, randomized, DB, active-controlled, non-inferiority study comparing ESL(n=96) with CBZ-CR(n=88) for a 26-week period. Patients completing this study continued into a 2-year OLE, where all received ESL (800–1600mg/day). Laboratory parameters assessed prior and after ESL and CBZ-CR were total cholesterol (TC), low (LDL) and high(HDL) density lipoproteins and triglycerides. Multiple comparison within treatment arm used p-values(p) with stringent alpha level (0.027)².

Proportion of CBZ-CR patients with high³ LDL and TC, increased significantly at the end of the DB, 11.54%(p=0.0124) and 14.94%(p=0.0008), respectively, compared to baseline. Patients treated with ESL showed no changes for LDL and 6.52% increase for TC (p=0.1088). Proportion of patients with high LDL and TC switching from CBZ-CR to ESL showed significant reduction, -11.11%(p=0.0209) and -15.28%(p=0.0076), respectively. Patients that continued with ESL in OLE showed no relevant changes(McNemar test).

At the end of DB, the proportion of patients with high LDL and TC levels between treatments was lower for ESL(-12.31%, p=0.061 and -13.64%, p=0.037 difference in proportions respectively). No significant differences between treatment were observed at baseline(Fisher´s test).

HDL and triglycerides had no conclusive changes.

Subpopulation analysis of patients not using concomitant statins showed similar results.

This post-hoc analysis in adult patients with newly diagnosed FOS, is consistent with literature^4,5, showing an increase in LDL and TC levels with CBZ-CR and minimal effect of ESL monotherapy after long-term. Switching from CBZ-CR to ESL showed improvement for TC and LDL, suggesting that ESL could be an option for patients with hypercholesterolemia.