Eslicarbazepine acetate (Aptiom, Zebinix) – Bial – Portela

• Objective: To evaluate the lipid changes in adult patients with newly diagnosed focal-onset seizures (FOS) treated during double-blind study with eslicarbazepine acetate (ESL) or controlled-release carbamazepine (CBZ-CR) monotherapy, and after a 2-year open-label extension study of ESL
• Trial details: Post-hoc analysis; Phase 3 in focal-onset seizures; N= 184; eslicarbazepine acetate (n=96) with controlled-release carbamazepine (n=88) for a 26-week period. Patients completing this study continued into a 2-year OLE, where all received ESL (800–1600 mg/day)
• Results: N= 184; ESL (n=96) with CBZ-CR (n=88) for a 26-week period
  • Proportion of CBZ-CR patients with high Low density lipoproteins (LDL) and total cholesterol (TC) – 11.54%(p=0.0124) and 14.94% (p=0.0008), respectively
  • ESL treatment 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 -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 double blind phase

• • • Proportion of patients with high LDL and TC levels between treatments for ESL – (-12.31%, p=0.061 and -1364%, p=0.037 difference in proportions respectively)
    • No significant differences between treatment were observed at baseline (Fisher´s test)

• Conclusion:
  • Switching from CBZ-CR to ESL showed improvement for TC and LDL. Eslicarbazepine acetate could be an option for patients with hypercholesterolemia