Markers of bone and lipid metabolism with eslicarbazepine acetate monotherapy

Abstract

Objective: To evaluate the impact of eslicarbazepine acetate (ESL) monotherapy on markers of bone and lipid metabolism.

Methods: We conducted a post-hoc analysis of data pooled from two Phase III, dose-blind, conversion-to-ESL (1600 mg and 1200 mg) monotherapy studies in patients with focal seizures. Laboratory measurements included lipids (total cholesterol [TC]; high-density lipoprotein cholesterol [HDL-C]; low-density lipoprotein cholesterol; and triglycerides) and markers of bone metabolism (alkaline phosphatase; 25-hydroxyvitamin D; osteocalcin; and parathyroid hormone [PTH]); measurements were taken at baseline, Week 18, and Month 12, and analyzed according to enzyme-inducing antiepileptic drugs (EIAEDs) use at baseline (+EIAED and -EIAED subgroups).

Results: Data from 337 treatment-compliant patients were used for the Week 18 analyses (+EIAED subgroup, n = 119; -EIAED subgroup, n = 218); data from 161 treatment-compliant patients were used for the Month 12 analyses (+EIAED subgroup, n = 53; -EIAED subgroup, n = 108). At baseline, alkaline phosphatase and PTH concentrations were higher in the + EIAED versus -EIAED subgroup. Changes from baseline in markers of bone turnover were generally insignificant, except for some elevation in alkaline phosphatase in the -EIAED subgroup (18 weeks and 12 months) and osteocalcin in both subgroups (18 weeks only). Regarding lipids, TC and HDL-C concentrations were higher in the + EIAED versus -EIAED subgroup at baseline. Concentrations of markers of lipid metabolism fell in the + EIAED group and rose in the -EIAED group, reaching very similar values that were intermediate between the -EIAED and + EIAED baseline values.

Conclusions: Based on this retrospective analysis, ESL seems to have had only a modest and primarily clinically insignificant impact on plasma lipids. More prospective data are needed to definitively ascertain the effects of ESL on bone metabolism.

Keywords: Bone metabolism; CYP450; Enzyme-inducing antiepileptic drug; Eslicarbazepine acetate; Focal seizure; Serum lipids.