Markers of bone and lipid metabolism with eslicarbazepine acetate monotherapy

Abstract

ObjectiveTo evaluate the impact of eslicarbazepine acetate (ESL) monotherapy on markers of bone and lipid metabolism. MethodsWe 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). ResultsData 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. ConclusionsBased 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.