Abstracts

Rationale: Cognitive dysfunction is frequently observed in patients with epilepsy and represents an important challenge in the management of patients with this disorder.¹ In this respect, the contribution of antiepileptic drugs (AEDs) is of relevance, and studies in healthy volunteers have shown that AEDs produce cognitive effects.^1,2 Eslicarbazepine acetate (ESL) is a novel AED currently in development in the US as adjunct treatment for partial-onset seizures.Methods: 797 subjects in the safety population were studied. Investigators recorded adverse events at each visit from Visit 1 and throughout the study (including at early discontinuation and at the post study visit). A Treatment Emergent Adverse Events (TEAE) was defined as an event that occurred on or after the date of first dose, or the date of randomization if the dates of the first dose or the onset of the event were missing or incomplete. All TEAEs affecting any aspect of cognition were tabulated.Results: The incidence of cognitive TEAEs in the integrated analysis is presented by dose group in Table 1. Identified events were attention, memory impairment, amnesia, aphasia, bradyphrenia, and psychomotor retardation. The incidence of these cognitive TEAEs was low in all ESL dose groups, with the highest incidence occurring in the ESL 1200 mg group (Table 1).Conclusions: Conclusions: In this analysis, treatment with eslicarbazepine acetate as adjunct therapy to 1 to 3 concomitant AEDs produced a low incidence of cognitive TEAEs.Studies supported by BIAL-Portela; analysis by Sunovion. Reference: 1. Mula M, et al. Antiepileptic drug-induced cognitive adverse effects. CNS Drugs. 2009;23:121-137. 2. Meador KJ. Cognitive and memory effects of the new antiepileptic drugs. Epilepsy Research. 2006;68:63-67.