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 effects1,2 Eslicarbazepine acetate (ESL) is a novel AED in development. Methods: We analyzed Treatment Emergent Adverse Events (TEAEs) related to cognition in three double-blind Phase III studies in subjects with partial-onset seizures. We studied all subjects (N=1049) who received at least 1 dose of study medication (400 mg, 800 mg, or 1200 mg of ESL or placebo) as adjunctive therapy to 1-3 concomitant AEDs. Investigators recorded AEs at each visit from Visit 1 and throughout the study (including at early discontinuation and at the post study visit). A 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. Cognitive TEAEs were defined as those affecting attention, memory impairment, amnesia, aphasia, bradyphrenia, or psychomotor retardation. Results: The incidence of cognitive TEAEs in the integrated analysis of three trials is presented by dose group in Table 1. The incidence of cognitive TEAEs was low in all ESL dose groups, with the highest incidence occurring in the ESL 1200 mg group. Conclusions: Conclusions: Treatment with eslicarbazepine acetate as adjunct therapy to 1 to 3 concomitant AEDs produced a low occurrence of cognitive TEAEs. 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.