The Incidence of Cognitive Adverse Events Related to Eslicarbazepine Acetate: An Integrated Analysis (P06.116)

Abstract

Objective: Eslicarbazepine acetate (ESL) is a novel AED currently in development in the US as adjunct treatment for partial-onset seizures. Background 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 Design/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: TEAEs identified as related to cognition were disturbance in attention, memory impairment, amnesia, aphasia, bradyphrenia, and psychomotor retardation. The incidence of these TEAEs was ≤ 2% in all ESL dose groups. The highest incidence occurred in the ESL 1200 mg group, with bradyphrenia and aphasia only observed in this dose group. Conclusions: In this analysis, treatment with eslicarbazepine acetate as adjunct therapy to 1 to 3 concomitant AEDs was associated with a low incidence of cognitive TEAEs.