Abstracts

Rationale: Psychiatric comorbidities (including depression) and intellectual disability (ID) are common in patients with epilepsy. Treatment with antiepileptic drugs (AEDs) may also cause and/or exacerbate psychiatric and/or cognitive comorbidities. Patients with such comorbidities are typically excluded from participation in clinical trials and real-world clinical practice data are therefore needed to determine the safety/tolerability of AEDs in these patient subgroups. Eslicarbazepine acetate (ESL) is approved in the USA and Europe for the treatment of partial-onset seizures as monotherapy or adjunctive therapy. The Euro-Esli study investigated the real-world effectiveness, safety and tolerability of ESL when used in everyday clinical practice in Europe. We present a subanalysis of safety/tolerability data from patients included in Euro-Esli who had psychiatric comorbidities, depression and/or ID at study entry.    Methods: Euro-Esli was a pooled analysis of 14 European clinical practice studies. Safety and tolerability were assessed throughout follow-up by evaluating adverse events (AEs) and ESL discontinuation due to AEs, respectively. Data were compared for patients with versus without (a) psychiatric comorbidities (including depression), (b) depression and (c) ID at study entry.  Results: Euro-Esli included a total of 2058 patients (age range 14–88 years; mean age 44.0 years; 52.1% male). At study entry, the presence/absence of psychiatric comorbidities, depression and ID were known for 1138, 1134 and 952 patients, respectively. Of these, 283/1138 (24.9%), 141/1134 (12.4%) and 108/952 (11.3%) had psychiatric comorbidities, depression and ID, respectively. A breakdown of the patients’ psychiatric comorbidities is presented in Table 1. The overall incidences of AEs and AEs leading to ESL discontinuation were significantly greater in patients with versus without psychiatric comorbidities, with versus without depression, and with versus without ID (Table 2). The incidence of psychiatric AEs was not significantly different for patients with versus without psychiatric comorbidities (p=0.076), or for patients with versus without depression (p=0.074) (Table 2). Similarly, the incidence of cognitive AEs was not significantly different for patients with versus without ID (p=0.919) (Table 2). Conclusions: Although patients included in Euro-Esli who had psychiatric comorbidities, depression and/or ID at study entry experienced significantly more overall AEs and AEs leading to ESL discontinuation than those without these comorbidities, the incidence of psychiatric AEs was not significantly higher in patients with versus without psychiatric comorbidities, or in patients with versus without depression. Similarly, the incidence of cognitive AEs was not significantly higher in patients with versus without ID. These real-world findings indicate that ESL is unlikely to exacerbate psychiatric or cognitive disturbances in patients with psychiatric comorbidities or ID. Funding: Study supported by Eisai