Abstracts

Rationale: Eslicarbazepine-acetate (ESL) is a third generation antiepileptic drug licensed as adjunctive therapy in adults with focal seizures after four pivotal clinical trials were developed. ESLIBASE study established the efficacy and safety of ESL in a real-life setting over 1 year. However, the information about outcomes in elderly patients (≥65 year-old) was scarce. A phase III, multicenter, open-label, non-controlled study in 72 elderly patients over 26 weeks demonstrated it was safe and efficacious. We analyzed safety and efficacy of ESL in the subgroup of elderly patients who participated in ESLIBASE studyMethods: ESLIBASE was a retrospective study that included all patients with focal seizures who started ESL between January 2010 and July 2012 at 12 Spanish Hospitals. ESL was prescribed individually according to real-life practice. Efficacy and safety were evaluated over 1 year. From all patients, we collected the subgroup of those ≥ 65 year-old and analyzed efficacy and safety separately in this particular group. Statistical analysis was performed with the Statistical Package for the Social Sciences (SPSS) version 16.0; P values of ≤0.05 were regarded as significantResults: ESLIBASE included 327 patients, of whom 29 were ≥ 65 year-old, most of them males (18 vs 11). Mean age was 71.2 year-old and epilepsy evolution was 20 years. Nine had an unknown etiology and six had vascular epilepsy. Temporal lobe was the most frequent localization (17 patients). Most (18) were taking ≥2 antiepileptic drugs (AEDs) at baseline. Twenty patients had taken ≥3 AED before. The reason of taking ESL was lack of efficacy in 24 patients. At 3, 6 and 12 months, the mean dose was 770, 840 and 850 mg/day; the responder rate was 55.2%, 48.2% and 62%; 20.7%, 24.1% and 24.1% were seizure-free. At 12 months, 16 patients (55.2%) had ≥1 adverse effect (AE). AEs led to treatment discontinuation in 7 patients (24.1%). Dizziness, nausea and ataxia were the most common AEs; three had hyponatremia and one developed a status epilepticus. The tolerability profile improved in 4 out of 5 patients who switched from carbamazepine (CBZ) or oxcarbazepine (OXC) to ESL due to AEsConclusions: ESL was well-tolerated and effective in elderly patients in a real-life setting over 1 year, with a dose around 800 mg/day. Both efficacy and safety outcomes are similar to obtained in the analysis of the whole group of adult people. AE effects improved in most of elderly patients who switched from CBZ or OXC to ESL