Abstracts

Rationale: Eslicarbazepine acetate (ESL) is indicated for the treatment of partial-onset seizures as monotherapy or adjunctive therapy in USA since 2015. Nevertheless, it was only recently approved as monotherapy by the European Medicines Agency in the treatment of partial-onset seizures, with or without secondary generalization, in adults with newly diagnosed epilepsy. Besides randomized clinical trials, real-life studies are necessary and add important information about drug use in a clinical practice. We defined a 1-year retrospective and observational study to investigate the effectiveness, safety and tolerability of ESL in clinical practice. We present a subanalysis of data from elderly patients (=65 years) included in this study.   Methods: The study included a total of 105 patients diagnosed of focal epilepsy with partial-onset seizures with or without secondary generalization, and receiving ESL as monotherapy, of whom 25 patients (23.8%) were aged = 65 years. We studied dose, titration, effectiveness, safety and tolerability in this age group. Data from clinical records were analyzed at baseline, 3, 6 and 12 months of treatment. For the statistic analysis we performed a descriptive study. Results: A total of 25 patients have been included. In all patients the onset dose was 400 mg/day with a median titration period of 15 days. The final median dose of ESL was 800 mg/day.  At 12-month retention rate was 92%. The 8% of patients discontinued treatment because of adverse events and or lack of efficacy.The mean number of seizures per month at onset was 0.8 (median 0.3). At the end of the study, 80% of patients were seizure free and a 96% were responders (= 50% of seizures). The number of seizures was reduced significantly at 12 months (p<0.001).During the follow up, 32% of the patients reported ESL related adverse events (AEs). Only one patient withdrew the drug due to severity of adverse event. The AEs most commonly referred were dizziness (8%), headache (4%), lip edema (4%) and tongue dysesthesias (4%). One patient had an allergic reaction with important lip edema. Hyponatremia was observed in 1 patient (4%). One patient (4%) needed the association of other antiepileptic drug to ESL for lack of control of seizures. Conclusions: In our study the use of ESL as monotherapy in elderly patients, in clinical practice, with a dose round 800 mg/day, shows high efficacy and excellent tolerability and safety.  Adverse events were considerate mild or moderate and reported in a few group of patients. These data support the use of ESL as monotherapy.  The ESL could be a real monotherapy option to treat the focal epilepsy in elderly patients. Funding: No funding