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 for adult patients with focal epilepsy by the European Medicines Agency. Besides randomized clinical trials, real-life studies are necessary and add important information about drug use in a clinical practice. Methods: We defined a 1-year retrospective and observational study. We included patients older than 16 years, diagnosed of focal epilepsy with partial-onset seizures with or without secondary generalization and receiving ESL as monotherapy. We studied dose, titration, effectiveness, safety and tolerability. Data from clinical records were analyzed at baseline, 3 and 6 months of treatment. For the statistic analysis we perform a descriptive study. Results: A total of 102 patients have been included. In all patients the onset dose was 400 mg/day with a median titration period of 15 days. The 6-month retention rate was 93.1%, 4.9% discontinued because of adverse events and 2% due to lack of efficacy. The final median dose of ESL was 800 mg/day.  The mean number of seizures per month at onset was 1.5. During these 6 months, 84.3% of patients were seizure free and a 94.1% were responders (≥ 50% of seizures). The number of seizures was reduced significantly at 6 months (p < 0.001). During follow up, 18.6% of the patients reported ESL related adverse events (AEs), 13.7% mild and 4.9% moderate. The AEs most commonly referred were irritability (3.9%), dizziness (2%), somnolence (2%), headache (2%), hypertransaminasemia (2%), constipation (1%), and nausea/vomiting (1%). One patient had an allergic reaction with important lip edema. Hyponatremia was observed in 2 patients (2%). Five patients (4.9%) were converted to ESL association with other antiepileptic drugs because no control of seizure Conclusions: In our experience, in a real-life setting for 6 months, the use of ESL monotherapy with a dose round 800 mg/day shows an excellent seizure control.  Adverse events were considerate mild or moderate and reported in a few group of patients. The effectiveness and improved tolerability could convert the ESL in a real monotherapy option to treat the focal epilepsy. Funding: 1. Villanueva et al. EARLY-ESLI study: Long-term experience with eslicarbazepine acetate after first monotherapy failure. Acta Neurol Scand. 2016 Dec 9.2. Villanueva et al. Long-term safety and efficacy of eslicarbazepine acetate in patients with focal seizures: results of the 1-year ESLIBASE retrospective study. Epilepsy Res 2014 Sep;108(7):1243-52.