Abstracts

Rationale: Eslicarbazepine acetate (ESL) has been recently approved as monotherapy by medical regulatory agencies. However there is a lack of real-world data on this indication. MONOZEB study is a long-term real-life experience with ESL monotherapy in a large series of patients with focal epilepsy Methods: MONOZEB is a multicenter, retrospective and observational study in patients taking ESL as monotherapy. The inclusion criteria are: 1) Patients with focal epilepsy; 2) Use of ESL as monotherapy (“de novo” or conversion to monotherapy). 3) Long-term follow-up. Exclusion criteria: 1) Patients whose information are not reliable The source of data is patient clinical records. Time-points for revision of ESL monotherapy are considered at 3, 6,  and 12 and 24 months. The main objectives are to assess effectiveness (with seizure freedom as primary end-point) and tolerability -including percentage of patients with adverse events (AE)- and patient withdrawal due to AE. Other variables as compliance were also analyzed. Results: A preliminary analysis evaluated a total of 97 patients (most of them were patients converted to ESL monotherapy). The main reason to initiate ESL was poor seizure control (47.4%), adverse events (AE) with other drugs (43.3%) and compliance problems (9.3%). The median number of seizures/month at onset was 0.7 (mean: 4.9 seizures/month) and 15 patients (15.5%) did not have seizures in the year prior to inclusion. The final mean dose was 830.9 mg. The mean time in monotherapy of this population was 39.2 weeks [95% confidence interval = (38.0; 40.5)]. Regarding effectiveness 74.2% of this population were seizure-free and 86.6% were =50% responder. Along the follow-up, 23.7% of the patients reported AE (16.5% mild, 5.2% moderate and 2.1% severe) and 1% discontinued for AE. The main AE was memory problems (6.2%). Hyponatremia was observed in 2 patients (2.1%). Compliance treatment problems were reported by 9.3% patients at baseline and 3.1% after 1 year (p=0.109). Conclusions: A preliminary analysis showed that ESL was effective and well tolerated in monotherapy with a long-term follow up. Further data are needed to confirm the first analysis. Funding: This work has been done with the support of an unrestricted grant of BIAL.