Abstracts

Rationale: The objective of this study was to investigate the effectiveness, efficacy and side effects of eslicarbazepine acetate (ESL) as initial monotherapy in patients with focal epilepsy in a real-world setting. Methods: We performed a multicentric, retrospective, electronic CRF-based study including all patients with focal epilepsy who had received at least a single dose of ESL monotherapy in 10 centers. To be included in the study, patients had to initiate ESL monotherapy at least one year before the study was presented to the local IRB (either as initial monotherapy or after withdrawal to monotherapy). The subset of patients in whom ESL was started as initial monotherapy was analyzed separately. The primary objective was retention rates at 6 and 12 months. Secondary objectives were efficacy and tolerability. Efficacy was assessed by measuring seizure-freedom rates at 6 and 12 months. Seizure-freedom was defined as no seizures since day 1 of ESL monotherapy. Tolerability was assessed by recording adverse events reported in follow-up visits.The study was approved by the IRBs of each participating center. Results: We collected information from a total of 265 patients of which 110 patients were started on ESL as the first choice AED. For this initial monotherapy group mean age was 50 years (range 19-88 years). Type of epilepsy was symptomatic in 63/110 (57,2%), probably symptomatic in 43/110 (39,1%), and unknown in 4/110 (3,6%). Most patients were started on 400 mg QD and titrated to 800 mg QD after 1-2 weeks. One patient was lost for follow-up at 6 months and 4 more at 12 months. Mean dose of ESL was 804 mg/day at 6 months and at 865 mg/day at 12 months. Retention rates were 88,1% (96/109) at 6 months and 81,9 % (86/105) at 12 months, similar to those for the overall group of 265 patients (88,1% at 6 months and 79,3 % at 12 months). At 12 months, main reasons to stop ESL were lack of efficacy in 7/19 patients (36,8%) and intolerable side effects in 11/19 (57,9%). Seizure-free rates were 60,6% (66/109) at 6 months and 52,4% (55/105) at 12 months. Adverse effects were recorded in 24/109 patients (22%) at 6 months and in 28/105 (26,7%) at 12 months. Intolerable side effects lead to discontinuation at 12 months in 11/105 patients (10,48%). The most common side effects were somnolence, dizziness, headache, and memory disorders. No serious adverse events were registered. Conclusions: In this retrospective real-world study of ESL as initial monotherapy in focal epilepsy, ESL showed high retention rates. Seizure-free rates were similar as those reported in the regulatory comparative non-inferiority monotherapy trial. Side effects were of moderate intensity and frequency. ESL is effective and safe as first line drug for patients with focal epilepsy. Funding: This work was supported by a grant from BIAL and EISAI.