Abstracts

Rationale: Eslicarbazepine acetate (ESL) is a once-daily oral antiepileptic drug (AED) approved as adjunctive treatment for partial-onset seizures (POS) in the USA, Europe and Canada, and as monotherapy for POS in the USA. The aim of this prospective, non-interventional study was to assess seizure control and tolerability of ESL as adjunctive therapy to one baseline AED, in adults with POS with or without secondary generalization. Methods: Multicenter, non-interventional, prospective cohort study conducted between March 2012 and September 2014 at 12 Neurology departments in Portugal. Adults with POS insufficiently controlled with one AED and who had initiated ESL as adjunctive treatment were enrolled. The primary endpoint was the retention rate (RR), defined as the proportion of patients on ESL treatment at the end of follow up, based on the patient diary records. The secondary endpoints included the proportion of responders (patients with at least 50% reduction in seizure frequency comparing to baseline), proportion of seizure-free patients and the change in frequency for partial seizures with or without secondary generalization. Adverse Events (overall and treatment-related) occurring during the follow up and the Clinical Global Impression of Change (CGI-C) and Severity (CGI-S) were recorded and assessed by the neurologist. Results: Overall, 52 patients were included. Patients' mean age was 41.5 13.3 years and almost half (48.1%) were male. Mean epilepsy duration was 18.5 14.8 years and mean seizure frequency in the 4 weeks previous to baseline was 7.5 12.7. At the final assessment (mean time between initial and final assessment: 7.80 months), the retention rate was 73.0% (95% CI, 61.0% ?" 85.2%); the responder rate and seizure free rates were 71.1% (95% CI, 56.7 ?" 85.5%) and 39.5% (95% CI, 24.00 ?" 55.04%), respectively. The highest seizure-free rates were found for the secondary generalized seizures (94.7% at final assessment). The median relative reduction in seizure frequency between baseline and final assessment was 82.2%. A reduction in epilepsy severity (CGI-S) was observed in 42.1% of the patients. According to CGI-C, 73.6% patients had their epilepsy "much improved" or "very much improved". Twelve patients (23.1%) had at least one adverse event (AE) and 10 (19.2%) had at least one AE related with the study drug, two patients (3.9%) had at least one serious AE. Most of the AE were classified as mild to moderate intensity (14) and 9 were classified as severe. Five patients were withdrawn from the study due to AEs. Conclusions: ESL showed good retention rates and elicited a significant reduction in seizure frequency in patients with POS not sufficiently controlled with monotherapy attending routine clinical practice. These finding suggest effective seizure control and favorable tolerability of ESL adjunctive treatment in this setting. Funding: This study was sponsored by Bial - Portela & C S.A.