Abstract
The Euro-Esli study was an exploratory pooled analysis of data from 14 European clinical practice studies, which was conducted to audit the real-world effectiveness, safety, and tolerability of eslicarbazepine acetate (ESL) as an adjunctive treatment for partial-onset seizures. Retention and effectiveness were assessed after 3, 6, and 12 months of ESL treatment, and at the final visit. Safety and tolerability were assessed throughout ESL treatment by evaluating adverse events (AEs) and ESL discontinuation due to AEs. Data from 2058 patients (52.1% male; mean age 44.0 years) were included. All 2058 patients were assessed for safety and 1975 (96.0%) patients were assessed for effectiveness. After 12 months, retention, responder (≥50% seizure frequency reduction), and seizure freedom rates were 73.4, 75.6, and 41.3%, respectively. AEs were reported for 34.0% of patients and led to discontinuation in 13.6% of patients. The most frequently reported AEs were dizziness (6.7% of patients), fatigue (5.4%), and somnolence (5.1%). No unexpected safety signals emerged over a median duration of follow-up of >5 years. Subgroup analyses revealed that ESL was significantly more effective in patients aged ≥65 versus <65 years, in patients who were not receiving treatment with other sodium channel blockers versus those who were receiving treatment with other sodium channel blockers, and in patients who were receiving <2 versus ≥2 concomitant antiepileptic drugs at baseline. Euro-Esli is the largest ESL clinical practice study conducted to date. This study provides strong and reassuring evidence of ESL’s safety profile, and complements the data from clinical trials.
Highlights
Eslicarbazepine acetate (ESL) is a once-daily antiepileptic drug (AED) that is approved for the treatment of partialonset seizures as monotherapy or adjunctive therapy [1, 2]
After 12 months of ESL treatment, 73.4% of patients were retained on ESL, 75.6% of patients had responded to treatment, and 41.3% of patients had been seizure free for ≥6 months
The most important finding of this study was that no unexpected safety signals emerged when ESL was used over the long term as adjunctive therapy for partial-onset seizures under real-world conditions
Summary
Eslicarbazepine acetate (ESL) is a once-daily antiepileptic drug (AED) that is approved for the treatment of partialonset seizures as monotherapy or adjunctive therapy [1, 2]. The efficacy of ESL as adjunctive therapy for partial-onset seizures in adults, together with its safety and tolerability profile in this setting, was established in a series of randomized, doubleblind, placebo-controlled, Phase III trials [4,5,6,7] and longterm extension studies [8,9,10]. The efficacy, safety, and tolerability of ESL as monotherapy for the treatment of partial-onset seizures in adults with newly diagnosed epilepsy were established in a Phase III, randomized, double-blind, active-controlled, non-inferiority trial [11, 12]. Clinical trials are essential in the development and approval of new AEDs, they do not necessarily reflect the effectiveness and tolerability of an agent when used in clinical practice. There is a need for real-world studies to complement evidence from clinical trials, by elucidating an agent’s effectiveness when used under everyday clinical practice conditions
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