Abstracts

Rationale: Eslicarbazepine acetate (ESL) is approved in the USA and Europe for the treatment of partial-onset seizures as monotherapy or adjunctive therapy. Real-world clinical practice data complement evidence from clinical trials by providing information on patients who are more diverse in terms of clinical characteristics than those recruited for clinical trials. The Euro-Esli study investigated the real-world effectiveness, safety and tolerability of ESL when used in everyday clinical practice in Europe. We present a subanalysis of Euro-Esli data from patients who were treated with ESL as initial monotherapy or converted to ESL monotherapy following ESL adjunctive therapy. Methods: Euro-Esli was a pooled analysis of 14 European clinical practice studies. Effectiveness assessments included responder rate (≥50% seizure frequency reduction) and seizure freedom rate (seizure freedom at least since prior visit), assessed after 3, 6 and 12 months of ESL treatment, and at last visit. Safety and tolerability were assessed throughout follow-up by evaluating adverse events (AEs) and ESL discontinuation due to AEs, respectively. Data were compared for patients treated initially with ESL monotherapy versus adjunctive therapy, and for patients treated at last visit with ESL monotherapy versus adjunctive therapy. Results: Of the 2058 patients included in Euro-Esli (mean age 44.0 years; 52.1% male), the number of concomitant AEDs used at baseline and last visit was known for 2045 and 1340 patients, respectively. ESL was used as monotherapy in 88/2045 (4.3%) patients initially and in 229/1340 (17.1%) patients at last visit. At 12 months, responder and seizure freedom rates were higher in patients treated initially with ESL monotherapy versus adjunctive therapy, and in patients treated at last visit with ESL monotherapy versus adjunctive therapy (Figure 1). The overall incidence of AEs was similar in patients treated initially with ESL monotherapy and adjunctive therapy, and in patients treated at last visit with ESL monotherapy and adjunctive therapy (Figure 2). The rate of discontinuation due to AEs was not markedly different in patients treated initially with ESL monotherapy versus adjunctive therapy, but the rate was lower in patients treated at last visit with ESL monotherapy versus adjunctive therapy (Figure 2). Conclusions: In Euro-Esli – the largest ESL clinical practice study conducted to date – ESL was shown to be more effective when used as monotherapy, compared with adjunctive therapy. ESL’s safety and tolerability were generally comparable when used as monotherapy or adjunctive therapy. These data support the use of ESL as monotherapy, as well as adjunctive therapy, for partial-onset seizures in clinical practice, complementing evidence from clinical trials. Funding: Study supported by Eisai.