Abstracts

Rationale: Treatment of epilepsy in the elderly is particularly challenging, due to age-related physiological changes and high rates of comorbidity and polypharmacy. 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 typically difficult to enroll in clinical trials, such as the elderly. 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 data from elderly patients (=60 years) included in Euro-Esli.    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 aged =60 versus <60 years at study entry. Results: Euro-Esli included a total of 2058 patients (age range 14 to 88 years; mean age 44.0 years; 52.1% male). Age at study entry was known for 2057 patients, of whom 358 (17.4%) and 1699 (82.6%) were aged =60 and <60 years, respectively. At all timepoints, responder and seizure freedom rates were significantly higher in patients aged =60 versus <60 years (Figures 1 and 2). For example, at 12 months, responder rates were 83.9% and 73.7% in patients aged =60 versus <60 years, respectively (X²=9.33; p=0.002; Chi-squared test) and corresponding seizure freedom rates were 58.5% and 37.1%, respectively (?²=31.16; p<0.001; Chi-squared test). The overall incidence of AEs was significantly higher in patients aged =60 versus <60 years (41.4% vs 32.5%; X²=10.20; p=0.001; Chi-squared test). However, the rate of discontinuation due to AEs was comparable in patients aged =60 versus <60 years (16.2% vs 13.1%; X²=2.35; p=0.126; Chi-squared test). Conclusions: Euro-Esli is the largest ESL clinical practice study conducted to date. Results from this Euro-Esli subanalysis demonstrate that in this clinical population, ESL responder rates and seizure freedom rates were significantly higher in patients aged =60 versus <60 years at study entry. Although the overall incidence of AEs was significantly higher in patients aged =60 versus <60 years, the incidence of AEs leading to ESL discontinuation was comparable between groups, suggesting that ESL was not more frequently associated with intolerable AEs in elderly patients relative to those of younger age. These data support the use of ESL as an effective and well tolerated treatment option for elderly patients with focal epilepsy. Funding: Study supported by Eisai.