Clinical outcomes of eslicarbazepine acetate monotherapy for focal‐onset seizures: A multicenter audit

Abstract

Objective To assess the effectiveness and tolerability of eslicarbazepine acetate (ESL) monotherapy in routine clinical practice for the treatment of focal‐onset seizures. Methods Multicenter, retrospective, observational study conducted in patients older than 16 years treated with ESL as first‐line monotherapy or converted to ESL monotherapy from polytherapy or other monotherapy. Outcomes included 1‐year retention rate, seizure‐free rates after 6 and 12 months of monotherapy treatment, and safety/tolerability issues. Results A total of 256 patients were included (106 first‐line and 150 conversion to monotherapy; 56 patients aged >65 years). Overall, the 1‐year retention rate was 79% (72.7% in the ≥65 years subgroup) and seizure‐free rates at 6 and 12 months were 59.3% and 55.3% (72.2% and 67.3% in the ≥65 years subgroup), without significant differences when comparing first‐line vs conversion‐to‐ESL monotherapy groups (P = .979). However, the conversion group was heterogeneous and included 43 (29.1%) patients that were seizure free the year prior ESL introduction. A substantially higher proportion of patients remained seizure free for the entire follow‐up among those who initiated ESL due to tolerability problems compared with those treated due to inadequate seizure control (71.4% vs 37.3%). Overall, 62 of 256 (24.2%) patients reported AEs (39.3% in >65 years subgroup) and led to discontinuation in 20/256 (7.8%) patients (12.5% in >65 years subgroup). Commonly reported AEs were somnolence (6.6%), dizziness (6.3%), and headache (4.3%). Hyponatremia was recorded in five patients, the majority (4/5) of whom were older than 65 years. Conclusions Eslicarbazepine acetate was effective and well‐tolerated as first‐line or conversion to monotherapy in a clinical setting in adult and elderly patients with focal‐onset seizures.

Initial monotherapy with eslicarbazepine acetate for the management of adult patients with focal epilepsy in clinical practice: a meta-analysis of observational studies

“…The mean dose of ESL at 12 months was 781 mg/day in the Giraldez et al [24] study and 895 mg/day in the Holtkamp et al study [25]. When reported, the median dose of ESL at the last visit was 800 mg/day.…”

“…Disease duration varies from a median of 0.9 months to a mean of 14 months, and the number of seizures also varies from a mean of approximately 1 to 5 per month. The proportion of ASM-naïve patients was over 65% in four studies [22][23][24]26], and 35% in one study [25].…”

“…Patients were middle-aged and evenly distributed regarding sex except for the Giraldez et al study, where over two-thirds of the patients were females [24]. Disease duration varies from a median of 0.9 months to a mean of 14 months, and the number of seizures also varies from a mean of approximately 1 to 5 per month.…”

“…After revising the abstracts, the full texts of 24 records were retrieved and reviewed. Finally, 5 studies met our selection criteria and were included in the quantitative synthesis [22][23][24][25][26]. The study selection flow chart is presented in Supplementary Figure 1.…”

“…In two studies, the authors reported seizure freedom at 6 months as the lack of seizures during the evaluated study period [23,24], and three studies reported it as the lack of seizures from the prior visit [22,25,26]. The pooled seizure freedom rate at 6 months as evaluated for the whole evaluation period was 64.6% (95% CI, 45.7 to 79.8) (Figure 1A), and for the studies evaluating it from the prior visit, it was 71.0% (95% CI, 61.8 to 78.7) (Figure 1B).…”