Akademik Veri Yönetim Sistemi
Epilepsy and Behavior, cilt.179, 2026 (SCI-Expanded, Scopus)
Objective: To evaluate the efficacy and tolerability of lacosamide (LCM) adjunctive therapy in a nationwide pediatric epilepsy cohort, including drug-refractory epilepsies (DREs). Methods: A retrospective nationwide Turkish cohort study included 334 pediatric epilepsy patients (aged 1–18 years) treated with LCM adjunctive therapy. The population was divided into the two cohorts: (I) DREs with developmental and epileptic encephalopaties (DEEs); early-onset DEEs (group A) and late-onset DEEs (group B), and (II) DRE without DEEs: focal/generalized electroclinical syndromes (group C) and well-defined epilepsy syndromes (group D). The effectiveness of LCM adjunctive therapy was assessed by seizure outcome (seizure freedom, ≥50% reduction, <50% reduction, no change, or worsening) and EEG outcome (no change, <50% improvement, >50% improvement, complete improvement, or worsening). Tolerability was evaluated via drug retention rate and treatment-emergent adverse events (TEAEs). Results: The mean duration of LCM adjunctive therapy was 24.63 ± 20.09 months in the cohort (mean age:13.28 ± 4.71 years; 53.8% male). The mean daily effective dose was 6.95 ± 2.25 mg/kg/day, and the time to effectiveness was 2.09 months. Etiological distribution differed across cohorts (p < 0.001), with structural etiology most frequent in groups C (47.1%) and A (34.4%), genetic in group A (22.9%), metabolic in groups A and B (6.3%), and immune/infectious in group D (13.6%). LCM adjunctive therapy provided sustained long-term seizure control in pediatric patients with DRE, with overall seizure control rates of 56.9% at 12 months and 55.6% at 24 months and a consistent responder rate (>50% seizure reduction) of 20.7% (n = 69/334). Cumulative EEG improvement was observed in 33.8% of patients receiving LCM adjunctive therapy, while complete EEG recovery rate was achieved in 6.3%. Similar seizure control rates was identified for DRE with DEEs (28.9%) and DRE without DEEs (35%). Drug retention was 73.9% at 12 months and 67.7% at 24 months, while TEAEs occurred in 20.7%, most commonly somnolence (10.4). Conclusions: LCM adjunctive therapy was associated with favorable electro-clinical outcomes and good tolerability across a broad spectrum of DREs with DEEs or without DEEs in childhood.