The efficacy and tolerability of lacosamide adjunctive therapy in children with drug-refractory epilepsy: A nationwide Turkish cohort study.
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Kart Pinar Ozkan, Serdaroglu Esra, Yildiz Nihal, Kılıç Recep Kamil, Sari Mehpare, Sahin Suleyman, Sen Gürsel, Karaoglu Pakize, Erdogan Irmak, Kilic Betul, Oztürk Selcan, Oncel Elif Perihan, Yilmaz Celil, Yücel Şen Arife Derda, Ersoy Ozlem, Kanmaz Seda, Yılmaz Sanem Keskin, Topcu Yasemin, Okuyaz Cetin, Yarar Coskun, Carman Kursat Bora, Polat Muzaffer, Erol Ilknur, Canpolat Mehmet, Gümüs Hakan, Per Hüseyin, Gencpinar Pinar, Dundar Nihal Olgac, Ünalp Aycan, Ünay Bülent, Bektaş Ömer, Teber Serap, Hirfanoğlu Tuğba, Arhan Ebru Petek, Aydin Kursad, Tekgul Hasan, Haspolat Senay, Serdaroglu Ayse, Cansu Ali
Аннотация
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.