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Evaluation of Efficacy and Tolerability of Lacosamide in Children with Drug-Resistant Epilepsy: A Multicenter Cohort Study

Objectives: We aim to evaluate the efficacy and tolerability of adjunctive lacosamide therapy in focal and generalized drug-resistant epilepsy in the pediatric population. Methods: A total of 289 patients, age at the onset of treatment ranged from 1 to 18 years, were included in the study from 14 centers. The safety, tolerability, side-effect rates, seizure frequency, and efficacy of lacosamide were evaluated. Results: The mean age of the patients included in the study was 13.52 ± 0.51 (1-24), 52.9 % (n = 153) of the patients were male (Table 1). The mean age of onset of lacosamide was 10.41 years ± 4.73 (1-18). The mean starting dose was 2.63 mg/kg/g, while the mean daily effective dose was 6.87 mg/kg/day (2.3-12) throughout the treatment period. The oral tablet form of lacosamide was found to be 88.9% (n=257) easy to use and tolerate. A significant decrease in seizure frequency was found at the 3rd month of additional lacosamide treatment [(p<0.001), Table 2]. The rate of treatment-emergent adverse events (TEAE) was 23.9% (n = 69), the most common somnolence was 10.4%(n=30, Table 3). While no change was detected in 62.6%(n:181) electroencephalographically, there was more than 50% improvement in 3.5% (n:10) and complete recovery in 3.8% (n:11). Treatment was continued in 67.8% (n=196) of the cases, and treatment was discontinued in 19.7% (n=57) because there was no change in seizure frequency. Conclusion: Our findings support that adjunctive lacosamide is effective, safe, and tolerable at doses up to 12 mg/kg/day in children with resistant epilepsy.