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

Pinar Ozkan Kart, Esra Serdaroglu, Nihal Yildiz, Mehpare Sari, Suleyman Sahin, Gursel Sen Sen, Pakize Karaoglu, Pinar Gencpinar, Betul Kilic, Selcan Ozturk, Elif Perihan Oncel, Celil Yilmaz, Arife Derda Yucel Sen, Ozlem Ersoy, Cetin Okuyaz, Kursat Bora Carman Carman, Muzaffer Polat, Ilknur Erol, Kursad Aydin Aydin, Hüseyin Per, Nihal Olgac Dundar, Aycan Unalp, Hasan Tekgul, Bülent Unay, Serap Teber, Senay Haspolat, Ayse Serdaroglu, Ali Cansu

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.
Keywords: Drug-resistant epilepsy, pediatric, lacosamide, efficacy

Pinar Ozkan Kart
Turkey

Esra Serdaroglu
Turkey

Nihal Yildiz
Turkey

Mehpare Sari
Turkey

Suleyman Sahin
Turkey

Gursel Sen Sen
Turkey

Pakize Karaoglu
Turkey

Pinar Gencpinar
Turkey

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Pinar Ozkan Kart 
Turkey