@article{discovery10112849,
         journal = {Epilepsy and Behavior},
           month = {November},
            year = {2020},
          volume = {112},
           title = {Long-term safety and tolerability of adjunctive eslicarbazepine acetate in children with focal seizures},
            note = {This article is published under a Creative Commons license (https://creativecommons.org/licenses/by-nc-nd/4.0/)},
          author = {Sankar, R and Kirkham, FJ and Holmes, GL and Pina-Garza, JE and Wheless, J and Gama, H and Moreira, J and Cantu, D and Tosiello, R and Blum, D and Grinnell, T},
        abstract = {Objective: The objective of this study was to evaluate long-term safety and tolerability outcomes in two open-label extension (OLE) studies of adjunctive eslicarbazepine acetate (ESL) in children with focal seizures. / Methods: Safety data from patients aged 4-17 years in OLEs of Studies 2093-208 and -305 were pooled and analyzed. Studies 208 and 305 were randomized, double-blind, placebo-controlled studies of adjunctive treatment with ESL in children with focal seizures refractory to treatment with 1-2 antiseizure drugs; patients could continue into uncontrolled OLEs (up to 5 years total duration). The OLEs evaluated the safety and tolerability of ESL (10-30 mg/kg/day; maximum 1200 mg/day). / Results: The 1-year OLE and post-1-year OLE safety populations comprised 337 and 177 ESL-treated patients, respectively. The overall incidence of treatment-emergent adverse events (TEAEs) with ESL was 64.1\% during the 1-year OLE and 52.5\% during the post-1-year OLE. Nasopharyngitis, partial seizures, vomiting, pyrexia, headache, somnolence, and respiratory tract infection were the most frequently reported TEAEs during the 1-year OLE. The overall incidence of serious adverse events (AEs) was 8.9\% during the 1-year OLE and 10.2\% during the post-1-year OLE. Partial seizures (1.2\%) and pneumonia (1.2\%) were the most frequently reported serious AEs during the 1-year OLE. The overall incidence of TEAEs leading to discontinuation was 4.2\% during the 1-year OLE and 0.6\% during the post-1-year OLE. Partial seizures (1.5\%) was the most frequently reported TEAE leading to discontinuation during the 1-year OLE. / Conclusions: Overall, long-term treatment with ESL was generally well tolerated in pediatric patients aged 4-17 years with focal seizures. TEAEs were comparable to those observed in adults with no new events of concern.},
             url = {http://dx.doi.org/10.1016/j.yebeh.2020.107458},
        keywords = {Pediatric, Eslicarbazepine acetate, Safety, Tolerability, Open-label extension, Antiseizure drug}
}