{Reference Type}: Observational Study
{Title}: Cenobamate in patients with highly refractory focal epilepsy: A retrospective real-world study.
{Author}: Beltrán-Corbellini Á;Romeral-Jiménez M;Mayo P;Sánchez-Miranda Román I;Iruzubieta P;Chico-García JL;Parra-Díaz P;García-Morales I;Toledano R;Aledo-Serrano Á;Gil-Nagel A;
{Journal}: Seizure
{Volume}: 111
{Issue}: 0
{Year}: 2023 Oct 2
{Factor}: 3.414
{DOI}: 10.1016/j.seizure.2023.07.026
{Abstract}: <B>OBJECTIVE: </B>To determine the effectiveness and safety outcomes of cenobamate in a cohort of patients with highly refractory focal epilepsy in routine clinical practice.<BR><B>METHODS: </B>Observational, retrospective, phase 4 study on subjects receiving cenobamate in three Spanish centers. The primary endpoint was the retention rate at the last follow-up. The main secondary endpoints were the 50%-responder  and seizure-free rates at three months and the last follow-up. Other secondary endpoints were Global Clinical Impressions-Improvement (CGI-I) scores and treatment-emergent adverse events (TEAEs).<BR><B>RESULTS: </B>Fifty-one patients with highly refractory focal epilepsy with 24.7 years of disease evolution, ten previously tried ASM, and a 23.5% of previous epilepsy surgery were included. The retention rate at the last follow-up was 80.4%. The 50% responder rate in focal seizures at three months was 56.5% (median reduction per month 51%, 0-74.6; p < 0.0001) and in focal to bilateral tonic-clonic seizures was 63.6% (median reduction per month 89%, 0-100; p = 0.022). A total of 54.3% of subjects reported a reduction in the intensity of focal seizures, and 66% manifested clinically significant satisfaction. Cenobamate allowed a significant decrease in concomitant ASM, especially sodium channel blockers. TEAEs were reported in 43.1% of individuals, 85% of whom resolved or improved, with no new safety findings.<BR><B>CONCLUSIONS: </B>In this analysis of patients with highly refractory focal epilepsy treated with cenobamate according to standard clinical practice, there was evidence of a high reduction in both seizure frequency and intensity, with a manageable safety profile.