Authors :
Presenting Author: Laura Abraira, MD, PhD – Epilepsy Unit, Neurology department, Vall d'Hebron University Hospital
Javier Martinez Poles, MD – Epilepsy Unit. Rey Juan Carlos University Hospital, Madrid, Spain; Ana Diez Barrio, MD – Epilepsy Unit. Rey Juan Carlos University Hospital, Madrid, Spain; Adrian García Hernandez, MD – Epilepsy Unit. Rey Juan Carlos University Hospital, Madrid, Spain; Maria Rosa Querol Pascual, MD – Epilepsy Unit. Neurology department. Badajoz University Hospital, Badajoz, Spain; Laura Olivie, MD – Epilepsy Unit, Neurology department, IIS-Jimenez Diaz Foundation, UAM, Madrid, Spain; Maria Machio, MD – . Epilepsy Unit, Neurology department, IIS-Jimenez Diaz Foundation, UAM, Madrid, Spain; Mario Hernandez-Holgado, MD – Epilepsy Unit. Neurology department. Infanta Elena University Hospital, Madrid, Spain; Manuel Quintana Luque, MD, PhD – Epilepsy Unit, Neurology department, Vall d’Hebron University Hospital, Barcelona, Spain; Elena Fonseca, MD, PhD – Epilepsy Unit, Neurology department, Vall d’Hebron University Hospital, Barcelona, Spain; Sofia Lallana, MD – Epilepsy Unit, Neurology department, Vall d’Hebron University Hospital, Barcelona, Spain; Daniel Campos, MD – Epilepsy Unit, Neurology department, Vall d’Hebron University Hospital, Barcelona, Spain; Samuel Lopez maza, MD – Epilepsy Unit, Neurology department, Vall d’Hebron University Hospital, Barcelona, Spain; Estevo Santamarina Perez, MD, PhD – Epilepsy Unit, Neurology department, Vall d’Hebron University Hospital, Barcelona, Spain; Jose María Serratosa, MD, PhD – Epilepsy Unit, Neurology department, IIS-Jimenez Diaz Foundation, UAM, Madrid, Spain; Manuel Toledo Argany, MD, PhD – Epilepsy Unit, Neurology department, Vall d’Hebron University Hospital, Barcelona, Spain
Rationale:
In one third of all patients with epilepsy, seizures remain uncontrolled despite anti-seizure medication (ASM). Cenobamate (CNB) has been recently approved as a novel adjunctive ASM drug for the treatment of adult patients with refractory focal-onset epilepsy. We aimed to assess the efficacy and safety of CNB in adult patients with refractory focal-onset epilepsy in clinical practice.
Methods:
This is a longitudinal study of patients with refractory focal-onset epilepsy included in a prospective register from the Spanish Epilepsy Society. All the patients in which CNB was started as an adjunctive ASM were assessed. Seizure frequency before and after starting treatment was obtained from medical records. We collected clinical and demographic features and evaluated efficacy and adverse events (AE) during follow-up.
Results:
Seventy patients were included (mean age 36.6±14.2 years; 51.4% women). Median age of epilepsy onset was 10 (IQR 3-22) with a median time evolution of epilepsy of 20 years (IQR 11-30). Structural (47.1%) and unknown (38.6%) etiology were the most frequent causes of epilepsy, being hippocampal mesial sclerosis (n=10) and cortical development malformation (n=9) the most frequent subtypes. Follow-up was analyzed in 66 patients (median six months [IQR 3-12]. Median number of concomitant ASM at the baseline visit was 4 [IQR (3-5)]. Median dose of CNB at six month-follow-up was 200 [RIQ 150-200)]. A significant reduction of monthly frequency total seizures was observed at three months, which was maintained during follow-up (8.5 vs 2.3; p< 0.001). 65.2% patients reported AE being drowsiness the most frequent one (60.6%), followed by instability (24.2%). Three patients (4.3%) withdrawn CNB due to AE and lack of efficacy. There was a reduction in the number of drugs during follow-up, mainly in the first six months (p < 0.001).