Outcomes from a Spanish Expanded Access Program on cannabidiol treatment in pediatric and adult patients with epilepsy.

AIM: To evaluate the effectiveness and tolerability of cannabidiol (CBD) in patients with developmental and epileptic encephalopathies, including Dravet syndrome (DS), and Lennox-Gastaut syndrome (LGS), in a Spanish Expanded Access Program (EAP). METHODS: This was a multicenter, retrospective, observational study of patients treated with purified CBD in 14 hospitals across Spain. Patients with (1) written informed consent and (2) at least 6 months follow-up before the closure of the database were included. Primary effectiveness endpoints included reductions (100 %, ≥75 %, ≥50 %, ≥25 %, or 0 %) or worsening in seizure frequency (all seizure types and most disabling seizures) at 1-, 3-, 6-, and 12-month visits and at the last visit, and median relative seizure reduction between baseline and last visit. Secondary effectiveness endpoints included retention rate, reduction in seizure severity, status epilepticus, healthcare utilization, and quality of life. Primary safety endpoints included rates of adverse events (AEs) and AEs leading to discontinuation. RESULTS: One hundred and two patients (DS 12 %; LGS 59 %; other epilepsy syndromes 29 %) with a mean age of 15.9 years were enrolled. Patients were highly refractory to antiseizure medications (ASMs); mean number of prior failed ASMs was 7.5 (SD 3.7). The mean CBD dose was 13.0 mg/kg/day at the last visit. The proportion of patients with ≥50 % reduction in the total number of seizures from baseline was 44.9 % at 6 months and 38.9 % at 12 months. The median number of total seizures per month reduced by 47.6 % from baseline to the last visit. At 12 months, seizure severity was lower in 33/54 patients (61.1 %) and unchanged in 17/54 patients (31.5 %). Quality of life, based on the CAVE scale, increased from a mean score of 17.9 ± 4.7 (n = 54) at baseline to 21.7 ± 5.5 (n = 51) at the last patient visit (21.2 % improvement). The mean treatment retention time was 10.3 months. There were no statistically significant changes in the number of status epilepticus episodes, but lower healthcare utilization was observed. Adverse events occurred in sixty-eight patients (66.7 %), and the most common were somnolence (34.3 %) and diarrhea (12.7 %). Cannabidiol was discontinued exclusively due to AEs in 7.8 % of patients, increasing to 25.5 % when both lack of efficacy and AEs were considered together. CONCLUSIONS: Cannabidiol demonstrated promising effectiveness and tolerability in patients with developmental and epileptic encephalopathies taking part in a Spanish EAP.

Observational retrospective analysis of vaccination against SARS-CoV-2 and seizures: VACCI-COVID registry.

BACKGROUND: We aimed to assess the risk of developing new-onset seizures or seizure decompensations in people with epilepsy (PWE) associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines. METHODS: A retrospective observational study in a tertiary hospital was conducted. Clinical records of all patients attended because of seizures or epilepsy at outpatient clinics, emergency department, or admitted to our hospital from January to December 2021 were reviewed, including patients older than 16 years who received some dose of coronavirus disease 2019 (COVID-19) vaccines. RESULTS: A total of 418 vaccinated PWE were analyzed: 6.2% presented an increase in seizure frequency and 1% reported different seizure types during the next month after vaccination. However, 61.5% had another possible cause for this decompensation. Having monthly seizures (1-3/month) was the only associated risk factor (OR 4.9, p < 0.001) while being seizure free > 1 year had a protective role (OR 0.36, p = 0.019). Patients with epileptic encephalopathies or a history of COVID-19 infection were not at increased risk of seizure decompensation. Besides this, 15 patients presented new-onset seizures within the first month post-vaccination, mean time from vaccination 15 ±â€¯8 days, 67% after the second dose. Again, 53.3% had another possible trigger for seizures. Eight debuted with status epilepticus or cluster of seizures. CONCLUSIONS: A small proportion of PWE (6.2%) had an increase in seizure frequency after COVID-19 vaccination and 15 patients had new-onset seizures during the first month after vaccination, though another reason for seizure exacerbation was identified in 61.5% and 53.3%, respectively. Severe acute respiratory syndrome COVID-19 vaccines appear to have little impact on the generation or decompensation of seizures.

Calidad de vida en pacientes adultos con epilepsia generalizada idiopática. Estudio EPILAK / Quality of life in adult patients with idiopathic generalised epilepsy. The EPILAK study

INTRODUCCIÓN: La calidad de vida (CV) es un aspecto importante en el tratamiento de los pacientes con epilepsia. OBJETIVO: Analizar la CV mediante el Quality of Life in Epilepsy Inventory-10 (QOLIE-10) en adultos con epilepsia generalizada idiopática y estudiar factores asociados a una peor CV. Pacientes y método. Estudio transversal, multicéntrico, observacional, realizado por 141 neurólogos de todas las comunidades autónomas de España. Cada investigador analizaba el QOLIE-10 de dos varones y dos mujeres mayores de 18 años con epilepsia generalizada idiopática visitados de forma consecutiva en consulta pública o privada. Los resultados se estandarizaron: 0 era la peor CV y 100, la mejor. RESULTADOS: Se analizó a 546 pacientes. Mujeres: 51,1% (n = 279). Edad media: 36 ± 15,3 años (18-87). Ausencias infantiles: 7,5% (n = 41); ausencias juveniles: 9,2% (n = 50); mioclónica juvenil: 29,8% (n = 163); sólo crisis tonicoclónicas: 53,5% (n = 292). Monoterapia: 63,2% (n = 345). Libres de crisis en el último año: 53,1% (n = 290). Comorbilidad psiquiátrica: ansiedad: 28,4% (n = 155); depresión: 14,1% (n = 77); déficit de atención: 10,1% (n = 55). Condición laboral: trabajador/a en activo: 47,2% (n = 258); estudiante: 20% (n = 109); amo/a de casa: 7,3% (n = 40); pensionista: 10,2% (n = 56); en paro: 14,3% (n = 78). Estado civil: casado/a o en pareja: 49,1% (n = 268); soltero/a: 43,7% (n = 239). Puntuación media en el QOLIE-10: 71,4 ± 19,1. Sexo femenino (p = 0,006), mayor frecuencia de crisis (p < 0,001), politerapia (p < 0,001), comorbilidad psiquiátrica (p < 0,001) y desempleo (p < 0,001) se asociaron de forma significativa con una peor CV. CONCLUSIONES: La CV de los pacientes con epilepsia generalizada idiopática/genética está afectada por el mal control de las crisis, la comorbilidad psiquiátrica y el desempleo, y las mujeres presentan una mayor afectación que los hombres

INTRODUCTION. Quality of life (QoL) is an important aspect in the treatment of patients with epilepsy. AIM. To analyse the QoL using the Quality of Life in Epilepsy Inventory-10 (QOLIE-10) in adults with idiopathic generalised epilepsy and to study factors associated with a worse QoL. PATIENTS AND METHODS. A cross-sectional, multicentre, observational study conducted by 141 neurologists in all the autonomous communities of Spain. Each researcher analysed the QOLIE-10 of two males and two females over 18 years of age with idiopathic generalised epilepsy seen consecutively in public or private practice. The results were standardised: 0 was the worst QoL and 100 was the best. RESULTS. A total of 546 patients were analysed. Women: 51.1% (n = 279). Mean age: 36 ± 15.3 years old (18-87). Childhood absence seizures: 7.5% (n = 41); juvenile absence seizures: 9.2% (n = 50); juvenile myoclonic seizures: 29.8% (n = 163); only tonic-clonic seizures: 53.5% (n = 292). Monotherapy: 63.2% (n = 345). Seizure-free in the last year: 53.1% (n = 290). Psychiatric comorbidity: anxiety: 28.4% (n = 155); depression: 14.1% (n = 77); attention deficit: 10.1% (n = 55). Employment status: in active employment: 47.2% (n = 258); student: 20% (n = 109); housewife/husband: 7.3% (n = 40); pensioner: 10.2% (n = 56); unemployed: 14.3% (n = 78). Marital status: married or in a relationship: 49.1% (n = 268); single: 43.7% (n = 239). Mean score on the QOLIE-10: 71.4 ± 19.1. Being female (p = 0.006), greater frequency of seizures (p < 0.001), polytherapy (p < 0.001), psychiatric comorbidity (p < 0.001) and unemployment (p < 0.001) were significantly associated with a worse QoL. CONCLUSIONS. The QoL of patients with idiopathic/genetic generalised epilepsy is affected by poor seizure control, psychiatric comorbidity and unemployment, and women are more affected than men