Outcome measures of epilepsy
epilepsy, seizure, Seizure, myoclonic, atonic, Epilepsy
EPILEPSY, MINOR, CLONIC SEIZURES, EPILEPSY, ATYPICAL ABSENCE
We investigated changes in seizure frequency from baseline to the last three months of everolimus treatment. We defined seizure frequency during the last three months before treatment as the baseline. Seizure response was divided into seizure freedom, ≥ 50% reduction, ≥ 30% reduction, clinically relevant reduction without a given percentage (when percentage change was not available), no change, or increase. The total reduction in the frequency of focal, tonic, myoclonic, atonic, and focal to bilateral tonic clonic seizures was calculated. Atypical absences were not included. Effectiveness was described in three groups: (a) all everolimus patients with epilepsy using anti-seizure medication (ASM), with ≥ 1 seizure/year (entire epilepsy group), (b) patients with epilepsy treated with everolimus for other indications (other indications group), and (c) patients treated with everolimus for epilepsy indication (epilepsy indication group). Changes in ASM treatment were described as none, minor (dosage adjustments, discontinuing an ASM), or major (adding an ASM, vagus nerve stimulator, or epilepsy surgery).We further investigated the association between epilepsy effectiveness and epilepsy severity, age, and concentration-to-dose ratio (C/D ratio) as a measure of drug exposure. The C/D ratio was calculated from the mean serum concentration/dose in patients with at least three everolimus measurements. Epilepsy severity was investigated by association between the number of seizure types (< 3, ≥ 3), occurrence of focal to bilateral tonic clonic seizures, median weekly seizure frequency (< 7, ≥ 7 in the entire epilepsy group, < 1.5, ≥ 1.5 in the other indication group and < 25, ≥ 25 in the epilepsy indication group), and number of ASMs (< 3, ≥ 3).