Study design
epilepsy, lymphangiomyomatosis, seizure
ADVERSE EFFECTS, LYMPHANGIOMYOMATOSIS, EPILEPSY
This was a retrospective observational study. Demography, patient history, indication for and duration of treatment, dosage, serum concentration measurements, dose modifications/discontinuation and adverse effects, and seizure response in epilepsy patients were collected from medical records through a web-based form. Imaging data were re-evaluated by an experienced abdominal and neuro-radiologist. Data related to adverse effects and seizure responses in epilepsy patients were further assessed with a semi-structured patient/parent interview. Patients treated solely for lymphangiomyomatosis (LAM) were only included in the evaluation of adverse effects. In Denmark, the use of everolimus for epilepsy is restricted and requires 33% and 50% seizure reduction, good cooperation, and tolerable adverse effects after 4 and 12 months respectively for permission to continue treatment. To fulfil these requirements, Danish patients submit seizure diaries for review, and the treating physician submits an evaluation to the Danish Medicines Authorities for documentation after the first treatment year. Patients are not obliged to submit seizure registrations in Norway.