Discussion
arrhythmia, seizure, epilepsy, hypotension, convulsive, SE, respiratory/circulatory arrest
ADVERSE EVENTS, ARRHYTHMIA, EPILEPSY
We compared the efficacies of intravenous LEV and intravenous FPHT as second-line treatments following the administration of diazepam for adult convulsive SE with a non-inferiority RCT. Similar efficacies for seizure cessation within 30 min were observed. No significant differences were noted in other efficacies and safety; however, serious adverse events potentially related to the study drugs were only detected in the FPHT group.This is the first study to confirm the non-inferior efficacy of LEV for the treatment of adult SE after the administration of diazepam in comparisons with FPHT. LEV has frequently been compared with phenytoin as a second-line treatment for SE.Nevertheless, the occasional adverse events of phenytoin/FPHT, such as hypotension, arrhythmia or respiratory/circulatory arrest, need to be considered in the treatment of SE.The present study focused on emergency clinical practice. Under life-threatening conditions, physicians cannot devote time to obtaining informed consent, registry and randomisation. A large RCT of SE was recently performed with the establishment of a system for after-acquired consent.The present study had several limitations. Physicians who treated patients and performed outcome assessments were not blinded. While the dose of phenytoin was 22.5 mg/kg, that of LEV ranged between 1000 mg and 3000 mg according to the Japanese epilepsy guidelines.