![]() ![]() ![]() Serious adverse events developed in three patients in the FPHT group and none in the LEV group (p=0.061). No significant differences were observed in the seizure recurrence rate or intubation rate within 24 hours. The non-inferiority of LEV to FPHT was confirmed with p<0.001 by the Farrington-Manning test. Seizure cessation rates within 30 min were 83.8% (67/80) in the FPHT group and 89.2% (83/93) in the LEV group. The primary outcome was assigned as the seizure cessation rate within 30 min of the administration of the study drug.Ī total of 176 adult patients with SE were enrolled (82 FPHT and 94 LEV), and 3 were excluded from the full analysis set. Diazepam was initially administered, followed intravenously by FPHT at 22.5 mg/kg or LEV at 1000-3000 mg. We initiated a multicentre randomised control trial in emergency departments with adult patients with convulsive SE. Therefore, we herein compared LEV with FPHT in adult SE. Although fosphenytoin (FPHT) is recommended as a second-line treatment, levetiracetam (LEV) reportedly has similar efficacy, but higher safety. Status epilepticus (SE) is an emergency condition for which rapid and secured cessation is crucial. 15 Department of Biostatistics, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.14 Tsukuba Clinical Research and Development Organization (T-CReDO), University of Tsukuba, Tsukuba, Ibaraki, Japan.13 Emergency and Critical Care Medical Center, Dokkyo Medical University, Shimotsuga, Tochigi, Japan.12 Department of Emergency and Critical Care Medicine, Jichi Medical University Hospital, Shimotsuke, Tochigi, Japan.11 Department of Emergency and Critical Care Medicine, Juntendo University Urayasu Hospital, Urayasu, Chiba, Japan.10 Department of Emergency and Critical Care Medicine, Nippon Medical School Tama Nagayama Hospital, Tama, Tokyo, Japan.9 Neurointensive Care Unit, Neurosurgery, Stroke and Epilepsy Center, TMG Asaka Medical Center, Asaka, Saitama, Japan.8 Department of Emergency Medicine, Teikyo University Hospital, Itabashi, Tokyo, Japan.7 Department of Emergency Medicine and Critical Care, National Center for Global Health and Medicine, Toyama Shinjuku, Tokyo, Japan.6 Epilepsy Center, University of Tsukuba Hospital, Tsukuba, Ibaraki, Japan.5 Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.3 Department of Emergency and Critical Care Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan 4 Division of Stroke prevention and treatment, Department of Neurosurgery, Faculty of Medicine,University of Tsukuba, Tsukuba, Ibaraki, Japan.2 Department of Emergency and Critical Care Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.1 Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki, Japan. ![]()
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