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J. Neurol. Neurosurg. Psychiatr. · Jan 2023
Randomized Controlled Trial Multicenter StudyLevetiracetam versus fosphenytoin as a second-line treatment after diazepam for adult convulsive status epilepticus: a multicentre non-inferiority randomised control trial.
- Kensuke Nakamura, Aiki Marushima, Yuji Takahashi, Masaki Mochizuki, Akio Kimura, Yu Fukuda, Masahiro Asami, Hidetoshi Nakamoto, Satoshi Egawa, Junya Kaneko, Kyoko Unemoto, Yutaka Kondo, Chikara Yonekawa, Masatoshi Uchida, Eisei Hoshiyama, Takeshi Yamada, Kazushi Maruo, Eiichi Ishikawa, Yuji Matsumaru, Yoshiaki Inoue, and IENE ECT with the LIFE study group.
- Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki, Japan.
- J. Neurol. Neurosurg. Psychiatr. 2023 Jan 1; 94 (1): 424842-48.
ObjectiveStatus epilepticus (SE) is an emergency condition for which rapid and secured cessation is crucial. Although fosphenytoin (FPHT) is recommended as a second-line treatment, levetiracetam (LEV) reportedly has similar efficacy, but higher safety. Therefore, we herein compared LEV with FPHT in adult SE.MethodsWe initiated a multicentre randomised control trial in emergency departments with adult patients with convulsive SE. Diazepam was initially administered, followed intravenously by FPHT at 22.5 mg/kg or LEV at 1000-3000 mg. The primary outcome was assigned as the seizure cessation rate within 30 min of the administration of the study drug.ResultsA total of 176 adult patients with SE were enrolled (82 FPHT and 94 LEV), and 3 were excluded from the full analysis set. 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 difference in these rates was 5.5% (95% CI -4.7 to 15.7, p=0.29). The non-inferiority of LEV to FPHT was confirmed with p<0.001 by the Farrington-Manning test. No significant differences were observed in the seizure recurrence rate or intubation rate within 24 hours. Serious adverse events developed in three patients in the FPHT group and none in the LEV group (p=0.061).ConclusionThe efficacy of LEV was similar to that of FPHT for adult SE following the administration of diazepam. LEV may be recommended as a second-line treatment for SE along with phenytoin/FPHT.Trial Registration NumberjRCTs031190160.© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.
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