RT Journal Article
SR Electronic
T1 Levetiracetam versus fosphenytoin as a second-line treatment after diazepam for adult convulsive status epilepticus: a multicentre non-inferiority randomised control trial
JF Journal of Neurology, Neurosurgery & Psychiatry
JO J Neurol Neurosurg Psychiatry
FD BMJ Publishing Group Ltd
SP 42
OP 48
DO 10.1136/jnnp-2022-329485
VO 94
IS 1
A1 Nakamura, Kensuke
A1 Marushima, Aiki
A1 Takahashi, Yuji
A1 Mochizuki, Masaki
A1 Kimura, Akio
A1 Fukuda, Yu
A1 Asami, Masahiro
A1 Nakamoto, Hidetoshi
A1 Egawa, Satoshi
A1 Kaneko, Junya
A1 Unemoto, Kyoko
A1 Kondo, Yutaka
A1 Yonekawa, Chikara
A1 Uchida, Masatoshi
A1 Hoshiyama, Eisei
A1 Yamada, Takeshi
A1 Maruo, Kazushi
A1 Ishikawa, Eiichi
A1 Matsumaru, Yuji
A1 Inoue, Yoshiaki
A1 
YR 2023
UL http://jnnp.bmj.com/content/94/1/42.abstract
AB Objective Status 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.Methods We 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.Results A 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).Conclusion The 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 number jRCTs031190160.Data are available upon reasonable request. The data sets generated and/or analysed during the present study are available from the corresponding author upon reasonable request.