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Levetiracetam versus fosphenytoin as a second-line treatment after diazepam for adult convulsive status epilepticus: a multicentre non-inferiority randomised control trial.
Nakamura, Kensuke; Marushima, Aiki; Takahashi, Yuji; Mochizuki, Masaki; Kimura, Akio; Fukuda, Yu; Asami, Masahiro; Nakamoto, Hidetoshi; Egawa, Satoshi; Kaneko, Junya; Unemoto, Kyoko; Kondo, Yutaka; Yonekawa, Chikara; Uchida, Masatoshi; Hoshiyama, Eisei; Yamada, Takeshi; Maruo, Kazushi; Ishikawa, Eiichi; Matsumaru, Yuji; Inoue, Yoshiaki.
Afiliación
  • Nakamura K; Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki, Japan.
  • Marushima A; Department of Emergency and Critical Care Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.
  • Takahashi Y; Department of Emergency and Critical Care Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan aiki.marushima@md.tsukuba.ac.jp.
  • Mochizuki M; Division of Stroke prevention and treatment, Department of Neurosurgery, Faculty of Medicine,University of Tsukuba, Tsukuba, Ibaraki, Japan.
  • Kimura A; Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.
  • Fukuda Y; Epilepsy Center, University of Tsukuba Hospital, Tsukuba, Ibaraki, Japan.
  • Asami M; Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki, Japan.
  • Nakamoto H; Department of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki, Japan.
  • Egawa S; Department of Emergency Medicine and Critical Care, National Center for Global Health and Medicine, Toyama Shinjuku, Tokyo, Japan.
  • Kaneko J; Department of Emergency Medicine and Critical Care, National Center for Global Health and Medicine, Toyama Shinjuku, Tokyo, Japan.
  • Unemoto K; Department of Emergency Medicine, Teikyo University Hospital, Itabashi, Tokyo, Japan.
  • Kondo Y; Neurointensive Care Unit, Neurosurgery, Stroke and Epilepsy Center, TMG Asaka Medical Center, Asaka, Saitama, Japan.
  • Yonekawa C; Neurointensive Care Unit, Neurosurgery, Stroke and Epilepsy Center, TMG Asaka Medical Center, Asaka, Saitama, Japan.
  • Uchida M; Department of Emergency and Critical Care Medicine, Nippon Medical School Tama Nagayama Hospital, Tama, Tokyo, Japan.
  • Hoshiyama E; Department of Emergency and Critical Care Medicine, Nippon Medical School Tama Nagayama Hospital, Tama, Tokyo, Japan.
  • Yamada T; Department of Emergency and Critical Care Medicine, Juntendo University Urayasu Hospital, Urayasu, Chiba, Japan.
  • Maruo K; Department of Emergency and Critical Care Medicine, Jichi Medical University Hospital, Shimotsuke, Tochigi, Japan.
  • Ishikawa E; Emergency and Critical Care Medical Center, Dokkyo Medical University, Shimotsuga, Tochigi, Japan.
  • Matsumaru Y; Emergency and Critical Care Medical Center, Dokkyo Medical University, Shimotsuga, Tochigi, Japan.
  • Inoue Y; Tsukuba Clinical Research and Development Organization (T-CReDO), University of Tsukuba, Tsukuba, Ibaraki, Japan.
J Neurol Neurosurg Psychiatry ; 94(1): 42-48, 2023 01.
Article en En | MEDLINE | ID: mdl-36207063
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Fenitoína / Estado Epiléptico Tipo de estudio: Clinical_trials Límite: Adult / Humans Idioma: En Revista: J Neurol Neurosurg Psychiatry Año: 2023 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Fenitoína / Estado Epiléptico Tipo de estudio: Clinical_trials Límite: Adult / Humans Idioma: En Revista: J Neurol Neurosurg Psychiatry Año: 2023 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Reino Unido