Evidence map›Paper›PMID 36207063›Full record

Trial reportJournal of neurology, neurosurgery, and psychiatry2023

Levetiracetam 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 and 11 more

Open access · hybridAbstract readRandomized Controlled TrialMulticenter StudyEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of neurology, neurosurgery, and psychiatry, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.2field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 17 citations in OpenAlex.

  1. Observational
  2. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 8 institutions in 1 country.

Kensuke NakamuraDepartment of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki, Japan.ORCID 0000-0001-8481-0294
Aiki MarushimaDepartment of Emergency and Critical Care Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan aiki.marushima@md.tsukuba.ac.jp.
Yuji TakahashiDepartment of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki, Japan.
Masaki MochizukiDepartment of Emergency and Critical Care Medicine, Hitachi General Hospital, Hitachi, Ibaraki, Japan.
Akio KimuraDepartment of Emergency Medicine and Critical Care, National Center for Global Health and Medicine, Toyama Shinjuku, Tokyo, Japan.
Yu FukudaDepartment of Emergency Medicine and Critical Care, National Center for Global Health and Medicine, Toyama Shinjuku, Tokyo, Japan.
Masahiro AsamiDepartment of Emergency Medicine, Teikyo University Hospital, Itabashi, Tokyo, Japan.
Hidetoshi NakamotoNeurointensive Care Unit, Neurosurgery, Stroke and Epilepsy Center, TMG Asaka Medical Center, Asaka, Saitama, Japan.
Satoshi EgawaNeurointensive Care Unit, Neurosurgery, Stroke and Epilepsy Center, TMG Asaka Medical Center, Asaka, Saitama, Japan.
Junya KanekoDepartment of Emergency and Critical Care Medicine, Nippon Medical School Tama Nagayama Hospital, Tama, Tokyo, Japan.
Kyoko UnemotoDepartment of Emergency and Critical Care Medicine, Nippon Medical School Tama Nagayama Hospital, Tama, Tokyo, Japan.
Yutaka KondoDepartment of Emergency and Critical Care Medicine, Juntendo University Urayasu Hospital, Urayasu, Chiba, Japan.
Chikara YonekawaDepartment of Emergency and Critical Care Medicine, Jichi Medical University Hospital, Shimotsuke, Tochigi, Japan.
Masatoshi UchidaEmergency and Critical Care Medical Center, Dokkyo Medical University, Shimotsuga, Tochigi, Japan.
Eisei HoshiyamaEmergency and Critical Care Medical Center, Dokkyo Medical University, Shimotsuga, Tochigi, Japan.
Takeshi YamadaTsukuba Clinical Research and Development Organization (T-CReDO), University of Tsukuba, Tsukuba, Ibaraki, Japan.
Kazushi MaruoDepartment of Biostatistics, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.
Eiichi IshikawaDepartment of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.
Yuji MatsumaruDivision of Stroke prevention and treatment, Department of Neurosurgery, Faculty of Medicine,University of Tsukuba, Tsukuba, Ibaraki, Japan.
Yoshiaki InoueDepartment of Emergency and Critical Care Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.
IENE ECT with the LIFE study group
University of Tsukuba · JPDokkyo Medical University · JPHitachi General Hospital · JPNational Center for Global Health and Medicine · JPNippon Medical School · JPJichi Medical University · JPJuntendo University Urayasu Hospital · JPTeikyo University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 NUMBER: jRCTs031190160.

Indexed as

PhenytoinStatus EpilepticusAdultAnticonvulsantsDiazepamHumansLevetiracetamSeizuresTreatment OutcomeAnticonvulsantsDiazepamfosphenytoinLevetiracetamPhenytoinEPILEPSYMEDICINE

Identifiers

PMID36207063
PMCPMC9763167
OpenAlexW4303453975

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.