Evidence map›Paper›PMID 29733464›Full record

Trial reportAnnals of neurology2018

Randomized trial of lacosamide versus fosphenytoin for nonconvulsive seizures.

Aatif M Husain, Jong W Lee, Bradley J Kolls, Lawrence J Hirsch, Jonathan J Halford, Puneet K Gupta, Yafa Minazad, Jennifer M Jones, Suzette M LaRoche, Susan T Herman and 11 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of neurology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 5% 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

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 63 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Observational
  4. Review
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
  10. Further advances in epilepsy.Journal of neurology · 2023
    Review
  11. Article
  12. Article
  13. Review
  14. Review
  15. Seizures and Sepsis: A Narrative Review.Journal of clinical medicine · 2021
    Review
  16. Diagnosis and Treatment of Status Epilepticus.Journal of epilepsy research · 2020
    Review
  17. A Theoretical Paradigm for Evaluating Risk-Benefit of Status Epilepticus Treatment.Journal of clinical neurophysiology : official publication of the American Electroencephalographic Society · 2020
    Review
  18. Review
  19. Article
  20. Observational
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 15 institutions in 2 countries.

Aatif M HusainDepartment of Neurology, Duke University Medical Center, Durham, NC.
Jong W LeeDepartment of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Bradley J KollsDepartment of Neurology, Duke University Medical Center, Durham, NC.
Lawrence J HirschDepartment of Neurology, Yale University School of Medicine, New Haven, CT.
Jonathan J HalfordDepartment of Neurology, Medical University of South Carolina, Charleston, SC.ORCID 0000-0003-1681-6744
Puneet K GuptaDepartment of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX.
Yafa MinazadNeurosciences Center, Huntington Memorial Hospital, Pasadena, CA.
Jennifer M JonesDepartment of Neurology, Mission Health, Asheville, NC.
Suzette M LaRocheDepartment of Neurology, Mission Health, Asheville, NC.
Susan T HermanDepartment of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.
Christa B SwisherDepartment of Neurology, Duke University Medical Center, Durham, NC.
Saurabh R SinhaDepartment of Neurology, Duke University Medical Center, Durham, NC.
Adriana PaladeDepartment of Neurology, University of Louisville, Louisville, KY.
Keith E DombrowskiDepartment of Neurology, Duke University Medical Center, Durham, NC.
William B GallentineDepartment of Pediatrics (Neurology), Duke University Medical Center, Durham, NC.
Cecil D HahnDivision of Neurology, Hospital for Sick Children and Department of Paediatrics, University of Toronto, Toronto, Ontario, Canada.
Elizabeth E GerardDepartment of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL.
Manjushri BhapkarDuke Clinical Research Institute, Durham, NC.
Yuliya LokhnyginaDuke Clinical Research Institute, Durham, NC.
M Brandon WestoverDepartment of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
Critical Care EEG Monitoring Research Consortium
Veterans Health Administration · USClinical Research Institute · USDuke Medical Center · USMission Health · USBeth Israel Deaconess Medical Center · USBrigham and Women's Hospital · USDuke University · USHarvard University · USHuntington Hospital · USNorthwestern University · USSewanee: The University of the South · USSouthwestern Medical Center · USUniversity of Louisville · USUniversity of Toronto · CAYale University · US

Funding

Investigation of Sleep in the Intensive Care Unit (ICU-SLEEP)R01NS102190 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI WESTOVER, MICHAEL BRANDON · 2018 to 2022
$3.2M
Big Data and Deep Learning for the Interictal-Ictal-Injury ContiuumR01NS107291 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI WESTOVER, MICHAEL BRANDON · 2018 to 2022
$2.8M
NINDS NIH HHS R01 NS102190NINDS NIH HHS R01 NS107291
6 · The paper itself

Abstract

objectiveThe optimal treatment of nonconvulsive seizures in critically ill patients is uncertain. We evaluated the comparative effectiveness of the antiseizure drugs lacosamide (LCM) and fosphenytoin (fPHT) in this population.

methodsThe TRENdS (Treatment of Recurrent Electrographic Nonconvulsive Seizures) study was a noninferiority, prospective, multicenter, randomized treatment trial of patients diagnosed with nonconvulsive seizures (NCSs) by continuous electroencephalography (cEEG). Treatment was randomized to intravenous (IV) LCM 400mg or IV fPHT 20mg phenytoin equivalents/kg. The primary endpoint was absence of electrographic seizures for 24 hours as determined by 1 blinded EEG reviewer. The frequency with which NCS control was achieved in each arm was compared, and the 90% confidence interval (CI) was determined. Noninferiority of LCM to fPHT was to be concluded if the lower bound of the CI for relative risk was >0.8.

resultsSeventy-four subjects were enrolled (37 LCM, 37 fPHT) between August 21, 2012 and December 20, 2013. The mean age was 63.6 years; 38 were women. Seizures were controlled in 19 of 30 (63.3%) subjects in the LCM arm and 16 of 32 (50%) subjects in the fPHT arm. LCM was noninferior to fPHT (p = 0.02), with a risk ratio of 1.27 (90% CI = 0.88-1.83). Treatment emergent adverse events (TEAEs) were similar in both arms, occurring in 9 of 35 (25.7%) LCM and 9 of 37 (24.3%) fPHT subjects (p = 1.0).

interpretationLCM was noninferior to fPHT in controlling NCS, and TEAEs were comparable. LCM can be considered an alternative to fPHT in the treatment of NCSs detected on cEEG. Ann Neurol 2018;83:1174-1185.

Indexed as

AdultAgedAged, 80 and overAnticonvulsantsBrain WavesCross-Over StudiesElectroencephalographyEpilepsy, GeneralizedFemaleGlasgow Coma ScaleHumansLacosamideMaleMiddle AgedPhenytoinProspective StudiesAnticonvulsantsfosphenytoinLacosamidePhenytoin

Identifiers

PMID29733464
PMCPMC6785201
OpenAlexW2799984727

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.