Evidence map›Paper›PMID 42723519›Full record

Trial reportPharmacotherapy2026

Pharmacokinetics of Loading Dose Vigabatrin Administered via Enteral Tube in Participants With Post-Anoxic Status Epilepticus.

Nicole F Maranchick, Katharina M Busl, Ralisa Pop, Camila Guerrero Miranda, Hector David Meza Comparan, Luciola Martins Frota, Lawrence J Hirsch, Stephan Eisenschenk, Charles A Peloquin, Carolina B Maciel

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Pharmacotherapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. Trial
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

10 authors.

Nicole F MaranchickDepartment of Pharmacotherapy and Translational Research, Infectious Disease Pharmacokinetics Lab, College of Pharmacy and Emerging Pathogens Institute, University of Florida, Gainesville, Florida, USA.ORCID https://orcid.org/0009-0002-3051-7062
Katharina M BuslDepartment of Neurology, Division of Neurocritical Care, College of Medicine, University of Florida, Gainesville, Florida, USA.ORCID https://orcid.org/0000-0001-9961-0527
Ralisa PopDepartment of Neurology, Division of Neurocritical Care, College of Medicine, University of Florida, Gainesville, Florida, USA.
Camila Guerrero MirandaDepartment of Neurology, Division of Neurocritical Care, College of Medicine, University of Florida, Gainesville, Florida, USA.
Hector David Meza ComparanDepartment of Neurology, Division of Neurocritical Care, College of Medicine, University of Florida, Gainesville, Florida, USA.
Luciola Martins FrotaDepartment of Neurology, Division of Neurocritical Care, College of Medicine, University of Florida, Gainesville, Florida, USA.
Lawrence J HirschDepartment of Neurology, Comprehensive Epilepsy Center, Yale University School of Medicine, New Haven, Connecticut, USA.
Stephan EisenschenkDepartment of Neurology, Malcolm Randall VA Medical Center, Gainesville, Florida, USA.
Charles A PeloquinDepartment of Pharmacotherapy and Translational Research, Infectious Disease Pharmacokinetics Lab, College of Pharmacy and Emerging Pathogens Institute, University of Florida, Gainesville, Florida, USA.ORCID https://orcid.org/0000-0001-9002-7052
Carolina B MacielDepartment of Neurology, Division of Neurocritical Care, College of Medicine, University of Florida, Gainesville, Florida, USA.

Funding

American Heart Association Innovative Award 20IPA35380013; Wayne Densch Epilepsy Research Fund, UF Health Foundation
6 · The paper itself

Abstract

introductionPost-anoxic status epilepticus (PASE) is a frequent neurologic complication following hypoxic-ischemic brain injury in cardiac arrest survivors, for which no definitive treatment exists. Early γ-Aminobutyric Acid (GABA) augmentation using vigabatrin, a GABA-transaminase inhibitor, has been proposed; however, its pharmacokinetics (PK) in this critically ill population are unknown. In this ancillary study of VIGAB-STAT, an open-label feasibility trial of loading dose vigabatrin via enteral tube, we evaluated vigabatrin PK. MATERIALS AND

methodsComatose adults with electrographic status epilepticus following return of spontaneous circulation received a loading dose of vigabatrin determined by renal function (creatinine clearance (CrCl) ≥ 50 mL/min, 4500 mg; CrCl 30-50 mL/min, 2250 mg; CrCl < 30 mL/min, 1125 mg). Pharmacokinetic sampling occurred at 0 (pre-dose), 0.5, 1, 2, 3, 6, 12, 24, 48, 72, and 168-h post-dose, and plasma concentrations were quantified using liquid chromatography tandem mass spectrometry. PK parameters were estimated using non-compartmental analysis.

resultsSix participants contributed 56 plasma samples. The median (range) age was 62 years (22-68), weight 80.9 kg (57.6-139.9), and four (66.7%) participants were male. Loading doses were evenly distributed: 4500 mg (n = 2), 2250 mg (n = 2), and 1125 mg (n = 2). Time to maximum concentration, maximum concentration, area under the concentration time curve from 0 to 24 h, area under the concentration time curve from 0 to infinity and half-life median (range) values were 2 h (1-3), 38.1 mg/L (16.9-91.8), 431.2 mg*h/L (254.6-979.3), 679.3 mg*h/L (340.3-1156.8), and 16.2 h (9.4-23.9), respectively.

conclusionsThis pioneer vigabatrin PK study in critically ill participants with PASE demonstrated absorption regardless of challenges such as enteral delivery type, co-administration of gastric pH modulators, vasopressors, and anesthetics. Notably, prolonged elimination half-lives and increased exposures were observed.

Indexed as

AnticonvulsantsStatus EpilepticusVigabatrinAdultAgedComaFemaleHumansIntubation, GastrointestinalMaleMiddle AgedAnticonvulsantsVigabatrincardiac arrestGABAheart arrestpharmacokineticspost‐anoxic status epilepticusvigabatrin

Identifiers

PMID42723519
PMCPMC13563110

What OpenQuestion holds

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Registered trials

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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.