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dc.contributor.authorEisenberg, H.M.
dc.contributor.authorSimard, J.M.
dc.contributor.authorAldrich, C.
dc.contributor.authorHayman, E.G.
dc.date.accessioned2020-01-07T20:35:37Z
dc.date.available2020-01-07T20:35:37Z
dc.date.issued2020
dc.identifier.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85076953339&doi=10.1089%2fneu.2019.6538&partnerID=40&md5=f0068230593bdae2df5689cfc44f342c
dc.identifier.urihttp://hdl.handle.net/10713/11564
dc.description.abstractPre-clinical studies of traumatic brain injury (TBI) show that glyburide reduces edema and hemorrhagic progression of contusions. We conducted a small Phase II, three-institution, randomized placebo-controlled trial of subjects with TBI to assess the safety and efficacy of intravenous (IV) glyburide. Twenty-eight subjects were randomized and underwent a 72-h infusion of IV glyburide or placebo, beginning within 10 h of trauma. Of the 28 subjects, 25 had Glasgow Coma Scale (GCS) scores of 6-10, and 14 had contusions. There were no differences in adverse events (AEs) or severe adverse events (ASEs) between groups. The magnetic resonance imaging (MRI) percent change at 72-168 h from screening/baseline was compared between the glyburide and placebo groups. Analysis of contusions (7 per group) showed that lesion volumes (hemorrhage plus edema) increased 1036% with placebo versus 136% with glyburide (p = 0.15), and that hemorrhage volumes increased 11.6% with placebo but decreased 29.6% with glyburide (p = 0.62). Three diffusion MRI measures of edema were quantified: mean diffusivity (MD), free water (FW), and tissue MD (MDt), corresponding to overall, extracellular, and intracellular water, respectively. The percent change with time for each measure was compared in lesions (n = 14) versus uninjured white matter (n = 24) in subjects receiving placebo (n = 20) or glyburide (n = 18). For placebo, the percent change in lesions for all three measures was significantly different compared with uninjured white matter (analysis of variance [ANOVA], p < 0.02), consistent with worsening of edema in untreated contusions. In contrast, for glyburide, the percent change in lesions for all three measures was not significantly different compared with uninjured white matter. Further study of IV glyburide in contusion TBI is warranted. Copyright Howard M. Eisenberg et al., 2019.en_US
dc.description.sponsorshipThis study was funded by a grant to HME from the Department of Defense U.S. Army Medical Research and Materiel Command (W81XWH-08-2-0159), INTRuST, and by Remedy Pharmaceuticals, Inc.en_US
dc.description.urihttps://doi.org/10.1089/neu.2019.6538en_US
dc.language.isoen_USen_US
dc.publisherMary Ann Liebert Inc.en_US
dc.relation.ispartofJournal of Neurotrauma
dc.subjectcontusionen_US
dc.subjectedemaen_US
dc.subjectglyburideen_US
dc.subjectMRIen_US
dc.subjectSUR1en_US
dc.subjectTBIen_US
dc.titleMagnetic resonance imaging pilot study of intravenous glyburide in traumatic brain injuryen_US
dc.typedc.type[en_US]en_US
dc.identifier.doi10.1089/neu.2019.6538
dc.identifier.pmid31354055


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