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Magnetic Resonance Imaging Pilot Study of Intravenous Glyburide in Traumatic Brain Injury.


ABSTRACT: Pre-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?

SUBMITTER: Eisenberg HM 

PROVIDER: S-EPMC6921286 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Magnetic Resonance Imaging Pilot Study of Intravenous Glyburide in Traumatic Brain Injury.

Eisenberg Howard M HM   Shenton Martha E ME   Pasternak Ofer O   Simard J Marc JM   Okonkwo David O DO   Aldrich Christina C   He Feng F   Jain Sonia S   Hayman Erik G EG  

Journal of neurotrauma 20190827 1


Pre-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, a  ...[more]

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