Abstract 5: Glyburide for Large Hemispheric Infarcts ≤125 mL: a Meta-Analysis of Individual Patient Data from the GAMES-RP and CHARM Trials

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Introduction: Two randomized trials have evaluated intravenous (IV) Glyburide for the treatment of large hemispheric infarction (LHI) patients at high risk for cerebral edema. Hypothesis: In this meta-analysis of two randomized trials, we aimed to determine whether subjects with a baseline stroke volume ≤125 mL who were treated with IV Glyburide would have better outcomes than those who received placebo. Methods: The source population included all GAMES-RP and CHARM subjects who were enrolled and treated with IV Glyburide or placebo, were ≤70 years of age, and had a baseline stroke volume ≤125 mL (n=138). The outcome of interest was the modified Rankin Scale (mRS) score at 90 days using 5 categories, where 0-1 and 5-6 were each collapsed into a single category. We used mixed-effects ordinal logistic regression models to calculate common odds ratios (cOR) for the primary outcome in the whole population (shift analysis) and in the subgroup with a baseline stroke volume ≤125 mL after adjustment for age, sex, baseline NIHSS, region of world, image modality, thrombolysis and thrombectomy (yes versus no). Results: The cohort included a total of 138 subjects with a mean age 58±10 years, 34% female, baseline NIHSS 18 (15-21), 46% received thrombolysis, baseline stroke volume 97 ml (84-108). The median 90-day mRS was 3 (2-4). Among these patients at 90 days, IV Glyburide was associated with better functional outcome (cOR 2.56, 95% CI 1.28-5.11, p=0.008). Conclusions: Individual patient data meta-analysis of 138 subjects enrolled in the GAMES-RP and CHARM trials show that IV Glyburide was associated with an improvement in functional outcome compared to placebo when the baseline stroke volume was ≤125 mL. This finding requires confirmation in a future clinical trial.

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