Effect of IV glyburide on adjudicated edema endpoints in the GAMES-RP Trial

Objective: In this secondary analysis of the GAMES-RP trial, we report the effect of IV glyburide on adjudicated, edema-related endpoints.
Methods: Blinded adjudicators assigned designations for hemorrhagic transformation, neurological deterioration, malignant edema and edema-related death to patients from the GAMES-RP Phase II randomized controlled trial of IV glyburide for large hemispheric infarct. Rates of these endpoints were compared between treatment arms in the per-protocol sample. In those participants with malignant edema, the effects of treatment on additional markers of edema and clinical determiration were examined. Results: In the per-protocol sample, 41 patients received glyburide and 36 received placebo. There was no difference in the frequency of hemorrhagic transformation [n=24 (58.5%) in IV glyburide versus n=23 (63.9%) in placebo, p=0.91], or the incidence of malignant edema [n=19 (46%) in IV glyburide versus n=17 (47%) in placebo, p=0.94]. However, treatment with I...