Abstract P280: Safety of Off-Label Oral Glyburide in Malignant Hemispheric Infarctions: A Single-Center Quality Improvement Study

Abstract

Introduction: Following the results of the GAMES-RP trial, which showed intravenous glyburide can safely reduce cerebral edema following stroke, our center implemented a quality improvement (QI) initiative using off-label glyburide (2.5mg PO BID x 3 days) to prevent malignant cerebral edema in patients at risk. Methods: Consecutive adults > 18 years of age with large hemispheric infarction at our center (9/20/2019-6/20/2020) were treated with off-label glyburide per an institutional protocol. In this interim analysis, we report the safety (use of D50 rescue, discontinuation of drug due to hypoglycemia <55mg/dL) and efficacy outcomes (midline shift, 90-day mRS) of patients with anterior circulation infarcts, as compared to the control arm of the GAMES-RP trial using a two-sample test of proportions. Results: Seventeen patients with anterior hemispheric stroke received glyburide (mean age 71y [SD 14], median NIHSS 19 [IQR 16-24], mean initial infarct volume on head CT 122cc [SD 68]). Demographic, clinical, and radiographic findings were well-matched to GAMES-RP controls (Table), except for internal carotid artery occlusion being twice as common (63% vs 36%, p=0.07). One patient developed hypoglycemia (6%) with the need to discontinue glyburide. Treated patients had numerically less midline shift when compared to historic controls (median 4 vs. 8.5mm). Comfort measures were pursued in 9 patients (47%), permitting long-term follow-up of 8 patients for whom the median 90-day mRS was 5 (IQR 4-6, n=6). Conclusion: In this interim analysis of a single-center QI initiative, glyburide was safe. Treated patients had severe deficits and large infarcts, more than half of whom opted for comfort measures, with poor long-term functional outcomes among remaining patients. Notably, the midline shift decreased by more than 50% compared to well-matched historic controls. Off-label use of glyburide will continue to be used at our center in light of these safety profile findings.