Abstract Details

Title Safety of Off-label Oral Glyburide in Malignant Hemispheric Infarctions: A Single-center Quality Improvement Study

Topic Cerebrovascular Disease and Interventional Neurology

Presentation(s) Cerebrovascular Disease and Interventional Neurology Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 116

Objective To investigate the safety of glyburide in large hemispheric infarcts, estimated risk reduction of edema formation, and long-term outcomes

Background 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.

Design/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 <50mg/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 of 71 years [SD 14], median NIHSS 19 [IQR 16-24], mean initial infarct volume on head CT of 122cc [SD 68]). Demographic, clinical, and radiographic findings were well-matched to GAMES-RP controls, except for the presence of 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).

Conclusions 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.

Authors/Disclosures
PRESENTER	No disclosure on file
Jesse Thon, MD (Cooper University Hospital)	An immediate family member of Dr. Thon has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Horizon. An immediate family member of Dr. Thon has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. An immediate family member of Dr. Thon has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Genentech.
	No disclosure on file
Ameena Rana, MD (Mount Sinai Health System)	Dr. Rana has nothing to disclose.
Ryna Then, MD, F�鶹��ýӳ�� (Jefferson Einstein Philadelphia Hospital)	Dr. Then has nothing to disclose.
Tudor G. Jovin, MD (Cooper University Healthcare)	Dr. Jovin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cerenovus. Dr. Jovin has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Contego Medical. Dr. Jovin has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Several law firms. Dr. Jovin has stock in Corindus. Dr. Jovin has stock in Methinks. Dr. Jovin has stock in Viz.ai. Dr. Jovin has stock in Route92. Dr. Jovin has stock in FreeOx Biotech. Dr. Jovin has stock in Galaxy. Dr. Jovin has stock in Kandu. The institution of Dr. Jovin has received research support from Stryker. The institution of Dr. Jovin has received research support from Medtronic.
James E. Siegler III, MD (University of Chicago)	Dr. Siegler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Siegler has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bayer. Dr. Siegler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Serb. Dr. Siegler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ceribell. Dr. Siegler has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Wallaby Phenox. Dr. Siegler has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Stroke: Vascular and Interventional Neurology. Dr. Siegler has received personal compensation in the range of $50,000-$99,999 for serving as an Expert Witness for Precision Medicine, LLC. The institution of Dr. Siegler has received research support from Philips. The institution of Dr. Siegler has received research support from Medtronic.

�鶹��ýӳ��

�鶹��ýӳ��