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Exploratory Analysis of Glyburide as a Novel Therapy for Preventing Brain Swelling

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Exploratory Analysis of Glyburide as a Novel Therapy for Preventing Brain Swelling. / Sheth, Kevin N; Taylor Kimberly, W; Elm, Jordan J; Kent, Thomas A; Yoo, Albert J; Thomalla, Götz; Campbell, Bruce; Donnan, Geoffrey A; Davis, Stephen M; Albers, Gregory W; Jacobson, Sven; Del Zoppo, Gregory; Marc Simard, J; Stern, Barney J; Mandava, Pitchaiah.

In: NEUROCRIT CARE, Vol. 21, No. 1, 2014, p. 43-51.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Sheth, KN, Taylor Kimberly, W, Elm, JJ, Kent, TA, Yoo, AJ, Thomalla, G, Campbell, B, Donnan, GA, Davis, SM, Albers, GW, Jacobson, S, Del Zoppo, G, Marc Simard, J, Stern, BJ & Mandava, P 2014, 'Exploratory Analysis of Glyburide as a Novel Therapy for Preventing Brain Swelling', NEUROCRIT CARE, vol. 21, no. 1, pp. 43-51. https://doi.org/10.1007/s12028-014-9970-2

APA

Sheth, K. N., Taylor Kimberly, W., Elm, J. J., Kent, T. A., Yoo, A. J., Thomalla, G., Campbell, B., Donnan, G. A., Davis, S. M., Albers, G. W., Jacobson, S., Del Zoppo, G., Marc Simard, J., Stern, B. J., & Mandava, P. (2014). Exploratory Analysis of Glyburide as a Novel Therapy for Preventing Brain Swelling. NEUROCRIT CARE, 21(1), 43-51. https://doi.org/10.1007/s12028-014-9970-2

Vancouver

Sheth KN, Taylor Kimberly W, Elm JJ, Kent TA, Yoo AJ, Thomalla G et al. Exploratory Analysis of Glyburide as a Novel Therapy for Preventing Brain Swelling. NEUROCRIT CARE. 2014;21(1):43-51. https://doi.org/10.1007/s12028-014-9970-2

Bibtex

@article{aedd6aa5cc1343fda1f3777b9bb229ee,
title = "Exploratory Analysis of Glyburide as a Novel Therapy for Preventing Brain Swelling",
abstract = "BACKGROUND: Malignant infarction is characterized by the formation of cerebral edema, and medical treatment is limited. Preclinical data suggest that glyburide, an inhibitor of SUR1-TRPM4, is effective in preventing edema. We previously reported feasibility of the GAMES-Pilot study, a two-center prospective, open label, phase IIa trial of 10 subjects at high risk for malignant infarction based on diffusion weighted imaging (DWI) threshold of 82 cm(3) treated with RP-1127 (glyburide for injection). In this secondary analysis, we tested the hypothesis that RP-1127 may be efficacious in preventing poor outcome when compared to controls.METHODS: Controls suffering large hemispheric infarction were obtained from the EPITHET and MMI-MRI studies. We first screened subjects for controls with the same DWI threshold used for enrollment into GAMES-Pilot, 82 cm(3). Next, to address imbalances, we applied a weighted Euclidean matching. Ninety day mRS 0-4, rate of decompressive craniectomy, and mortality were the primary clinical outcomes of interest.RESULTS: The mean age of the GAMES cohort was 51 years and initial DWI volume was 102 ± 23 cm(3). After Euclidean matching, GAMES subjects showed similar NIHSS, higher DWI volume, younger age and had mRS 0-4-90 % versus 50 % in controls p = 0.049; with a similar trend in mRS 0-3 (40 vs. 25 %; p = 0.43) and trend toward lower mortality (10 vs. 35 %; p = 0.21).CONCLUSIONS: In this pilot study, RP-1127-treated subjects showed better clinical outcomes when compared to historical controls. An adequately powered and randomized phase II trial of patients at risk for malignant infarction is needed to evaluate the potential efficacy of RP-1127.",
author = "Sheth, {Kevin N} and {Taylor Kimberly}, W and Elm, {Jordan J} and Kent, {Thomas A} and Yoo, {Albert J} and G{\"o}tz Thomalla and Bruce Campbell and Donnan, {Geoffrey A} and Davis, {Stephen M} and Albers, {Gregory W} and Sven Jacobson and {Del Zoppo}, Gregory and {Marc Simard}, J and Stern, {Barney J} and Pitchaiah Mandava",
year = "2014",
doi = "10.1007/s12028-014-9970-2",
language = "English",
volume = "21",
pages = "43--51",
journal = "NEUROCRIT CARE",
issn = "1541-6933",
publisher = "Humana Press",
number = "1",

}

RIS

TY - JOUR

T1 - Exploratory Analysis of Glyburide as a Novel Therapy for Preventing Brain Swelling

AU - Sheth, Kevin N

AU - Taylor Kimberly, W

AU - Elm, Jordan J

AU - Kent, Thomas A

AU - Yoo, Albert J

AU - Thomalla, Götz

AU - Campbell, Bruce

AU - Donnan, Geoffrey A

AU - Davis, Stephen M

AU - Albers, Gregory W

AU - Jacobson, Sven

AU - Del Zoppo, Gregory

AU - Marc Simard, J

AU - Stern, Barney J

AU - Mandava, Pitchaiah

PY - 2014

Y1 - 2014

N2 - BACKGROUND: Malignant infarction is characterized by the formation of cerebral edema, and medical treatment is limited. Preclinical data suggest that glyburide, an inhibitor of SUR1-TRPM4, is effective in preventing edema. We previously reported feasibility of the GAMES-Pilot study, a two-center prospective, open label, phase IIa trial of 10 subjects at high risk for malignant infarction based on diffusion weighted imaging (DWI) threshold of 82 cm(3) treated with RP-1127 (glyburide for injection). In this secondary analysis, we tested the hypothesis that RP-1127 may be efficacious in preventing poor outcome when compared to controls.METHODS: Controls suffering large hemispheric infarction were obtained from the EPITHET and MMI-MRI studies. We first screened subjects for controls with the same DWI threshold used for enrollment into GAMES-Pilot, 82 cm(3). Next, to address imbalances, we applied a weighted Euclidean matching. Ninety day mRS 0-4, rate of decompressive craniectomy, and mortality were the primary clinical outcomes of interest.RESULTS: The mean age of the GAMES cohort was 51 years and initial DWI volume was 102 ± 23 cm(3). After Euclidean matching, GAMES subjects showed similar NIHSS, higher DWI volume, younger age and had mRS 0-4-90 % versus 50 % in controls p = 0.049; with a similar trend in mRS 0-3 (40 vs. 25 %; p = 0.43) and trend toward lower mortality (10 vs. 35 %; p = 0.21).CONCLUSIONS: In this pilot study, RP-1127-treated subjects showed better clinical outcomes when compared to historical controls. An adequately powered and randomized phase II trial of patients at risk for malignant infarction is needed to evaluate the potential efficacy of RP-1127.

AB - BACKGROUND: Malignant infarction is characterized by the formation of cerebral edema, and medical treatment is limited. Preclinical data suggest that glyburide, an inhibitor of SUR1-TRPM4, is effective in preventing edema. We previously reported feasibility of the GAMES-Pilot study, a two-center prospective, open label, phase IIa trial of 10 subjects at high risk for malignant infarction based on diffusion weighted imaging (DWI) threshold of 82 cm(3) treated with RP-1127 (glyburide for injection). In this secondary analysis, we tested the hypothesis that RP-1127 may be efficacious in preventing poor outcome when compared to controls.METHODS: Controls suffering large hemispheric infarction were obtained from the EPITHET and MMI-MRI studies. We first screened subjects for controls with the same DWI threshold used for enrollment into GAMES-Pilot, 82 cm(3). Next, to address imbalances, we applied a weighted Euclidean matching. Ninety day mRS 0-4, rate of decompressive craniectomy, and mortality were the primary clinical outcomes of interest.RESULTS: The mean age of the GAMES cohort was 51 years and initial DWI volume was 102 ± 23 cm(3). After Euclidean matching, GAMES subjects showed similar NIHSS, higher DWI volume, younger age and had mRS 0-4-90 % versus 50 % in controls p = 0.049; with a similar trend in mRS 0-3 (40 vs. 25 %; p = 0.43) and trend toward lower mortality (10 vs. 35 %; p = 0.21).CONCLUSIONS: In this pilot study, RP-1127-treated subjects showed better clinical outcomes when compared to historical controls. An adequately powered and randomized phase II trial of patients at risk for malignant infarction is needed to evaluate the potential efficacy of RP-1127.

U2 - 10.1007/s12028-014-9970-2

DO - 10.1007/s12028-014-9970-2

M3 - SCORING: Journal article

C2 - 24671831

VL - 21

SP - 43

EP - 51

JO - NEUROCRIT CARE

JF - NEUROCRIT CARE

SN - 1541-6933

IS - 1

ER -