glyburide has been researched along with Brain Swelling in 44 studies
Glyburide: An antidiabetic sulfonylurea derivative with actions like those of chlorpropamide
glyburide : An N-sulfonylurea that is acetohexamide in which the acetyl group is replaced by a 2-(5-chloro-2-methoxybenzamido)ethyl group.
| Excerpt | Relevance | Reference |
|---|---|---|
| "Preclinical models of stroke have shown that intravenous glyburide reduces brain swelling and improves survival." | 9.22 | Safety and efficacy of intravenous glyburide on brain swelling after large hemispheric infarction (GAMES-RP): a randomised, double-blind, placebo-controlled phase 2 trial. ( Beslow, LA; Del Zoppo, GJ; Elm, JJ; Hinson, H; Jacobson, S; Kimberly, WT; Molyneaux, BJ; Ostwaldt, AC; Sheth, KN; Simard, JM; Sze, GK, 2016) |
| " Blockade of this channel by the small molecule glyburide results in improved survival and neurological outcome in multiple preclinical models of ischemic stroke." | 8.93 | Human Data Supporting Glyburide in Ischemic Stroke. ( Elm, J; Kimberly, WT; Kronenberg, G; Kunte, H; Sheth, KN; Simard, JM, 2016) |
| "Intravenous glyburide has demonstrated safety when used for attenuation of cerebral edema, although safety data are lacking for enteral glyburide when used for this indication." | 8.02 | Risk Factors for Hypoglycemia with the Use of Enteral Glyburide in Neurocritical Care Patients. ( Armahizer, MJ; Howard, AK; Kalasapudi, L; Morris, NA; Sansur, C; Seung, H, 2021) |
| "Several surrogate markers of vasogenic edema appear to be reduced in the setting of IV glyburide treatment in human stroke." | 7.80 | Glyburide is associated with attenuated vasogenic edema in stroke patients. ( Battey, TW; Elm, JJ; Furie, KL; Kimberly, WT; Pham, L; Sheth, KN; Singhal, AB; Stern, BJ; Wu, O; Yoo, AJ, 2014) |
| " Here, we seek to identify pharmacodynamic markers of edema that are modified by intravenous (i." | 5.72 | Hypoxanthine is a pharmacodynamic marker of ischemic brain edema modified by glibenclamide. ( Acharjee, A; Ament, Z; Hinson, HE; Irvine, HJ; Kimberly, WT; Molyneaux, BJ; Sheth, KN; Simard, JM; Wolcott, Z, 2022) |
| "In this secondary analysis of the Glyburide Advantage in Malignant Edema and Stroke (GAMES-RP) Trial, we report the effect of IV glyburide on adjudicated, edema-related endpoints." | 5.27 | Effect of IV glyburide on adjudicated edema endpoints in the GAMES-RP Trial. ( Bevers, MB; Demchuk, AM; Elm, JJ; Hinson, HE; Kimberly, WT; Molyneaux, BJ; Romero, JM; Sheth, KN; Simard, JM; von Kummer, R, 2018) |
| "Preclinical models of stroke have shown that intravenous glyburide reduces brain swelling and improves survival." | 5.22 | Safety and efficacy of intravenous glyburide on brain swelling after large hemispheric infarction (GAMES-RP): a randomised, double-blind, placebo-controlled phase 2 trial. ( Beslow, LA; Del Zoppo, GJ; Elm, JJ; Hinson, H; Jacobson, S; Kimberly, WT; Molyneaux, BJ; Ostwaldt, AC; Sheth, KN; Simard, JM; Sze, GK, 2016) |
| " Blockade of this channel by the small molecule glyburide results in improved survival and neurological outcome in multiple preclinical models of ischemic stroke." | 4.93 | Human Data Supporting Glyburide in Ischemic Stroke. ( Elm, J; Kimberly, WT; Kronenberg, G; Kunte, H; Sheth, KN; Simard, JM, 2016) |
| "Intravenous glyburide has demonstrated safety when used for attenuation of cerebral edema, although safety data are lacking for enteral glyburide when used for this indication." | 4.02 | Risk Factors for Hypoglycemia with the Use of Enteral Glyburide in Neurocritical Care Patients. ( Armahizer, MJ; Howard, AK; Kalasapudi, L; Morris, NA; Sansur, C; Seung, H, 2021) |
| "Several surrogate markers of vasogenic edema appear to be reduced in the setting of IV glyburide treatment in human stroke." | 3.80 | Glyburide is associated with attenuated vasogenic edema in stroke patients. ( Battey, TW; Elm, JJ; Furie, KL; Kimberly, WT; Pham, L; Sheth, KN; Singhal, AB; Stern, BJ; Wu, O; Yoo, AJ, 2014) |
| " Total bolus osmotherapy dosing was quantified by "osmolar load"." | 2.94 | Osmotherapy for malignant cerebral edema in a phase 2 prospective, double blind, randomized, placebo-controlled study of IV glibenclamide. ( Demchuk, A; Hinson, HE; Molyneaux, BJ; Romero, J; Sheth, KN; Sun, E; Taylor Kimberly, W; von Kummer, R, 2020) |
| "Cerebral edema is a key contributor to death and disability in several forms of brain injury." | 2.72 | Emerging therapeutic targets for cerebral edema. ( Casabella, AM; Catapano, JS; Desai, S; Gerzanich, V; Jha, RM; Mihaljevic, S; Raikwar, SP; Rani, A; Simard, JM, 2021) |
| "Focal cerebral ischemia was induced in adult male rats by permanent middle cerebral artery occlusion (pMCAo)." | 2.66 | SUR1-TRPM4 channels, not K ( Gerzanich, V; Ivanova, S; Simard, JM; Tsymbalyuk, N; Tsymbalyuk, O; Woo, SK, 2020) |
| "Early brain injury (EBI) after subarachnoid hemorrhage (SAH) is a new therapeutic target." | 1.91 | Glibenclamide reduces secondary brain injury in a SAH rat model by reducing brain swelling and modulating inflammatory response. ( Igarashi, T; Kajimoto, R; Moro, N; Oshima, H; Otani, N; Suma, T; Yoshino, A, 2023) |
| " Here, we seek to identify pharmacodynamic markers of edema that are modified by intravenous (i." | 1.72 | Hypoxanthine is a pharmacodynamic marker of ischemic brain edema modified by glibenclamide. ( Acharjee, A; Ament, Z; Hinson, HE; Irvine, HJ; Kimberly, WT; Molyneaux, BJ; Sheth, KN; Simard, JM; Wolcott, Z, 2022) |
| "Here, in rat model of cardiac arrest with brain edema combined with neuroinflammation, GLB significantly alleviated neurocognitive deficit and neuropathological damage, via the inhibition of microglial NLRP3 inflammasome activation by blocking SUR1-TRPM4." | 1.72 | Glibenclamide Directly Prevents Neuroinflammation by Targeting SUR1-TRPM4-Mediated NLRP3 Inflammasome Activation In Microglia. ( Chang, Y; Chen, J; Gupta, S; He, Y; Huang, K; Ji, Z; Lin, Z; Liu, K; Pan, S; Peng, Y; Wang, S; Wu, Y; Zang, N; Zhu, J, 2022) |
| "Using a transient middle cerebral artery occlusion (tMCAo) rodent model of stroke, we studied two rat cohorts, one without rt-PA and a second cohort treated with rt-PA." | 1.62 | Continuous Glibenclamide Prevents Hemorrhagic Transformation in a Rodent Model of Severe Ischemia-Reperfusion. ( Igarashi, T; Kimberly, WT; Sastre, C; Wolcott, Z, 2021) |
| "Brain edema was quantified using the wet-dry method 3 days after injury." | 1.51 | Glibenclamide ameliorates the disrupted blood-brain barrier in experimental intracerebral hemorrhage by inhibiting the activation of NLRP3 inflammasome. ( He, Z; Shen, G; Su, Z; Xu, F; Yuan, L, 2019) |
| "Cerebral edema is one of the major causes of mortality following cardiac arrest (CA) and cardiopulmonary resuscitation (CPR)." | 1.48 | Glibenclamide and Therapeutic Hypothermia Have Comparable Effect on Attenuating Global Cerebral Edema Following Experimental Cardiac Arrest. ( Isaka, Y; Nakamura, T; Nakayama, S; Taguchi, N; Tanaka, M, 2018) |
| " Interspecies dosing differences versus prior studies may play an important role in these findings." | 1.48 | Glibenclamide Produces Region-Dependent Effects on Cerebral Edema in a Combined Injury Model of Traumatic Brain Injury and Hemorrhagic Shock in Mice. ( Hoshitsuki, K; Jackson, TC; Janesko-Feldman, KL; Jha, RM; Kochanek, PM; Minnigh, MB; Molyneaux, BJ; Park, SY; Poloyac, S; Vagni, VA; Wallisch, JS, 2018) |
| "Meanwhile, cerebral edema, as well as neuronal loss, was decreased in several brain areas in the GBC group." | 1.46 | Glibenclamide ameliorates cerebral edema and improves outcomes in a rat model of status epilepticus. ( Gu, Y; Hu, Y; Huang, H; Huang, K; Ji, Z; Lin, Z; Pan, S; Wang, S; Wu, Y; Yang, T, 2017) |
| "Brain edema following intracerebral hemorrhage (ICH) causes severe secondary brain injury, and no efficient pharmacological preventions are available." | 1.46 | Role of Glibenclamide in Brain Injury After Intracerebral Hemorrhage. ( Chen, Q; Chen, Z; Feng, H; Jiang, B; Li, L; Tang, J; Tao, Y; Yang, L; Zhang, B; Zhang, JH; Zhu, G, 2017) |
| "Astrocyte swelling (cytotoxic brain edema) is the major neurological complication of acute liver failure (ALF), a condition in which ammonia has been strongly implicated in its etiology." | 1.40 | Sulfonylurea receptor 1 contributes to the astrocyte swelling and brain edema in acute liver failure. ( Gonzalez, W; Jayakumar, AR; Norenberg, MD; Shamaladevi, N; Tong, XY; Valdes, V, 2014) |
| "To create HT model, right middle cerebral artery occlusion (MCAO) was conducted with intraluminal thread technique; 30 min after MCAO, 50 microL arterial blood was injected into the caudate nucleus where the infarction occurred." | 1.35 | Brain damage related to hemorrhagic transformation following cerebral ischemia and the role of K ATP channels. ( Li, LT; Yang, Y; Yin, J; Zhang, XJ, 2008) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 4 (9.09) | 29.6817 |
| 2010's | 25 (56.82) | 24.3611 |
| 2020's | 15 (34.09) | 2.80 |
| Authors | Studies |
|---|---|
| Chen, Y | 1 |
| Chen, S | 1 |
| Chang, J | 1 |
| Wei, J | 1 |
| Feng, M | 1 |
| Wang, R | 1 |
| Jha, RM | 4 |
| Raikwar, SP | 1 |
| Mihaljevic, S | 2 |
| Casabella, AM | 1 |
| Catapano, JS | 1 |
| Rani, A | 2 |
| Desai, S | 1 |
| Gerzanich, V | 6 |
| Simard, JM | 18 |
| Kajimoto, R | 2 |
| Igarashi, T | 3 |
| Moro, N | 2 |
| Oshima, H | 2 |
| Suma, T | 2 |
| Otani, N | 2 |
| Yoshino, A | 2 |
| Irvine, HJ | 1 |
| Acharjee, A | 1 |
| Wolcott, Z | 2 |
| Ament, Z | 1 |
| Hinson, HE | 3 |
| Molyneaux, BJ | 5 |
| Sheth, KN | 13 |
| Kimberly, WT | 12 |
| Shiokawa, R | 1 |
| He, Y | 1 |
| Chang, Y | 1 |
| Peng, Y | 1 |
| Zhu, J | 1 |
| Liu, K | 1 |
| Chen, J | 1 |
| Wu, Y | 4 |
| Ji, Z | 3 |
| Lin, Z | 3 |
| Wang, S | 3 |
| Gupta, S | 1 |
| Zang, N | 1 |
| Pan, S | 3 |
| Huang, K | 3 |
| Zusman, BE | 1 |
| Kochanek, PM | 2 |
| Vagni, VE | 1 |
| Janesko-Feldman, K | 1 |
| Karahalios, K | 1 |
| Raikwar, S | 1 |
| Rulney, J | 1 |
| Desai, SM | 1 |
| Catapano, J | 1 |
| Pergakis, M | 1 |
| Badjatia, N | 1 |
| Chaturvedi, S | 1 |
| Cronin, CA | 1 |
| Jacobson, SM | 1 |
| MacAllister, TW | 1 |
| Geliebter, DM | 1 |
| Woo, SK | 2 |
| Tsymbalyuk, N | 2 |
| Tsymbalyuk, O | 1 |
| Ivanova, S | 3 |
| Sun, E | 1 |
| von Kummer, R | 2 |
| Demchuk, A | 1 |
| Romero, J | 1 |
| Taylor Kimberly, W | 1 |
| Armahizer, MJ | 1 |
| Howard, AK | 1 |
| Seung, H | 1 |
| Kalasapudi, L | 1 |
| Sansur, C | 1 |
| Morris, NA | 1 |
| Sastre, C | 1 |
| Kung, TFC | 1 |
| Wilkinson, CM | 2 |
| Dirks, CA | 1 |
| Jickling, GC | 1 |
| Colbourne, F | 2 |
| Huang, H | 1 |
| Gu, Y | 3 |
| Hu, Y | 1 |
| Yang, T | 1 |
| Nakayama, S | 1 |
| Taguchi, N | 1 |
| Isaka, Y | 1 |
| Nakamura, T | 1 |
| Tanaka, M | 1 |
| Wang, Z | 1 |
| Jackson, TC | 1 |
| Wallisch, JS | 1 |
| Park, SY | 1 |
| Poloyac, S | 1 |
| Vagni, VA | 1 |
| Janesko-Feldman, KL | 1 |
| Hoshitsuki, K | 1 |
| Minnigh, MB | 1 |
| King, ZA | 1 |
| Bevers, MB | 1 |
| Demchuk, AM | 1 |
| Romero, JM | 1 |
| Elm, JJ | 6 |
| Xu, F | 1 |
| Shen, G | 1 |
| Su, Z | 1 |
| He, Z | 1 |
| Yuan, L | 1 |
| Brar, PS | 1 |
| Balay, CJ | 1 |
| Eisenberg, HM | 1 |
| Shenton, ME | 1 |
| Pasternak, O | 1 |
| Okonkwo, DO | 1 |
| Aldrich, C | 1 |
| He, F | 1 |
| Jain, S | 1 |
| Hayman, EG | 1 |
| Battey, TW | 1 |
| Pham, L | 1 |
| Wu, O | 1 |
| Yoo, AJ | 3 |
| Furie, KL | 1 |
| Singhal, AB | 1 |
| Stern, BJ | 4 |
| del Zoppo, GJ | 2 |
| Jacobson, S | 4 |
| Kent, TA | 2 |
| Mandava, P | 2 |
| Thomalla, G | 2 |
| Campbell, B | 2 |
| Donnan, GA | 2 |
| Davis, SM | 2 |
| Albers, GW | 2 |
| Khanna, A | 1 |
| Walcott, BP | 1 |
| Kahle, KT | 1 |
| Jayakumar, AR | 1 |
| Valdes, V | 1 |
| Tong, XY | 1 |
| Shamaladevi, N | 1 |
| Gonzalez, W | 1 |
| Norenberg, MD | 1 |
| Boggs, DH | 1 |
| Steven, A | 1 |
| Mehta, MP | 1 |
| del Zoppo, G | 1 |
| Zweckberger, K | 1 |
| Hackenberg, K | 1 |
| Jung, CS | 1 |
| Hertle, DN | 1 |
| Kiening, KL | 1 |
| Unterberg, AW | 1 |
| Sakowitz, OW | 1 |
| Welling, LC | 1 |
| Welling, MS | 1 |
| Teixeira, MJ | 1 |
| Figueiredo, EG | 1 |
| Beslow, LA | 2 |
| Sze, GK | 2 |
| Elm, J | 1 |
| Kronenberg, G | 1 |
| Kunte, H | 1 |
| Wu, Z | 1 |
| Zhu, SZ | 1 |
| Hu, YF | 1 |
| Wang, SN | 1 |
| Lin, ZZ | 1 |
| Xie, ZS | 1 |
| Pan, SY | 1 |
| Hankey, GJ | 1 |
| Hinson, H | 1 |
| Ostwaldt, AC | 1 |
| Jiang, B | 1 |
| Li, L | 1 |
| Chen, Q | 1 |
| Tao, Y | 1 |
| Yang, L | 1 |
| Zhang, B | 1 |
| Zhang, JH | 2 |
| Feng, H | 1 |
| Chen, Z | 1 |
| Tang, J | 2 |
| Zhu, G | 1 |
| Yang, Y | 1 |
| Zhang, XJ | 1 |
| Yin, J | 1 |
| Li, LT | 1 |
| Geng, Z | 1 |
| Tosun, C | 1 |
| Melnichenko, L | 1 |
| Zhou, Y | 1 |
| Fathali, N | 1 |
| Lekic, T | 1 |
| Chen, M | 1 |
| Tarasov, KV | 1 |
| Bhatta, S | 1 |
| Melnitchenko, L | 1 |
| West, GA | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Randomized, Multi-Center, Prospective, Double Blind, Phase II Trial of RP- 1127 (Glyburide for Injection) in Patients With a Severe Anterior Circulation Ischemic Stroke Who Are Likely to Develop Malignant Edema[NCT01794182] | Phase 2 | 86 participants (Actual) | Interventional | 2013-06-13 | Completed | ||
| A Multi-Center, Prospective, Open Label, Phase IIa Trial of RP-1127 (Glyburide for Injection) in Patients With a Severe Anterior Circulation Ischemic Stroke Who Are Likely to Experience Clinically Significant Brain Swelling.[NCT01268683] | Phase 1/Phase 2 | 10 participants (Actual) | Interventional | 2011-05-26 | Completed | ||
| Conivaptan for the Reduction of Cerebral Edema in Intracerebral Hemorrhage- A Safety and Tolerability Study[NCT03000283] | Phase 1 | 7 participants (Actual) | Interventional | 2017-03-22 | Completed | ||
| Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage (GATE-ICH): a Multi-center Randomized, Controlled, Assessor-blinded Trial[NCT03741530] | 220 participants (Actual) | Interventional | 2018-12-15 | Completed | |||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
(NCT01268683)
Timeframe: Baseline, Day 1, Day 2, and Day 3 (Day 3 reported)
| Intervention | Cm^3 (Mean) |
|---|---|
| RP-1127 (Glyburide for Injection) | 60.30 |
(NCT01268683)
Timeframe: Up to Day 3
| Intervention | Number of MRIs (Mean) |
|---|---|
| RP-1127 (Glyburide for Injection) | 3.9 |
(NCT01268683)
Timeframe: Up to Day 90
| Intervention | Number of Participants (Number) |
|---|---|
| RP-1127 (Glyburide for Injection) | 2 |
(NCT01268683)
Timeframe: Up to Day 3
| Intervention | Percentage of Participants (Number) |
|---|---|
| RP-1127 (Glyburide for Injection) | 0 |
(NCT01268683)
Timeframe: Day 1
| Intervention | Percentage of Participants (Number) |
|---|---|
| RP-1127 (Glyburide for Injection) | 5.7 |
(NCT01268683)
Timeframe: Day 90
| Intervention | Percentage of Participants (Number) |
|---|---|
| RP-1127 (Glyburide for Injection) | 80 |
(NCT01268683)
Timeframe: Up to Day 4
| Intervention | Percentage of Participants (Number) |
|---|---|
| RP-1127 (Glyburide for Injection) | 0 |
(NCT01268683)
Timeframe: Up to Day 3
| Intervention | Percentage of Participants (Number) |
|---|---|
| RP-1127 (Glyburide for Injection) | 90 |
(NCT01268683)
Timeframe: Up to Day 4
| Intervention | Percentage of Participants (Number) |
|---|---|
| RP-1127 (Glyburide for Injection) | 0 |
The number of months to enroll 10 participants. (NCT01268683)
Timeframe: Day 1
| Intervention | Months (Number) |
|---|---|
| RP-1127 (Glyburide for Injection) | 9.6 |
(NCT01268683)
Timeframe: Baseline, Day 1, Day 2, and Day 3
| Intervention | Cm^3 (Mean) | |||
|---|---|---|---|---|
| Baseline | Day 1 | Day 2 | Day 3 | |
| RP-1127 (Glyburide for Injection) | 101.76 | 141.62 | 152.31 | 169.73 |
(NCT01268683)
Timeframe: Day 1, Day 2, and Day 3
| Intervention | Number of Events (Number) | |||
|---|---|---|---|---|
| Hemorrhagic Infarction Type 1 | Hemorrhagic Infarction Type 2 | Parenchymal Hematoma Type 1 | Parenchymal Hematoma Type 2 | |
| RP-1127 (Glyburide for Injection) | 3 | 8 | 0 | 0 |
The FOUR Score is a 17-point scale (with potential scores ranging from 0 - 16). Decreasing FOUR Score is associated with worsening level of consciousness. The FOUR Score assesses four domains of neurological function: eye responses, motor responses, brainstem reflexes, and breathing pattern. (NCT01268683)
Timeframe: Baseline, Day 1, Day 2, Day 3, and Day 7
| Intervention | Score on a Scale (Mean) | ||||
|---|---|---|---|---|---|
| Baseline | Day 1 | Day 2 | Day 3 | Day 7 | |
| RP-1127 (Glyburide for Injection) | 15.1 | 14.5 | 14.6 | 14.6 | 14.8 |
The GCS is scored on a scale between 3 and 15 (3 = the worst, and 15 = best). It is composed of three parameters : Best Eye Response (scored on a scale of 1-4), Best Verbal Response (scored on a scale of 1-5), Best Motor Response (scored on a scale of 1-6) (NCT01268683)
Timeframe: Baseline, Day 1, Day 2, Day 3, and Day 7
| Intervention | Score on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Baseline | Day 1 | Day 2 | Day 3 | Day 7 | |
| RP-1127 (Glyburide for Injection) | 12.5 | 11.9 | 12.5 | 12.8 | 13.5 |
(NCT01268683)
Timeframe: Baseline, Day 1, Day 2, and Day 3
| Intervention | Centimeters cubed (cm^3) (Mean) | |||
|---|---|---|---|---|
| Baseline | Day 1 | Day 2 | Day 3 | |
| RP-1127 (Glyburide for Injection) | 135.20 | 156.78 | 165.38 | 181.71 |
(NCT01268683)
Timeframe: Baseline, Day 1, Day 2, and Day 3
| Intervention | Cm^3 (Mean) | |||
|---|---|---|---|---|
| Baseline | Day 1 | Day 2 | Day 3 | |
| RP-1127 (Glyburide for Injection) | 11.78 | 9.25 | 8.92 | 10.07 |
(NCT01268683)
Timeframe: Baseline, Day 1, Day 2, and Day 3
| Intervention | Millimeters (mm) (Mean) | |||
|---|---|---|---|---|
| Baseline | Day 1 | Day 2 | Day 3 | |
| RP-1127 (Glyburide for Injection) | 0.56 | 2.00 | 2.63 | 2.50 |
The NIHSS is composed of 11 categories, each of which is scored between 0 and 4. A score of 0 indicates normal function, a higher score indicates more impairment. Category scores are summed to generate the total NIHSS score (possibles scores range from 0-42). (NCT01268683)
Timeframe: Baseline, Day 1, Day 2, Day 3, and Day 7
| Intervention | Score on a Scale (Mean) | ||||
|---|---|---|---|---|---|
| Baseline | Day 1 | Day 2 | Day 3 | Day 7 | |
| RP-1127 (Glyburide for Injection) | 17.8 | 18.4 | 15.6 | 16.2 | 13.9 |
The mRS scale runs from 0-6, the scoring is as follows: 0 - No symptoms, 1 - No significant disability, 2 - Slight disability, 3 - Moderate disability, 4 - Moderately severe disability, 5 - Severe disability, 6 - Dead (NCT01268683)
Timeframe: Day 30, Day 90
| Intervention | Number of Participants (Number) | |
|---|---|---|
| Day 30 | Day 90 | |
| RP-1127 (Glyburide for Injection) | 9 | 8 |
Adverse Events (AE's) of special interest (cardiac events, difficulty controlling blood sugar, liver problems, and blood disorders, including anemia) will be followed for 30 days and all Severe Adverse Events (SAE's) will be followed for 90 days. SAE's and AE's were reviewed, and the number of participants with unanticipated adverse events, or drug-related SAE's were assessed. (NCT01268683)
Timeframe: Up to Day 90
| Intervention | Number of Participants (Number) | |
|---|---|---|
| Adverse Events | Serious Adverse Events | |
| RP-1127 (Glyburide for Injection) | 10 | 3 |
Changes in cerebral edema (CE) as measured on CT. Goal is a -5 to -10% change in CE over time. Change will be measured both as absolute change in volume, calculated as the final volume minus the baseline volume measure and converted to a percentage of the baseline volume measure. (NCT03000283)
Timeframe: Baseline to 168 hours post-enrollment
| Intervention | percentage of change from baseline (Mean) |
|---|---|
| Conivaptan Treatment Group | -37.1 |
Cost as measured by length of stay in the neuro ICU. (NCT03000283)
Timeframe: Enrollment through hospital discharge, up to 3 weeks
| Intervention | days (Mean) |
|---|---|
| Conivaptan Treatment Group | 14.4 |
All-cause deaths during hospitalization (NCT03000283)
Timeframe: Enrollment through hospital discharge, up to 3 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Conivaptan Treatment Group | 0 |
Modified Rankin Scale (0 to 6) at discharge from the hospital. A score of 0 indicates no disability and a score of 6 indicates the patient died. Functional independence is defined as a score of 2 or less. (NCT03000283)
Timeframe: At discharge from ICU and from hospital, up to 3 weeks
| Intervention | score on a scale (Median) |
|---|---|
| Conivaptan Treatment Group | 5 |
"Cost as measured by:~Need for external ventricular drain (EVD)/bolt or surgical procedures (craniectomy, clot evacuation,VPS) for reduction/management of CE.~Need for central venous lines, arterial lines, peripherally inserted central venous catheter (PICC) lines, tracheostomy/percutaneous endoscopic gastrostomies (PEGs).~Number of patients requiring a ventilator." (NCT03000283)
Timeframe: Baseline to 168 hours post-enrollment
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| EVD/bolt or surgical procedures | Lines or tracheostomy/PEG | Ventilator | |
| Conivaptan Treatment Group | 0 | 7 | 1 |
The number of participants with abnormal seizure activity and/or abnormal lab values and/or increase in infection rate and/or any drug-related adverse events. (NCT03000283)
Timeframe: Baseline to 168 hours post-enrollment
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| Abnormal Seizure Activity | Abnormal Lab Values | Infections | Drug-related Adverse Events | |
| Conivaptan Treatment Group | 0 | 0 | 1 | 0 |
11 reviews available for glyburide and Brain Swelling
| Article | Year |
|---|---|
Perihematomal Edema After Intracerebral Hemorrhage: An Update on Pathogenesis, Risk Factors, and Therapeutic Advances.
Topics: Brain; Brain Edema; Cerebral Hemorrhage; Glyburide; Hematoma; Humans; Hypoglycemic Agents; Magnetic | 2021 |
Emerging therapeutic targets for cerebral edema.
Topics: Brain Edema; Glyburide; Humans; Sulfonylurea Receptors; TRPM Cation Channels | 2021 |
Glibenclamide for Brain Contusions: Contextualizing a Promising Clinical Trial Design that Leverages an Imaging-Based TBI Endotype.
Topics: Brain Contusion; Brain Edema; Clinical Trials as Topic; Contusions; Glyburide; Hemorrhage; Humans; R | 2023 |
BIIB093 (IV glibenclamide): an investigational compound for the prevention and treatment of severe cerebral edema.
Topics: Administration, Intravenous; Animals; Brain Edema; Drugs, Investigational; Glyburide; Humans; Neurop | 2019 |
Found in translation: The rationale behind the early development of glibenclamide in large hemispheric infarction.
Topics: Animals; Brain Edema; Cerebral Infarction; Disease Models, Animal; Glyburide; Humans | 2020 |
SUR1-TRPM4 channels, not K
Topics: Animals; Brain Edema; Brain Ischemia; Gene Knockdown Techniques; Glyburide; KATP Channels; Male; Rat | 2020 |
Profile of intravenous glyburide for the prevention of cerebral edema following large hemispheric infarction: evidence to date.
Topics: Administration, Intravenous; Animals; Aquaporin 4; Brain; Brain Edema; Cerebral Infarction; Evidence | 2018 |
Glibenclamide in cerebral ischemia and stroke.
Topics: Animals; Brain Edema; Brain Ischemia; Glyburide; Humans; Hypoglycemic Agents; Stroke | 2014 |
Effect of glibenclamide on the prevention of secondary brain injury following ischemic stroke in humans.
Topics: Brain Diseases; Brain Edema; Brain Ischemia; Clinical Trials, Phase II as Topic; Glyburide; Humans; | 2014 |
Potential of glyburide to reduce intracerebral edema in brain metastases.
Topics: Brain Edema; Brain Neoplasms; Glyburide; Humans; Hypoglycemic Agents; Sulfonylurea Receptors | 2014 |
Human Data Supporting Glyburide in Ischemic Stroke.
Topics: Brain Edema; Fibrinolytic Agents; Glyburide; Humans; Hypoglycemic Agents; Intracranial Hemorrhages; | 2016 |
6 trials available for glyburide and Brain Swelling
| Article | Year |
|---|---|
Osmotherapy for malignant cerebral edema in a phase 2 prospective, double blind, randomized, placebo-controlled study of IV glibenclamide.
Topics: Administration, Intravenous; Aged; Brain Edema; Decompressive Craniectomy; Double-Blind Method; Fema | 2020 |
Effect of IV glyburide on adjudicated edema endpoints in the GAMES-RP Trial.
Topics: Adult; Aged; Brain Edema; Endpoint Determination; Female; Glyburide; Humans; Male; Middle Aged; Neur | 2018 |
Magnetic Resonance Imaging Pilot Study of Intravenous Glyburide in Traumatic Brain Injury.
Topics: Adult; Brain Edema; Brain Injuries, Traumatic; Cerebral Hemorrhage; Double-Blind Method; Female; Gly | 2020 |
Pilot study of intravenous glyburide in patients with a large ischemic stroke.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Brain Edema; Brain Ischemia; Comorbidity; | 2014 |
Pilot study of intravenous glyburide in patients with a large ischemic stroke.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Brain Edema; Brain Ischemia; Comorbidity; | 2014 |
Pilot study of intravenous glyburide in patients with a large ischemic stroke.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Brain Edema; Brain Ischemia; Comorbidity; | 2014 |
Pilot study of intravenous glyburide in patients with a large ischemic stroke.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Brain Edema; Brain Ischemia; Comorbidity; | 2014 |
Glyburide Advantage in Malignant Edema and Stroke (GAMES-RP) Trial: Rationale and Design.
Topics: Adult; Aged; Brain Edema; Brain Infarction; Double-Blind Method; Female; Glyburide; Humans; Hypoglyc | 2016 |
Safety and efficacy of intravenous glyburide on brain swelling after large hemispheric infarction (GAMES-RP): a randomised, double-blind, placebo-controlled phase 2 trial.
Topics: Administration, Intravenous; Aged; Brain Edema; Cerebral Infarction; Double-Blind Method; Female; Gl | 2016 |
27 other studies available for glyburide and Brain Swelling
| Article | Year |
|---|---|
Glibenclamide reduces secondary brain injury in a SAH rat model by reducing brain swelling and modulating inflammatory response.
Topics: Animals; Brain Edema; Brain Injuries; Brain Neoplasms; Cytokines; Endothelial Cells; Glyburide; Rats | 2023 |
Hypoxanthine is a pharmacodynamic marker of ischemic brain edema modified by glibenclamide.
Topics: Administration, Intravenous; Biomarkers; Brain Edema; Glyburide; Humans; Hypoxanthine; Matrix Metall | 2022 |
Glibenclamide attenuates brain edema associated with microglia activation after intracerebral hemorrhage.
Topics: Animals; Brain Edema; Cerebral Hemorrhage; Galectin 3; Glyburide; Hematoma; Microglia; Rats | 2022 |
Glibenclamide Directly Prevents Neuroinflammation by Targeting SUR1-TRPM4-Mediated NLRP3 Inflammasome Activation In Microglia.
Topics: Animals; Anti-Inflammatory Agents; Brain Edema; Glucose; Glyburide; Heart Arrest; Inflammasomes; Mal | 2022 |
Precision Effects of Glibenclamide on MRI Endophenotypes in Clinically Relevant Murine Traumatic Brain Injury.
Topics: Animals; Bayes Theorem; Brain Contusion; Brain Edema; Brain Injuries; Brain Injuries, Traumatic; Dis | 2023 |
Risk Factors for Hypoglycemia with the Use of Enteral Glyburide in Neurocritical Care Patients.
Topics: Administration, Oral; Adult; Aged; Body Mass Index; Brain Edema; Central Nervous System Neoplasms; C | 2021 |
Continuous Glibenclamide Prevents Hemorrhagic Transformation in a Rodent Model of Severe Ischemia-Reperfusion.
Topics: Animals; Brain Edema; Disease Models, Animal; Fibrinolytic Agents; Glyburide; Infarction, Middle Cer | 2021 |
Glibenclamide does not improve outcome following severe collagenase-induced intracerebral hemorrhage in rats.
Topics: Animals; Behavior, Animal; Blood-Brain Barrier; Brain Edema; Cerebral Hemorrhage; Collagenases; Dise | 2021 |
Glibenclamide ameliorates cerebral edema and improves outcomes in a rat model of status epilepticus.
Topics: Animals; Blood-Brain Barrier; Brain; Brain Edema; Cognition Disorders; Disease Models, Animal; Gene | 2017 |
Glibenclamide and Therapeutic Hypothermia Have Comparable Effect on Attenuating Global Cerebral Edema Following Experimental Cardiac Arrest.
Topics: Animals; Brain Edema; Disease Models, Animal; Glyburide; Heart Arrest; Hypoglycemic Agents; Hypother | 2018 |
Glibenclamide Prevents Water Diffusion Abnormality in the Brain After Cardiac Arrest in Rats.
Topics: Animals; Brain Edema; Diffusion Magnetic Resonance Imaging; Glyburide; Heart Arrest; Male; Neuroprot | 2018 |
Glibenclamide Produces Region-Dependent Effects on Cerebral Edema in a Combined Injury Model of Traumatic Brain Injury and Hemorrhagic Shock in Mice.
Topics: Animals; Blood Glucose; Brain Edema; Brain Injuries, Traumatic; Disease Models, Animal; Glyburide; H | 2018 |
Glibenclamide ameliorates the disrupted blood-brain barrier in experimental intracerebral hemorrhage by inhibiting the activation of NLRP3 inflammasome.
Topics: Animals; Apoptosis; Blood-Brain Barrier; Brain Edema; Cerebral Hemorrhage; Cytokines; Glyburide; Inf | 2019 |
Glibenclamide, a Sur1-Trpm4 antagonist, does not improve outcome after collagenase-induced intracerebral hemorrhage.
Topics: Animals; Behavior, Animal; Blood Glucose; Blood-Brain Barrier; Brain; Brain Edema; Cerebral Hemorrha | 2019 |
Novel approaches to the primary prevention of edema after ischemia.
Topics: ATP-Binding Cassette Transporters; Brain Edema; Brain Ischemia; Clinical Trials, Phase II as Topic; | 2013 |
Glyburide is associated with attenuated vasogenic edema in stroke patients.
Topics: Adult; Aged; Biomarkers; Brain Edema; Brain Ischemia; Case-Control Studies; Clinical Trials as Topic | 2014 |
Sulfonylurea receptor 1 contributes to the astrocyte swelling and brain edema in acute liver failure.
Topics: Ammonia; Animals; Astrocytes; Brain Edema; Cell Size; Cells, Cultured; Glyburide; Hypoglycemic Agent | 2014 |
Exploratory analysis of glyburide as a novel therapy for preventing brain swelling.
Topics: Adult; Aged; Brain Edema; Brain Infarction; Clinical Trials, Phase II as Topic; Diffusion Magnetic R | 2014 |
Glibenclamide reduces secondary brain damage after experimental traumatic brain injury.
Topics: Animals; Brain Edema; Brain Injuries; Disease Models, Animal; Electroencephalography; Glyburide; Int | 2014 |
Glibenclamide for acute brain edema. Is the good news coming?
Topics: Animals; Brain Edema; Glyburide; Humans; Hypoglycemic Agents; Rats; Rats, Sprague-Dawley; Sulfonylur | 2015 |
Glibenclamide enhances the effects of delayed hypothermia after experimental stroke in rats.
Topics: Animals; Blood-Brain Barrier; Brain Edema; Cyclooxygenase 2; Encephalitis; Glyburide; Hyperthermia, | 2016 |
Glyburide for cerebral oedema: could an old dog have a new trick?
Topics: Brain Edema; Glyburide; Humans | 2016 |
Role of Glibenclamide in Brain Injury After Intracerebral Hemorrhage.
Topics: Animals; Blood Glucose; Blood-Brain Barrier; Brain Edema; Cerebral Hemorrhage; Endothelium; Glyburid | 2017 |
Brain damage related to hemorrhagic transformation following cerebral ischemia and the role of K ATP channels.
Topics: Adenosine Triphosphatases; Animals; Brain; Brain Edema; Brain Infarction; Brain Ischemia; Cerebral H | 2008 |
Glibenclamide reduces inflammation, vasogenic edema, and caspase-3 activation after subarachnoid hemorrhage.
Topics: Animals; ATP-Binding Cassette Transporters; Blood-Brain Barrier; Brain Edema; Carotid Artery Injurie | 2009 |
Glibenclamide improves neurological function in neonatal hypoxia-ischemia in rats.
Topics: Animals; Animals, Newborn; ATP-Binding Cassette Transporters; Behavior, Animal; Blood Glucose; Brain | 2009 |
Newly expressed SUR1-regulated NC(Ca-ATP) channel mediates cerebral edema after ischemic stroke.
Topics: Adenosine Triphosphate; Animals; Astrocytes; ATP-Binding Cassette Transporters; Brain Edema; Brain I | 2006 |