385
Views
39
CrossRef citations to date
0
Altmetric
Drug Evaluation

BIIB093 (IV glibenclamide): an investigational compound for the prevention and treatment of severe cerebral edema

, , , , , & show all
Pages 1031-1040 | Received 06 Sep 2019, Accepted 15 Oct 2019, Published online: 24 Oct 2019

References

  • Heinsius T, Bogousslavsky J, Van Melle G. Large infarcts in the middle cerebral artery territory. Etiology and outcome patterns. Neurology. 1998;50(2):341–350.
  • Hacke W, Schwab S, Horn M, et al. ‘Malignant’ middle cerebral artery territory infarction: clinical course and prognostic signs. Arch Neurol. 1996;53(4):309–315.
  • Kasner SE, Demchuk AM, Berrouschot J, et al. Predictors of fatal brain edema in massive hemispheric ischemic stroke. Stroke. 2001;32(9):2117–2123.
  • Mukherjee D, Patil CG. Epidemiology and the global burden of stroke. World Neurosurg. 2011;76(6 Suppl):S85–90.
  • Iaccarino C, Carretta A, Nicolosi F, et al. Epidemiology of severe traumatic brain injury. J Neurosurg Sci. 2018;62(5):535–541.
  • Taylor CA, Bell JM, Breiding MJ, et al. Traumatic brain injury-related emergency department visits, hospitalizations, and deaths – United States, 2007 and 2013. MMWR Surveill Summ. 2017;66(9):1–16.
  • Donkin JJ, Vink R. Mechanisms of cerebral edema in traumatic brain injury: therapeutic developments. Curr Opin Neurol. 2010;23(3):293–299.
  • Urday S, Kimberly WT, Beslow LA, et al. Targeting secondary injury in intracerebral haemorrhage–perihaematomal oedema. Nat Rev Neurol. 2015;11(2):111–122.
  • Hayman EG, Wessell A, Gerzanich V, et al. Mechanisms of global cerebral edema formation in aneurysmal subarachnoid hemorrhage. Neurocrit Care. 2017;26(2):301–310.
  • Roth P, Wick W, Weller M. Steroids in neurooncology: actions, indications, side-effects. Curr Opin Neurol. 2010;23(6):597–602.
  • Bemeur C, Cudalbu C, Dam G, et al. Brain edema: a valid endpoint for measuring hepatic encephalopathy?. Metab Brain Dis. 2016;31(6):1249–1258.
  • Kampondeni SD, Birbeck GL, Seydel KB, et al. Noninvasive measures of brain edema predict outcome in pediatric cerebral malaria. Surg Neurol Int. 2018;9(53).
  • Wijdicks EF, Sheth KN, Carter BS, et al. Recommendations for the management of cerebral and cerebellar infarction with swelling: a statement for healthcare professionals from the american heart association/american stroke association. Stroke. 2014;45(4):1222–1238.
  • Kurland DB, Khaladj-Ghom A, Stokum JA, et al. Complications associated with decompressive craniectomy: a systematic review. Neurocrit Care. 2015;23(2):292–304.
  • Das S, Mitchell P, Ross N, et al. Decompressive hemicraniectomy in the treatment of malignant middle cerebral artery infarction: a meta-analysis. World Neurosurg. 2019;123:8–16.
  • Tsaousi GG, Marocchi L, Sergi PG, et al. Early and late clinical outcomes after decompressive craniectomy for traumatic refractory intracranial hypertension: a systematic review and meta-analysis of current evidence. J Neurosurg Sci 2018. Epub ahead of print.
  • Battey TW, Karki M, Singhal AB, et al. Brain edema predicts outcome after nonlacunar ischemic stroke. Stroke. 2014;45(12):3643–3648.
  • Marble A. Glibenclamide, a new sulphonylurea: whither oral hypoglycaemic agents? Drugs. 1971;1(2):109–115.
  • Seino S. Physiology and pathophysiology of K(ATP) channels in the pancreas and cardiovascular system: a review. J Diabetes Complications. 2003;17(2 Suppl):2–5.
  • Tinker A, Aziz Q, Li Y, et al. Atp-sensitive potassium channels and their physiological and pathophysiological roles. Compr Physiol. 2018;8(4):1463–1511.
  • Szeto V, Chen NH, Sun HS, et al. The role of K ATP channels in cerebral ischemic stroke and diabetes. Acta Pharmacol Sin. 2018;39(5):683–694.
  • Simard JM, Chen M, Tarasov KV, et al. Newly expressed SUR1-regulated NC(Ca-ATP) channel mediates cerebral edema after ischemic stroke. Nat Med. 2006;12(4):433–440.
  • Woo SK, Kwon MS, Ivanov A, et al. The sulfonylurea receptor 1 (sur1)-transient receptor potential melastatin 4 (trpm4) channel. J Biol Chem. 2013;288(5):3655–3667.
  • Zhang G, Lin X, Zhang S, et al. A protective role of glibenclamide in inflammation-associated injury. Mediators Inflamm. 2017;2017:3578702.
  • Simard JM, Sheth KN, Kimberly WT, et al. Glibenclamide in cerebral ischemia and stroke. Neurocrit Care. 2014;20(2):319–333.
  • Chen M, Simard JM. Cell swelling and a nonselective cation channel regulated by internal Ca2+ and ATP in native reactive astrocytes from adult rat brain. J Neurosci. 2001;21(17):6512–6521.
  • Chen M, Dong Y, Simard JM. Functional coupling between sulfonylurea receptor type 1 and a nonselective cation channel in reactive astrocytes from adult rat brain. J Neurosci. 2003;23(24):8568–8577.
  • Woo SK, Kwon MS, Ivanov A, et al. Complex n-glycosylation stabilizes surface expression of transient receptor potential melastatin 4b protein. J Biol Chem. 2013;288(51):36409–36417.
  • Woo SK, Kwon MS, Geng Z, et al. Sequential activation of hypoxia-inducible factor 1 and specificity protein 1 is required for hypoxia-induced transcriptional stimulation of abcc8. J Cereb Blood Flow Metab. 2012;32(3):525–536.
  • Simard JM, Yurovsky V, Tsymbalyuk N, et al. Protective effect of delayed treatment with low-dose glibenclamide in three models of ischemic stroke. Stroke. 2009;40(2):604–609.
  • Simard JM, Tsymbalyuk N, Tsymbalyuk O, et al. Glibenclamide is superior to decompressive craniectomy in a rat model of malignant stroke. Stroke. 2010;41(3):531–537.
  • Simard JM, Woo SK, Tsymbalyuk N, et al. Glibenclamide-10-h treatment window in a clinically relevant model of stroke. Transl Stroke Res. 2012;3(2):286–295.
  • Wali B, Ishrat T, Atif F, et al. Glibenclamide administration attenuates infarct volume, hemispheric swelling, and functional impairments following permanent focal cerebral ischemia in rats. Stroke Res Treat. 2012;2012:460909.
  • Huang K, Gu Y, Hu Y, et al. Glibenclamide improves survival and neurologic outcome after cardiac arrest in rats. Crit Care Med. 2015;43(9):e341–349.
  • Huang K, Wang Z, Gu Y, et al. Glibenclamide is comparable to target temperature management in improving survival and neurological outcome after asphyxial cardiac arrest in rats. J Am Heart Assoc. 2016;5(7):e003465.
  • Huang K, Wang Z, Gu Y, et al. Glibenclamide prevents water diffusion abnormality in the brain after cardiac arrest in rats. Neurocrit Care. 2018;29(1):128–135.
  • Nakayama S, Taguchi N, Isaka Y, et al. Glibenclamide and therapeutic hypothermia have comparable effect on attenuating global cerebral edema following experimental cardiac arrest. Neurocrit Care. 2018;29(1):119–127.
  • Simard JM, Kilbourne M, Tsymbalyuk O, et al. Key role of sulfonylurea receptor 1 in progressive secondary hemorrhage after brain contusion. J Neurotrauma. 2009;26(12):2257–2267.
  • Patel AD, Gerzanich V, Geng Z, et al. Glibenclamide reduces hippocampal injury and preserves rapid spatial learning in a model of traumatic brain injury. J Neuropathol Exp Neurol. 2010;69(12):1177–1190.
  • Zweckberger K, Hackenberg K, Jung CS, et al. Glibenclamide reduces secondary brain damage after experimental traumatic brain injury. Neuroscience. 2014;272:199–206.
  • Xu ZM, Yuan F, Liu YL, et al. Glibenclamide attenuates blood-brain barrier disruption in adult mice after traumatic brain injury. J Neurotrauma. 2017;34(4):925–933.
  • Jha RM, Molyneaux BJ, Jackson TC, et al. Glibenclamide produces region-dependent effects on cerebral edema in a combined injury model of traumatic brain injury and hemorrhagic shock in mice. J Neurotrauma. 2018;35(17):2125–2135.
  • Kochanek PM, Bramlett HM, Dixon CE, et al. Operation brain trauma therapy: 2016 update. Mil Med. 2018;183(suppl_1):303–312.
  • Simard JM, Tsymbalyuk O, Ivanov A, et al. Endothelial sulfonylurea receptor 1-regulated NC Ca-ATP channels mediate progressive hemorrhagic necrosis following spinal cord injury. J Clin Invest. 2007;117(8):2105–2113.
  • Simard JM, Woo SK, Norenberg MD, et al. Brief suppression of abcc8 prevents autodestruction of spinal cord after trauma. Sci Transl Med. 2010;2(28):28ra29.
  • Simard JM, Popovich PG, Tsymbalyuk O, et al. Spinal cord injury with unilateral versus bilateral primary hemorrhage–effects of glibenclamide. Exp Neurol. 2012;233(2):829–835.
  • Hosier H, Peterson D, Tsymbalyuk O, et al. A direct comparison of three clinically relevant treatments in a rat model of cervical spinal cord injury. J Neurotrauma. 2015;32(21):1633–1644.
  • Simard JM, Geng Z, Woo SK, et al. Glibenclamide reduces inflammation, vasogenic edema, and caspase-3 activation after subarachnoid hemorrhage. J Cereb Blood Flow Metab. 2009;29(2):317–330.
  • Tosun C, Kurland DB, Mehta R, et al. Inhibition of the sur1-trpm4 channel reduces neuroinflammation and cognitive impairment in subarachnoid hemorrhage. Stroke. 2013;44(12):3522–3528.
  • Jiang B, Li L, Chen Q, et al. Role of glibenclamide in brain injury after intracerebral hemorrhage. Transl Stroke Res. 2017;8(2):183–193.
  • Simard PF, Tosun C, Melnichenko L, et al. Inflammation of the choroid plexus and ependymal layer of the ventricle following intraventricular hemorrhage. Transl Stroke Res. 2011;2(2):227–231.
  • Thompson EM, Pishko GL, Muldoon LL, et al. Inhibition of sur1 decreases the vascular permeability of cerebral metastases. Neoplasia. 2013;15(5):535–543.
  • Jayakumar AR, Valdes V, Tong XY, et al. Sulfonylurea receptor 1 contributes to the astrocyte swelling and brain edema in acute liver failure. Transl Stroke Res. 2014;5(1):28–37.
  • Tosun C, Koltz MT, Kurland DB, et al. The protective effect of glibenclamide in a model of hemorrhagic encephalopathy of prematurity. Brain Sci. 2013;3(1):215–238.
  • Schattling B, Steinbach K, Thies E, et al. Trpm4 cation channel mediates axonal and neuronal degeneration in experimental autoimmune encephalomyelitis and multiple sclerosis. Nat Med. 2012;18(12):1805–1811.
  • Makar TK, Gerzanich V, Nimmagadda VK, et al. Silencing of abcc8 or inhibition of newly upregulated sur1-trpm4 reduce inflammation and disease progression in experimental autoimmune encephalomyelitis. J Neuroinflammation. 2015;12:210.
  • Gerzanich V, Makar TK, Guda PR, et al. Salutary effects of glibenclamide during the chronic phase of murine experimental autoimmune encephalomyelitis. J Neuroinflammation. 2017;14(1):177.
  • Mehta RI, Ivanova S, Tosun C, et al. Sulfonylurea receptor 1 expression in human cerebral infarcts. J Neuropathol Exp Neurol. 2013;72(9):871–883.
  • Mehta RI, Tosun C, Ivanova S, et al. Sur1-trpm4 cation channel expression in human cerebral infarcts. J Neuropathol Exp Neurol. 2015;74(8):835–849.
  • Martinez-Valverde T, Vidal-Jorge M, Martinez-Saez E, et al. Sulfonylurea receptor 1 in humans with post-traumatic brain contusions. J Neurotrauma. 2015;32(19):1478–1487.
  • Castro L, Noelia M, Vidal-Jorge M, et al. Kir6.2, the pore-forming subunit of ATP-sensitive k(+) channels, is overexpressed in human posttraumatic brain contusions. J Neurotrauma. 2018;36:165–175.
  • Gerzanich V, Stokum JA, Ivanova S, et al. Sulfonylurea receptor 1, transient receptor potential cation channel subfamily m member 4, and kir6.2: role in hemorrhagic progression of contusion. J Neurotrauma. 2019;36(7):1060–1079.
  • Jha RM, Puccio AM, Chou SH, et al. Sulfonylurea receptor-1: a novel biomarker for cerebral edema in severe traumatic brain injury. Crit Care Med. 2017;45(3):e255–e264.
  • Simard JM, Woo SK, Schwartzbauer GT, et al. Sulfonylurea receptor 1 in central nervous system injury: a focused review. J Cereb Blood Flow Metab. 2012;32(9):1699–1717.
  • Simard JM, Woo SK, Gerzanich V. Transient receptor potential melastatin 4 and cell death. Pflugers Arch. 2012;464(6):573–582.
  • Simard JM, Geng Z, Silver FL, et al. Does inhibiting sur1 complement rt-pa in cerebral ischemia? Ann N Y Acad Sci. 2012;1268:95–107.
  • Wali B, Ishrat T, Atif F, et al. Glibenclamide administration attenuates infarct volume, hemispheric swelling, and functional impairments following permanent focal cerebral ischemia in rats. Stroke Res Treat. 2012;2012:1–6.
  • Gerzanich V, Kwon MS, Woo SK, et al. Sur1-trpm4 channel activation and phasic secretion of mmp-9 induced by tpa in brain endothelial cells. PLoS One. 2018;13(4):e0195526.
  • Radermecker RP, Scheen AJ. Management of blood glucose in patients with stroke. Diabetes Metab. 2010;36:S94–99.
  • King ZA, Sheth KN, Kimberly WT, et al. Profile of intravenous glyburide for the prevention of cerebral edema following large hemispheric infarction: evidence to date. Drug Des Devel Ther. 2018;12:2539–2552.
  • Sheth KN, Kimberly WT, Elm JJ, et al. Pilot study of intravenous glyburide in patients with a large ischemic stroke. Stroke. 2014;45(1):281–283.
  • Sheth KN, Elm JJ, Molyneaux BJ, et al. Safety and efficacy of intravenous glyburide on brain swelling after large hemispheric infarction (games-RP): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2016;15(11):1160–1169.
  • Eisenberg HM, Shenton ME, Pasternak O, et al. An MRI pilot study of intravenous glyburide in traumatic brain injury. J Neurotrauma. 2019. Epub ahead of print.
  • Kimberly WT, Battey TW, Pham L, et al. Glyburide is associated with attenuated vasogenic edema in stroke patients. Neurocrit Care. 2014;20(2):193–201.
  • Nedergaard M, Kraig RP, Tanabe J, et al. Dynamics of interstitial and intracellular pH in evolving brain infarct. Am J Physiol. 1991;260(3 Pt 2):R581–588.
  • Sheth KN, Kimberly WT, Elm JJ, et al. Exploratory analysis of glyburide as a novel therapy for preventing brain swelling. Neurocrit Care. 2014;21(1):43–51.
  • Davis SM, Donnan GA, Parsons MW, et al. Effects of alteplase beyond 3 h after stroke in the echoplanar imaging thrombolytic evaluation trial (epithet): a placebo-controlled randomised trial. Lancet Neurol. 2008;7(4):299–309.
  • Thomalla G, Hartmann F, Juettler E, et al. Prediction of malignant middle cerebral artery infarction by magnetic resonance imaging within 6 hours of symptom onset: a prospective multicenter observational study. Ann Neurol. 2010;68(4):435–445.
  • Montaner J, Alvarez-Sabin J, Molina C, et al. Matrix metalloproteinase expression after human cardioembolic stroke: temporal profile and relation to neurological impairment. Stroke. 2001;32(8):1759–1766.
  • Kimberly WT, Bevers MB, von Kummer R, et al. Effect of iv glyburide on adjudicated edema endpoints in the games-RP trial. Neurology. 2018;91(23):e2163–e2169.
  • Sheth KN, Petersen NH, Cheung K, et al. Long-term outcomes in patients aged</=70 years with intravenous glyburide from the phase ii games-RP study of large hemispheric infarction: an exploratory analysis. Stroke. 2018;49(6):1457–1463.
  • Vorasayan P, Bevers MB, Beslow LA, et al. Intravenous glibenclamide reduces lesional water uptake in large hemispheric infarction. Stroke. 2019. in press.
  • Lahmann C, Kramer HB, Ashcroft FM. Systemic administration of glibenclamide fails to achieve therapeutic levels in the brain and cerebrospinal fluid of rodents. PLoS One. 2015;10(7):e0134476.
  • Ekker MS, Verhoeven JI, Vaartjes I, et al. Stroke incidence in young adults according to age, subtype, sex, and time trends. Neurology. 2019;92(21):e2444–e2454.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.