Safety and efficacy of intravenous glyburide on brain swelling after large hemispheric infarction (GAMES-RP): a randomised, double-blind, placebo-controlled phase 2 trial

The Lancet Neurology

Volumn 15, Issue 11, 2016, Pages 1160-1169

  Sheth, Kevin N ^a   Elm, Jordan J ^b   Molyneaux, Bradley J ^c   Hinson, Holly ^d   Beslow, Lauren A ^a   Sze, Gordon K ^a   Ostwaldt, Ann Christin ^e   del Zoppo, Gregory J ^f   Simard, J Marc ^g   Jacobson, Sven ^h   Kimberly, W Taylor ^e  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^c UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^d OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^e MASSACHUSETTS GENERAL HOSPITAL   (United States)

^f UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^g UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^h Remedy Pharmaceuticals Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GLIBENCLAMIDE; GLUCOSE; PLACEBO; ANTIDIABETIC AGENT;

ADULT; ARTICLE; BRAIN EDEMA; BRAIN INFARCTION; CLINICAL OUTCOME; CONTROLLED STUDY; DECOMPRESSIVE CRANIECTOMY; DIFFUSION WEIGHTED IMAGING; DOUBLE BLIND PROCEDURE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ELECTROCARDIOGRAPHY; FEMALE; GLUCOSE BLOOD LEVEL; HEART ARREST; HEART DEATH; HUMAN; HYPOGLYCEMIA; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; NEUROIMAGING; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; QTC INTERVAL; RANDOMIZED CONTROLLED TRIAL; RANKIN SCALE; SIDE EFFECT; UNSPECIFIED SIDE EFFECT; AGED; CEREBRAL INFARCTION; CLINICAL TRIAL; COMPLICATION; DIAGNOSTIC IMAGING; INTRAVENOUS DRUG ADMINISTRATION; OUTCOME ASSESSMENT;

ADMINISTRATION, INTRAVENOUS; AGED; BRAIN EDEMA; CEREBRAL INFARCTION; DOUBLE-BLIND METHOD; FEMALE; GLYBURIDE; HUMANS; HYPOGLYCEMIC AGENTS; MALE; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE);

EID: 84990898443     PISSN: 14744422     EISSN: 14744465     Source Type: Journal    
DOI: 10.1016/S1474-4422(16)30196-X     Document Type: Article

References (31)

1. 1 Wijdicks, EFM, 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 45 (2014), 1222–1238.
2. 2 Torbey, MT, Bösel, J, Rhoney, DH, et al. Evidence-based guidelines for the management of large hemispheric infarction: a statement for health care professionals from the Neurocritical Care Society and the German Society for Neuro-Intensive Care and Emergency Medicine. Neurocrit Care 22 (2015), 146–164.
3. 3 Ropper, AH, Lateral displacement of the brain and level of consciousness in patients with an acute hemispheral mass. N Engl J Med 314 (1986), 953–958.
4. 4 Hacke, W, Schwab, S, Horn, M, Spranger, M, De Georgia, M, von Kummer, R, ‘Malignant’ middle cerebral artery territory infarction: clinical course and prognostic signs. Arch Neurol 53 (1996), 309–315.
5. 5 Vahedi, K, Hofmeijer, J, Juettler, E, et al. Early decompressive surgery in malignant infarction of the middle cerebral artery: a pooled analysis of three randomised controlled trials. Lancet Neurol 6 (2007), 215–222.
6. 6 Kurland, DB, Khaladj-Ghom, A, Stokum, JA, et al. Complications associated with decompressive craniectomy: a systematic review. Neurocrit Care 23 (2015), 292–304.
7. 7 Sheth, KN, Novel approaches to the primary prevention of edema after ischemia. Stroke, 44, 2013, S136.
8. 8 Simard, JM, Chen, M, Tarasov, KV, et al. Newly expressed SUR1-regulated NC(Ca-ATP) channel mediates cerebral edema after ischemic stroke. Nat Med 12 (2006), 433–440.
9. 9 Simard, JM, Tsymbalyuk, N, Tsymbalyuk, O, Ivanova, S, Yurovsky, V, Gerzanich, V, Glibenclamide is superior to decompressive craniectomy in a rat model of malignant stroke. Stroke 41 (2010), 531–537.
10. 10 Simard, JM, Sheth, KN, Kimberly, WT, et al. Glibenclamide in cerebral ischemia and stroke. Neurocrit Care 20 (2014), 319–333.
11. 11 Sheth, KN, Kimberly, WT, Elm, JJ, et al. Pilot study of intravenous glyburide in patients with a large ischemic stroke. Stroke 45 (2014), 281–283.
12. 12 Sheth, KN, Kimberly, WT, Elm, JJ, et al. Exploratory analysis of glyburide as a novel therapy for preventing brain swelling. Neurocrit Care 21 (2014), 43–51.
13. 13 Sheth, KN, Elm, JJ, Beslow, LA, Sze, GK, Kimberly, WT, Glyburide Advantage in Malignant Edema and Stroke (GAMES-RP) Trial: rationale and design. Neurocrit Care 24 (2016), 132–139.
14. 14 Sims, JR, Gharai, LR, Schaefer, PW, et al. ABC/2 for rapid clinical estimate of infarct, perfusion, and mismatch volumes. Neurology 72 (2009), 2104–2110.
15. 15 Hacke, W, Kaste, M, Bluhmki, E, et al. Thrombolysis with alteplase 3 to 4·5 hours after acute ischemic stroke. N Engl J Med 359 (2008), 1317–1329.
16. 16 Mlynash, M, Lansberg, MG, De Silva, DA, et al. Refining the definition of the malignant profile: insights from the DEFUSE-EPITHET pooled data set. Stroke 42 (2011), 1270–1275.
17. 17 Simard, JM, Woo, SK, Tsymbalyuk, N, et al. Glibenclamide-10-h treatment window in a clinically relevant model of stroke. Transl Stroke Res 3 (2012), 286–295.
18. 18 Saver, JL, Filip, B, Hamilton, S, et al. Improving the reliability of stroke disability grading in clinical trials and clinical practice: the rankin focused assessment (RFA). Stroke 41 (2010), 992–995.
19. 19 Yoo, AJ, Sheth, KN, Kimberly, WT, et al. Validating imaging biomarkers of cerebral edema in patients with severe ischemic stroke. J Stroke Cerebrovasc Dis 22 (2013), 742–749.
20. 20 Battey, TWK, Karki, M, Singhal, AB, et al. Brain edema predicts outcome after nonlacunar ischemic stroke. Stroke 45 (2014), 3643–3648.
21. 21 Kimberly, WT, Battey, TWK, Pham, L, et al. Glyburide is associated with attenuated vasogenic edema in stroke patients. Neurocrit Care 20 (2014), 193–201.
22. 22 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 7 (2008), 299–309.
23. 23 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 68 (2010), 435–445.
24. 24 Saver, JL, Optimal endpoints for acute stroke therapy trials: best ways to measure treatment effects of drugs and devices. Stroke 42 (2011), 2356–2362.
25. 25 Juttler, E, Unterberg, A, Woitzik, J, et al. Hemicraniectomy in older patients with extensive middle-cerebral-artery stroke. N Engl J Med 370 (2014), 1091–1100.
26. 26 Pullicino, PM, Alexandrov, A V, Shelton, JA, Alexandrova, NA, Smurawska, LT, Norris, JW, Mass effect and death from severe acute stroke. Neurology 49 (1997), 1090–1095.
27. 27 Foerch, C, Montaner, J, Furie, KL, Ning, MM, Lo, EH, Invited article: searching for oracles? Blood biomarkers in acute stroke. Neurology 73 (2009), 393–399.
28. 28 Serena, J, Blanco, M, Castellanos, M, et al. The prediction of malignant cerebral infarction by molecular brain barrier disruption markers. Stroke 36 (2005), 1921–1926.
29. 29 Simard, JM, Geng, Z, Silver, FL, et al. Does inhibiting Sur1 complement rt-PA in cerebral ischemia?. Ann N Y Acad Sci 1268 (2012), 95–107.
30. 30 Del Zoppo, GJ, Izawa, Y, Hawkins, BT, Hemostasis and alterations of the central nervous system. Semin Thromb Hemost 39 (2013), 856–875.
31. 31 Bassler, D, Briel, M, Montori, VM, et al. Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis. JAMA 303 (2010), 1180–1187.