Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/34442
Title: Management of Poststroke Hyperglycemia: Results of the TEXAIS Randomized Clinical Trial.
Austin Authors: Bladin, Christopher F;Wah Cheung, Ngai;Dewey, Helen M;Churilov, Leonid ;Middleton, Sandy;Thijs, Vincent N ;Ekinci, Elif I ;Levi, Christopher R;Lindley, Richard;Donnan, Geoffrey A ;Parsons, Mark W;Meretoja, Atte;Tiainen, Marjaana;Choi, Philip M C;Cordato, Dennis;Brown, Helen;Campbell, Bruce C V;Davis, Stephen M;Cloud, Geoffrey;Grimley, Rohan;Lee-Archer, Matthew;Ghia, Darshan;Sanders, Lauren;Markus, Romesh;Muller, Claire;Salvaris, Patrick;Wu, Teddy;Fink, John
Affiliation: Department of Neurosciences, Eastern Health and Eastern Health Clinical School, Department of Neurology, Monash University, Clayton, Victoria, Australia (C.F.B., H.M.D., P.M.C.C.).;The Florey Institute of Neuroscience and Mental Health (C.F.B., V.T., B.C.V.C.), University of Melbourne, Parkville, Australia.
Faculty of Medicine and Health, Westmead Hospital (N.W.C.), University of Sydney, New South Wales, Australia.
Department of Neurosciences, Eastern Health and Eastern Health Clinical School, Department of Neurology, Monash University, Clayton, Victoria, Australia (C.F.B., H.M.D., P.M.C.C.).
Department of Medicine (L.C.), University of Melbourne, Parkville, Australia.;Australian Centre for Accelerating Diabetes Innovations (L.C., E.E.), University of Melbourne, Parkville, Australia.
Nursing Research Institute, St Vincent's Health Network Sydney, St Vincent's Hospital Melbourne and School of Nursing, Midwifery and Paramedicine, Australian Catholic University, Sydney, Australia (S.M.).
The Florey Institute of Neuroscience and Mental Health (C.F.B., V.T., B.C.V.C.), University of Melbourne, Parkville, Australia.
Australian Centre for Accelerating Diabetes Innovations (L.C., E.E.), University of Melbourne, Parkville, Australia.;Austin Health, Australia (L.C., E.E.).
Department of Neurology, Priority Research Centre for Brain and Mental Health Research, John Hunter Hospital, University of Newcastle, Newcastle, Australia (C.R.L.).
Faculty of Medicine and Health, Sydney Medical School (R.L.), University of Sydney, New South Wales, Australia.;George Institute for Global Health, Sydney, Australia (R.L.).
Department of Medicine and Neurology, Melbourne Brain Centre, Royal Melbourne Hospital (G.A.D., B.C.V.C., S.M.D), University of Melbourne, Parkville, Australia.
Department of Neurology, Ingham Institute for Applied Medical Research, Liverpool Hospital, University of New South Wales, Sydney, Australia (M.W.P., D.C.).
Austin Health
Department of Neurology, Helsinki University Hospital, Finland (A.M., M.T.).
Department of Neurosciences, Eastern Health and Eastern Health Clinical School, Department of Neurology, Monash University, Clayton, Victoria, Australia (C.F.B., H.M.D., P.M.C.C.).
Department of Neurology, Ingham Institute for Applied Medical Research, Liverpool Hospital, University of New South Wales, Sydney, Australia (M.W.P., D.C.).
Princess Alexandra Hospital, Brisbane, Queensland, Australia (H.B.).
The Florey Institute of Neuroscience and Mental Health (C.F.B., V.T., B.C.V.C.), University of Melbourne, Parkville, Australia.;Department of Medicine and Neurology, Melbourne Brain Centre, Royal Melbourne Hospital (G.A.D., B.C.V.C., S.M.D), University of Melbourne, Parkville, Australia.
Department of Medicine and Neurology, Melbourne Brain Centre, Royal Melbourne Hospital (G.A.D., B.C.V.C., S.M.D), University of Melbourne, Parkville, Australia.
School of Medicine and Dentistry, Griffith University, Birtinya, Queensland, Australia (R.G.).
Department of Neurology, Launceston General Hospital, Tasmania, Australia (M.L.-A.).
Department of Neurology, Fiona Stanley Hospital, Perth, Western Australia, Australia (D.G.).
Department of Neurosciences, St Vincent's Hospital, Melbourne, Australia (L.S.).
Department of Neurology, St Vincent's Hospital, Sydney, Australia (R.M.).
Department of Neurology, Royal Brisbane and Women's Hospital, University of Queensland, Brisbane, Australia (C.M.).
Department of Medicine, St John of God Midland Public and Private Hospitals, Perth, Western Australia (P.S.).
Department of Neurology, Christchurch Hospital, New Zealand (T.W., J.F.).
Issue Date: Dec-2023
Date: 2023
Publication information: Stroke 2023-12; 54(12)
Abstract: Hyperglycemia in acute ischemic stroke reduces the efficacy of stroke thrombolysis and thrombectomy, with worse clinical outcomes. Insulin-based therapies are difficult to implement and may cause hypoglycemia. We investigated whether exenatide, a GLP-1 (glucagon-like peptide-1) receptor agonist, would improve stroke outcomes, and control poststroke hyperglycemia with minimal hypoglycemia. The TEXAIS trial (Treatment With Exenatide in Acute Ischemic Stroke) was an international, multicenter, phase 2 prospective randomized clinical trial (PROBE [Prospective Randomized Open Blinded End-Point] design) enrolling adult patients with acute ischemic stroke ≤9 hours of stroke onset to receive exenatide (5 µg BID subcutaneous injection) or standard care for 5 days, or until hospital discharge (whichever sooner). The primary outcome (intention to treat) was the proportion of patients with ≥8-point improvement in National Institutes of Health Stroke Scale score (or National Institutes of Health Stroke Scale scores 0-1) at 7 days poststroke. Safety outcomes included death, episodes of hyperglycemia, hypoglycemia, and adverse event. From April 2016 to June 2021, 350 patients were randomized (exenatide, n=177, standard care, n=173). Median age, 71 years (interquartile range, 62-79), median National Institutes of Health Stroke Scale score, 4 (interquartile range, 2-8). Planned recruitment (n=528) was stopped early due to COVID-19 disruptions and funding constraints. The primary outcome was achieved in 97 of 171 (56.7%) in the standard care group versus 104 of 170 (61.2%) in the exenatide group (adjusted odds ratio, 1.22 [95% CI, 0.79-1.88]; P=0.38). No differences in secondary outcomes were observed. The per-patient mean daily frequency of hyperglycemia was significantly less in the exenatide group across all quartiles. No episodes of hypoglycemia were recorded over the treatment period. Adverse events of mild nausea and vomiting occurred in 6 (3.5%) exenatide patients versus 0 (0%) standard care with no withdrawal. Treatment with exenatide did not reduce neurological impairment at 7 days in patients with acute ischemic stroke. Exenatide did significantly reduce the frequency of hyperglycemic events, without hypoglycemia, and was safe to use. Larger acute stroke trials using GLP-1 agonists such as exenatide should be considered. URL: www.australianclinicaltrials.gov.au; Unique identifier: ACTRN12617000409370. URL: https://www.clinicaltrials.gov; Unique identifier: NCT03287076.
URI: https://ahro.austin.org.au/austinjspui/handle/1/34442
DOI: 10.1161/STROKEAHA.123.044568
ORCID: 0000-0002-1729-0855
0000-0001-6323-8006
0000-0001-9484-2070
0000-0002-9807-6606
0000-0002-6614-8417
0000-0003-2372-395X
0000-0002-9474-796X
0000-0002-0104-5679
0000-0001-6324-3403
0000-0001-8874-2487
0000-0001-6433-1931
0000-0001-5107-1990
0000-0003-0339-3439
0000-0001-8447-6644
0000-0001-9142-2708
0000-0003-3632-9433
0000-0003-0962-2300
0000-0002-8365-6907
0000-0002-7006-6908
0000-0003-0518-5887
0000-0001-6420-0181
0000-0002-3664-3353
0000-0002-9250-936X
0009-0008-9928-5750
0000-0003-1845-1769
Journal: Stroke
Start page: 2962
End page: 2971
PubMed URL: 38011235
ISSN: 1524-4628
Type: Journal Article
Subjects: exenatide
hyperglycemia
ischemic stroke
stroke
thrombectomy
Exenatide/therapeutic use
Ischemic Stroke/complications
Stroke/complications
Stroke/drug therapy
Hyperglycemia/drug therapy
Hyperglycemia/complications
Hypoglycemia/complications
Glucagon-Like Peptide 1/therapeutic use
Appears in Collections:Journal articles

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