دورية أكاديمية

Management of Poststroke Hyperglycemia: Results of the TEXAIS Randomized Clinical Trial

التفاصيل البيبلوغرافية
العنوان: Management of Poststroke Hyperglycemia: Results of the TEXAIS Randomized Clinical Trial
المؤلفون: Bladin, Christopher F., Wah Cheung, Ngai, Dewey, Helen M., Churilov, Leonid, Middleton, Sandy, Thijs, Vincent, Ekinci, Elif, 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
المصدر: Stroke ; volume 54, issue 12, page 2962-2971 ; ISSN 0039-2499 1524-4628
بيانات النشر: Ovid Technologies (Wolters Kluwer Health)
سنة النشر: 2023
الوصف: BACKGROUND: 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. METHODS: 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. RESULTS: 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 ...
نوع الوثيقة: article in journal/newspaper
اللغة: English
DOI: 10.1161/strokeaha.123.044568
DOI: 10.1161/STROKEAHA.123.044568
الإتاحة: https://doi.org/10.1161/strokeaha.123.044568Test
حقوق: https://creativecommons.org/licenses/by-nc-nd/4.0Test/
رقم الانضمام: edsbas.2FE22E8B
قاعدة البيانات: BASE