Medical principles and practice : international journal of the Kuwait University, Health Science Centre · 2025
Efficacy and Safety of Glibenclamide on Functional Outcomes and Cerebral Edema following Ischemic and Hemorrhagic Stroke: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
СтатьяСистематический обзорМетаанализНазвание и аннотация: Перевод пока не подготовлен
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Hegazi Amir, Mohamed Rashad G, Kashbour Muataz, Hussien Hussien O, Amin Ahmed Mostafa, Kassar Omar, Nashwan Abdulqadir J, Abouelmagd Moaz Elsayed
Аннотация
UNLABELLED: <p>Objective: This systematic review and meta-analysis aimed to evaluate the clinical and radiological outcomes of glibenclamide versus control in acute stroke.
METHODS: In accordance with PRISMA guidelines, a comprehensive literature search was conducted to identify relevant studies up to January 15, 2025. Efficacy outcomes included modified Rankin Scale (mRS) score at 3 and 6 months, Barthel index, midline shift at 72-96 h, serum matrix metalloproteinase-9 levels, and decompressive craniectomy. Safety analysis assessed the incidence of hypoglycemia, mortality, and serious adverse events (SAEs).
RESULTS: A total of seven randomized controlled trials involving 1,225 patients were included in the meta-analysis. No statistically significant differences were observed in the efficacy outcomes in the pooled analysis. In subgroup analysis of mRS, glibenclamide was superior in intracerebral hemorrhage (mean difference [MD] = -0.67, 95% confidence interval [CI] [-1, -0.34], p value <0.0001) but not ischemic or subarachnoid hemorrhage subtypes (MD = -0.03, 95% CI [-0.34, 0.28], p value = 0.86) and (MD = 0.06, 95% CI [-0.6, 0.71], p value = 0.86), respectively. In terms of safety, there were no significant differences in SAE or mortality (odds ratio [OR] = 1.34, 95% CI [0.99, 1.8], p value = 0.06) and (OR = 0.67, 95% CI [0.31, 1.45], p value = 0.31), respectively. However, glibenclamide was associated with an increased risk of hypoglycemia (OR = 5.03, 95% CI [2.17, 11.66], p value = 0.0002).
CONCLUSION: The use of glibenclamide did not demonstrate improved outcomes in patients with acute stroke. However, real-time pharmacokinetic monitoring, identifying optimal administration route, and patient subgroups, which may potentially benefit from glibenclamide are essential before the drug's efficacy can be conclusively determined. </p>.
METHODS: In accordance with PRISMA guidelines, a comprehensive literature search was conducted to identify relevant studies up to January 15, 2025. Efficacy outcomes included modified Rankin Scale (mRS) score at 3 and 6 months, Barthel index, midline shift at 72-96 h, serum matrix metalloproteinase-9 levels, and decompressive craniectomy. Safety analysis assessed the incidence of hypoglycemia, mortality, and serious adverse events (SAEs).
RESULTS: A total of seven randomized controlled trials involving 1,225 patients were included in the meta-analysis. No statistically significant differences were observed in the efficacy outcomes in the pooled analysis. In subgroup analysis of mRS, glibenclamide was superior in intracerebral hemorrhage (mean difference [MD] = -0.67, 95% confidence interval [CI] [-1, -0.34], p value <0.0001) but not ischemic or subarachnoid hemorrhage subtypes (MD = -0.03, 95% CI [-0.34, 0.28], p value = 0.86) and (MD = 0.06, 95% CI [-0.6, 0.71], p value = 0.86), respectively. In terms of safety, there were no significant differences in SAE or mortality (odds ratio [OR] = 1.34, 95% CI [0.99, 1.8], p value = 0.06) and (OR = 0.67, 95% CI [0.31, 1.45], p value = 0.31), respectively. However, glibenclamide was associated with an increased risk of hypoglycemia (OR = 5.03, 95% CI [2.17, 11.66], p value = 0.0002).
CONCLUSION: The use of glibenclamide did not demonstrate improved outcomes in patients with acute stroke. However, real-time pharmacokinetic monitoring, identifying optimal administration route, and patient subgroups, which may potentially benefit from glibenclamide are essential before the drug's efficacy can be conclusively determined. </p>.