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Background <p>Stroke is a significant cause of morbidity and mortality worldwide, with cerebral edema being a major complication. Glibenclamide, a SUR1-TRPM4 channel inhibitor, has been proposed to reduce cerebral edema, but its clinical efficacy remains uncertain. This meta-analysis aimed to evaluate the efficacy and safety of glibenclamide in patients with stroke, including acute ischemic stroke, acute subarachnoid hemorrhage, and intracerebral hemorrhage.</p> Methods <p>A comprehensive literature search was conducted in PubMed, Web of Science, and Scopus up to January 2025. The primary efficacy outcomes included excellent (modified Rankin Scale [mRS] score 0–1) and good (mRS score 0–2) functional outcomes at 90&#xa0;days. Safety outcomes included the incidence of hypoglycemia and decompressive craniectomy. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation approach.</p> Results <p>Ten and eight randomized controlled trials (RCTs) were included in our qualitative and quantitative analysis, respectively, encompassing 1,691 participants aged 18 to 85. No significant difference was observed between the glibenclamide and control groups regarding excellent functional outcome (risk ratio [RR] 1.10, 95% confidence interval [CI] 0.92–1.32, <i>P</i> = 0.29) and good functional outcome (RR 1.07, 95% CI 0.96–1.18, <i>P</i> = 0.22). Safety analysis revealed no significant increase in serious adverse events (RR 1.11, 95% CI 1.00–1.23, <i>P</i> = 0.06). Notably, hypoglycemia incidence after sensitivity analysis was higher in the glibenclamide group (RR 4.56, 95% CI 2.07–10.03, <i>P</i> = 0.0002).</p> Conclusions <p>Glibenclamide did not significantly improve functional outcomes or reduce mortality in stroke patients but was associated with a higher incidence of hypoglycemia. Further well-designed RCTs are needed to clarify its therapeutic role and optimize safety protocols.</p> <p><i>Clinical trial registration</i>: PROSPERO registration number: CRD420251008350.</p>

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The Efficacy and Safety of Glibenclamide in Improving Cerebral Edema and Neurological Outcomes in Stroke: a GRADE-Evaluated Systematic Review and Meta-analysis with Subgroup Analysis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月8日

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  • Hazem E. Mohammed,
  • Mohamed E. Haseeb,
  • Zeyad Bady,
  • Mohamed Nasser,
  • Mostafa Meshref

摘要

Background

Stroke is a significant cause of morbidity and mortality worldwide, with cerebral edema being a major complication. Glibenclamide, a SUR1-TRPM4 channel inhibitor, has been proposed to reduce cerebral edema, but its clinical efficacy remains uncertain. This meta-analysis aimed to evaluate the efficacy and safety of glibenclamide in patients with stroke, including acute ischemic stroke, acute subarachnoid hemorrhage, and intracerebral hemorrhage.

Methods

A comprehensive literature search was conducted in PubMed, Web of Science, and Scopus up to January 2025. The primary efficacy outcomes included excellent (modified Rankin Scale [mRS] score 0–1) and good (mRS score 0–2) functional outcomes at 90 days. Safety outcomes included the incidence of hypoglycemia and decompressive craniectomy. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation approach.

Results

Ten and eight randomized controlled trials (RCTs) were included in our qualitative and quantitative analysis, respectively, encompassing 1,691 participants aged 18 to 85. No significant difference was observed between the glibenclamide and control groups regarding excellent functional outcome (risk ratio [RR] 1.10, 95% confidence interval [CI] 0.92–1.32, P = 0.29) and good functional outcome (RR 1.07, 95% CI 0.96–1.18, P = 0.22). Safety analysis revealed no significant increase in serious adverse events (RR 1.11, 95% CI 1.00–1.23, P = 0.06). Notably, hypoglycemia incidence after sensitivity analysis was higher in the glibenclamide group (RR 4.56, 95% CI 2.07–10.03, P = 0.0002).

Conclusions

Glibenclamide did not significantly improve functional outcomes or reduce mortality in stroke patients but was associated with a higher incidence of hypoglycemia. Further well-designed RCTs are needed to clarify its therapeutic role and optimize safety protocols.

Clinical trial registration: PROSPERO registration number: CRD420251008350.