Effectiveness and safety of glibenclamide for stroke: protocol for a systematic review and meta-analysis

INTRODUCTION: Despite the continuous improvement in modern medical treatment, stroke is still a leading cause of death and disability worldwide. How to effectively improve the survival rate and reduce disability in patients who had a stroke has become the focus of many investigations. Recent findings concerning the benefits of glibenclamide as a neuroprotective drug have initiated a new area for prospective studies on the effects of sulfonylureas. Given the high mortality and disability associated with stroke, it is essential to weigh the benefits of neuroprotective drugs against their safety. Therefore, the objective of the current study is to conduct a systematic review using meta-analysis to assess the benefits and safety of glibenclamide as a neuroprotective drug. METHODS AND ANALYSIS: This study will analyse randomised clinical trials (RCTs) and observational studies published up to 31 December 2020 and include direct or indirect evidence. Studies will be retrieved by searching PubMed, EMBASE, Web of Science, the Cochrane Library and China National Knowledge Infrastructure (CNKI) and WanFang Databases. The outcomes of this study will be mortality, scores from the Modified Rankin Scale and the occurrence of hypoglycaemic events. The risk of bias will be assessed using the Cochrane risk of bias assessment instrument for RCTs. A random-effect/fixed-effect model will be used to summarise the estimates of the mean difference/risk ratio using a 95% CI. ETHICS AND DISSEMINATION: This meta-analysis is a secondary research project, which is based on previously published data. Therefore, ethical approval and informed consent were not required for this meta-analysis. The results of this study will be submitted to a peer-reviewed journal for publication. PROSPERO REGISTRATION NUMBER: CRD42020144674.