Abstract

We performed a systematic search and meta-analysis of available literature to determine the safety profile of Cerebrolysin in acute ischemic stroke, filling existing safety information gaps and inconsistent results. We searched EMBASE, PubMed, and Cochrane Databases of Systematic Reviews and Clinical Trials up to the end of February 2021. Data collection and analysis were conducted using methods described in the Cochrane Handbook for Systematic Reviews of Interventions. All safety outcomes were analyzed based on risk ratios (RR) and their 95% confidence intervals. The meta-analysis pooled 2202 patients from twelve randomized clinical trials, registering non-statistically significant (p > 0.05) differences between Cerebrolysin and placebo throughout main and subgroup analyses. The lowest rate of Serious Adverse Events (SAE), as compared to placebo, was observed for the highest dose of Cerebrolysin (50 mL), highlighting a moderate reduction (RR = 0.6). We observed a tendency of superiority of Cerebrolysin regarding SAE in high dose treatment courses for moderate-severe ischemic stroke, suggesting some effect of the agent against adverse events. This comprehensive safety meta-analysis confirms the safety profile for patients treated with Cerebrolysin after acute ischemic stroke, as compared to placebo.

Highlights

  • IntroductionIschemic stroke continues to have overwhelming impact on health of populations and is expected to maintain its leading contribution to global mortality well into this century [1]

  • Ischemic stroke continues to have overwhelming impact on health of populations and is expected to maintain its leading contribution to global mortality well into this century [1].Studies have shown that post-stroke patients experience a wide range of adverse outcomes, such as aphasia, post-stroke anxiety, and depression, among others

  • Our meta-analysis aimed to explore the safety profile of Cerebrolysin, using a broad approach in identifying and appraising the available literature

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Summary

Introduction

Ischemic stroke continues to have overwhelming impact on health of populations and is expected to maintain its leading contribution to global mortality well into this century [1]. Studies have shown that post-stroke patients experience a wide range of adverse outcomes, such as aphasia, post-stroke anxiety, and depression, among others. Patient-level health outcomes for acute ischemic stroke have significantly improved in the last decade primarily because of superior overall case management, availability of tailored drug interventions, and advances in endovascular procedures. Due to the ongoing COVID-19 pandemic, as well as other factors that hamper provision of quality services [2]. Several factors, including financing and infrastructure constraints, limited expertise, and clinical uncertainty, still prevent adherence to evidencebased clinical guidelines and optimal care pathways [3].

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