Preprint Review Version 1 Preserved in Portico This version is not peer-reviewed

Safety of Cerebrolysin for Neurorecovery After Acute Ischemic Stroke: A Systematic Review and Meta-Analysis of Twelve Randomized-Controlled Trials

Version 1 : Received: 26 September 2021 / Approved: 27 September 2021 / Online: 27 September 2021 (11:53:49 CEST)

How to cite: Strilciuc, S.; Vécsei, L.; Boering, D.; Pražnikar, A.; Riederer, P.; Battistin, L. Safety of Cerebrolysin for Neurorecovery After Acute Ischemic Stroke: A Systematic Review and Meta-Analysis of Twelve Randomized-Controlled Trials. Preprints 2021, 2021090446 (doi: 10.20944/preprints202109.0446.v1). Strilciuc, S.; Vécsei, L.; Boering, D.; Pražnikar, A.; Riederer, P.; Battistin, L. Safety of Cerebrolysin for Neurorecovery After Acute Ischemic Stroke: A Systematic Review and Meta-Analysis of Twelve Randomized-Controlled Trials. Preprints 2021, 2021090446 (doi: 10.20944/preprints202109.0446.v1).

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 (Excerpta Medica Database, 1947 to March 2021), MEDLINE (1946 to March 2021), CENTRAL (1948 to March 2021) and Cochrane Database of Systematic Reviews (1995 to March 2021). Data collection and analysis was 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 moderat 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.

Keywords

ischemic stroke; safety; cerebrolysin; neurorehabilitation

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