Efficacy and Safety of Cerebrolysin for Acute Ischemic Stroke: A Meta-Analysis of Randomized Controlled Trials

Abstract

Cerebrolysin was reported to be effective in the neurological improvement of patients with acute ischemic stroke (AIS) in experimental models, while data from clinical trials were inconsistent. We performed a meta-analysis to explore the efficacy and safety of cerebrolysin for AIS. PubMed, EMBASE, and Cochrane Library were searched for randomized controlled trials, which intervened within 72 hours after the stroke onset. We investigated the efficacy and safety outcomes, respectively. Risk ratios and mean differences were pooled with fixed-effects model or random-effects model. Seven studies were identified, involving 1779 patients with AIS. The summary results failed to demonstrate significant superiority of cerebrolysin in the assessment of efficacy outcomes of mRS and BI. Similarly, administration of cerebrolysin had neutral effects on safety outcomes compared with placebo, including mortality and SAE. However, the number of included studies was small, especially in the analysis of efficacy outcomes, which might cause publication bias and inaccurate between-studies variance in the meta-analysis. Conclusively, although it seemed to be safe, routine use of cerebrolysin to improve the long-term rehabilitation after stroke could not be supported by available evidence.

Figure 1

The flow diagram of the search process.

Figure 2

Forest plots of cerebrolysin administration and mRS at endpoint. (a) Subgroup analysis of dichotomous data for mRS defined by time widow of intervention. (b) Overall analysis of continuous data for mRS. CI, confidence interval; RR, risk ratio; WMD, weighted mean difference; mRS, modified Rankin Scale.

Figure 3

Forest plots of cerebrolysin administration and BI at endpoint. CI, confidence interval; WMD, weighted mean difference; BI, Barthel Index.

Figure 4

Forest plots of cerebrolysin administration and mortality at endpoint. (a) Subgroup analysis defined by sample size. (b) Subgroup analysis defined by the time widow of intervention. CI, confidence interval; RR, risk ratio.

Figure 5

Forest plots of cerebrolysin administration and AE and SAE at endpoint. (a) Overall analysis for AE. (b) Overall analysis for SAE. CI, confidence interval; RR, risk ratio; AE, adverse event; SAE, serious adverse event.