Efficacy, safety, and cost-effectiveness analysis of Cerebrolysin in acute ischemic stroke: A rapid health technology assessment

Abstract

This study conducts a rapid health technology assessment to systematically evaluate the effectiveness, safety, and cost-effectiveness of Cerebrolysin as an adjunctive therapy for acute ischemic stroke to provide evidence-based medicine for clinical decisions of Cerebrolysin. All systematic reviews/meta-analyses, pharmacoeconomic studies, and health technology assessment reports of Cerebrolysin for the treatment of acute ischemic stroke before August 17, 2023, were retrieved from PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, Wanfang, Weipu, Sinomed database and the official website of health technology assessment. According to the inclusion and exclusion criteria, 2 researchers independently carried out screening, data extraction, and quality evaluation and descriptively analyzed the results of the included studies. A total of 14 pieces of literature were incorporated, comprising 8 systematic reviews/meta-analyses and 6 pharmacoeconomic studies. In terms of effectiveness, compared to control groups, the use of Cerebrolysin as a treatment for acute ischemic stroke demonstrates certain advantages, including enhancement in total efficacy rate, neurological function, upper limb motor dysfunction, and facilitation of the recovery of activities of daily living. Especially in patients with moderate to severe acute ischemic stroke, Cerebrolysin has demonstrated the ability to enhance neurological function recovery and ameliorate disabilities. Regarding safety, adverse reactions were mild or comparable to those in the control group. The primary findings of economic studies reveal that advocating for the use of Cerebrolysin offers certain cost-effectiveness advantages. Cerebrolysin contributes to improved clinical efficacy and evaluation indexes while demonstrating favorable safety and economic benefits.

Life‐Threatening Anaphylaxis due to Cerebrolysin®

“…Interestingly, the study by Strilciuc et al indicated that compared to the placebo, the highest dose of cerebrolysin (50 mL, as we use it in sTBI) had the lowest occurrence rate of SAE and nonfatal SAE, with a risk reduction of >25%, thus suggesting some effects of the agent against adverse events [ 16 ]. Nevertheless, in controlled clinical trials as well as recent meta-analysis, the frequency of adverse events was quite similar in the groups treated with cerebrolysin and placebo [ 20 , 21 ]. It may be noteworthy that anaphylaxis was not explicitly reported in any of the RCTs cited in the meta-analysis.…”

Current neuroprotective agents in stroke

“…However, neuroprotective agents are commonly used as supplementary therapy for AIS in clinical practice. [ 3 ] A recent comprehensive examination and analysis of registered pharmacological treatments aimed at enhancing neurorecovery following a stroke has been released. The agents are listed in Table 1.…”

“…Wan et al,[ 3 ] after their research of the meta-analyses and systematic review of cerebrolysin in AIS, reported that cerebrolysin improved neurological function, aided in daily activities, lowered blood viscosity and fibrinogen levels, and ultimately led to better patient outcomes. The safety profile of cerebrolysin was found to be similar to the controls.…”