Blog Post 1
Recently published meta-analyses on CytoSorb have created concerns for healthcare providers and their patients. The conclusions reached, and the statements appearing in the press and social media have created a stir about the product’s safety and effectiveness.
We welcome any investigation of our product because generating data and formulating conclusions encourages discussions that drive further discovery and applications.
It also made us take note of the product information out there, allowing us to review the information and establish its relevance and impact. It made us focus on providing information that assures that this product reaches the right patient, at the right time and at the right dose.
In this initial series of blogs, we will first address the issues of product effectiveness and safety that those publications have raised. Following that, we will address the issue of appropriate study endpoints in studies using Cytosorb.
Meta-analyses represent a tremendous statistical tool to combine smaller individual studies with the same population characteristics, therapeutic interventions, and endpoints to create extensive research that can help show the therapeutic effect and increase precision.
However, the meta-analyses in question concluded that using CytoSorb in critically ill patients was not associated with a survival advantage (Becker et al., 2023) and may even cause higher mortality (Heymann et al., 2022). In addition, it was described that CytoSorb did not influence the course of inflammatory mediators, especially IL-6 (Heymann et al., 2023), contrary to one of its prescribed actions.
When these results were disseminated via social media, the impression was given that there was “no benefit whatsoever from CytoSorb therapy” or that the therapy was even associated with possible harmful effects.
The authors of the three meta-analyses also noted significant limitations of their own investigations, arising from uncertainties regarding the quality of the underlying evidence. Pronounced heterogeneity also existed in the clinical applications and patient groups receiving Cytosorb therapy, and less than half of the included studies were randomised control trials (RCT). Yet, they still considered their findings to be an absolute fact.
Other recent publications have reported that cytokines are removed from the blood, highlighting that the right treatment be considered for the right patient. One such scientific study (Jansen et al., March 2023) was not even considered for the Heymann et al. 2023 meta-analysis, even though it was published within the stated time frame (cut-off May 2023). The study used a highly reproducible model to show, in normal human subjects, that the adsorber leads to a rapid and significant decrease of circulating TNFα and IL-6 in response to an inflammatory stimulus. Just because it was an experimental group and not treated patients did not warrant excluding this information.
The three meta-analyses also included numerous older studies in which the principles we recommend today for this therapy were not always considered. Experience has shown that the selection of patients, the timing of the treatment, and adequate dosing are essential with this therapy.
Despite the negative meta-analysis results, CytoSorb therapy remains an essential tool that allows one to regain control and contribute to the rapid stabilization of selected patients with specific conditions.
Our next blog will address the issue of product safety.
Cytosorbents Europe GmbH, headquartered in Berlin, is a wholly owned subsidiary of CytoSorbents Corporation of Monmouth Junction, New Jersey, USA, where the CytoSorb product is manufactured. CytoSorb is the company’s flagship product, backed by more than 30 patent families.
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