Review Becker Paper
- In this meta-analysis, the authors searched various databases regarding the effectiveness of CytoSorb adsorber on mortality in different settings between 2010 and May 2022.
- All randomized controlled trials and intervention studies with control groups were considered, with the longest reported mortality defined as the primary endpoint. All studies were analyzed together and divided into the following subgroups: Sepsis, Cardiac Surgery, Other Serious Illness, SARS-CoV-2 Infection, and Recovery from Cardiac Arrest.
- The authors state that there is a great deal of heterogeneity among the studies, with substantial differences in the results. There were also large differences in the use of CytoSorb (number of adsorbers used, time to adsorber use, duration of use, etc.).
- They conclude that there is no evidence to date of a beneficial effect of CytoSorb hemoadsorption on mortality for a variety of indications that would justify widespread use of the adsorber in critical care.To be considered in the interpretation:
- In none of the studies analyzed mortality was defined as an endpoint; accordingly, the studies were not designed to show any effect at all on mortality.
- The highly heterogeneous patient populations and substantial differences in underlying pathology are unsuitable for pooled analysis.„One limitation of our meta-analysis is the heterogeneity of the studies.”
„ First, there are a fair number of studies with only few study participants yet large effect sizes.”
„ Secondly, the use of CytoSorb® differed in many ways.”
„Thirdly, medical conditions were compared that differ completely in their pathophysiology.“
„Finally, the variances proved to be quite large due to the non-normal distribution of some variables.”
- Older studies with inadequate criteria for patient selection, timing, and dosing, which are prerequisites for therapeutic success, were included in the analysis. For example, some of the patients and CytoSorb treatment modalities were poorly defined compared with current standards, and it was not even possible to demonstrate a reduction in IL-6 levels, as recently confirmed by Jansen et al. 2023 in their established and highly reproducible model as definitive proof of principle. However, without changes in the extent of inflammation, clinical effects of therapy cannot be expected either.
- The analysis was primarily related to the effects on mortality. Other potential and known effects (e.g., stabilization of hemodynamics) were not properly investigated, so the conclusion that “CytoSorb cannot be recommended in ICU patients” is not justified. A neutral mortality outcome is also typical of many therapies used in the acute phase in the ICU and is not necessarily a negative outcome, which is why international experts express serious concerns about mortality as a primary endpoint in RCTs in critical care and suggest pathophysiologically based endpoints instead (Girbes 2019, Laterre 2019, Angus 2020).
- None of the 34 included studies concluded that CytoSorb is hazardous. Only in the area of cardiac arrest, with only one small study, was there a significant survival advantage for the control group, which, however, can be explained very well by serious differences in patient baseline characteristics. Fundamental speculations about the lack of safety of the therapy are therefore in no way justified.
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.
CytoSorbents Europe was founded in February 2012 by Dr. Christian Steiner and Dr. Phillip Chan, shortly after the CytoSorb product received CE approval. All sales and marketing activities as well as most of the scientific studies are controlled and organized from Berlin.
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