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Redefining Cardiovascular (CV) Death as a primary end point component in Cardiovascular Outcome Trials

Author(s):

Samit Ghosal* and Binayak Sinha  

Abstract:


Sodium Glucose cotransporter-2 inhibitors (SGLT-2i) and Glucagon like peptide 1 receptor agonists (GLP1-RA) have revolutionised the approach for modern management of type 2 diabetes in view of their outcome altering abilities. An objective component of the primary endpoints used in the Cardiovascular Outcome Trials (CVOT) is cardiovascular (CV) death. However, the reason behind the decrease in CV deaths (compared to the placebo arm) appear to arise from divergent underlying processes. Recent meta-analysis of SGLT-2i and GLP1-RA indicated that the reduction in CV death associated with the former is predominantly due to its impact on heart failure (HF), while the association with the latter is due to effect on atherosclerotic cardiovascular disease (ASCVD). We performed a Pearson’s product moment correlation coefficient (r) analysis on SGLT-2i exposed to CVOTs, exploring the strength of the association between CV death and hospitalisation for HF (hHF) and myocardial infarction (MI). The strength of association was strongest with hHF and negative with MI. In view of these findings we propose that future CVOTs should use a more objective definition of CVD, defining well in advance the anticipated impact on CVD (either as a consequence of reduction in HF or ASCVD).

Keywords:

CVOT, MACE, MI, hHF, SGLT-2i, CV death, Type 2 diabetes, Correlation coefficient

Affiliation:

Department of Endocrinology, Nightingale Hospital, Kolkata, Department of Endocrinology, AMRI Hospitals, Kolkata



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