Redefining Cardiovascular (CV) Death as a Primary Endpoint Component in Cardiovascular Outcome Trials

Title:Redefining Cardiovascular (CV) Death as a Primary Endpoint Component in Cardiovascular Outcome Trials

Volume: 16 Issue: 9

Author(s): Samit Ghosal*Binayak Sinha

Affiliation:

• Department of Endocrinology, Nightingale Hospital, Kolkata,India

Keywords: CVOT, MACE, MI, hHF, SGLT-2i, CV death, type 2 diabetes, correlation coefficient.

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. A 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 its effect on atherosclerotic cardiovascular disease (ASCVD). A Pearson’s product- moment correlation coefficient (r) analysis was performed 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, it has been proposed 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 the reduction in HF or ASCVD).

Cite this article as:

Ghosal Samit *, Sinha Binayak , Redefining Cardiovascular (CV) Death as a Primary Endpoint Component in Cardiovascular Outcome Trials, Current Diabetes Reviews 2020; 16 (9) . https://dx.doi.org/10.2174/1573399816666200206113549