Why the study?
SGLT2 inhibitors reduce hospitalization for heart failure and composite kidney outcomes, but the mediators underlying these benefits remain unknown.
Does ertugliflozin reduce hospitalization for heart failure and composite kidney outcomes in patients with type 2 diabetes mellitus and atherosclerotic cardiovascular disease?
Population
Patients with type 2 diabetes mellitus and atherosclerotic cardiovascular disease from the VERTIS CV trial
Comparison
Ertugliflozin vs placebo
Design
Mediation analysis of a randomized controlled trial
Key result
Markers of volume status and haemoconcentration, particularly haemoglobin, mediated 63.3% of the effect of ertugliflozin on reducing the risk of hospitalization for heart failure in patients with type 2 diabetes.
Authors
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Reinforces ertugliflozin use in T2D with ASCVD; extends prior SGLT2i trials by identifying volume and hematopoiesis mediators.
RCT (n=8,246)
Double-blind
1:1:1
Yes
Does ertugliflozin reduce hospitalization for heart failure and composite kidney outcomes in patients with type 2 diabetes mellitus and atherosclerotic cardiovascular disease?
Effect estimate: 63.33% mediation (95% CI 26.08-231.35)
The cardioprotective and renoprotective effects of ertugliflozin in patients with type 2 diabetes appear to be primarily mediated by changes in markers of volume status and hemoconcentration.
Segar et al. (2022) conducted an RCT in Type 2 diabetes mellitus and established atherosclerotic cardiovascular disease (n=8,246). Ertugliflozin vs. Placebo was evaluated on Percentage mediation of ertugliflozin's effect on hospitalization for heart failure by average change in haemoglobin (63.33% mediation, 95% CI 26.08-231.35). Markers of volume status and haemoconcentration, particularly haemoglobin, mediated 63.3% of the effect of ertugliflozin on reducing the risk of hospitalization for heart failure in patients with type 2 diabetes.