Why the study?
To explore the associations between indices of hepatic steatosis and fibrosis and cardiorenal outcomes in individuals with type 2 diabetes and atherosclerotic cardiovascular disease.
Do indices of liver steatosis and fibrosis predict cardiorenal outcomes, and does ertugliflozin affect these indices in patients with type 2 diabetes and atherosclerotic cardiovascular disease?
Population
Patients with type 2 diabetes and atherosclerotic cardiovascular disease
Comparison
Stratification by baseline HSI and FIB-4 quartiles, and ertugliflozin vs placebo
Design
Post hoc analysis of a randomized trial
Key result
Higher baseline FIB-4 score (Q4 vs Q1) was associated with an increased risk of MACE (HR 1.48; 95% CI 1.25-1.76; P<0.0001) in patients with type 2 diabetes and atherosclerotic CV disease.
Authors
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Supports FIB-4-guided risk stratification in T2D/ASCVD; extends liver indices as prognostic markers in this population.
RCT
Do indices of liver steatosis and fibrosis predict cardiorenal outcomes, and does ertugliflozin affect these indices in patients with type 2 diabetes and atherosclerotic cardiovascular disease?
Effect estimate: HR 1.48 (95% CI 1.25-1.76)
p-value: p=<0.0001
In patients with type 2 diabetes and ASCVD, higher baseline liver fibrosis and steatosis indices are associated with increased risk of cardiovascular events and heart failure hospitalization, while ertugliflozin treatment reduces these liver indices.
Corbin et al. (2022) conducted an RCT in Type 2 diabetes and atherosclerotic cardiovascular disease. Ertugliflozin vs. Placebo was evaluated on Major adverse CV events (MACE) by FIB-4 score quartile (Q4 vs. Q1) (HR 1.48, 95% CI 1.25-1.76, p=<0.0001). Higher baseline FIB-4 score (Q4 vs Q1) was associated with an increased risk of MACE (HR 1.48; 95% CI 1.25-1.76; P<0.0001) in patients with type 2 diabetes and atherosclerotic CV disease.