Cardiorenal outcomes by indices of liver steatosis and fibrosis in individuals with type 2 diabetes and atherosclerotic cardiovascular disease: Analyses from VERTIS cardiovascular (CV) , a randomized trial of the sodium‐glucose cotransporter‐2 inhibitor ertugliflozin
Authors' conclusion
In VERTIS CV, higher FIB-4 score was associated with CV events. HSI correlated with HHF. Neither measure was associated with the composite kidney outcome. Ertugliflozin was associated with a reduction in liver enzymes and HSI.
Study context
- Population
- Patients with T2D and atherosclerotic CVD randomised to ertugliflozin or placebo; mean age 64.4 years, BMI 32.0 kg/m², hepatic steatosis index (HSI) 44.0, FIB-4 1.34
- Participants
- 8,246 patients
- Comparison
- Highest vs lowest baseline FIB-4 and HSI quartiles
- Primary endpoint
- Cardiorenal outcomes (MACE; HHF/CV death; CV death; HHF; composite kidney outcome) by baseline HSI and FIB-4 quartiles
Methodological detailspooled ertugliflozin and placebo data, intention-to-treat analysis set
- Pooled ertugliflozin and placebo data
- Intention-to-treat analysis set
Primary result
As reported in the abstract
Cardiorenal outcomes by FIB-4 quartile
Q4 vs Q1Hazard ratio (95% CI)P value
MACE, FIB-4
1.48(1.25–1.76)
P < 0.0001 for allHHF/CV death, FIB-4
2.0(1.63–2.51)
P < 0.0001 for allCV death, FIB-4
1.85(1.45–2.36)
P < 0.0001 for allHHF, FIB-4
2.94(1.98–4.37)
P < 0.0001 for allHHF, HSI; higher in Q4
1.52(1.07–2.17)
P < 0.05Further findings
Liver enzymes and HSI over time (ertugliflozin vs placebo)
- Liver enzymes and HSI decreased over time with ertugliflozin
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Cardiorenal outcomes by indices of liver steatosis and fibrosis in individuals with type 2 diabetes and atherosclerotic cardiovascular disease: Analyses from VERTIS CV , a randomized trial of the sodium‐glucose cotransporter‐2 inhibitor ertugliflozin. Diabetes Obes Metab. Published 26 December 2022. doi:10.
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