Effects of Dapagliflozin on Cardiovascular Outcomes in Patients With Type 2 Diabetes at Risk of Liver Fibrosis
Authors' conclusion
Highest FIB-4 scores were associated with increased CV risk in patients with T2D. Dapagliflozin reduced CV risk across FIB-4 categories without significant interactions.
Study context
- Population
- Patients with T2D and either atherosclerotic CVD (atherosclerotic cardiovascular disease (ASCVD)) or high ASCVD risk, stratified by baseline FIB-4 score (<1.30, 1.30 to <2.67, ≥2.67)of 17,160 enrolled
- Participants
- 16,361 patients
- Comparison
- Dapagliflozin vs placebo, by baseline FIB-4 category
- Primary endpoint
- Two primary outcomes: MACE and the composite of CV death and hospitalisation for HF (HHF)
- Follow-up
- Median 4.2 years
Methodological detailsplacebo-controlled, phase 3
- Placebo-controlled
- Phase 3
Primary result
As reported in the abstract
MACE by FIB-4 category
Dapagliflozin vs PlaceboHazard ratio (95% CI)
FIB-4 < 1.30 (n = 9084)
0.95(0.83–1.10)
FIB-4 1.30 to < 2.67 (n = 6556)
0.92(0.79–1.08)
FIB-4 ≥ 2.67 (n = 621)
0.61(0.38–0.97)
Further findings
Cardiovascular (CV) death or HHF composite (second primary outcome), dapagliflozin vs placebo, by baseline FIB-4 · median follow-up 4.2 years
- HR (95% CI), FIB-4 <1.30
- 0.81 (0.67-0.98)
- HR (95% CI), FIB-4 1.30 to <2.67
- 0.90 (0.73-1.10)
- HR (95% CI), FIB-4 ≥2.67
- 0.50 (0.28-0.90)
- Post hoc analysis
Event rates in placebo arm by FIB-4
- FIB-4 ≥2.67 had the highest event rates for MACE, HHF, CV death and all-cause death
Liver enzymes
- Dapagliflozin reduced AST and ALT levels vs placebo
Original publication
Effects of Dapagliflozin on Cardiovascular Outcomes in Patients With Type 2 Diabetes at Risk of Liver Fibrosis. Diabetes Obes Metab. Published 27 April 2026. doi:10.
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