Impact of baseline FIB-4 score on efpeglenatide benefits on cardiovascular outcomes in people with type 2 diabetes: a participant-level exploratory analysis of the AMPLITUDE-O trial
Authors' conclusion
In high-risk people with type 2 diabetes, the degree of liver fibrosis, as estimated by FIB-4 score, was not related to incident cardiovascular outcomes. The beneficial effect of efpeglenatide on these outcomes is independent of FIB-4 category.
Study context
- Population
- People with T2D in the AMPLITUDE-O trial with baseline FIB-4 score, subdivided in tertiles99.6% with FIB-4
- Participants
- 4,059 people
- Comparison
- Efpeglenatide effect on cardiovascular outcomes across baseline FIB-4 tertiles
- Primary endpoint
- Incidence of MACE, expanded MACE, and MACE or death across FIB-4 categories; variation of efpeglenatide's effect with FIB-4
Methodological detailsparticipant-level exploratory analysis
- Participant-level exploratory analysis
Primary result
As reported in the abstract
MACE, expanded MACE, MACE or death across FIB-4 tertiles · median follow-up 1.8 years
- Numerical increases in incidence of all 3 outcomes did not change significantly across FIB-4 tertiles
- P for trend ≥ 0.25
- Major adverse cardiovascular events (MACE) HR per 1 SD higher FIB-4 score
- 1.00 (95% CI 0.89-1.13)
- Efpeglenatide's effect on all MACE outcomes did not vary across FIB-4 tertiles
- all interaction p values ≥ 0.64
Original publication
Impact of baseline FIB-4 score on efpeglenatide benefits on cardiovascular outcomes in people with type 2 diabetes: a participant-level exploratory analysis of the AMPLITUDE-O trial. Cardiovasc Diabetol. Published 28 September 2024. doi:10.
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