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This is a post-hoc analysis of the CLEAR Outcomes trial (n=13,970) evaluating the association between non-invasive measures of liver steatosis/fibrosis and cardiovascular outcomes (MACE4). The study found that both liver steatosis and fibrosis were associated with increased MACE4 risk in the placebo group. Bempedoic acid treatment reduced MACE4 risk, particularly in patients with elevated steatosis scores.
Bempedoic acid reduces cardiovascular event risk in patients with metabolic dysfunction-associated steatotic liver disease, especially those with elevated liver steatosis scores.
AIMS Metabolic dysfunction-associated steatotic liver disease (MASLD) encompasses a spectrum of disease starting with liver steatosis and progressing to fibrosis. We evaluated whether non-invasive tests of steatosis and fibrosis are associated with cardiovascular outcomes, and whether bempedoic acid treatment reduced cardiovascular risk. METHODS A post-hoc exploratory analysis of CLEAR Outcomes (n=13,970, median follow-up 40·6 months) was carried out using non-invasive tests to estimate liver steatosis and fibrosis: Framingham Steatosis Index (FSI), Fibrosis-4 index (FIB-4) and NAFLD fibrosis score (NFS). The endpoint was a 4-component major adverse cardiovascular event. Time-to-event was analyzed using Cox proportional hazards models. RESULTS The mean (±SD) age was 66 ±9 years and BMI 30 ±5 kg/m2. Adjusted for other risk factors, liver steatosis was associated with an increased incidence of MACE4 in the placebo group, with hazard ratio (HRFSI) 1·13 (95%CI 1·08-1·18) for 1 unit of FSI increase. Similarly, liver fibrosis was associated with increased risk of MACE4, HRFIB4 1·21 (95%CI 1·09-1·34) and HRNFS 1·16 (95%CI 1·10-1·23) for 1 unit of increase in score. In patients at risk for liver steatosis, the HR for MACE4 associated with 1-unit of FSI increase was lower in the bempedoic acid group: HRFSI_BA 1·04 (95%CI 0·99-1·09) vs. HRFSI_PBO 1·14 (95%CI 1·09-1·18). Treatment effect was not related to the degree of fibrosis. CONCLUSION Liver steatosis and fibrosis assessed with non-invasive tests are associated with an increased risk of MACE4. Bempedoic acid reduced MACE4 risk, with an additional benefit in patients with elevated steatosis scores.
