CONGRESS ABSTRACT

Background: Bempedoic acid (BA), an adenosine triphosphate-citrate lyase inhibitor, effectively reduces low-density lipoprotein cholesterol (LDL-C) and cardiovascular (CV) risk, as shown in randomised clinical trials. However, real-world evidence documenting its use in clinical practice remains limited. Methods: MILOS, a European, prospective, observational study (NCT04579367), evaluates the effectiveness and safety of BA or BA+ezetimibe fixed-dose combination (BA/BA+EZE FDC) in patients with hypercholesterolaemia or mixed dyslipidaemia. Here, we present the interim 8-week follow‑up (8W) data from Italian patients (enrollment: March 2023–December 2023). Results: Of 1,310 patients at baseline, 855 patients (BA=445, BA+EZE FDC=410) had LDL‑C data at both pre-treatment and 8W. The overall mean (standard deviation [SD]) age was 66.0 (10.7) years and 59.2% were male (Table). 11.1% had heterozygous familial hypercholesterolemia and 15.1% had diabetes. More patients (57.7%) were secondary prevention patients and 82.5% were categorized by the investigators as high and very high CV risk patients. Before starting BA or BA+EZE FDC, 33.1% of patients had no background lipid-lowering therapies (LLTs). Over a mean 8W period (mean [SD] treatment duration: 59.3 [19.3] days), patients experienced a mean (SD)/median (interquartile range) relative reduction in LDL-C of 22.6% (32.3)/25.4% (8.1;43.2), decreasing from 2.9 (1.2) mmol/L (110.7 [44.8] mg/dL) to 2.1 (0.8) mmol/L (79.2 [32.2] mg/dL), following BA/BA+EZE FDC treatment with or without background LLTs. The overall proportion of patients achieving LDL-C goals increased from 7.1% (61/855) at pre‑treatment to 37.2% (318/855) at 8W, with a 29.4% increase in patients with very high CV risk (Figure). Compared to previous reports, no new safety signals were observed during the follow-up period. Conclusions: The data from the Italian cohort of the MILOS study showed that the addition of BA or BA+EZE for 8 weeks, with or without other LLTs, was associated with approximately a 5-fold increase in the proportion of patients achieving their LDL-C goal.