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Real-world effectiveness of BA vs. BA + ezetimibe in dyslipidemia

Dyslipidemia Dyslipidemia
Dyslipidemia Dyslipidemia

Bempedoic acid (BA), an adenosine triphosphate-citrate lyase inhibitor, has been proven in randomized clinical trials to substantially reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular (CV) risk.

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Key take away

Bempedoic acid, alone or with ezetimibe, shows robust real-world efficacy by reducing LDL-C by about 30% and increasing goal attainment six-fold in 8 weeks in patients with dyslipidemia.

Background

Bempedoic acid (BA), an adenosine triphosphate-citrate lyase inhibitor, has been proven in randomized clinical trials to substantially reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular (CV) risk. Despite this, real-world data on its clinical application remain limited. Hence, this study sought to offer real-world insights into BA's usefulness for dyslipidaemia management.

Method

The MILOS study was a prospective, observational study conducted across Europe to assess the real-world effectiveness and safety of BA or BA combined with ezetimibe in a fixed-dose combination (BA+EZE FDC) among patients with hypercholesterolemia or mixed dyslipidemia. This interim analysis reported 8-week (8W) outcomes from UK patients enrolled between March 2023 and February 2024.

Result

Among 236 enrolled subjects, 67 (BA=36, BA+EZE FDC=31) had paired LDL-C data at baseline and week 8. The mean age was 65.2 years, and 46.2% were male. Notably, 14.4% had heterozygous familial hypercholesterolemia and 22.0% had diabetes. Around 30.1% were secondary prevention patients, and 56.8% were categorized as high or very high CV risk. Before treatment initiation, 41.5% were not receiving any lipid-lowering therapy (LLT).

After an average treatment duration of 69 days, patients illustrated a mean LDL-C reduction of nearly 30%, dropping from 3.6 mmol/L to 2.4 mmol/L following BA or BA+EZE FDC therapy, with or without additional LLTs. The percentage of patients attaining LDL-C target levels escalated more than 6-fold — from 7.5% at baseline to 44.8% at 8 weeks (Figure1).

Importantly, no novel safety concerns emerged during this observation period.

Conclusion

BA alone or in combination with ezetimibe yields a rapid, clinically meaningful reduction in LDL-C within 8 weeks. These findings reinforce the real-world value of BA as an effective lipid-lowering option, helping more patients reach LDL-C goals safely and efficiently.

Source:

Atherosclerosis

Article:

Real world insights from the United Kingdom on 8-week effectiveness of bempedoic acid and/or its fixed-dose combination with ezetimibe in patients with dyslipidaemia

Authors:

Kausik Ray et al.

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