Bempedoic Acid Cuts 10-year CV Risk 17% in MILOS Real-World Data

One year of bempedoic acid-based therapy was associated with a 17.1% relative reduction and a 4.8% absolute reduction in predicted 10-year cardiovascular risk, according to new analyses from the real-world MILOS study presented at the European Society of Cardiology (ESC) Congress 2026, according to an announcement from Daiichi Sankyo.

According to the company, the new MILOS analyses extend prior randomized-trial evidence for bempedoic acid, including CLEAR Outcomes, into multinational routine-care populations, quantifying how real-world LDL-C reductions translate into projected long-term cardiovascular benefit across patient subgroups including sex and glycemic status.¹

“The clinical relevance of this new data is clear,” said Klaus G. Parhofer, MD, professor of endocrinology and metabolism, University of Munich. “These results reinforce physicians’ confidence in using bempedoic acid and its combination with ezetimibe in real-world clinical practice, across a broad range of patient types, including in people with diabetes. The confirmation from real-world data gives us confidence to use bempedoic acid, so that we can better manage our at-risk patients.”¹

MILOS study design and predicted cardiovascular risk reduction

MILOS is an ongoing, multinational, European observational study (NCT04579367) evaluating the real-world effectiveness and safety of bempedoic acid, administered alone or as a fixed-dose combination with ezetimibe, in adults with primary hypercholesterolemia or mixed dyslipidemia, with sites in Austria, Belgium, Germany, Italy, the Netherlands, Spain, Switzerland, and the UK.¹ In an analysis of 960 at-risk patients with a mean age of 66.8 years, most classified at high or very high cardiovascular risk with established atherosclerotic cardiovascular disease, mean predicted 10-year cardiovascular risk was 28.9% before treatment initiation, estimated using SCORE2, SCORE2-OP, or the REACH equation depending on ASCVD status.²

Mean LDL-C reduction from baseline to 1-year follow-up was 0.88 mmol/L, translating to an estimated absolute risk reduction of 4.8% (SD, 6.7) and a relative risk reduction of 17.1% (SD, 20.5) in predicted 10-year cardiovascular risk, with directionally consistent findings across countries (relative risk reduction range, 14%-24%).

Patients at higher baseline cardiovascular risk were predicted to derive greater absolute risk reduction with treatment.² Investigators applied Cholesterol Treatment Trialists’ methodology to translate individual LDL-C changes into relative risk reductions per mmol/L decrease, with probabilistic sampling used to account for estimate uncertainty.

LDL-C reductions by sex and glycemic status in MILOS

In a pooled analysis of 3138 patients across 5 countries, bempedoic acid or the fixed-dose combination was associated with a 31% relative LDL-C reduction in women and 25% in men, with women more often treated for primary prevention and classified at lower cardiovascular risk than men at baseline.³

Among 2071 patients with LDL-C data available before treatment and at 1 year, absolute goal attainment increased by approximately 31% in both sexes, and adverse drug reactions considered treatment-related occurred in 10.3% of women and 8.3% of men, most commonly myalgia, with no new safety signals identified.

A separate analysis stratifying the same pooled cohort by glycemic status found bempedoic acid-based therapy delivered a mean relative LDL-C reduction of at least 24.9% regardless of diabetes status, with reductions of 24.9% in patients with diabetes, 28.7% in prediabetes, and 28.2% in normoglycemia.⁴

LDL-C goal attainment increased from approximately 7% at baseline to 37.9%-39.4% at 1 year across all 3 glycemic subgroups, and no new safety signals were observed.

“At Daiichi Sankyo, our ongoing investment in cardiovascular research is driven by our desire to care for every heartbeat,” said Stefan Seyfried, MD, vice president and head of medical affairs, Specialty Medicines, Daiichi Sankyo Europe. “We are committed to supporting better outcomes in CVD, and our latest real-world results continue to demonstrate the impact of bempedoic acid alone or as a fixed-dose combination tablet with ezetimibe in CVD management across a broad range of patient types, so that no patient will be left behind.”¹

References

1. Daiichi Sankyo. New Daiichi Sankyo data underscore the effect of bempedoic acid in the real-world management of dyslipidemia and cardiovascular risk. Published August 28, 2026. Accessed August 29, 2026. businesswire.com

2. Parhofer KG, et al. Predicted change in 10-year cardiovascular risk one year after initiation of bempedoic acid-based therapy in the MILOS study. Presented at: European Society of Cardiology (ESC) Congress 2026; August 28-31, 2026; Munich, Germany.

3. Gouni-Berthold I, et al. Real-world use of bempedoic acid in women and men: pooled 1-year follow-up data from the observational, prospective, real-world MILOS study in Austria, Belgium, Germany, Italy, and the United Kingdom. Presented at: European Society of Cardiology (ESC) Congress 2026; August 28-31, 2026; Munich, Germany.

4. Stulnig T, et al. Bempedoic acid for LDL-cholesterol management in patients with and without diabetes: insights from the MILOS study. Presented at: European Society of Cardiology (ESC) Congress 2026; August 28-31, 2026; Munich, Germany.