Bempedoic Acid Boosts LDL-C Goal Achievement in MILOS German Cohort Final Results

Daiichi Sankyo Europe recently released two-year follow-up data from the German segment of the European observational MILOS study. This research assessed the real-world application of bempedoic acid, marketed as NILEMDO® and its fixed-dose combination (FDC) with ezetimibe, known as NUSTENDI®, in patients suffering from primary hypercholesterolaemia or mixed dyslipidaemia. The findings, unveiled at DGK Hertztage 2024 in Hamburg, Germany, highlighted the drug's effectiveness and safety profile when used alone or alongside other lipid-lowering therapies (LLTs).

Elevated LDL-C (low-density lipoprotein cholesterol) is a significant modifiable risk factor for major cardiovascular events. Studies indicate that a 1 mmol/L reduction in LDL-C can lead to a 22% decrease in major cardiovascular events within a year. The German cohort involved 973 patients from 125 sites across Germany, marking one of the most thorough real-world investigations of bempedoic acid's clinical use in the country.

Patients in the study were monitored over two years, with LDL-C levels measured at pre-treatment, one year, and two years. Out of the 973 patients, 638 completed the two-year follow-up, with LDL-C levels available for 451 patients. These patients showed an average LDL-C reduction from 3.1 mmol/L (121.4 mg/dL) at the start to 2.0 mmol/L (77.2 mg/dL) after two years, representing a 30.3% decrease. Moreover, the percentage of patients achieving their LDL-C goals surged from 4.9% at the beginning to 35.3% after two years — roughly a seven-fold increase. High-risk and very high-risk patients meeting LDL-C goals also saw significant improvements.

More than 80% of patients used bempedoic acid in conjunction with other LLTs, such as statins and ezetimibe, both at the beginning and at the two-year mark. The safety profile of bempedoic acid observed in this real-world population aligned with results from the CLEAR clinical trial program.

Professor Ioanna Gouni-Berthold of the University of Cologne emphasized the importance of significantly lowering LDL-C levels to reduce cardiovascular event risks, which can greatly improve long-term health and quality of life. Dr. Stefan Seyfried, Vice President Medical Affairs at Daiichi Sankyo Europe, noted that cardiovascular disease remains the leading cause of death in Europe, yet many premature cardiovascular events are preventable. He highlighted that the study's findings reinforce the benefits of bempedoic acid in lowering LDL-C levels and aim to provide the medical community with insights to improve cardiovascular disease prevention and patient care.

The MILOS study is an ongoing, multinational European observational study focusing on adult patients with primary hypercholesterolaemia or mixed dyslipidaemia. It aims to evaluate the real-world use of bempedoic acid and its combination with ezetimibe. Patients in the German cohort were recruited from 125 sites between January 2021 and January 2022 and were monitored for two years. LDL-C levels and the proportion of patients achieving LDL-C goals were assessed at pre-treatment, one year, and two years.

Beyond Germany, MILOS has sites in Austria, Belgium, Italy, the Netherlands, Spain, Switzerland, and the UK.

Bempedoic acid, marketed as NILEMDO®, is an oral treatment designed to lower cholesterol and can be combined with other treatments for enhanced efficacy. It inhibits ATP citrate lyase (ACL), an enzyme involved in cholesterol production in the liver. This mechanism allows for additional LDL-C reduction when added to statin or other LDL-C-lowering therapies, without activation in skeletal muscle.

The fixed-dose combination of bempedoic acid and ezetimibe (NUSTENDI®) provides a complementary approach to reducing cholesterol in a once-daily tablet. This combination is indicated for adults with primary hypercholesterolaemia or mixed dyslipidaemia, either in combination with a statin or alone for those who are statin-intolerant.

Daiichi Sankyo Europe holds exclusive commercialization rights for bempedoic acid and its FDC with ezetimibe in the European Economic Area, UK, Turkey, and Switzerland, licensed from Esperion.

Daiichi Sankyo is a global healthcare company committed to developing and delivering innovative medicines to improve quality of life, with a focus on areas like cancer and cardiovascular diseases.