Study, addition of bempedoic acid effectively reduces LDL cholesterol

The final 2-year follow-up results of the German cohort of the observational, multinational, European Milos study on the use, in daily clinical practice, of bempedoic acid, or of its fixed-dose association with ezetimibe, in patients with primary hypercholesterolemia or mixed dyslipidemia. The data demonstrated the efficacy and safety profile of bempedoic acid, both alone and in combination with other lipid-lowering therapies, in a real-life context in reducing LDL cholesterol (LDL-C) by almost a third.

The increase in LDL cholesterol – recalls a note released by Daiichi Sankyo Europe – is a key modifiable factor in the risk of major cardiovascular events. Studies show that every reduction of approximately 39 mg/dL (1 mmol/L) in LDL-C is associated with a 22% reduction in major cardiovascular events after one year. To date, the German cohort of the Milos study, which includes 973 patients from 125 sites in Germany, is one of the most comprehensive evaluations of bempedoic acid in clinical practice carried out in the country. The patients were followed for 2 years. LDL-C levels were assessed before starting treatment, at one and 2 years. Overall, 638 of 973 patients (65.6%) completed 2-year follow-up, with complete pre-treatment, first- and second-year LDL-C values ​​available for 451 patients. These 451 patients demonstrated a mean reduction in LDL-C levels from 121.4 mg/dL (3.14 mmol/L) at baseline to 77.2 mg/dL (2.0 mmol/L), which represents a average relative reduction of 30.3% in the overall population. Overall, more than 80% of patients received bempedoic acid in combination with other lipid-lowering therapies before treatment and at two years, including statins and ezetimibe. The safety profile of bempedoic acid – subject to additional monitoring – in this real-world population was evaluated at one and 2 years and was consistent with that observed in the Clear clinical trial program.

“By significantly reducing LDL-C levels toward guideline goals, we are taking a critical step in reducing the risk of cardiovascular events that can have a profound impact on a person’s long-term health and quality of life,” he said. declared Ioanna Gouni-Berthold, Center for Endocrinology, Diabetology and Preventive Medicine at the University of Cologne and member of the board of directors of the International Atherosclerosis Society. “Cardiovascular disease remains the leading cause of death in Europe, but the majority of premature cardiovascular events are preventable – commented Stefan Seyfried, vice president of Medical Affairs, Specialty Medicines, Daiichi Sankyo Europe – The results of this cohort strengthen the evidence on the benefits of bempedoic acid for reducing LDL-C levels. Our long-term goal is to provide the medical community with concrete information to improve the prevention of cardiovascular disease and ultimately improve patient care. ”.