Esperion says DSE reports final real-world results from MILOS German cohort

Esperion (ESPR) announced that its European partner, Daiichi Sankyo Europe (DSNKY), reported final 2-year follow-up data from the German cohort of the multinational, European observational MILOS study. The European study evaluated the real-world use of bempedoic acid, marketed as NILEMDO in the EU and bempedoic acid and ezetimibe, marketed as NUSTENDI in the EU, in patients with primary hypercholesterolemia or mixed dyslipidemia. The products are marketed as NEXLETOL and NEXLIZET in the U.S. The results, presented in Hamburg, Germany at DGK Herztage 2024, demonstrated the effectiveness and safety profile of bempedoic acid, both alone and in combination with other lipid-lowering therapies in clinical practice. Raised LDL-C is a key modifiable contributor to risk of major cardiovascular events, with studies showing that every 1 mmol/L reduction in LDL-C is associated with a 22% reduction in major cardiovascular events after one year. The German cohort of the MILOS study comprising 973 patients from 125 sites in Germany, is one of the most comprehensive assessments of bempedoic acid in a real-world clinical setting to-date in Germany. Patients were followed-up for two years, with LDL-C levels assessed at pre-treatment, one year and two years. Overall, 638 of 973 patients completed 2Y follow up, with LDL-C values at pre-treatment, 1Y and 2Y available for 451 patients. In these 451 patients, a mean reduction of LDL-C levels from 3.1 mmol/L at pre-treatment, to 2.0 mmol/L was observed, representing an average relative reduction of 30.3% in the overall population. Additionally, the percentage of patients reaching their LDL-C goals increased from 4.9% at pre-treatment to 35.3% at the 2Y follow-up – an approximately 7-fold increase. The proportions of high-risk and very high-risk patients reaching LDL-C goals increased from 5.6% to 32.5%, and 3.6% to 35.2%, respectively. Overall, more than 80% of patients received bempedoic acid in combination with other LLTs at pre-treatment and 2Y, including statins and ezetimibe. The safety profile of bempedoic acid in this real-world population was assessed at 1Y and 2Y and was consistent with that observed in the CLEAR clinical trial program.