Simulation Model based on Pooled Phase 3 Data Demonstrating NEXLETOL (bempedoic acid) Tablet’s Potential to Lower Absolute Cardiovascular Event Risk Presented at ACC.21 - Seite 2

In this poster presentation, among the group of patients taking maximally tolerated statins, baseline 10-year cardiovascular event risk based on the SMART model was estimated at 25.9% for those treated with bempedoic acid and 26.6% for those who received placebo. In the statin intolerant group, baseline 10-year cardiovascular event risk based on the SMART model was estimated at 31.9% for those treated with bempedoic acid and 30.9% for those who received placebo.³ The simulation predicted that patients treated with bempedoic acid on top of maximally tolerated statins would experience a 3.3% further absolute reduction in 10-year cardiovascular event risk compared with statins alone (p< 0.0001).^3-5 For statin-intolerant patients, defined as patients receiving no more than low-dose statin including no statin, the simulation predicted a further 6.0% absolute reduction in 10-year cardiovascular event risk with bempedoic acid compared with placebo (p< 0.0001).^3,6-7

“Using the well-established relationship between LDL-C lowering and ASCVD risk reduction, as well as validated models, these data from ASCVD patients in our Phase 3 pivotal trials estimate a significant risk reduction in major cardiovascular events with NEXLETOL treatment,” said Ashley Hall, chief development officer of Esperion. “These data reinforce the potential incremental cardiovascular benefits of LDL-C lowering in high-risk ASCVD patients.”

“Published analyses with validated models like SMART and CTT can help inform treatment decisions now, ahead of clinical data availability,” said Professor Kausik K. Ray, MBChB, MD, Mphil, FRCP; Professor of Public Health at the School of Public Health, Imperial College London; Consultant Cardiologist; member of the CLEAR Outcomes steering committees; and senior author of the ACC presentation. “The data in this analysis are encouraging, particularly for physicians and their patients with ASCVD who want to lower cardiovascular event risk but have had difficulty managing LDL-C.”

Based on readily available baseline characteristics, the SMART risk calculation estimates an individual ASCVD patient’s 10-year risk of cardiovascular death, stroke, or myocardial infarction, also known as three-point MACE. The SMART risk score was developed based on data from a population of 5,788 patients who were part of the SMART study in the Netherlands during a 14-year period.¹ The model was validated and updated based on pooled data from more than 18,000 patients across four continents.⁸ Because cardiovascular event risk can vary greatly across patients with previous cardiovascular disease, the SMART risk score allows physicians and patients to better estimate individual risk to tailor treatment and follow up.