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
- Patients with atherosclerotic cardiovascular disease (ASCVD) on maximally tolerated statins and treated with NEXLETOL predicted to experience a 3.3% further absolute reduction in 10-year
cardiovascular event risk compared with statins alone (p<0.0001) -
- Patients considered intolerant to statin therapy treated with NEXLETOL predicted to experience a further 6.0% absolute reduction in 10-year cardiovascular event risk compared with placebo (p<0.0001) -
- Esperion’s CLEAR Outcomes landmark cardiovascular outcomes trial (CVOT), evaluating bempedoic acid’s impact on cardiovascular risk in statin-intolerant patients with ASCVD, is ongoing -
ANN ARBOR, Mich., May 15, 2021 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced the poster presentation of an analysis applying the validated Second Manifestations of ARTerial disease (SMART) model1 and Cholesterol Treatment Trialists’ (CTT) coefficient2 to pooled Phase 3 data to assess the potential of NEXLETOL (bempedoic acid) Tablet to reduce cardiovascular event risk at the American College of Cardiology’s 70th Annual Scientific Session (ACC.21).
The poster, entitled “Estimated Cardiovascular Benefits of Bempedoic Acid in Patients With Established Cardiovascular Disease,” was presented by Dr. Laura H. Gunn, Associate Professor, Department of Public Health Sciences, and Affiliate Faculty, School of Data Science, University of North Carolina at Charlotte, and Honorary Research Fellow, School of Public Health, Imperial College London. Using the validated SMART model, Dr. Gunn and co-authors simulated the baseline 10-year risk score for major adverse cardiovascular events (MACE) for more than 3,000 patients with ASCVD.3 The data were pooled from four completed pivotal Phase 3 studies of bempedoic acid, where change in low-density lipoprotein cholesterol (LDL-C) at Week 12 was the primary endpoint.4-7 Patients were stratified into two groups: those taking maximally tolerated statins and those considered statin intolerant. Using observed changes in LDL-C at week 12, researchers applied the CTT coefficient to calculate an estimated 10-year cardiovascular event relative risk reduction rate. By applying the resulting relative risk reduction rate to the baseline SMART risk score, researchers were able to estimate the new absolute risk for each patient.3