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A pooled risk simulation of phase 3 data of bempedoic acid suggests the first-in-class ATP citrate lyase inhibitor could reduce risk of cardiovascular events in patients with established cardiovascular disease and elevated LDL-C.
A new study estimating the cardiovascular benefits of bempedoic acid provides further support for use of the first-in-class ATP citrate lyase inhibitor from Esperion.
Presented at the American College of Cardiology’s 70th Annual Scientific Session (ACC.21), the simulation pooled data from 4 phase 3 trials and, using SMART risk equation, concluded bempedoic acid could significantly lower risk of cardiovascular event in patients with atherosclerotic cardiovascular disease (ASCVD).
“Published analyses with validated models like SMART and CTT can help inform treatment decisions now, ahead of clinical data availability,” said senior investigator Kausik Ray, MBChB, MD, Professor of Public Health at the School of Public Health, Imperial College London and member of the CLEAR Outcomes steering committees, in a statement. “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.”
With multiple phase 3 trials outlining the effects of bempedoic acid on LDL-C, the nonstatin, lipid-lowering agent stands poised to play a role in improving health among patients who are statin-intolerant or already on statin therapy. While many cardiology care professionals are waiting anxiously on the results of the ongoing CLEAR OUTCOMES trial to learn about the effects on cardiovascular outcomes among patients.
Despite the lack of conclusive data from this trial, many still have a heightened interest in furthering the knowledge base surrounding use of bempedoic acid. The study presented at ACC.21 was born out of this same idea. Designed as a simulation study, investigators pooled data from 4 phase 3 studies of bempedoic acid where change in LDL-C at week 12 was the primary endpoint.
Using the SMART risk equation, investigators estimated the 10-year cardiovascular event risk among more than 3100 patients included in the phase 3 trials. Investigators hoped to compare 10-year risk by applying Cholesterol Treatment Trialists' (CTT) Collaboration relative risk reduction to the absolute change in LDL-C seen from baseline.
For the purpose of analysis, investigators planned to compare change in risk among patients stratified by their use of statins—the first group included patients on maximally-tolerated statin therapy and the second group included patients who were considered statin intolerant. Of note, the follow-up for the first group included 1869 patients on bempedoic acid and 954 on placebo and, among the second group, these groups included 149 and 70 patients, respectively.
Upon analysis, results indicated the difference in the least square mean percent change in LDL-C from baseline for bempedoic acid versus placebo was -17.8% (SD, 0.9) in the maximally tolerated statin group and -23.3% (SD, 2.7) among those who were statin intolerant (P <.001). For 10-year absolute cardiovascular event risk, investigators noted risk was lowered by 3.0 (95% CI, -3.36 to -2.64) percentage points versus placebo in the maximally tolerated statin group and 6.27 (95% CI, -7.87 to -4.67) percentage points lower versus placebo in the statin-intolerant group (P <.001).
This study, “Estimated Cardiovascular Benefits of Bempedoic Acid in Patients with Established Cardiovascular Disease,” was presented at ACC.21.