Impact of Bempedoic Acid on Total Cardiovascular Events

• DOI: 10.1001/jamacardio.2023.5155
• Publication Date: 2024-01-17T17:53:19Z
• Authors: Stephen J. Nicholls; Adam J. Nelson; A. Michael Lincoff; Danielle Brennan; Kausik K. Ray; Leslie Cho; Venu Menon; Na Li; LeAnne Bloedon; Steven E. Nissen
• Keywords: Mace; Stroke; Clinical endpoint; Surrogate endpoint

Importance The ATP citrate lyase (ACL) inhibitor, bempedoic acid, reduces low-density lipoprotein cholesterol (LDL-C) level and major adverse cardiovascular events (MACE) by 13% in patients at high risk with intolerance of statin high-intensity medications. effects acid on total remain unknown. Objective To determine the impact incidence MACE. Design, Setting, Participants Included this prespecified analysis Cholesterol Lowering via Bempedoic Acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial were with, or for, disease, hypercholesterolemia inability to take guideline-recommended statins. Study data analyzed from December 2016 November 2022. Interventions Patients randomly assigned treatment placebo daily. Main Measures primary end point was time first event for a composite death, nonfatal myocardial infarction, stroke, coronary revascularization (MACE-4). key secondary stroke (MACE-3). This compared number groups. Results A 13 970 (mean [SD] age, 65 [9] years; 7230 male [51.8%]) included study. 9764 participants (69.9%) had prior atherosclerotic disease baseline LDL-C 139 mg/dL; resulted 21% reduction 22% high-sensitivity C-reactive protein (hsCRP) 6 months. Median (IQR) follow-up 3.4 (3.1-3.9) years. 1746 positively adjudicated MACE-4 915 additional MACE 612 recorded, representing 32.8% (573 1746) 69.4% (635 915) events. For events, associated (hazard ratio [HR], 0.80; 95% CI, 0.72-0.89; P <.001), MACE-3 (HR, 0.83; 0.73-0.93; = .002), infarction 0.69; 0.58-0.83; < .001), 0.78; 0.68-0.89; although no statistically significant difference observed 0.63-1.03). lower HR protection increasing experienced patients. Conclusion Relevance reduced risk, therapy intolerance, elevated levels.