- Question
- Can bempedoic acid, an ATP citrate lyase inhibitor that lowers LDL cholesterol, reduce cardiovascular events in statin-intolerant patients?
- Design
- Phase 3, randomized, double-blind, placebo-controlled trial enrolling 13970 patients; median follow-up was 40.6 months.
- Population
- Patients unable or unwilling to take statins because of unacceptable adverse effects (statin-intolerant) who had, or were at high risk for, cardiovascular disease.
- Intervention
- Oral bempedoic acid 180 mg once daily (6992 patients).
- Control
- Matching oral placebo once daily (6978 patients).
- Primary outcome
- Four-component composite of major adverse cardiovascular events: death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization.
- Results
- The primary end point occurred in 819 patients (11.7%) with bempedoic acid vs. 927 (13.3%) with placebo (HR 0.87; 95% CI 0.79 to 0.96; P = 0.004). Fatal or nonfatal myocardial infarction was lower with bempedoic acid (3.7% vs. 4.8%; HR 0.77; 95% CI 0.66 to 0.91).
- Safety
- Gout (3.1% vs. 2.1%) and cholelithiasis (2.2% vs. 1.2%) were more frequent with bempedoic acid, as were small increases in creatinine, uric acid, and hepatic enzyme levels.
- Conclusion
- In statin-intolerant patients, bempedoic acid was associated with a lower risk of major adverse cardiovascular events, with no significant effect on stroke, cardiovascular death, or all-cause death.
- Why it matters
- It provided the first clinical-event evidence for a non-statin oral lipid-lowering drug in patients who cannot tolerate statins, a group with few proven therapeutic options.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 7, 2026