Bempedoic Acid for Elevated LDL Cholesterol in Statin-Intolerant Patients
Introduction to Bempedoic Acid
- Bempedoic acid offers a 21-24.5% LDL-C reduction without causing muscle-related side effects and has proven cardiovascular benefit with a 13% reduction in major adverse cardiovascular events in statin-intolerant patients, according to the American College of Cardiology 1, 2, 3
Mechanism of Action
- The American College of Cardiology notes that bempedoic acid works by inhibiting ATP-citrate lyase, an enzyme upstream of HMG-CoA reductase in the cholesterol synthesis pathway, resulting in upregulation of LDL receptors and improved LDL clearance 4, 2, 3
Efficacy Data
- The American College of Cardiology recommends bempedoic acid 180 mg daily as monotherapy in statin-intolerant patients, which reduces LDL-C by approximately 21-24.5% compared with placebo 1, 4, 2, 3
- When added to existing statin therapy, bempedoic acid provides an additional 15-17.8% LDL-C reduction, as suggested by the American College of Cardiology 4, 2, 3
- The fixed-dose combination of bempedoic acid 180 mg plus ezetimibe 10 mg achieves 38% additional LDL-C reduction when added to statin therapy, according to the American College of Cardiology 4, 2, 3
Cardiovascular Outcomes
- The CLEAR Outcomes trial, cited by the American College of Cardiology, provides evidence that bempedoic acid reduces cardiovascular events by 13% compared with placebo in 13,970 statin-intolerant patients with established ASCVD or high cardiovascular risk 1, 5
Treatment Algorithm
- The American College of Cardiology suggests confirming true statin intolerance by attempting at least 2 different statins at varying doses before labeling a patient as statin-intolerant 5
- The treatment algorithm for statin-intolerant patients involves initiating ezetimibe 10 mg daily first, then adding bempedoic acid 180 mg daily if LDL-C targets are not met, as recommended by the American College of Cardiology 6, 7
Safety Profile
- The American College of Cardiology notes that muscle-related adverse events are not increased with bempedoic acid, with myalgia occurring in 4.7% of patients versus 7.2% with placebo 4, 2
- Bempedoic acid increases serum uric acid by a mean of 0.8 mg/dL, and gout occurred in 1.5% of patients versus 0.4% with placebo, according to the American College of Cardiology 8, 4, 2
Monitoring
- The American College of Cardiology recommends monitoring liver function tests at baseline and periodically as clinically indicated, as well as monitoring serum uric acid due to the increased risk of gout 8