From the Guidelines
Bempedoic acid should be considered for patients with established atherosclerotic cardiovascular disease who require additional LDL-C lowering beyond maximally tolerated statin therapy, ezetimibe, and a PCSK9 mAb, as it may provide a mean expected reduction of approximately 17% in LDL-C levels 1.
Key Points
- Bempedoic acid is a novel LDL cholesterol–lowering agent that acts in the same pathway as statin but without activity in skeletal muscle, limiting muscle-related adverse effects 1.
- It can be used in combination with ezetimibe to achieve an additional 19% reduction in LDL cholesterol 1.
- The CLEAR Outcomes trial found a reduction in four-point major adverse cardiovascular events by 13% compared with placebo for individuals with established ASCVD or at high risk for ASCVD considered to be intolerant to statin therapy 1.
- Prescribed subanalyses evaluated the impact for individuals with diabetes and showed a 17% reduction in four-point major adverse cardiovascular events when treated with bempedoic acid 1.
Considerations
- Bempedoic acid should be used with caution in patients who have a history of gout or tendon rupture 1.
- Patients with severe kidney impairment or on dialysis should use it cautiously, and it's not recommended during pregnancy or breastfeeding.
- Common side effects include upper respiratory tract infections, muscle spasms, back pain, abdominal pain, and elevated liver enzymes.
Recommendations
- Bempedoic acid may be considered for patients who require further LDL-C reduction, have documented statin intolerance, or prefer to avoid injectable medications 1.
- It is essential to weigh the benefits and risks of bempedoic acid in individual patients, considering their specific clinical context and medical history.
- The use of bempedoic acid should be guided by the most recent clinical guidelines and evidence-based recommendations, such as those provided by the American College of Cardiology 1 and the American Diabetes Association 1.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Bempedoic Acid Overview
- Bempedoic acid is a first-in-class, once-daily oral agent used to lower low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia 2.
- It works by inhibiting adenosine triphosphate citrate lyase, an enzyme involved in the synthesis of cholesterol, and ultimately up-regulating the LDL receptors 3.
Efficacy and Safety
- Bempedoic acid has been shown to significantly lower LDL-C and other atherogenic lipoprotein measures, and high-sensitivity C-reactive protein when added to background lipid-lowering therapy in patients with and without statin intolerance 2, 4.
- The safety profile of bempedoic acid is generally well-tolerated, with no significant increase in muscle-related symptoms, and a small increase in serum uric acid as the most noteworthy adverse effect 5, 4.
- Bempedoic acid has been demonstrated to lower LDL-C levels by 15-25% in clinical trials and up to 38% when combined with ezetimibe 6.
Clinical Use
- Bempedoic acid is approved for use as monotherapy and in combination with ezetimibe, as an adjunct to maximally tolerated statin therapy in patients with ASCVD or heterozygous familial hypercholesterolemia who require additional LDL-C lowering 2, 6.
- It provides an effective tool to further reduce LDL-C as add-on therapy in patients unable to reach the target despite maximally tolerated lipid-lowering therapy 3.
- The potential for a reduced incidence of major cardiovascular events with bempedoic acid is being investigated in the CLEAR Outcomes trial 4, 6.