Bempedoic acid Reference

Plain English

What it is

Bempedoic acid is a prescription pill the FDA has approved, sold as Nexletol (and as Nexlizet when combined with ezetimibe). It lowers "bad" LDL cholesterol by acting in the liver.

What people use it for

Doctors prescribe it to lower LDL cholesterol and reduce the risk of heart attacks, strokes, and related heart problems, mainly in adults who cannot tolerate statins. Because it switches on only in the liver and not in muscle, it tends to cause fewer muscle aches than statins.

What the science shows

A large trial of nearly 14,000 people who could not take statins (called CLEAR Outcomes) found that bempedoic acid lowered the chance of major heart events compared with a placebo pill. On the strength of that evidence the FDA broadened its approval to include reducing heart risk, including in people not on a statin.

The catch

It can raise uric acid in the blood and lead to gout, and its label warns about tendon rupture and rises in liver enzymes. It also interacts with certain statins, so amounts of those have to be limited. This is a prescription medicine that needs a doctor's oversight, not a casual supplement.

Reference summary

Bempedoic acid is a prodrug activated to the active form (ETC-1002-CoA) only in liver tissue; the activating enzyme is absent in skeletal muscle, which is the rationale for the favorable myalgia profile in statin-intolerant patients. CLEAR Outcomes (Nissen 2023 NEJM, n=13,970) randomized statin-intolerant patients to bempedoic acid 180 mg daily vs placebo and reported a 13 percent relative reduction in the primary 4-component MACE composite over a median 3.4 years.

Regulatory and posture

Categories

Metabolic

Aliases

Nexletol, ETC-1002, ATP-citrate lyase inhibitor (small molecule, not a peptide)

Evidence posture

human

Regulatory status

FDA-approved as Nexletol (2020) as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) requiring additional LDL-C lowering. A fixed-dose combination with ezetimibe (Nexlizet) is also approved.

Content review status

label verified