Bempedoic acid was found to be safe and effective at lowering low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia, when added to maximally tolerated statin treatment, according to a study published in JAMA Cardiology.

For this analysis, data from 4 double-blind, placebo-controlled randomized clinical trials conducted in North America and Europe between 2016 and 2018 were pooled. Patients with hypercholesterolemia and atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) receiving stable lipid-lowering therapy as well as patients who were statin-intolerant were eligible for the studies. Patients were randomly assigned to receive bempedoic acid (180 mg; n=2425) or placebo (n=1198) daily for 12 to 52 weeks.

The patient groups were well balanced for age (mean age, 65.5±9.2 years), but not for sex (P =.04) and body mass index (P =.007). The mean baseline LDL-C was 107.6±32.7 mg/dL in patients with ASCVD or HeFH and 144.4±38.8 mg/dL in those who were intolerant to statins.

In patients with ASCVD or HeFH, the change in LDL-C at 12 weeks compared with baseline was -16% in patients receiving bempedoic acid vs 1.8% in those in the placebo group (difference, -17.8%; 95% CI, -19.5% to -16.0%; P <.001). In patients who were statin-intolerant, of the change from baseline in LDL-C at 12 weeks was of -23.0% in the bempedoic acid group vs 1.5% in the placebo group (difference, -24.5%; 95% CI, -27.8 to -21.1%; P <.001).


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These reductions in LDL-C levels were maintained through week 24 in patients with statin intolerance (-22.2%) and through week 52 in patients with ASCVD or HeFH (-12.7%). The degree of reduction in LDL-C after 12 weeks of treatment was found to be greater in non-Hispanics vs Hispanics (P <.001), in those with a history vs no history of diabetes mellitus status (P =.03), and in those with vs without baseline statin use (P =.03).

In addition to reductions in LDL-C, patients receiving bempedoic acid also had reductions in total cholesterol, non-high-density lipoprotein cholesterol, apolipoprotein B, and high-sensitivity C-reactive protein levels.

A greater percentage of patients in the bempedoic acid vs placebo group discontinued treatment due to adverse events (11.3% vs 7.8%, respectively; P =.001). The significant adverse effects were increased blood uric acid levels (2.1% vs 0.5%, respectively; P <.001), increased levels of hepatic enzymes (2.8% vs 1.3%, respectively; P =.004), hyperuricemia (1.7% vs 0.6%, respectively; P =.007), gout (1.4% vs 0.4%, respectively; P =.008), decreased glomerular filtration rate (0.7% vs <0.1%, respectively; P =.02), and pain in the extremities (3.1% vs 1.8%, respectively; P =.02).

A major limitation of this analysis the studies examined had different durations and inclusion criteria.

”As a nonstatin adjunct or alternative to statin therapy, bempedoic acid has the potential for use in a broad spectrum of patients,” noted the study authors.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

Reference

Banach M, Duell P B, Gotto A M, et al. Association of bempedoic acid administration with atherogenic lipid levels in phase 3 randomized clinical trials of patients with hypercholesterolemia. [Published online July 1, 2020] JAMA Cardiol. doi:10.1001/jamacardio.2020.2314