STEPS

New Drug Reviews

Bempedoic Acid (Nexletol) for the Treatment of Hyperlipidemia and Familial Hypercholesterolemia

 

Am Fam Physician. 2021 Mar 15;103(6):377-378.

Bempedoic acid (Nexletol) is labeled as an adjunct to diet plus a maximally tolerated dosage of statin for the treatment of familial hypercholesterolemia or atherosclerotic cardiovascular disease (ASCVD)in patients requiring additional reduction of low-density lipoprotein (LDL) cholesterol.1 Bempedoic acid lowers LDL cholesterol by inhibiting ATP citrate lyase. This mechanism differs from statins, which inhibit the HMG-CoA reductase enzyme.

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DrugDosageDose formMonthly cost*

Bempedoic acid (Nexletol)

180 mg taken orally once daily with or without food

Tablet: 180 mg

$350


*—Estimated lowest GoodRx price for one month of treatment. Actual cost will vary with insurance and by region. Information obtained at https://www.goodrx.com (accessed February 4, 2021; zip code: 66211).

DrugDosageDose formMonthly cost*

Bempedoic acid (Nexletol)

180 mg taken orally once daily with or without food

Tablet: 180 mg

$350


*—Estimated lowest GoodRx price for one month of treatment. Actual cost will vary with insurance and by region. Information obtained at https://www.goodrx.com (accessed February 4, 2021; zip code: 66211).

Safety

Patients taking bempedoic acid are at risk of increased serum uric acid levels and tendon rupture. Serum uric acid may increase by 0.6 mg per dL (0.04 mmol per L) to 0.9 mg per dL (0.05 mmol per L) from baseline, usually in the first four weeks of treatment. Clinically significant hyperuricemia will develop in 3.5% of patients.25 Gout has been shown to occur in 1.5% of patients on bempedoic acid therapy, and about 10% of patients with a history of gout will experience a gout attack. Patients taking bempedoic acid should be monitored for signs and symptoms of hyperuricemia, and serum uric acid should be assessed as indicated. Tendon rupture has been reported in 0.5% of patients, usually within weeks to months of starting treatment with bempedoic acid.1 Patients at higher risk of tendon rupture include those older than 60 years, patients taking corticosteroids or fluoroquinolones, patients with kidney failure, and those with previous tendon disorders. Patients should discontinue use of bempedoic acid if tendon rupture occurs. In clinical trials, benign prostatic hyper-trophy and atrial fibrillation occurred at a higher rate than with placebo. Kidney, liver, and blood indices can be mildly affected by treatment, but typically these changes are not clinically important. Rates of myalgia in patients taking bempedoic acid are similar to those seen with placebo and occur in about 3% to 6% of patients.25 Although there are no human data on use of bempedoic acid during pregnancy, animal studies suggest skeletal variations, decreased fetal weight, and fetal loss. Bempedoic acid should not be used in patients who are pregnant or breastfeeding.1 Bempedoic acid has not been studied in children.1

Tolerability

Bempedoic acid is well tolerated by most patients. The most common adverse effects leading to

Address correspondence to Elizabeth Lawrence, MD, FAAFP, at Elizabeth.Lawrence@Baycare.org. Reprints are not available from the authors.

Author disclosure: No relevant financial affiliations.

References

show all references

1. DailyMed. Drug label information: Nexletol—bempedoic acid tablet, film coated. Accessed June 12, 2020. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=88d06d89-a3da-40b4-b273-8f4f7d56c4c9...

2. Ballantyne CM, Laufs U, Ray KK, et al. Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy. Eur J Prev Cardiol. 2020;27(6):593–603.

3. Goldberg AC, Leiter LA, Stroes ESG, et al. Effect of bempedoic acid vs placebo added to maximally tolerated statins on low-density lipoprotein cholesterol in patients at high risk for cardiovascular disease: the CLEAR wisdom randomized clinical trial [published correction appears in JAMA. 2020;323(3):282]. JAMA. 2019;322(18):1780–1788.

4. Laufs U, Banach M, Mancini GBJ, et al. Efficacy and safety of bempedoic acid in patients with hypercholesterolemia and statin intolerance. J Am Heart Assoc. 2019;8(7):e011662.

5. Ray KK, Bays HE, Catapano AL, et al.; CLEAR Harmony Trial. Safety and efficacy of bempedoic acid to reduce LDL cholesterol. N Engl J Med. 2019;380(11):1022–1032.

6. Ballantyne CM, Banach M, Mancini GBJ, et al. Efficacy and safety of bempedoic acid added to ezetimibe in statin-intolerant patients with hypercholesterolemia: a randomized, placebo-controlled study. Atherosclerosis. 2018;277:195–203.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

The series is coordinated by Allen F. Shaughnessy, PharmD, MMedED, assistant medical editor.

A collection of STEPS published in AFP is available at https://www.aafp.org/afp/steps.

 

 

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