Bempedoic acid, also known as Nexletol, is a once-daily medication used in patients with increased atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia who are requiring additional LDL-C lowering previously on a maximally tolerated statin therapy along with maintaining a healthy diet. In this article, we will further break down some of the most important bempedoic acid clinical pearls.
Dosing of Bempedoic Acid
What is the dosing for bempedoic acid? Bempedoic is a once-daily medication that doesn’t need to be titrated. Standard dosing is 180mg once daily which can be taken with or without food. There is no dose adjustment needed in patients with mild or moderate renal impairment, however, there is limited data available in patients with severe renal impairment which is classified as having an eGFR<30mL/min/1.73m2. If a patient presents with hepatic insufficiencies, there is no dose adjustment needed, although patients with severe hepatic impairment, defined as Child-Pugh C, have not been studied.
Bempedoic Acid Clinical Pearls and Adverse Effects
What are the most common side effects? One of the most notable adverse effects is hyperuricemia. This is usually seen within the first 4 weeks of being on the medication but could happen throughout the treatment. These high levels of uric acid could lead to symptoms like warm tender joints, swelling, and may even lead to gout. Other noted side effects include back and stomach pain, muscle spasms, pain in the shoulder, legs, or arms, bronchitis, and anemia. Tendon problems can happen as well, especially in patients who are greater than 60 years old, on fluoroquinolones, have renal failure, or are taking corticosteroids. There is no data available that shows Bempedoic acid is safe in pregnancy. Risk vs. benefit should be discussed before using in this population.
Drug Interactions
Are there any drug interactions? If Bempedoic acid is taken along with Simvastatin, it is recommended to avoid doses greater than 20mg. This is partly because Bempedoic Acid 180mg along with 40mg of Simvastatin was found to increase Simvastatin AUC by 2-fold. The mechanism of this interaction has yet to be reported. Bempedoic acid or any of its active metabolites are not metabolized or interact with any cytochrome P450 enzymes. Pravastatin doses greater than 40mg are to be avoided as well due to an increased risk of myopathy. Atorvastatin and Rosuvastatin didn’t have any maximum dose considerations.
Where Might You See It?
What patients could benefit from this medication? This medication could be used as an adjunct in patients who eat a healthy diet and can’t tolerate a max dose statin whose LDL-C is not at goal. Bempedoic acid is a prodrug that gets converted into the active moiety, ACSVL1 which is not present in muscles. This medication gives patients a more affordable option compared to injectable PCSK9 medications although the LDL lowering effect is less (15-20% range). Representatives from the company have eyed a price range of around $10 a pill or $3,650 per year. Compared to PCSK9 injectables like Repatha, which costs patients around $6,000 per year. This would save the patient around 65% per year.
In addition, this agent is oral, so in patients who will not accept an injection (i.e. PCSK9 medications), we have another option besides ezetimibe in cholesterol management.
This article (Bempedoic Acid Clinical Pearls) was written by Cody Springer, PharmD Candidate in collaboration with Eric Christianson, PharmD, BCPS, BCGP
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References:
- “Pam R. Taub, MD, on a New Approach for Managing Lipids.” Consultant360, www.consultant360.com/exclusive/cardiology/lipid-metabolic/5-questions-about-new-approach-managing-lipids.
- Nadeem, Dania, and Trisha Roy. “Esperion Says Cholesterol Drug Gets U.S. Approval; Eyes $10 per Pill Pricing.” Reuters, Thomson Reuters, 21 Feb. 2020, www.reuters.com/article/us-esperion-thera-fda/u-s-fda-approves-esperions-cholesterol-drug-idUSKBN20F2NQ.
- Nexeltol (Bempedoic acid) package insert: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211616s000lbl.pdf
Excellent article discussed bambedoic acid and Repatha
I think it’s not registered yet in Canada but hopefully soon as more patient getting sick of Repatha inj. And huge price difference.
We now have clinical outcome data from the clear CLEAR outcomes trial published in New England Journal of Medicine March 4, 2023 however, I’m concerned that the only outcome that drove the composite results was non-fatal MI and not fatal MI or total mortality. The new ACC updated guidelines for non statin’s also have added it. I am still not a great fan but it does offer another option.
Great comment, thank you so much!