by Maria Gorla, Doctor of Pharmacy Candidate and Daniel M. Riche PharmD, BCPS, AHA-CHC, CLS, University of Mississippi School of Pharmacy
It is well established that elevated low-density lipoprotein cholesterol (LDL-C) is directly associated with the development of atherosclerotic cardiovascular disease (ASCVD). More than 70 million adults in the United States have elevated LDL-C, yet less than half receive treatment, and only a third reach the desired LDL-C target.1 Statin therapy is the cornerstone of pharmacologic treatment for hypercholesterolemia; however, some patients are unable to tolerate statin therapy, and not all who tolerate statin therapy achieve lipid goals with statins alone. In patients with clinical ASCVD, it is recommended to reduce LDL-C to less than 70 mg/dL.2 If this target is not attainable with statins alone, additional agents should be employed to reduce the risk of recurrent ASCVD events. Furthermore, a combination of therapies is often needed to achieve appropriate LDL-C reduction in patients with familial hypercholesterolemia (FH). FH is a genetic condition that results in a defective LDL receptor and prevents the efficient removal of LDL cholesterol from the bloodstream. Patients with FH generally have LDL >190 mg/dL, which places them at a much higher risk for developing ASCVD. FH accelerates the risk of coronary heart disease by 10 to 20 years in men and by 20 to 30 years in women.3 Patients with FH or those with clinical ASCVD on maximally tolerated statin therapy often require additional lipid-lowering therapies, and bempedoic acid is a new treatment option for these patients.
References
- Roy S. Atherosclerotic Cardiovascular Disease Risk and Evidence-Based Management of Cholesterol. North American Journal of Medical Sciences [Internet]. 2014;6:191. Accessed: April 17, 2020. Available from: http://dx.doi.org/10.4103/1947-2714.132916
- Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol. Journal of the American College of Cardiology [Internet]. 2019;73:E285–E350. Accessed: April 21, 2020. Available from: http://dx.doi.org/10.1016/j.jacc.2018.11.003
- American Heart Association (AHA). Familial Hypercholesterolemia. Updated April 30, 2017. Accessed April 21, 2020. Available from: https://www.heart.org/en/health-topics/cholesterol/causes-of-high-cholesterol/familial-hypercholesterolemia-fh
- Lemus HN, Mendivil CO. Adenosine Triphosphate Citrate Lyase: Emerging Target in the Treatment of Dyslipidemia. Journal of Clinical Lipidology [Internet]. 2015;9:384–389. Accessed: April 20, 2020. Available from: http://dx.doi.org/10.1016/j.jacl.2015.01.002
- Food and Drug Administration (FDA). Drug Trials Snapshot: Nexletol. FDA, 2020. Updated March 2, 2020. Accessed April 21, 2020. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/drug-trials-snapshots-nexletol
- 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. JAMA [Internet]. 2019;322:1780. Accessed: April 20, 2020. Available from: http://dx.doi.org/10.1001/jama.2019.16585
- 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 [Internet]. 2018;277:195–203. Accessed: April 17, 2020. Available from: http://dx.doi.org/10.1016/j.atherosclerosis.2018.06.002
- Ray KK, Bays HE, Catapano AL, et al. Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. New England Journal of Medicine [Internet]. 2019;380:1022–1032. Accessed: April 21, 2020. Available from: http://dx.doi.org/10.1056/NEJMoa1803917
- Nexletol [package insert]. Ann Arbor, MI: Esperion Therapeutics, INC; 2020
- Virani SS, Kennedy KF, Akeroyd JM, et al. Variation in Lipid-Lowering Therapy Use in Patients With Low-Density Lipoprotein Cholesterol ≥190 mg/dL. Circulation: Cardiovascular Quality and Outcomes [Internet]. 2018;11. Accessed: April 20, 2020. Available from: http://dx.doi.org/10.1161/CIRCOUTCOMES.118.004652
- Keown A. Esperion Wins FDA Approval for its Oral, Cholesterol-Lowering Drug. Biospace [Internet]. 2020 [cited 2020 April]. Available from: https://www.biospace.com/article/esperion-wins-fda-approval-for-its-oral-cholesterol-lowering-drug-nexletol/