Bempedoic Acid: A New Drug for an Old Problem

Abstract

Objective: To review the pharmacology, pharmacokinetics, safety, and efficacy of bempedoic acid for low-density lipoprotein cholesterol (LDL-C) reduction. Data Sources: A PubMed search was conducted from January 2000 to June 15, 2020, using the keyword bempedoic acid for phase III clinical trials published in the English language. Study Selection and Data Extraction: Articles related to the Food and Drug Administration (FDA) approval of bempedoic acid and other trials relating to the safety and efficacy of this drug were included. Data Synthesis: The findings from this review show that bempedoic acid is a safe and effective option for lowering LDL-C levels in patients requiring LDL-C lowering for primary or secondary prevention of cardiovascular events. Relevance to Patient Care and Clinical Practice: Statin therapy remains the mainstay of treatment for both primary and secondary prevention. However, many patients cannot tolerate statin therapy because of statin-associated muscle symptoms. Bempedoic acid may be a reasonable adjunct for LDL-C reduction, though further evaluation of cardiovascular outcomes with bempedoic acid in this population is needed. Conclusions: The recent FDA approval of bempedoic acid offers an additional option for lowering LDL-C levels in patients with atherosclerotic cardiovascular disease or heterozygous familial hyperlipidemia. Additional data regarding effect on long-term cardiovascular outcomes with bempedoic acid are currently being studied.

Advances in Treatment of Dyslipidemia

“…In these trials, most adverse events were considered mild or moderate. The most common events are depicted in Figure 3 [67].…”

Emerging Non-statin Treatment Options for Lowering Low-Density Lipoprotein Cholesterol

“…BDA has a volume of distribution of 18 L. Both BDA and its active metabolite are highly (99.3 and 99.2%, respectively) plasma protein bound ( 62 ). BDA achieves maximum concentration within a median time of 3.5 h and steady state after approximately 7 days ( 62 ). The half-life of BDA is 15–24 h ( 62 ).…”

“…BDA achieves maximum concentration within a median time of 3.5 h and steady state after approximately 7 days ( 62 ). The half-life of BDA is 15–24 h ( 62 ).…”

Presente y futuro del tratamiento hipolipemiante, nuevas moléculas a la vista

“…Inhibition of ACL decreases cholesterol biosynthesis and causes an upregulation in lipoprotein receptors to increase LDL-C clearance. 15 Efficacy of bempedoic acid was evaluated in four phase III randomized double-blind clinical trials: CLEAR Tranquility, patients with a history of statin intolerance and use of ezetimibe; CLEAR Serenity, subjects with statin intolerance but hypolipidemic therapy for primary prevention; CLEAR harmony, patients in statin therapy with maximum tolerable and CLEAR Wisdom, in patients at high cardiovascular risk and in statin therapy at tolerable maximums. A daily dose of 180 mg achieved LDL-C reduction from 12.6 (at 52 weeks of follow-up) to 23.6% (within 12 weeks of surgery).…”

“…Main reported adverse events were nasopharyngitis, urinary tract infections, arthralgia, hyperuricemia, gout, decreased glomerular filtration rate, and risk of tendon rupture. 15 Despite the observed results, it is considered an expensive therapy.…”