Bempedoic acid, ezetimibe, atorvastatin combination lowers LDL in hypercholesterolemia
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Triple combination therapy with bempedoic acid, ezetimibe and atorvastatin significantly reduced LDL among patients with hypercholesterolemia, researchers reported.
“As reported in phase 3 clinical trials, bempedoic acid significantly lowered LDL, non-HDL cholesterol, total cholesterol, apolipoprotein B and high-sensitivity C-reactive protein levels when administered alone or in combination with background lipid-lowering therapies, including statins and/or ezetimibe,” John Rubino, MD, principal investigator at PMG Research of Raleigh, North Carolina, and colleagues wrote in Atherosclerosis. “Given their impact on LDL levels via different mechanisms, the combination of multiple, orally administered agents has the potential to achieve highly effective lipid lowering; however, this has not been previously studied.”
The phase 2, randomized, double-blind, placebo-controlled study included 63 patients with hypercholesterolemia (mean age, 61 years; mean baseline LDL, 154.8 mg/dL). Patients were randomly assigned to triple therapy with bempedoic acid 180 mg/ezetimibe 10 mg (Nexlizet, Esperion Therapeutics) plus atorvastatin 20 mg or placebo once daily for 6 weeks.
The primary endpoint was the percent change in LDL from baseline at 6 weeks.
At 6 weeks, the triple therapy group had a mean LDL reduction of –63.6% compared with –3.1% among patients treated with placebo (P < .001). For non-HDL, total cholesterol, ApoB and hsCRP, there were also reductions after triple combination therapy treatment compared with placebo (P < .001 for all).
At 6 weeks, in the triple therapy group, 90% of patients achieved LDL of less than 70 mg/dL and 95% of patients had LDL lowered by at least 50%. No patients treated with placebo demonstrated either achievement.
Treatment-emergent adverse events occurred at a rate of 35% in both groups. Most treatment-emergent adverse events were mild to moderate in severity with the most common adverse events being headache, diarrhea, fatigue, increased hepatic enzymes, osteoarthritis, pain in extremity or rash, all occurring in 5% of patients in the triple combination therapy group.
There were no clinically relevant changes in clinical laboratory results, vital sign measurements or physical examination findings among participants, the researchers wrote.
“This provides a potential novel combination strategy for effective lipid lowering in patients at high cardiovascular risk who are unable to achieve treatment goals with conventional therapy,” the researchers wrote. “The ultimate impact of this combination strategy on long-term clinical events will need to be determined by future studies.”
Editor’s Note: This article was updated on March 25, 2021 to correct the dosage of bempedoic acid. The Editors regret the error.
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