Effect of Bempedoic Acid on Cardiovascular Outcomes by Sex
abstract
This abstract is available on the publisher's site.
Access this abstract nowLipid lowering therapies are crucial to reduce cardiovascular (CV) risk; yet outcomes data in women are limited. Further, women are less likely to have hypercholesterolemia diagnosed or treated and more likely to report statin intolerance.1 CLEAR (Cholesterol Lowering via Bempedoic Acid [ECT1002], an ACL-Inhibiting Regimen) Outcomes showed patients with, or at high risk for, CV disease who are unable or unwilling to take guideline-recommended doses of statins had a significantly lower risk of major adverse cardiovascular events (MACE) with bempedoic acid, an adenosine triphosphate (ATP) citrate lyase inhibitor, than with placebo.2CLEAR Outcomes is notable for having 48% (N=6,740) female subjects — the highest percent enrollment of females among contemporary lipid-lowering outcomes trials — affording the opportunity to assess whether improvements in CV risk seen with bempedoic acid varied by sex.2,3CLEAR Outcomes methods have been previously published.2 In brief, it was a double-blind, randomized, placebo-controlled trial which enrolled 13,970 patients at 1250 sites in 32 countries.2 The study was approved by individual site institutional review committees and participants gave informed consent. P articipants were randomized to 180 mg oral bempedoic acid daily or placebo and followed for a median of 3.4 years. Approximately 91% of participants enrolled identified as white race, and 17% as Hispanic/Latinx ethnicity.
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Impact of Bempedoic Acid on Cardiovascular Outcomes by Sex
Circulation 2024 Apr 06;[EPub Ahead of Print], L Cho, J Plutzky, D Brennan, MJ Louie, L Lei, P Robinson, HA Powell, SJ Nicholls, AM Lincoff, SE NissenFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
The cornerstone of prevention and treatment of atherosclerotic cardiovascular disease (ASCVD) has been HMG-CoA reductase inhibitors, statins; however, there are patients who are unwilling or unable to use statins due to intolerance. Women are more likely to report statin intolerance.1 Recently, the Cholesterol Lowering via Bempedoic Acid (CLEAR Outcomes) trial showed that patients with or at high risk for CVD who are unable or unwilling to take guideline-recommended doses of statins had a significantly lower risk of major adverse cardiovascular events (MACE) with bempedoic acid, an adenosine triphosphate citrate lyase inhibitor, than with placebo. Among modern day cholesterol trials, CLEAR Outcomes had the highest rates of women enrolled (48%) and offers a unique insight into the characteristics of women at high CVD risk.
In brief, the CLEAR Outcomes trial2 enrolled 13,970 patients with or at high risk for CVD and high LDL-C levels, who were randomized to either 180 mg oral bempedoic acid daily or placebo and followed for a median period of 3.4 years. At baseline women had older age, diabetes, higher LDL-C and hs-CRP levels, and less use of lipid-lowering therapies. The proportion of patients who received primary versus secondary prevention was higher in women. Women more likely had peripheral and cerebrovascular disease and less likely had coronary disease.
In both sexes, bempedoic acid reduced CVD risk, lowered LDL-C and hs-CRP levels, and was well-tolerated. Bempedoic acid reduced CVD risk similarly in women and men, particularly the risks of MACE-4 (CVD death, nonfatal myocardial infarction, nonfatal stroke, and coronary revascularization; [aHR, 0.89; 95% CI, 0.75–1.04] and [aHR, 0.86; 95% CI, 0.77–0.97], respectively) and MACE-3 (CVD death, nonfatal myocardial infarction, and nonfatal stroke; [aHR, 0.88; 95% CI, 0.73–1.06] and [aHR, 0.84; 95% CI, 0.73–0.97], respectively).3
Treatment discontinuation rates were lower with bempedoic acid than placebo in women (30.5% vs 33.4%) and men (27.9% vs 30.0%). Similar rates of serious adverse events occurred in women (24.2%) and men (26.2%) treated with bempedoic acid.
Although there remains controversy regarding statin intolerance, alternative nonstatin lipid-modifying therapies are needed to manage patients and achieve guideline-recommended LDL-C level goals. Bempedoic acid should be considered as a viable option for those unwilling or unable to tolerate statins.
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