CLEAR Outcomes: Similar CV Risk Reduction With Bempedoic Acid and Statins

Bempedoic acid is similar with statin therapy at decreasing the risk of a first major vascular event per every 1 mmol/L reduction in LDL-C, according to a post hoc analysis of the CLEAR Outcomes trial, published in JACC.

The primary results of the CLEAR Outcomes trial showed that bempedoic acid (180 mg) compared with placebo produced a 21% decrease in LDL-C and a 13% relative reduction in the risk of major adverse cardiovascular events. All 13,970 patients were statin intolerant and had, or were at high risk for, cardiovascular disease. Their mean baseline LDL-C was 139.0 mg/dL.

In the present analysis, A. Michael Lincoff, MD, FACC, et al., used a methodology developed by the Cholesterol Treatment Trialists' Collaboration (CTTC) to compare the treatment effect of bempedoic acid and statins.

Results showed that the CCTC endpoint of major vascular event, defined as composite of coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal stroke, or coronary revascularization, occurred in 10.1% and 11.7% of the patients in the treatment and placebo groups, respectively (hazard ratio [HR], 0.85; 95% CI, 0.77-0.94).

When normalized by 1 mmol/L reduction in LDL-C, the risk of a major vascular event was reduced by 25% with bempedoic acid (HR, 0.75; 95% CI, 0.63-0.90) and by 22% (HR, 0.78; 95% CI, 0.76-0.80) with statins using data from a series of 2010 meta-analyses by CCTC with 174,149 patients. Each of the individual endpoints were similarly reduced with both agents.

Lincoff, et al., write that by confirming the proportional relationship between risk reduction and LDL-C with bempedoic acid and statins is similar, the results of this analysis "reinforce the primary goal of lipid management to achieve optimal LDL-C, rather than focus on the specific class of agent to do so."

In an accompanying editorial comment, Maya S. Safarova, MD, FACC, et al., write the analysis "suggests that in at-risk patients, the goal should be to use medications and combinations that are well tolerated and achieve optimal LDL-C reduction." They also commend the CLEAR Outcomes investigators for a trial population that is 48% women, "generating key outcomes data in women who historically have higher reported statin intolerance."

Clinical Topics: Dyslipidemia, Lipid Metabolism, Nonstatins

Keywords: Cholesterol, LDL, Cardiovascular Diseases, Myocardial Infarction, Stroke, Coronary Disease, Risk Reduction Behavior, Statins

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