The Cholesterol Lowering via Bempedoic Acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial investigated the impact of bempedoic acid, an ATP citrate lyase inhibitor, on the total incidence of major adverse cardiovascular events (MACE) in patients with high cardiovascular risk, statin intolerance, and elevated low-density lipoprotein cholesterol (LDL-C). The study included 13,970 patients with or at high risk for cardiovascular disease, hypercholesterolemia, and an inability to take recommended statins. The primary endpoint was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization (MACE-4).
Participants were randomly assigned to receive either bempedoic acid or a placebo daily. The results showed that bempedoic acid led to a 21% reduction in LDL-C levels and a 22% reduction in high-sensitivity C-reactive protein (hsCRP) levels at 6 months. The median follow-up duration was 3.4 years. The study recorded 1746 positively adjudicated first MACE-4 events and 915 additional MACE events, with coronary revascularization representing a significant portion of these events.
In terms of the total incidence of cardiovascular events, treatment with bempedoic acid demonstrated a significant reduction in the risk of MACE-4 (hazard ratio [HR], 0.80; 95% CI, 0.72-0.89; P < .001), MACE-3 (HR, 0.83; 95% CI, 0.73-0.93; P = .002), myocardial infarction (HR, 0.69; 95% CI, 0.58-0.83; P < .001), and coronary revascularization (HR, 0.78; 95% CI, 0.68-0.89; P <.001). However, there was no statistically significant difference observed for stroke (HR, 0.80; 95% CI, 0.63-1.03). It’s noteworthy that a lower HR for protection with bempedoic acid was observed as the number of MACE events experienced by patients increased.
In conclusion, lowering LDL-C levels with bempedoic acid proved effective in reducing the total number of cardiovascular events in patients with high cardiovascular risk, statin therapy intolerance, and elevated LDL-C levels. The findings highlight the potential of bempedoic acid as a therapeutic option for individuals facing challenges with statin treatment, providing valuable insights for managing cardiovascular risk in this specific patient population.
https://jamanetwork.com/journals/jamacardiology/article-abstract/2813647
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