Why this research?
Most clinical studies of lipid-lowering agents have been conducted in patients with a history of cardiovascular events. Bempedoic acid is a relatively new cholesterol-lowering drug. It is unclear whether treatment with bempedoic acid is useful in patients without a history of cardiovascular disease.
Research question
What is the effect of bempedoic acid treatment on cardiovascular outcomes in statin-intolerant patients at high risk for a first cardiovascular event?
How was this investigated?
The researchers conducted a predefined subgroup analysis of the CLEAR Outcomes trial, a randomized, double-blind, placebo-controlled trial conducted in 1,250 hospitals in 32 countries. This subgroup analysis included statin intolerant patients aged 18-85 years who were at high risk for a first cardiovascular event. Patients who successfully completed the ‘run-in’ period – that is, not intolerant to placebo and compliance ≥ 80% – were randomized 1:1 to bempedoic acid (180 mg/day) or placebo. The primary outcome measure was the time to a first major adverse cardiovascular event (MACE), composed of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and coronary revascularization. Key secondary outcomes were: (a) time to MACE, composed of 3 components (cardiovascular death, non-fatal myocardial infarction and non-fatal stroke); (b) fatal or nonfatal myocardial infarction; (c) coronary revascularization; (d) fatal or non-fatal stroke; (e) cardiovascular mortality; and (f) overall mortality. The safety of the treatments was also examined.
Main results
A total of 13,970 statin-intolerant patients participated in the study, of whom 4206 patients were at high risk for a first cardiovascular event (mean age: 68 years; 59% female; 66% with diabetes mellitus). After a median follow-up of 39.9 months, treatment with bempedoic acid was associated with a lower risk of the primary outcome (111 (5.3%) vs. 161 (7.6%) events; adjusted hazard ratio (HR): 0 .70; 95% CI: 0.55-0.89) and a lower risk of major secondary outcomes, including the 3-component MACE (83 (4.0%) vs. 134 (6.4%) events ; HR: 0.64; 95% CI: 0.48-0.84), fatal or non-fatal myocardial infarction (29 (1.4%) vs. 47 (2.2%) events; HR: 0. 61; 95% CI: 0.39-0.98), cardiovascular mortality (37 (1.8%) vs. 65 (3.1%) events; HR: 0.61; 95% CI: 0. 41-0.92) and overall mortality (75 (3.6%) vs. 109 (5.2%) events; HR: 0.73; 95% CI: 0.54-0.98). There was no difference in the risk of fatal or non-fatal stroke or coronary revascularization between the two groups. Patients treated with bempedoic acid were more likely to have gout (2.6 vs. 2.0%), cholelithiasis (2.5 vs. 1.1%), and elevated creatinine, uric acid, and liver enzyme levels than patients receiving placebo.
2023-12-06 05:00:00
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