The efficacy of bempedoic acid on cardiovascular outcomes is not impacted by autoimmune or inflammatory disease

Bempedoic acid, compared with placebo, reduced the risk of major adverse cardiovascular events among patients with statin intolerance, regardless of the presence of autoimmune or inflammatory disease.

Dr Bernardo Frison Spiazzi (Cleveland Clinic, OH, USA) presented a subanalysis of CLEAR Outcomes (NCT02993406), a randomised, double-blind, placebo-controlled trial that assigned patients intolerant of statins and at high risk for cardiovascular disease to bempedoic acid or placebo [1]. The primary endpoint was a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or coronary revascularisation. In total, 13,970 patients were enrolled, including 1,044 with a history of autoimmune or inflammatory disease at baseline.

Bempedoic acid versus placebo led to similar improvements in the primary endpoint among patients with a history of autoimmune or inflammatory disease (HR 0.89; 95% CI 0.65–1.21) and those without such a history (HR 0.87; 95% CI 0.79–0.96). Comparable effects were observed across secondary endpoints, including the composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke, as well as individual endpoints such as fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, and coronary revascularisation.

In addition, bempedoic acid significantly reduced low-density lipoprotein cholesterol (LDL-C) from baseline to month 6 in both patients with autoimmune or inflammatory disease (-23.8% vs -0.5% with placebo) and those without such conditions (-21.5% vs -0.6% with placebo).

Overall, Dr Spiazzi concluded that, in the CLEAR Outcomes trial, “bempedoic acid demonstrates a consistent efficacy profile in lowering LDL-C and major adverse cardiovascular events in participants with and without autoimmune inflammatory disease.”

Spiazzi BF, et al. Bempedoic acid and cardiovascular outcomes in patients with autoimmune or inflammatory diseases: An analysis of the CLEAR Outcomes trial. ACC 2026, 28–30 March, New Orleans, LA, USA.