Efficacy and safety of bempedoic acid among patients with and without diabetes: prespecified analysis of the CLEAR Outcomes randomised trial
Analysis (n=13,970) found over median of 3.4 years, bempedoic acid reduced risk of primary MACE-4 endpoint in diabetic patients (DBPs) by 17% (HR 0.83; 95%CI 0.72–0.95; absolute risk reduction 2.4%) vs placebo. Non-DBPs had no increase in new-onset diabetes or worsening HbA1c.
Source:
The Lancet Diabetes & Endocrinology
SPS commentary:
The four-component major adverse cardiovascular event (MACE-4) was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularisation.
A related commentary notes that most of the benefit was clearly attributable to the diabetes subgroup because of their higher baseline atherosclerotic cardiovascular risk and event rate. It notes cases of new-onset diabetes (which has been reported with statins) with bempedoic acid versus placebo were similar: 11.1% versus 11.5%, respectively. It suggests this substudy validates the atherosclerotic cardiovascular disease benefit of LDL cholesterol reduction via a mechanism that is distinct from statins, ezetimibe, and PCSK9 inhibitors. It notes the study’s limitations include the short follow-up period and small normoglycaemia cohort.