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CLEAR Outcomes confirms bempedoic acid benefits for recurrent CV events

Posted on 25 March 2024 | Posted in News

Bempedoic acid reduces recurrent as well as first major adverse cardiovascular events (MACE), according to data from a prespecified analysis of the CLEAR Outcomes trial published in JAMA Cardiology.1

In the study of 13,970 participants, 9764 of whom had prior atherosclerotic cardiovascular disease (ASCVD) and a baseline LDL-C level of 139mg/dL, there were a total of 1746 first MACE-4 events (composite of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or coronary revascularisation). In addition, 915 MACE recurrent events were recorded in 612 patients. Coronary revascularisation represented 573/1746 (32.8%) of first events and 635/915 (69.4%) of additional events.

For the total incidence of CV events (first and recurrent), treatment with bempedoic acid was associated with a reduction in risk of MACE-4 (hazard ratio [HR], 0.80; 95%CI, 0.72-0.89; p<0.001), MACE-3 (HR, 0.83; 95%CI, 0.73-0.93; p=0.002), MI (HR, 0.69; 95%CI, 0.58-0.83; p<0.001), and coronary revascularisation (HR, 0.78; 95%CI, 0.68-0.89; p <0.001). No statistically significant difference was observed for stroke (HR, 0.80; 95%CI, 0.63-1.03).

The greatest benefit with bempedoic acid was seen in patients experiencing the most events. For the first event, the HR was 0.87 (95% CI, 0.79-0.96; p= 0.004) and for the second, third and fourth events it was 0.74 (95% CI, 0.63-0.87; p<0.001), 0.69 (95%CI,0.51-0.93; p = 0.02), and 0.51 (95%CI,0.31-0.88; p=0.02) respectively.

The study authors projected that treatment with bempedoic acid would result in 66 fewer primary MACE-4 events, 25 fewer MIs, 32 fewer coronary revascularisations, and seven fewer strokes over a five year period.

The study investigators concluded that their findings highlight the importance of lipid lowering in patients at high CV risk and suggested that more effective clinical models are needed to achieve more sustainable adherence to optimised lipid-lowering strategies in order to produce greater reductions in CV risk.

 

Reference

Nicholls SJ, Nelson AJ, Lincoff AM et al. Impact of Bempedoic Acid on Total Cardiovascular Events: A Prespecified Analysis of the CLEAR Outcomes Randomized Clinical Trial. JAMA Cardiol. 2024 Mar 1;9(3):245-253

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