Impact of Bempedoic Acid on Total Cardiovascular Events – A Pre-Specified Analysis of the CLEAR Outcomes Study

Presented at the ESC Congress 2023 by:Stephen Nicholls, MD - Melbourne, Australia

Introduction and methods

The CLEAR Outcomes trial recently showed that bempedoic acid reduced first MACE events in high-risk patients with high LDL-c levels who were unwilling or unable to take statins. The current prespecified analysis of the trial assessed the effect of bempedoic acid on total MACE events.

CLEAR Outcomes randomized a total of 13.970 patients to receive either bempedoic acid or placebo for 3.4 years. The primary composite endpoint included CV death, MI, stroke, or coronary revascularization. The key secondary endpoint was the composite of CV death, MI or stroke.

Main results

• 65.6% of the total amount of events that occurred during the study were first events. 34.4% were additional events.
• Bempedoic acid reduced LDL-c by 22% and hsCRP by 21%.
• In the total event analysis, Bempedoic acid reduced the primary endpoint by 20% (HR 0.80, 95%CI 0.72-0.89, P=0.0001) and the key secondary outcome by 17% (HR 0.83, 95%CI 0.73-0.93) compared with placebo.
• Bempedoic acid also showed a benefit in the total event analysis compared with placebo for the secondary outcomes of non-fatal MI (HR 0.69, 95%CI 0.58-0.83, P=0.0001), and coronary revascularization (HR 0.78, 95%CI 0.68-0.89, P=0.003). There was no significant difference between groups for stroke (HR 0.80, 95%CI 0.63-1.03, P=0.09).
• The greater the number of events experienced by participants, the lower the hazard ratio in favor of bempedoic acid compared with placebo. HR’s for the primary endpoint for 1st, 2nd, 3rd and >4 events were respectively 0.87, 0.74, 0.69 and 0.52.

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Conclusion

This prespecified, secondary analysis of the CLEAR Outcomes trial showed that bempedoic acid reduced the total incidence of the composite outcome of CV death, MI, stroke, or coronary revascularization by 20% and the composite of CV death, MI or stroke by 17%. “These findings emphasize the benefits of lowering levels of LDL-C and hsCRP with bempedoic acid in high risk, statin intolerant patients” said Stephen Nicholls.

• Our reporting is based on the information provided at the ESC Congress 2023 -