BEMPEDOIC ACID AND MAJOR ADVERSE CARDIOVASCULAR EVENTS ACROSS THE SPECTRUM OF KIDNEY FUNCTION: A SECONDARY ANALYSIS OF THE CLEAR OUTCOMES TRIAL

Abstract

Therapeutic Area

CVD Prevention – Primary and Secondary

Background

Decreased kidney function is an independent risk marker for increased cardiovascular morbidity and mortality. Statins are a cornerstone of cardiovascular disease prevention, however statins are frequently not tolerated. Bempedoic acid prevents major adverse cardiovascular events (MACE) among statin-intolerant patients. However, the effect of bempedoic acid in preventing MACE at different levels of kidney function is unknown.

Methods

The CLEAR Outcomes trial randomized statin-intolerant adults at high risk of, or with established cardiovascular disease, to bempedoic acid 180 mg or placebo. We analyzed MACE-4 and MACE-3 outcomes in subgroups by estimated glomerular filtration rate (eGFR), ≥90; ≥60 to <90; ≥45 to <60; and <45mL/min/1.73m2. We also analyzed the interaction between treatment effects and eGFR in a continuous manner.

Results

13970 adults were randomized to bempedoic acid or placebo, 2449 of them had eGFR ≥90 ml/min/1.73m2, 8604 had eGFR of 60-90 ml/min/1.73m2, 2342 had eGFR of 45-60 ml/min/1.73m2 and 574 had eGFR below 45 ml/min/1.73m2. The effect of bempedoic acid on prevention of MACE did not differ by eGFR groups for both MACE-4 (pinteraction = 0.93) and MACE-3 (pinteraction = 0.51). No interaction was detected by examining eGFR as a continuous measurement. The proportion of patients experiencing any adverse event in both groups increased with decreasing baseline eGFR but was similar between the bempedoic acid and placebo groups.

Conclusions

Compared with placebo, bempedoic acid reduced MACE among statin-intolerant patients irrespective of baseline eGFR.