Top line results of the CLEAR Outcomes trial have been published and they bring great cheer for patients with statin intolerance at high risk for adverse cardiovascular events.

The trial met the primary composite endpoint of cardiovascular death, nonfatal myocardial infarction (MI), nonfatal stroke, and unstable angina requiring hospitalization by demonstrating a significant decrease in major cardiovascular events (MACE) in patients treated with bempedoic acid compared to placebo. This makes bempedoic acid the first non-statin drug in the class of ATP-citrate lyase inhibitors, to demonstrate significant and "clinically meaningful" effects in the treatment of statin intolerant patients, according to a press release from the manufacturer Esperion.^1,2

At this point of time, however, we do not have enough details about the results. Only the top line results have been released. The complete data is likely to be shared in the coming year.

About the CLEAR Outcomes trial

The Cholesterol Lowering via bEmpedoic Acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial, conducted in 32 countries, examined the effects of 180 mg daily bempedoic acid in lowering the elevated lipid levels (LDL-C ≥100 mg/dL) and its ability to reduce the occurrence of MACE in at-risk patients in whom statins and other lipid-lowering drugs failed to reach the optimal lipid targets.

The randomized, double-blind, placebo-controlled trial had enrolled nearly 15,000 patients with cardiovascular disease (CVD) or those who are at high risk for CVD and had exhibited intolerance to at least 2 statins.

Bempedoic acid was FDA approved in February 2020 as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic CV disease (ASCVD) who require additional lowering of LDL-C in the dose of 180 mg administered orally once daily.

However, the press release has cautioned about the simultaneous use of bempedoic acid with simvastatin or pravastatin due to the risk of risk for "simvastatin- or pravastatin-related myopathy."

References

1. https://www.esperion.com/news-releases/news-release-details/esperion-announces-clear-cardiovascular-outcomes-trial-nexletolr, December 7, 2022.
2. Bempedoic acid cuts CV risk in the statin-intolerant: clear top-line results - Medscape - Dec 07, 2022.

Track our earlier editorial on Bempedoic acid

• https://www.emedinexus.com/post/32089/bempedoic-acid:-a-novel-lipid-lowering-option-for-hyperlipidemia