Cleveland Clinic-led trial shows cholesterol-lowering drug reduces cardiac events, including death, in statin-intolerant patients at high cardiovascular risk

• The patients had risk factors but no pre-existing heart disease.

Findings from a clinical trial led by Cleveland Clinic showed that the use of bempedoic acid (a cholesterol-lowering drug) in statin-intolerant patients who have not yet had a cardiovascular event but have risk factors such as diabetes significantly reduced the chance of death from heart disease and other major adverse cardiovascular events, such as heart attacks and strokes.

The findings were presented during a late-breaking scientific session at the American Diabetes Association’s 83rd Scientific Sessions in San Diego and published simultaneously in the Journal of the American Medical Association.

In March, results from the CLEAR Outcomes trial showed that bempedoic acid reduced adverse cardiovascular outcomes in 14,000 statin-intolerant patients. Within the CLEAR trial, 4,200 enrolled patients were at high risk of heart disease but had no previous cardiovascular events (primary prevention).

After six months of treatment, bempedoic acid, compared with placebo, lowered LDL cholesterol by 23.2% and reduced inflammation as measured by C-reactive protein by 22.7%. In this primary prevention subgroup, there was also a 30% reduction in major cardiovascular events, a 39% reduction in death from heart disease and a 39% decrease in heart attacks.

“These findings emphasise the major benefits of lipid-lowering therapy in patients without a previous cardiovascular event but who are at risk of a first event,” said the study’s lead author, Dr. Steven E. Nissen, Chief Academic Officer of the Heart, Vascular & Thoracic Institute at Cleveland Clinic. “Approximately two-thirds of participants had diabetes, which further supports recommendations that primary prevention patients with diabetes should be treated with cholesterol-lowering therapies.”

Primary prevention patients are currently undertreated in the United States, and more than half of patients at high risk of a cardiovascular event are not currently receiving cholesterol-lowering medication. Few clinical trials in recent years have studied patients who have not yet had a cardiac event.

High LDL cholesterol can build up in the walls of blood vessels, creating blockages and increasing the risk of heart attack or stroke. Statins are the standard first-line treatment for preventing cardiovascular disease and work by lowering blood cholesterol levels. However, some patients struggle with adverse side effects, particularly muscle pain or weakness, that prevent them from using statins at recommended doses. Bempedoic acid differs from statins in that it is not activated until it reaches the liver, which limits the drug’s potential to cause adverse effects in muscle.

Adverse effects seen with bempedoic acid included a higher incidence of gout and gallstones.

The study was funded by Esperion Therapeutics, the developer of bempedoic acid.

Dr. Nissen has served as a consultant for many pharmaceutical companies and has overseen clinical trials for AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Novartis, Mineralys, Silence Therapeutics and Pfizer. However, he does not accept fees for services or other compensation from commercial entities.

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About Cleveland Clinic

Cleveland Clinic is a nonprofit multispecialty academic medical centre that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based on the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States.  

U.S. News & World Report consistently names Cleveland Clinic as one of the nation’s best hospitals in its annual “America’s Best Hospitals” survey. Among Cleveland Clinic’s 72,500 employees worldwide are more than 5,050 salaried physicians and researchers, and 17,800 registered nurses and advanced practice providers, representing 140 medical specialties and subspecialties.  Cleveland Clinic is a 6,500-bed health system that includes a 173-acre main campus near downtown Cleveland, 21 hospitals, more than 220 outpatient facilities, and locations in northeast Ohio; southeast Florida; Las Vegas, Nevada; Toronto, Canada; Abu Dhabi, UAE; and London, England.

In 2021, there were 10.2 million outpatient visits, 304,000 hospital admissions and observations, and 259,000 surgeries across Cleveland Clinic’s health system. Patients came for treatment from every state and 185 countries.  

Visit us at clevelandclinic.org. Follow us at twitter.com/ClevelandClinic. News and resources available at newsroom.clevelandclinic.org.

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