Cleveland Clinic-Led Trial Shows Cholesterol-Lowering Drug Reduces Heart-Related Events Including Death in Statin-Intolerant Patients with Elevated Cardiovascular Risk

Patients in primary prevention subgroup studied by global health system had risk factors but no pre-existing heart disease

Tuesday, July 11, 2023, Cleveland: Findings from a clinical trial led by global health system 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 do have risk factors, like diabetes, significantly reduced the chance of death from heart disease and other major adverse cardiovascular events such as heart attacks and strokes.

Findings were presented during a Late Breaking Science Session at the American Diabetes Association’s 83^rd Annual Scientific Session in San Diego and simultaneously published in the Journal of the American Medical Association.

Back in March, results from the CLEAR Outcomes trial showed that bempedoic acid reduced adverse cardiovascular outcomes in a mixed population of primary and secondary prevention patients unable to take guideline-recommended doses of statins. Within this CLEAR trial of 14,000 statin-intolerant patients, there were 4,200 patients enrolled with high risk for heart disease but no previous cardiovascular events (primary prevention) who form the basis of the current findings.

After six months of treatment, bempedoic acid, compared with placebo, reduced LDL cholesterol by 23.2% and reduced inflammation 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% decline in heart attacks.

“These findings emphasize the large benefits from lipid-lowering therapy in patients with no prior cardiovascular event, but who are at risk for a first event,” said the study’s lead author Steven E. Nissen, MD, Chief Academic Officer of the Heart Vascular & Thoracic Institute at Cleveland Clinic. “Approximately two thirds of the participants had diabetes, which further supports recommendations that primary prevention patients with diabetes should be treated with cholesterol-lowering therapies.”

 Few clinical trials in recent years have studied patients who have not yet had a cardiac event.

Elevated LDL cholesterol can accumulate in the walls of blood vessels, creating blockages and raising the risk of heart attack or stroke. Statins are the standard first-line treatment for the prevention of cardiovascular disease and work by lowering cholesterol levels in the blood.  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 by not activating until it reaches the liver which limits the drug’s potential to cause adverse muscle effects on muscle.

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

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