CLEVELAND — A trial led by the Cleveland Clinic has showed the use of bempedoic acid – a cholesterol-lowering drug – in statin-intolerant patients who have not yet had a cardiovascular event “significantly reduced the chance of death from heart disease and other major adverse cardiovascular events such as heart attacks and strokes.”
“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.”
Results from the CLEAR Outcomes trial back in March showed that bempedoic acid reduced adverse cardiovascular outcomes in 14,000 statin-intolerant patients, according to a press release from the Cleveland Clinic.
“Within this CLEAR trial, there were 4,200 patients enrolled with high risk for heart disease but no previous cardiovascular events (primary prevention),” the Clinic explains. “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.”
The Cleveland Clinic says primary prevention patients are currently undertreated in the United States, with more than half of patients at high risk for a cardiovascular event not currently receiving cholesterol-lowering drugs.
“Elevated LDL cholesterol can accumulate in the walls of blood vessels, creating blockages and raising the risk of heart attack or stroke,” the Cleveland Clinic explains. “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.
The study was funded by Esperion Therapeutics, developer of bempedoic acid.
