“We’re very pleased with the results,” said study chair Dr. Steven Nissen, chief academic officer of the Heart, Vascular & Thoracic Institute at Cleveland Clinic, in Ohio. “People who couldn’t tolerate a statin did tolerate bempedoic acid and had a very good outcome. We are glad that we were able to demonstrate this level of efficacy on the outcomes that really matter to patients.”
The trial was the first to assess whether bempedoic acid could reduce poor cardiovascular outcomes.
The researchers enrolled more than 14,000 patients between December 2016 and August 2019 at 1,200 sites in 32 countries. The patients were not able to tolerate statins.
All of the study participants had LDL (“bad”) cholesterol levels of 100 mg/dL or higher at baseline. They also had either a previous cardiac event or other risk factors for heart disease.
The patients were an average age of 65; about 70% had experienced a previous cardiac event.
Patients were randomly assigned to either a placebo or 180 milligrams (mg) of bempedoic acid. They were followed for an average of three years.
The study found the drug was associated with significant reductions in the trial’s primary endpoint, which was a composite of cardiovascular death, heart attack, stroke or a procedure that opens blocked arteries called coronary revascularization.
The researchers found that bempedoic acid led to a 23% reduction in heart attacks. It also led to a 19% reduction in coronary revascularizations.
About 12% of patients taking bempedoic acid had cardiovascular death, heart attack, stroke or coronary revascularization compared to just over 13% taking the placebo, the investigators found.
Those who took the bempedoic acid had their LDL cholesterol levels drop by about 20% to 25%, on average, during the study.
Those taking the placebo also saw a reduction, but it was modest, about 10% on average. This likely reflects closer monitoring and the addition of other cholesterol-lowering agents as part of their background therapy, the researchers suggested.
Statins, which are the standard first-line treatment for lowering cholesterol and reducing heart disease risk typically lower LDL levels by 40% to 50%.
However, even though bempedoic acid makes a smaller change, it still makes a difference in the overall risk of cardiac events for patients who cannot tolerate statins, Nissen said.
The findings were presented Saturday at the American College of Cardiology’s annual meeting in New Orleans. They were also published simultaneously online in the New England Journal of Medicine.
“Statins are the cornerstone of risk reduction in patients with elevated LDL cholesterol,” Nissen said in a meeting news release. “Most people can take statins, but some cannot. This is the first study that directly addressed the problem of statin-intolerant patients. We achieved what we hoped we would get — a very positive result in a population of people who just could not tolerate statins.”
The participants taking bempedoic acid did have higher rates of other adverse events, including kidney impairment, gout and gallstones, as well as elevated liver enzymes. This is likely due to the drug’s activity in the liver, according to the researchers.
Heart experts also questioned the value of the findings.
Yale cardiologist Dr. Harlan Krumholz told The New York Times that because bempedoic acid’s effects were modest and other drugs exist that also lower LDL, it “is unlikely to be a game-changer.”
And Dr. Benjamin Ansell, a lipid expert at University of California, Los Angeles, told the Times that the drug was “better than nothing” but that “it isn’t enough” for people who have high LDL levels and are at high risk.
Bempedoic acid uses the same biological pathway as statins do, but isn’t activated until it gets to the liver, which may be why it doesn’t have the same side effects on muscle, the brain and other tissues and organs as statins do.
The drug’s developer, Esperion Therapeutics, funded the study.
The U.S. Centers for Disease Control and Prevention has some cholesterol myths and facts.
SOURCES: American College of Cardiology, news release, March 4, 2023; The New York Times
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