LDL drug may be an alternative to statins
Statins are the gold standard when it comes to lowering LDL, or “bad” cholesterol, but many patients at risk for heart disease refuse to take them due to serious side effects, such as pain. muscles or weakness.
An alternative drug, bempedoic acid, significantly lowers cholesterol and the risk of heart attacks, as well as the need for a procedure that unblocks clogged arteries, according to a large clinical trial presented Saturday at the annual meeting of the American College of Cardiology. The research was published Saturday in the New England Journal of Medicine.
“Statins are the cornerstone of cardiovascular disease prevention, and they are recommended for a large number of people who have or are at risk for cardiovascular disease,” said study lead author Dr Steven E. Nissen, academic director of the Heart and Vascular Institute at the Cleveland Clinic. “7% to 29% of patients experience side effects that they cannot tolerate. The main problem is muscle pain.
These patients won’t be successful if they can’t lower their cholesterol levels, Nissen said. Bempedoic does not cause muscle side effects because it is not activated in muscles and other body tissues, he explained. Until the drug reaches the liver, it is not activated at all.
LDL, or low-density lipoprotein, cholesterol contributes to the buildup of fat in the arteries, increasing the risk of heart attacks and strokes. Reducing LDL is a major means of protection against heart disease, the leading cause of death for men and women in the United States. According to the American Heart Association, the optimal total cholesterol level for an adult is around 150 mg/dL, with LDL levels at or below 100 mg/dL.
Bempedoic acid, which is already approved by the Food and Drug Administration, has already been shown to lower cholesterol when used in combination with statins.
In the new trial, Nissen and colleagues recruited 13,970 patients who could not tolerate statins and randomly assigned them to receive a daily dose of bempedoic acid or a placebo. At baseline, the patients’ average LDL cholesterol level was 139.0.
After six months, LDL cholesterol levels had dropped by 29.2 points. At the end of the follow-up period, which lasted a median of 40.6 months, the risk of heart attacks in patients who received the drug had been reduced by 23%, while the risk of needing a cardiac revascularization (the procedure to open the arteries) was cut by 19%.
There was a small increased risk of complications, including gout and gallstones, in patients who received the drug compared to those who received placebos.
The researchers found that, compared to people in the placebo group, patients who took bempedoic acid had a combined 13% risk of death from cardiovascular disease, non-fatal stroke, and non-fatal heart attack.
Rather than just focusing on cholesterol levels, the researchers looked at data that might be more meaningful to patients — heart attack risk, for example — which Nissen hopes will encourage more patients to take a cholesterol-lowering drug. .
Esperion, the company that manufactures and markets bempedoic acid, markets it alone or combined with a second cholesterol-lowering drug, ezetimibe. Both versions are priced at $395 per month, said Dr. JoAnne Foody, cardiologist and chief medical officer at Esperion.
“We’re not looking to supplant statins,” Foody said. “They are the first-line treatment. Anyone who can take statins should.
Bempedoic acid may not be as effective as statins, but could be a life-saving drug for people at risk of cardiovascular disease but who can’t or won’t take statins, says Dr. Howard Weintraub , clinical director of the Center for the Prevention of Cardiovascular Disease in the Leon H. Cheney Division of Cardiology at NYU Langone Health.
Dr. Marc Eisenberg welcomed the new research.
“This is an exciting study, but at present, statins remain the best treatment for most people with high cholesterol and cardiovascular risk factors,” said Eisenberg, a cardiologist and associate professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons.
“More studies comparing bempedoic acid and established drugs like statins and ezetimibe in head-to-head trials will be very helpful in the future,” Eisenberg said in an email.
Dr. Robert Rosenson cautioned against physicians and patients considering bempedoic as the equivalent of statins.
“Bempedoic acid is not a replacement for statin therapy,” said Rosenson, a professor of medicine at the Icahn School of Medicine at Mount Sinai in New York. “The LDL lowering efficacy and reductions in cardiovascular events were modest and lower than those of statins.”