Statins have revolutionized heart disease by lowering cholesterol effectively—by up to 50% or more. But anywhere from 7% to 29% of people who take them may be more susceptible to its side effects, which include weakening of muscles and pain, and decide they can’t tolerate them. In a recent study published in JAMA Network Open, for example, researchers at Brigham and Women’s Hospital reported that more than 20% of patients seen at the hospital from 2000 to 2018 who were recommended to take statins refused to take them, and those who refused took three times as long to lower their LDL cholesterol to target levels. While alternative drugs, such as PCSK9 inhibitors, exist, they must be injected (unlike statins, which are pills), and can be far more costly than statins, many of which are available in generic form.
In a study published in the New England Journal of Medicine and presented at the annual meeting of the American College of Cardiology, researchers report on a study testing the effectiveness of another potential alternative—bempedoic acid—to lower cholesterol and reduce the risk of heart disease. Made by the U.S. pharmaceutical company Esperion Therapeutics (which funded the study) and sold under the brand name Nexletol, bempedoic acid is approved by the U.S. Food and Drug Administration (FDA) to lower cholesterol. But doctors have been hesitant to prescribe it for people who can’t take statins because they haven’t been convinced that the medication could contribute to lowering heart events and heart disease in their patients.
The new study provides that data, showing that the drug can not only lower LDL cholesterol but also contribute to reductions in adverse heart events—including heart attack, stroke, clogged heart vessels that need to be cleared, and death from heart disease.
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The study included nearly 14,000 people with high cholesterol, and therefore at higher risk of heart disease. Most had already experienced a heart event, while about 30% of participants had not. All were randomly assigned to take either bempedoic acid or a placebo. (Some in the placebo group were taking other cholesterol-lowering medications, such as low doses of statins, niacin, or PCSK-9 inhibitors, all of which reduce cholesterol but were not able to get the patients to low enough levels.) The researchers documented their heart events as well as changes in their cholesterol levels for an average of just over three years.
At the end of the study, those taking the drug had 21% lower LDL cholesterol levels than those taking a placebo. They also had a 13% lower risk of having a heart event like a heart attack, stroke, needing stents, or dying of heart disease compared to the placebo group.
While bempedoic acid does not appear to reduce cholesterol levels to the same extent as statins can, the study documented that it can be an effective alternative for lowering the risk of heart events and dying of a heart event. “The bottom line is that for patients who cannot tolerate statins, we can offer them an alternative,” says Dr. Steven Nissen, a cardiologist at the Cleveland Clinic and lead author of the study.
Bempedoic acid avoids the muscle-weakening issues of statins because it doesn’t get activated in all cells—just the liver. The targeted location means less side effects in other tissues. But as with any drug, bempedoic acid does come with side effects. It can increase levels of uric acid and creatinine in the blood, which the current study found, and therefore be risky for those with gout. Still, says Nissen, gout can be treated with the proper medications, and “for somebody who is on a therapy to lower uric acid, it’s probably safe to give bempedoic acid. From my perspective, if I were a patient, I would take the slight increased risk of gout over a heart attack, but the risks are something that doctors and patients will have to discuss and balance.”
The current study should give doctors more confidence in turning to bempedoic acid as an alternative to statins. “It hasn’t been widely used,” says Nissen. “The medical community has been waiting for more evidence, and now we’ve got good evidence [of its benefits].” That data could also help to convince more insurers to cover the drug for those who are statin intolerant.
Dr. JoAnne Micale Foody, chief medical officer of Esperion, says the company plans to request a change in the drug’s label to indicate that it can lower the risk of heart disease, in addition to lowering cholesterol. That would make the drug applicable to a broader population.