STatins have revolutionized heart disease by effectively lowering cholesterol, up to 50% or more. But anywhere from 7% to 29% of people who take them may be more susceptible to their side effects, including muscle weakness and pain, and decide they cannot tolerate them. In a recent study published in JAMA Open NetworkFor example, researchers at Brigham and Women’s Hospital reported that more than 20% of patients seen at the hospital between 2000 and 2018 who were recommended to take statins refused to take them, and those who refused took three times as long to take them. reduce your LDL cholesterol to desired levels. While there are alternative medications, such as PCSK9 inhibitors, they must be injected (unlike statins, which are pills) and can be much more expensive 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 a study testing the efficacy of another potential alternative, bempedoic acid, in lowering cholesterol and reducing the risk of heart disease. Manufactured by the US pharmaceutical company Esperion Therapeutics (which funded the study) and sold under the brand name Nexletol, bempedoic acid is approved by the US Food and Drug Administration (FDA) to lower cholesterol. But doctors have been hesitant to prescribe it to people who can’t take statins because they aren’t convinced the drug can help reduce cardiac events and heart disease in their patients.
The new study provides data showing that the drug can not only lower LDL cholesterol, but also contribute to the reduction of adverse cardiac events, including heart attacks, strokes, clogged heart vessels that need to be cleared, and death from heart disease.
read more: How to lower your cholesterol naturally
The study included nearly 14,000 people with high cholesterol and therefore an increased risk of heart disease. Most had already experienced a cardiac event, while around 30% of participants had not. All were randomly assigned to take bempedoic acid or a placebo. (Some in the placebo group were taking other cholesterol-lowering drugs, such as low-dose statins, niacin, or PCSK-9 inhibitors, all of which lower cholesterol but failed to get patients to low enough levels.) The researchers documented their cardiac 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 cardiac event such as a heart attack, stroke, needing stents, or dying from heart disease compared to the placebo group.
Although bempedoic acid does not appear to lower cholesterol levels to the same extent as statins, the study documents that it may be an effective alternative for reducing the risk of cardiac events and death from a cardiac event. “The bottom line is that for patients who can’t tolerate statins, we can offer an alternative,” says Dr. Steven Nissen, a cardiologist at the Cleveland Clinic and lead author of the study.
Bempedoic acid avoids the muscle-wasting problems of statins because it is not activated in all cells, only in the liver. The specific location means fewer side effects on other tissues. But like any medication, bempedoic acid has side effects. It can increase uric acid and creatinine levels in the blood, which the current study found, and therefore may be risky for people with gout. Still, Nissen says, gout can be treated with the right medications, and “for someone who is on uric acid-lowering therapy, it’s probably safe to give bempedoic acid. From my perspective, if I were a patient, I would be at a slightly higher risk of overcoming 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 to turn 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 have good evidence [of its benefits].” That data could also help convince more insurers to cover the drug for those who are intolerant of statins.
dr. JoAnne Micale Foody, Esperion’s chief medical officer, says the company plans to request a change to the drug’s label to indicate that it may reduce the risk of heart disease, as well as lower cholesterol. That would make the drug applicable to a broader population.
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