STatins have revolutionized heart disease by effectively lowering cholesterol by up to 50% or more. But between 7% and 29% of people who take it may be more sensitive to its side effects, including muscle weakness and pain, and decide they can’t tolerate them. In a recent study published in Open JAMA Network, for example, researchers at Brigham and Women’s Hospital reported that more than 20% of patients seen in the hospital from 2000 to 2018 who were recommended to take statins refused to take them, and those who refused put three times longer to lower their LDL cholesterol to target levels. Although alternative drugs, such as PCSK9 inhibitors, exist, 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 on a study testing the effectiveness 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) for lowering cholesterol. But doctors were hesitant to prescribe it to people who can’t take statins because they weren’t convinced the drug could help reduce 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 help reduce adverse heart events, including heart attacks, strokes, clogged heart vessels that need to be cleared, and death. by heart disease.
Learn more: How to lower your cholesterol naturally
The study included nearly 14,000 people with high cholesterol, and therefore at higher risk of heart disease. Most had already suffered a cardiac event, while about 30% of participants had not. All were randomly assigned to take either bempedoic acid or a placebo. (Some members of the placebo group were taking other cholesterol-lowering drugs, such as low doses of statins, niacin, or PCSK-9 inhibitors, all of which lower cholesterol but failed to bring patients to lower levels. low enough.) The researchers documented their cardiac events as well as changes in their cholesterol levels for just over three years on average.
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 documented that it may be an effective alternative for reducing the risk of cardiac events and dying from an event. cardiac. “Ultimately, for patients who cannot tolerate statins, we can offer them an alternative,” says Dr. Steven Nissen, cardiologist at the Cleveland Clinic and senior 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 targeted location means fewer side effects in other tissues. But like any medicine, bempedoic acid has side effects. It may increase blood uric acid and creatinine levels, which the current study found, and therefore be risky for gout sufferers. Still, says Nissen, gout can be treated with the proper medications, and “for someone on therapy to lower uric acid, it’s probably safe to give bempedoic acid. From my perspective, if I was a patient, I would take the slight increased risk of gout versus a heart attack, but the risks are something that doctors and patients will need 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).” This data could also help convince more insurers to cover the drug for those who are intolerant to statins.
Dr JoAnne Micale Foody, Esperion’s chief medical officer, said the company is considering seeking a change to the drug’s label to say it can reduce the risk of heart disease, in addition to lowering cholesterol. This would make the drug applicable to a wider population.
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