While some people can control their cholesterol levels through diet and exercise alone, many others require medication. However, the side effects of the most commonly prescribed medications to treat high cholesterol, known as statins, can be severe enough that people stop taking the drugs or refuse to start taking them at all.
A non-statin medication, according to a new study, can help people lower their cholesterol and prevent heart disease without causing muscle pain, which is a common side effect of statins. The drug could also be used as a supplement for people who are already taking statins. Here’s what doctors want you to know about the medication and whether it’s right for you.
Bempedoic Acid: A Statin Alternative to Reduce Cholesterol
Statins lower the risk of heart attacks and strokes, which is why they are first-line therapy, but the side effects can be unpleasant for some people.
The new study, published this month in the New England Journal of Medicine, shows that bempedoic acid, a drug, is a promising option for patients who cannot or will not take statins.
Nexletol, the brand name for bempedoic acid, is a first-of-its-kind drug known as an adenosine triphosphate-citrate lyase (ACL) inhibitor. The medication works by preventing the synthesis of cholesterol in the liver.
The researchers conducted a trial with nearly 14,000 patients who could not or would not take statins to see if the drug could safely and effectively lower cholesterol. All of the patients had a history of heart disease or were at high risk of developing it. Around 7,000 patients were given Nexletol, while the rest were given a placebo.
After about three years of follow-up, the researchers discovered that the Nexletol group had a 21% greater drop in cholesterol levels than the placebo group. They were also at a lower risk of certain heart-related events, such as heart attacks.
What Are Nexletol’s Drawbacks?
Nexletol may be safe and effective, and it does not cause muscle pain, but it is not without risks and side effects.
Nexletol raises uric acid levels in the blood, which can lead to gout and gallstones. Patients in the Nexletol trial had a higher incidence of gout than the placebo group. People who are predisposed to these health issues should consult with their doctors to determine whether the statin alternative is appropriate for them.
According to Joshua Knowles, MD, PhD, associate professor of cardiovascular medicine at Stanford Health Care, while statins lower LDL cholesterol, or “bad” cholesterol, by an average of 50%, Nexletol lowers LDL cholesterol by 25%, making it less potent.
Other options for patients who cannot take statins include ezetimibe or PCSK9 inhibitors, but their efficacy varies.
Furthermore, injectable medications, such as PCSK9 inhibitors, are typically more expensive than oral medications.
Why Are Some People Unable to Take Statins?
Muscle aches are the most well-known side effect of statin medications and the most common reason people discontinue them.
While some studies suggest that 5%-30% of people who take statins stop taking them because they can’t handle the side effects, Knowles believes that figure is likely exaggerated—rather, many patients stop taking statins because they’re afraid of the side effects.
According to Knowles, the true number of patients who are unable to take statins is likely to be closer to 2%-5%.
“Overcoming some of the limitations of statins was the major driver for this trial,” Michael Lincoff, MD, a cardiologist at the Cleveland Clinic and one of the study’s authors, told Verywell. In his experience, patients who believe they are statin-intolerant tolerate Nexletol well.
Statins and bempedoic acid both act on the same pathway in the body that produces cholesterol, but bempedoic acid is only active in the liver and has no effect on the muscles. Researchers believe this is why study participants who received bempedoic acid experienced no muscle pain.
Can Statins and Nexletol Be Taken Together?
Patients with familial hypercholesterolemia (also known as “familial hypercholesteremia”), an inherited predisposition to high cholesterol, may struggle to achieve a healthy LDL level if they only take one medication.
“With statins alone, only half of patients with familial hypercholesterolemia achieve goal LDL cholesterol,” Knowles said. “Many patients with familial hypercholesterolemia begin with LDL levels in the 250s or 300s. If you’ve already had a heart attack or stroke, an LDL of 70 or lower is ideal.”
According to Knowles, providers typically want to reduce a patient’s LDL by more than 50% to reduce their risk of heart disease, but this is beyond the scope of statins alone.
Some patients have high LDL despite lifestyle changes and maximal statin therapy. Nexletol could be an effective add-on treatment for these patients.
“Some patients, even those who do not have familial hypercholesterolemia,” Knowles explained, “do not respond as well to statins.” “Statins may only provide a 30% reduction in LDL, so they require additional medication options.”
What Does the Future Hold for Nexletol?
Nexletol was approved by the Food and Drug Administration (FDA) in 2020 for familial hypercholesterolemia and patients with confirmed heart disease, but this is the first study to show that the drug may be useful for preventing heart disease.
“Our study shows that not only does bempedoic acid lower LDL, but it also lowers cardiovascular events,” Lincoff said. “This should improve payer coverage for the drug and increase practitioners’ motivation to prescribe it.”
With new evidence, Esperio, the Nexletol manufacturer, will be able to seek permission to update drug labels to include the benefit of lowering heart disease risk.
While the recent trial showed promising evidence that Nexletol could play a role in the treatment of high cholesterol, statins still have the longest track record, so providers will likely continue to use them as first-line treatment.
Erin Balsa is a highly skilled and knowledgeable health journalist with a passion for educating the public on important health and wellness topics. With extensive experience in both traditional and digital media, Erin has established herself as a trusted voice in the field.