This New Drug Lowers Cholesterol Without the Side Effects of Statins

<p>Esperion Therapeutics, Inc</p>

Esperion Therapeutics, Inc

  • Drugs called statins have been the go-to for helping people lower their cholesterol and reduce their risk of heart disease.

  • Statins alone or with lifestyle changes are not always enough to help people get their cholesterol numbers down. Even when they work, the side effects of statins—particularly muscle pain—can be enough to make people stop taking the drugs.

  • A new study has shown that another drug called Nexletol (bempedoic acid) can help people lower their cholesterol and prevent heart disease without causing the muscle pain that can come with taking statins.

While some people can lower their cholesterol through lifestyle changes alone, many people need to take medication to get their levels in check. But side effects of the most commonly prescribed medications to treat high cholesterol, called statins, can be enough of a problem that people stop taking the drugs, or won’t start taking them to begin with.

According to a new study, a non-statin medication can help people lower their cholesterol and prevent heart disease without causing muscle pain, which is a major side effect of statins. The drug could also be an add-on treatment for people already takings statins. Here’s what experts want you to know about the medication and whether it could be an option for you.

Learn More:Do You Need to Take Statins?

Bempedoic Acid: A Statin Alternative to Reduce Cholesterol

Statins reduce heart attacks and strokes, which is why they’re first-line therapy, but those side effects can be a problem for people.

The new study, published this month in the New England Journal of Medicine, shows a drug called bempedoic acid is a promising option for patients who can’t or won’t take statins.

Bempedoic acid, sold under the brand name Nexletol, is a first-of-its-kind drug called an adenosine triphosphate-citrate lyase (ACL) inhibitor. The drug works by preventing cholesterol synthesis in the liver.

Bempedoic acid is sold under the brand name Nexletol on its own and as a combination drug with ezetimibe called Nexlizet.

To find out if the drug could safely and effectively lower cholesterol, the researchers conducted a trial with almost 14,000 patients who could not or were not willing to take statins. All of the patients had a history of or were at high risk for getting heart disease. About 7,000 of the patients took Nexletol, and the rest took a placebo.

After about three years of follow-up, the researchers found that the group who took Nexletol experienced more of a cholesterol level decrease than the placebo group—about a 21% greater drop. They also had a lower risk for certain heart health-related events, like heart attacks.

Learn More:Why Do Statins Cause Muscle Aches?

What Are the Limitations of Nexletol?

Nexletol might be safe and effective and not cause muscle pain, but it’s not without side effects and risks.

Nexletol increases uric acid in the blood, which can cause gout and gallstones. The patients in the trial who took Nexletol had a higher incidence of gout than the placebo group. People who are prone to these health problems would need to talk to their providers about whether the statin alternative would be right for them.

Gout is a painful form of arthritis defined by inflammation and the accumulation of uric acid crystals in joints. It commonly affects the big toe.

Joshua Knowles, MD, PhD, associate professor of cardiovascular medicine at Stanford Health Care, told Verywell that while statins lower LDL cholesterol, or “bad” cholesterol, by an average of 50%, Nexletol lowers LDL by 25%, so it’s not as potent.

Ezetimibe or PCSK9 inhibitors are other options for patients who can’t take statins, but they can vary in effectiveness. Plus, injectable medications like PCSK9 inhibitors tend to be more expensive than oral medications.

Learn More:Should You Stop Taking Cholesterol Medication?

Why Can’t Some People Take Statins?

Muscle aches are the best-known side effect of statin drugs and the most common reason people stop taking them.

While some studies suggest that between 5%–30% of people who take statins stop because they can’t handle the side effects, Knowles said that number is probably inflated—instead, many patients stop taking statins because they’re afraid of side effects.

According to Knowles, the actual number of patients who truly cannot take statins is probably closer to 2%–5%.

“Overcoming some of the limitations of statins was the major driver for this trial,” Michael Lincoff, MD, one of the study’s authors and a cardiologist with the Cleveland Clinic, told Verywell. In his experience, patients who perceive themselves to be statin-intolerant tolerate Nexletol pretty well.

Statins and bempedoic acid act on the same pathway the body uses to form cholesterol, but bempedoic acid is only active in the liver and does not affect the muscles. Researchers think that’s why the study participants who received bempedoic acid didn’t experience muscle pain.

Learn More:What Medications Lower Cholesterol?

Can You Take Statins and Nexletol Together?

Patients with an inherited predisposition to high cholesterol called familial hypercholesterolemia (also called “familial hypercholesteremia”) may have a hard time achieving a healthy LDL level if they’re only taking one medication.

“Only half of the patients with familial hypercholesteremia achieve goal LDL cholesterol with statins alone,” Knowles said. “Many patients with familial hypercholesteremia start with an LDL of 250 or 300. If you’ve already had a heart attack or stroke, you ideally need an LDL of 70 or lower.”

According to Knowles, providers usually want to reduce a patient’s LDL by over 50% to have a positive effect on their heart disease risk, but that’s beyond what can be achieved with statins alone.

Even with lifestyle modifications and maximum statin therapy, some patients still have high LDL. For these patients, Nexletol could be an effective add-on treatment.

“Some patients, even those that don’t have familial hypercholesteremia, don’t respond as well to statins,” Knowles said. “They might only have a 30% reduction in LDL with statins, so they need additional medication options.”

Learn More:What Are the Benefits of Taking Statins?

What’s Next for Nexletol?

The Food and Drug Administration (FDA) actually approved Nexletol back in 2020 for familial hypercholesterolemia and for patients with confirmed heart disease, but the latest study was the first to prove that the drug could be useful for preventing heart disease.

“Our trial proves that not only does bempedoic acid reduce LDL, it also reduces cardiovascular events,” Lincoff said. “That will hopefully enhance payer coverage for the drug and increase the motivation for practitioners to prescribe it.”

With new evidence in hand, Esperio, the company that manufactures Nexletol, 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 have a role in high cholesterol treatment, statins still have the longest track record, so providers will probably keep using them as first-line treatment.

Patients who can’t (or won’t) take statins or those who need another treatment in addition to statins and lifestyle changes to lower their cholesterol might benefit from Nexletol (bempedoic acid).

Learn More:What Medications Interact With Statins?