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FDA Approves Two New Drugs to Treat High Cholesterol

FDA Approves Two New Drugs to Treat High Cholesterol

Plus, find out which lifestyle habits and other medications can help lower your cholesterol for a healthier heart.

About 95 million Americans have high cholesterol, but only about 55 percent of those are being treated for it. High cholesterol raises your risk for heart disease, the nation’s number one killer of both men and women.

Luckily there are a number of ways to lower cholesterol, from healthy living to emerging treatments to gold-standard drugs—and scientists are always working on newer, better methods.

In fact, in February 2020, the U.S. Food and Drug Administration (FDA) approved two new drugs to treat high cholesterol in certain patients. One drug, bempedoic acid, was the first oral non-statin medication approved for this purpose since 2002. The other drug, a single-pill combination of bempedoic acid and a medication called ezetimibe, was approved just days later. Both will become available via prescription later on in the year.

We asked Vinayak Manohar, MD, an interventional cardiologist with Mercy Health Saint Mary’s in Grand Rapids, Michigan, about tried and true treatments and some of the newer drugs.

The perils of high cholesterol
Cholesterol is a waxy substance found in the bloodstream and all the cells in your body. It’s made by the liver, and you also can get a small amount from food. It comes in several forms in the blood, including high-density lipoprotein (HDL) and low-density lipoprotein (LDL).

LDL is the "bad" cholesterol. When you have too much in your blood, it forms a plaque that sticks to the inside of your blood vessels. This plaque can break open and cause a blood clot to form. A big enough clot can block blood flow to the heart, causing a heart attack, or to the brain, which could result in a stroke.

HDL, on the other hand, clears LDL from your bloodstream. That’s why it’s often called the “good” kind of cholesterol. You want high levels of HDL and low levels of LDL to have healthy cholesterol.

The top cholesterol treatment
Statins are the gold standard for cholesterol lowering,” says Dr. Manohar. Statins tell the liver to produce less LDL cholesterol. The drugs might also help dissolve plaque.

“A lot of people see a big benefit with statins,” says Manohar. “It’s a workhorse.” Statins are given to people at high risk for heart disease to prevent either a first heart attack or stroke, or subsequent heart attacks and strokes.

“Statins are not without side effects,” says Manohar. “Muscle aches are the most common.” Up to 15 percent of people on statins may have these muscle aches, known as statin myalgia. 

“There’s a lot of conjecture on why we see muscle aches and myalgia, but studies have shown an increase in muscle enzymes, which often means muscles have been damaged,” says Manohar. “The bottom line is, I take patients seriously if they’re having these symptoms.” 

Muscle injury is usually temporary and reversible. In rare and severe cases permanent damage to the muscles and kidneys may result.

Newer medication options
While statins remain the medication of choice for lowering cholesterol, other drugs have entered the scene in recent years.

PCSK9 inhibitors: Where statins reduce the amount of cholesterol the liver makes, a newer type of drug called PCSK9 inhibitors help remove cholesterol from the bloodstream. 

A 2017 trial including more than 27,000 people found that one of these drugs, called evolocumab, was effective in reducing LDL cholesterol to very low levels—from an average of 92 mg/dl, which is already a low level, all the way down to 30 mg/dl. It reduced the risk of heart attacks by 27 percent and stroke by 21 percent in the group who were also taking statins.

The trial found no reduction in the risk of death from heart disease. However, earlier, shorter-term trials suggested a reduction in mortality from PCSK9 inhibitors. Manohar says more studies are needed to figure out the best use for these drugs in treating high cholesterol. 

The high cost of PCSK9 inhibitors—evolocumab was originally listed at more than $14,000 per year—and the uncertainly about whether they save lives initially presented a barrier to the wider use of the drugs. But in October 2019, the manufacturer of evolocumab announced they were lowering the price to $5,850 per year for all patients, in the hopes that better affordability would increase prescriptions.

Cholesterol absorption inhibitors: Another class of drugs called selective cholesterol absorption inhibitors focuses on lowering LDL cholesterol by blocking the absorption of cholesterol in the intestine. Ezetimibe is the first drug in this class of medications. It’s often prescribed to be used in combination with a statin. 

Bempedoic acid: In February 2020 the FDA approved bempedoic acid (Nexletol) for the treatment of high LDL cholesterol in some patients. Shortly afterward, they gave the go-ahead to a combination bempedoic acid/ezetimibe pill (Nexlizet). Unlike PCSK9 inhibitors, which are injected, these drugs come in a once-daily pill; typically, people who need to lower their cholesterol would take it along with their statins.

In trials, patients on moderate or high doses of statins who also took bempedoic acid lowered their LDL cholesterol by an average of 18 percent compared to those taking a placebo. In studies where patients weren’t taking statins—or could only take a low dose—bempedoic acid cut LDL cholesterol up to 28 percent. 

In a separate trial, patients on a maximum dose of statins who used the bempedoic acid/ezetimibe pill reduced their LDL cholesterol by 38 percent compared to those who took a placebo.

Make smart lifestyle choices
A good diet and regular exercise provide plenty of benefits for your heart and beyond. “Lifestyle is huge,” says Manohar, but he notes that for people with elevated LDL levels, lifestyle and medication together may be needed.

“Once your numbers start getting high, cholesterol is more difficult to control with lifestyle alone,” he says. “But if you use the cholesterol-lowering medications and if you’re successful with diet, we can talk about cutting back the drugs.”

Manohar finds that adding healthy foods before taking away less nutritious options helps people stay on track better. “I ask people to get six servings of fruits and vegetables, but then I ask them if they can think of some fruits and veggies they like eating. It’s a gentle approach that tends to yield longer-term change,” he says.

Saturated and trans fats are some of the worst food offenders because they tell your liver to make more LDL cholesterol. Trans fats also reduce your HDL level, and diets high in both trans and saturated fats are linked with higher risk of death from heart disease.

To help people eat better Manohar also recommends they swap unhealthy foods for healthier versions. “For example, if you like ice cream, switch to sorbet,” he says. “Patients are usually receptive to making small changes when they can still have similar things. It’s all about customizing a diet plan for each patient.”

Medically reviewed in November 2019. Updated in March 2020.

Sources:
Centers for Disease Control and Prevention. “High Cholesterol Facts.”
National Heart, Lung and Blood Institute. “High Blood Cholesterol.”
American Heart Association. “Cholesterol Medications,” “Control Your Cholesterol.”
American Family Physician. “U.S. Preventive Services Task Force: Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: Recommendation Statement.”
American College of Cardiology. “Secondary Prevention of Atherosclerotic Cardiovascular Disease in Older Adults,” “FOURIER: Evolocumab Significantly Reduces Risk of Cardiovascular Events.”
DH Fitchett, RA Hegele, S Verma. “Statin Intolerance.” Circulation. 2015;131:e389–e391.
A Gupta, D Thompson, et al. “Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial—Lipid-Lowering Arm (ASCOT-LLA): a randomised double-blind placebo-controlled trial and its non-randomised non-blind exten.” The Lancet. 2017.
SE Nissen, E Stroes, et al. “Efficacy and Tolerability of Evolocumab vs Ezetimibe in Patients With Muscle-Related Statin Intolerance: The GAUSS-3 Randomized Clinical Trial.” JAMA. 2016;315(15):1580–1590.
MM Page and GF Watts. “PCSK9 inhibitors - mechanisms of action.” Australian prescriber vol. 39,5 (2016): 164-167. 
MS Sabatine, RP Giugliano, et al. “Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease.” New England Journal of Medicine. 2017; 376:1713-1722. 
MedlinePlus Magazine. “Understanding Cholesterol and Heart Health.” Summer 2012.
Steve Stiles. “Amgen Affirms Evolocumab (Repatha) Price Reduction Across the Board.” Medscape. October 24, 2019.
KR Kausik, HE Bays, et al. “Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol.” New England Journal of Medicine.  380 (11), 1022-1032, March 14 ,2019.
Drugs.com. “FDA Approves Nexletol.” Februrary 21, 2020.
Laurie McGinley. “FDA approves first non-statin pill to treat high cholesterol in almost two decades.” Washington Post. February 21, 2020.

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