The First Daily Cholesterol Pill of Its Kind Is Here. What It Means for Black Patients. – BlackDoctor

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Heart disease often develops quietly, and high cholesterol is one of its biggest drivers. Many people do not know they have high cholesterol until they have a heart attack, stroke, or routine blood test, according to the Centers for Disease Control and Prevention.

Now, the U.S. Food and Drug Administration announced in a press release that it has approved the first daily pill in a class of cholesterol-lowering drugs that previously required injections. Health experts say the new option could make treatment easier for some adults who need additional help lowering their “bad” LDL cholesterol.

For Black Americans, the approval comes as heart disease remains the leading cause of death in the United States and Black adults continue to face disproportionately high rates of high blood pressure, stroke and other cardiovascular conditions.

Why this matters for Black Americans

Heart disease affects Black Americans in ways that are not always reflected by cholesterol numbers alone.

A study published by the National Library of Medicine found that Black women often had lower LDL cholesterol and triglyceride levels than white women, yet they still faced a high risk of cardiovascular disease. Researchers said current metabolic syndrome criteria and traditional cholesterol measures may underestimate heart disease risk in some Black patients.

That is one reason healthcare providers encourage looking at the full picture of heart health, including blood pressure, blood sugar, family history, weight and lifestyle habits, instead of relying on a single cholesterol measurement.

According to the Centers for Disease Control and Prevention, high cholesterol usually causes no symptoms. The only way to know if your cholesterol is too high is through a blood test. Routine screenings become even more important for people with other heart disease risk factors, including diabetes, obesity or a family history of cardiovascular disease.

What you should know

Lowering cholesterol involves more than taking medication. The CDC has recommended several steps that can help lower your risk of heart disease. Experts have said these healthy habits work together with medication to reduce the risk of heart attack and stroke.

Doctors consider LDL — the “bad” cholesterol — to be high when it’s above 160 mg/dL, according to the CDC and the National Heart, Lung, and Blood Institute. People with levels in that range have a higher risk of heart disease, which is why medications that lower LDL can help.

Have your cholesterol checked as recommended by your healthcare provider.
Eat a heart-healthy diet rich in fruits, vegetables, whole grains, beans, nuts and lean proteins while limiting foods high in saturated and trans fats.
Stay physically active. Adults should aim for at least 150 minutes of moderate-intensity physical activity each week.
Maintain a healthy weight.
Avoid smoking and talk with your healthcare provider about quitting if you use tobacco.
Manage other conditions such as high blood pressure and diabetes.
Take cholesterol-lowering medications exactly as prescribed if lifestyle changes alone are not enough.

First oral PCSK9 inhibitor

Lipfendra is the first oral PCSK9 inhibitor. Until now, medications in this class have only been available as injections. The once-daily tablet may provide a more convenient option for some patients who require aggressive cholesterol lowering.

The FDA approved Lipfendra (enlicitide) for adults with hypercholesterolemia, including people with heterozygous familial hypercholesterolemia, an inherited condition that causes very high LDL cholesterol beginning at a young age.

The medication is approved as an addition to diet, exercise and other cholesterol-lowering therapies for adults who need further reductions in LDL cholesterol despite existing treatment.

“Cardiovascular disease remains the leading cause of death in the United States, and elevated LDL cholesterol is one of its most important modifiable risk factors,” Dr. Michael Davis, acting director of the FDA’s Center for Drug Evaluation and Research, said in the press release.

LDL cholesterol is often called “bad” cholesterol because it can build up inside artery walls over time, the CDC noted. Those fatty deposits form plaque, which narrows blood vessels and makes it harder for blood to flow. If a plaque ruptures, it can trigger a blood clot that causes a heart attack or stroke.

What the studies found

According to the FDA’s press release, the approval was based on two randomized clinical trials involving 3,207 adults with high cholesterol who were already receiving the highest tolerated dose of a statin.

In one study, participants with established cardiovascular disease or those at high risk saw their LDL cholesterol fall by an average of 56 percent after 24 weeks compared with placebo.

In a second study involving adults with inherited high cholesterol, LDL cholesterol fell by an average of 59 percent, according to the FDA.

Nearly all participants in both studies were taking statins, and many were also taking another cholesterol-lowering medication called ezetimibe.

“It’s a very effective reduction,” Dr. Steven Nissen, chief academic officer of the Heart, Vascular and Thoracic Institute at the Cleveland Clinic, told NBC News.

He said the medication appears to provide even greater cholesterol-lowering when used alongside statins rather than replacing them.

Is the medication right for everyone?

Not necessarily.

Statins remain the first-line treatment for most adults with high LDL cholesterol because they have decades of evidence showing they lower the risk of heart attack and stroke, according to the American Heart Association and cholesterol treatment guidelines.

However, health experts say the approval gives patients and doctors another tool to fight heart disease.

Lipfendra works differently from statins because it blocks a protein called PCSK9, which helps lower LDL (“bad”) cholesterol more strongly than statins for some people. According to the FDA, it may help patients who can’t tolerate statins or whose cholesterol stays high even after taking statins. PCSK9 inhibitors are often used for people with very high LDL, familial hypercholesterolemia, or existing heart disease who need extra lowering.

But they stress that no medication replaces healthy eating, regular exercise, routine cholesterol screening, and ongoing conversations with a healthcare provider about overall cardiovascular health.

According to the FDA, the most common side effects reported during clinical trials were diarrhea and dizziness. The number of people who stopped taking the medication because of side effects was similar to those taking a placebo.

What’s next?

The FDA says Lipfendra is expected to become available later this year, though the exact release date hasn’t been announced. Esperion has not yet shared pricing, but PCSK9 inhibitors are typically more expensive than statins, and insurance coverage will depend on each plan’s rules for cholesterol‑lowering drugs. Health experts recommend that patients talk with their doctor about whether Lipfendra makes sense for them, especially if their LDL remains high or they cannot tolerate statins.