New cholesterol guideline expands treatment eligibility to 55% of U.S. adults

Under the American Heart Association (AHA) and American College of Cardiology's (ACC) new 2026 cholesterol guideline, the number of U.S. adults eligible for cholesterol-lowering therapy rose to 54.6%, up from 41.3% under the prior 2018 guideline, according to a study published and conducted by Epic Research.

High cholesterol, or hyperlipidemia, is a leading cause of heart attacks and strokes, and statins are typically the standard medications used to prevent a first cardiovascular event. In March 2026, the AHA and ACC released an updated guideline that replaced the Pooled Cohort Equations (PCE)—the risk calculator used since 2018—with a newer tool called Predicting Risk of Cardiovascular Disease EVENTs-Atherosclerotic Cardiovascular Disease, or PREVENT-ASCVD. The new equations add kidney function and statin use as inputs and drop race as a factor.

The guideline also made three other changes: it lowered the 10-year risk threshold for starting treatment from 7.5% to 3%, expanded the eligible age range to include patients 76 to 79 and elevated chronic kidney disease and HIV from risk-modifying factors to conditions that qualify a patient for treatment on their own.

While the new PREVENT guidelines were created to produce different risk assessments than the PCE across demographic groups, the effects of the new guidelines on who is offered treatment and whether some groups lose or gain eligibility haven’t been identified in a large real-world population.

Researchers studied more than 21 million U.S. adults ages 20 to 79. All had cholesterol testing and an outpatient visit between March 2025 and February 2026, and none had a history of atherosclerotic cardiovascular disease (ASCVD), meaning a prior heart attack, stroke or related condition caused by plaque buildup in the arteries.

The team evaluated each patient under both the 2018 and 2026 guidelines. They used lab results, diagnoses, medications and demographic data drawn from Cosmos, a database built from more than 307 million patient records across Epic health systems.

Overall, 40.7% of patients were eligible for treatment under both guidelines, and 13.9% became newly eligible under the 2026 version. Just 0.6% of patients lost eligibility they had under the 2018 guideline. The remaining 44.8% did not qualify for treatment under either version.

The patients who changed eligibility status did not mirror the overall study population. Among those who gained eligibility, 66.4% were women, compared with 57.9% of the overall population, and 36.1% were ages 70 to 79, compared with 15.8% of the overall population.

Researchers said that pattern reflects the guideline's expanded age range and the addition of chronic kidney disease as a standalone qualifying condition. The smaller group that lost eligibility presented differently: 79.6% were men, compared with 42.1% of the overall population; 47.5% were Black patients, compared with 11.6% overall; and 50.1% were ages 50 to 59, compared with 21.3% overall. The researchers added that pattern is consistent with prior research.

In addition, earlier studies found the PREVENT guidelines estimate lower 10-year cardiovascular risk than the PCE guidelines for some demographic groups, particularly Black adults. One reason is that the newer equations do not use race as an input.

While differences existed, every demographic subgroup studied experienced eligibility, overall. For instance, eligibility increased 10% among men and 16% among women. Gains grew with age, from less than 1% among adults ages 20 to 29 to 32% among those ages 70 to 79. In addition, adults ages 30 to 39 saw a 15% increase. That's more than the 3% increase among those ages 40 to 49.

Researchers said this might be explained by the guideline lowering the screening age from 40 to 30. Every race and ethnicity group also gained eligibility, ranging from an 8% increase among Black patients to 15% among White patients.

The overall findings are based on real-world electronic health record data rather than a clinical trial. While most of the data is promising, Epic Research noted some limitations. Patients already taking statins may have had artificially lowered cholesterol readings, and some risk factors used under the 2026 guideline depend on whether a clinician ordered the relevant lab test.

“The newly eligible group was roughly 23 times larger than the no longer eligible group, indicating that the 2026 guideline operates almost entirely as an expansion rather than a substitution of the prior treatment population,” the study's researchers wrote.