'New Guidelines Expand Statin Eligibility to More Than Half of US Adults'

 Newly released US dyslipidemia guidelines would expand recommendations for primary prevention statin therapy to 87.5 million US adults, new research suggested.

Released in March, the 2026 American Heart Association/American College of Cardiology multisociety guideline on dyslipidemia broadened recommendations for statin therapy by extending atherosclerotic cardiovascular disease (ASCVD) risk assessment from adults aged 40-75 years to those aged 30-79 years, expanding risk estimation beyond the next 10 years to several decades, and incorporating an updated risk calculator.

In a new analysis that used weighted data from the National Health and Nutrition Examination Survey (NHANES), researchers estimated that the updated recommendations would make an additional 21.5 million US adults eligible for statins, increasing total eligibility to 87.5 million adults, or 56.6% of those aged 30-79 years.

Study investigator Timothy Anderson, MD, assistant professor of medicine at the University of Pittsburgh in Pittsburgh, said the shift toward a longer-term view of cardiovascular disease (CVD) risk represents “a sea change” in discussions with patients.

“It’s moving from a focus on talking about 10-year risk to talking about 30-year and lifetime risk. It’s fundamentally a different conversation than most clinicians have with patients primarily because of prior recommendations,” he told Medscape Medical News.

The findings were published online on July 20 in JAMA, along with several accompanying papers, including an editorial.

A Starting Point?

Anderson, who also serves on the guideline writing committee, said the updated dyslipidemia guidelines were needed to reflect new evidence on emerging treatments and advances in how CVD risk is assessed.

He added that patients in their thirties and forties with high cholesterol, but without CVD or other conditions that place them at high cardiovascular risk, have often been advised to focus on diet and lifestyle changes rather than medication.

In addition to expanding ASCVD risk assessment to adults aged 30-79 years, the new clinical practice guideline recommends using the PREVENT-ASCVD equations and lowers the thresholds for ASCVD risk categories, defining low 10-year risk as less than 3% and high risk as 10% or greater.

To assess how the 2026 guideline would change statin eligibility among US adults without ASCVD compared with the 2018 guideline, researchers analyzed data from 4366 nonpregnant participants in the NHANES 2017-2023. The weighted sample represented nearly 154.5 million US adults (mean age, 51 years; 52% women).

Results showed that, in addition to the estimated 66 million US adults aged 30-79 years who were eligible for statins under the 2018 guideline, an additional 21.5 million would become eligible under the 2026 recommendations, increasing the total to an estimated 87.5 million adults.

Statin eligibility increased with age, ranging from 11.1% of adults aged 30-39 years to 93.5% of those aged 70-79 years. The largest increase in newly eligible individuals occurred among adults in their fifties (26.5%), followed by those in their forties (17.0%). Compared with those eligible under the 2018 guideline, newly eligible individuals generally had a lower estimated ASCVD risk.

Anderson noted in a news release that younger patients may question the need to start statin therapy when their short-term risk for a cardiovascular event appears low. “But for patients seeking to minimize risks of heart attacks and strokes, early statin therapy may be a good choice,” he said.

“The new guideline is first and foremost a starting point for a more individualized or personalized risk-benefit discussion between a patient and their physician. It’s not necessarily an ironclad requirement that all patients need to be on therapy,” Anderson added.

'Missed Opportunity of Millions’

A second analysis, led by Allison Peng, MD, of the Ciccarone Center for the Prevention of Cardiovascular Disease at Johns Hopkins University School of Medicine in Baltimore, also evaluated the potential impact of the new guideline using NHANES data from 1999 to 2020. The study included 24,403 participants, representing nearly 98.5 million US adults aged 40-79 years.

Results showed an estimated 22% of US adults would be reclassified under the new guideline, primarily because more individuals would be categorized as having borderline 10-year risk for ASCVD.

Finally, a third study published the same day in JAMA and led by Shady Abohashem, MD, of the Cardiology Department at Massachusetts General Hospital in Boston, assessed the prevalence of low-density lipoprotein cholesterol (LDL-C) levels above the new guideline targets. The analysis included 2313 NHANES participants aged 30-79 years from 2021 to 2023, representing 177.7 million US adults.

These results showed that an estimated 32.2% of US adults had LDL-C levels above the new guideline targets. The prevalence ranged from 9.9% among those at low ASCVD risk to 63.6% among those at borderline or intermediate risk and 82.0% among those at high risk. Among adults with LDL-C levels above the recommended target, 76.1% in the primary prevention group were not receiving lipid-lowering therapy (LLT).

“The gap between where the country’s cholesterol levels actually are and where the new guidelines say they should be is much wider than most people realize,” Abohashem noted in a release.

He added that although many heart attacks and strokes are preventable with medication, these treatments often fail to reach those who could benefit most, “and that is a missed opportunity at the scale of millions,” he said.

Public Health Burden

In an accompanying editorial, Philip Greenland, MD, and Karen E. Lasser, MD, senior and deputy editors of JAMA, respectively, noted that the differing estimates of newly statin-eligible adults reported by Anderson and Peng may reflect, in part, Anderson’s inclusion of a broader age range and the use of different NHANES survey years.

Anderson said the discrepancy may also reflect differences in study design. He noted that Peng’s analysis did not include lower-risk adults who became eligible for statins under the new guideline because of elevated 30-year ASCVD risk or high LDL-C levels. “And I think that’s where the biggest expansion in new recommendations comes from,” he added.

In their editorial, Greenland and Lasser wrote that the three studies together “confirm the long-standing observations” that a large proportion of US adults are candidates for LLT.

“This is a huge public health burden for the US population for a medical condition that should be highly treatable,” they wrote.

They also encouraged physicians to educate patients about the new guideline and statin therapy. “Patients should be primed to come to their medical visits asking, ‘Should I be taking a statin?’,” Greenland and Lasser wrote.

“We should also continue to advocate for universal health insurance coverage so that all US patients can receive medical care that includes screening and treatment for hyperlipidemia,” they concluded.

Anderson’s study was funded by the National Institute on Aging. Disclosure information for all study authors and the editorialists is available in the original publications.

https://www.medscape.com/viewarticle/new-guidelines-expand-statin-eligibility-more-than-half-us-2026a1000p5p