Illustration of red blood cells moving through clogged artery to indicate cholesterol build up as a result of familial hypercholesterolemia and atherosclerosis, which are being targeted by Verve Therapeutics
Credit: wildpixel/Getty Images

Millions of U.S. adults should no longer take cholesterol-lowering drugs under updated guidelines released by the American Heart Association (AHA) late last year, research indicates.

Overall, 4.1 million people aged 40 to 75 years currently using statins no longer met primary prevention criteria for their use under the revised estimates for the 10-year risk of atherosclerotic cardiovascular disease.

If all adults who were previously recommended primary prevention statin therapy under the older recommendations were included, this number rose to 17.3 million.

The findings, in JAMA Internal Medicine, covered all subpopulations and risk levels and were particularly marked for Black people and for those aged 70 to 75 years.

“This is an opportunity to refocus our efforts and invest resources in the populations of patients at the highest risk,” said lead author Timothy Anderson, an assistant professor of medicine at the University of Pittsburgh.

In November 2023, the AHA released the Predicting Risk of Cardiovascular Disease Events (PREVENT) equations to calculate estimated 10-year risk of atherosclerotic cardiovascular disease.

These acted as an update to the previous 2013 tool called the pooled cohort equations (PCEs) produced by the AHA and the American College of Cardiology, which included decades-old data and did not reflect the diversity of the modern U.S. population, particularly regarding people of Asian and Hispanic descent.

The latest equations include substantial changes to estimating atherosclerotic cardiovascular risk, adding kidney function in recognition of the link between cardiovascular, kidney, and metabolic health, adding current use of statins and removing race.

“The removal of race reflects the growing consensus of race and ethnicity as social constructs and the reconsideration of current clinical tools to ensure these constructs do not perpetuate inequities in clinical care,” the researchers noted in their article.

The researchers applied the two risk calculations to estimate the 10-year risk of atherosclerotic cardiovascular disease in 3785 adults, ages 40 to 75, who participated in the National Health and Nutrition Examination Survey from January 2017 to March 2020.

None of the adults studied had known atherosclerotic cardiovascular disease and the group was weighted to be representative of the US population.

Using the PREVENT equations was associated with reduced estimates for the risk of atherosclerotic disease across all age, sex, and racial subgroups compared with the PCEs, the researchers report.

The mean estimated 10-year risk of atherosclerotic cardiovascular disease was 8.0% using the PCEs versus 4.3% using the PREVENT equations.

The greatest difference was seen for Black adults in whom the calculated risk was 10.9% versus 5.1%, respectively.

The difference between calculators also increased with age, with adults aged 70 to 75 years having an estimated mean risk of 22.8% with the PCEs versus 10.2% with PREVENT.

Using PREVENT equations instead of the PCEs could reduce the number of adults meeting criteria for primary prevention statin therapy from 45.4 million to 28.3 million.

Anderson and team note that the majority of adults eligible for receiving statin therapy under PREVENT were not currently receiving them.

In all, 44.1% of adults eligible for primary prevention statin therapy according to the PREVENT equations reported currently taking them, meaning that 15.8 million individuals eligible for primary prevention statins reported not taking them.

They point out that removing statins for the millions who no longer meet risk criteria could be challenging “with the potential to lead to patient confusion over shifting recommendations, particularly as many adults at borderline risk of [atherosclerotic cardiovascular disease] may again reach statin eligibility after a few years.”

The team added: “The process of risk estimation is sufficiently uncertain and unstable that we should consider moving away from precise treatment thresholds toward recommendations that encourage risk communication and shared decision-making.”

Also of Interest