New Analysis Finds Millions of People on Statins May Not Need Them

Statins and heart disease in brief

Healthline spoke with Cheng-Han Chen, MD, a board-certified interventional cardiologist and medical director of the Structural Heart Program at MemorialCare Saddleback Medical Center in Laguna Hills, CA. Chen was not involved in the study.

“Statins are commonly used in clinical practice in two scenarios,” he explained, “firstly, people who have already suffered a cardiovascular event such as heart attack or stroke, or secondly, people with risk factors for developing heart disease.”

For those in the second category, “the decision to start a statin depends on our evaluation of their risk for developing cardiovascular disease in the future. To help us decide whether to start someone on a statin, we will frequently use a risk calculator to estimate someone’s 10-year risk of developing cardiovascular disease.” This includes equations like PCE and PREVENT.

New analysis may be more accurate at predicting heart disease risk

Both PCE and PREVENT estimate an individual’s 10-year risk of developing atherosclerotic cardiovascular disease. Atherosclerosis is a condition wherein plaque builds up inside arteries, slowly narrowing them and interrupting blood flow.

PCE calculations are the current standard, but they are based on decades-old data that lack diversity. The newer PREVENT equations, however, were released by the American Heart Association (AHA) in 2023. They are based on more recent data and a more representative sample of people and incorporate physiologic factors relevant to people who may take statins.

PREVENT includes new variables, such as kidney and metabolic function and statin use. Also, it no longer includes race. Taken together, experts believe that these changes make the tool more accurate.

Over 17 million people may be taking statins they do not need

To investigate how PREVENT works, the scientists took data from the National Health and Nutrition Examination Survey from January 2017–March 2020. This nationally representative data included information from 3,785 adults ages 40–75.

After crunching the numbers, there were significant differences between the PCE and PREVENT estimates.

First, looking at the entire group of participants, PCE estimated an 8% risk of developing atherosclerotic cardiovascular disease over 10 years. Using PREVENT, this figure dropped to 4%.

These changes were most pronounced in Black people and adults aged 70–75. For Black people, the overall risk in the entire cohort changed from 10.9% to 5.1%. In those ages 70–75, it changed from 22.8%–10.2%.

They also found that if PREVENT was rolled out nationwide, the number of people meeting the criteria for statins would decline from from 45.4 million to 28.3 million.

“In other words,” the authors write, “17.3 million adults recommended statins based on the PCEs would no longer be recommended statins based on PREVENT equations, including 4.1 million adults currently taking statins.”

They also found that 15.8 million people who are currently not taking statins might in fact benefit from the medications.

Although the changes seem dramatic, Chen told Healthline that they are “consistent with previous analyses that indicated that the older model seemed to overestimate risk.”

If PREVENT is rolled out widely, doctors will need to communicate the changes carefully. Patients who may be taken off the drugs could be confused and concerned. Patients who may need to start statins may have questions about why their risk has changed.

“We don’t want people to think they were treated incorrectly in the past,” explained one of the study’s authors, Dr. Timothy Anderson, MD, from the University of Pittsburgh, PA. “They were treated with the best data we had when the PCE was introduced back in 2013. The data have changed.”

He also notes that, because everyone’s risk tends to increase as they age, some people may be taken off statins and eventually return to them.

“For a patient who we now know is at lower risk than we previously thought, if we recommend they stop taking statins, they still could be back to a higher risk 5 years down the road, for the simple reason that everybody’s risk goes up as we get older,” explains Anderson.

Physicians may soon use new tool to assess heart disease risk

Healthline spoke with Donald M. Lloyd-Jones, MD, chair in the Department of Preventive Medicine and professor of preventive medicine, cardiology, and pediatrics at Northwestern University’s Feinberg School of Medicine in Chicago, IL.

We asked Lloyd-Jones, who was not involved in the study, whether the PREVENT equations are more accurate than PCEs:

“They are clearly more accurate and precise. PCEs were derived in 30,000 people, some from older birth cohorts that have not lived in contemporary conditions (different exposures to food, smoking, etc). PREVENT was developed in a much more contemporary sample of around 3.2 million adults, and validated in another 3.3 million different US adults.”

We also asked whether PREVENT would be rolled out throughout the U.S., “That will be up to the AHA and American College of Cardiology guideline committees,” he explained.

While they assess the tool, “Clinicians can use them now — on the AHA website, for instance — with confidence about their precision and accuracy.”

Takeaway

New research finds that millions of people on statins may not need to be taking the drugs.

Researchers came to this conclusion after updating the method of assessing an individual’s 10-year risk of heart disease.