Statins

(Credit: Roger Ashford on Shutterstock)

PITTSBURGH – Are statins the right drug for everyone trying to prevent heart disease? Researchers from the University of Pittsburgh say that a new risk scale for heart health could change the entire landscape of prescription drug use.

In their study, researchers found that if national guidelines incorporate a new risk equation called PREVENT, about 40% fewer Americans could meet the criteria for taking cholesterol-lowering statin drugs to prevent heart disease and stroke. The findings published in JAMA Internal Medicine examined the potential widespread impact of adopting the PREVENT equations, released by the American Heart Association in November 2023, to update the standard method doctors use to calculate patients’ 10-year risk of having a heart attack or stroke.

At a national level, the researchers estimate the number of U.S. adults recommended for statin therapy could plummet from 45.4 million to 28.3 million if PREVENT is widely adopted. Strikingly, the study also revealed that most people who would still qualify for statins under PREVENT are currently not taking these preventative medications.

“This is an opportunity to refocus our efforts and invest resources in the populations of patients at the highest risk,” says lead author Dr. Timothy Anderson, M.D., M.A.S., a primary care physician at UPMC and health services researcher and assistant professor of medicine at Pitt, in a media release.

A statin tablet emerging from a marked weekly blister pack
If national guidelines incorporate a new risk equation called PREVENT, about 40% fewer Americans could meet the criteria for taking cholesterol-lowering statin drugs. (© roger ashford – stock.adobe.com)

The research team leveraged nationally representative data from nearly 3,800 American adults between the ages of 40 and 75 who participated in a major government health survey from 2017-2020. They calculated each participant’s 10-year risk of developing atherosclerotic cardiovascular disease (ASCVD), a dangerous condition where plaque builds up in arteries, using both the new PREVENT equations and the older, standard Pooled Cohort Equations (PCE) currently used by doctors.

The PREVENT formulas aim to enhance accuracy by incorporating more current data reflecting the U.S. population today, as the previous PCE drew from decades-old patient data lacking diversity. PREVENT also accounts for factors like current statin use, metabolic diseases, and kidney problems – while removing the controversial use of race as a biological risk factor. When applying PREVENT, the researchers found the average 10-year ASCVD risk across all participants was just half (4%) of the rate that was estimated by the older PCE method (8%). The differences were even starker for Black adults and older adults between 70 and 75 years-old.

“We don’t want people to think they were treated incorrectly in the past. They were treated with the best data we had when the PCE was introduced back in 2013. The data have changed,” Anderson says. “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 five years down the road, for the simple reason that everybody’s risk goes up as we get older.”

Paper Summary

Methodology

The study utilized data from nearly 3,800 U.S. adults ages 40-75 who participated in the National Health and Nutrition Examination Survey from 2017-2020. The researchers calculated each participant’s 10-year atherosclerotic cardiovascular disease (ASCVD) risk using both the new PREVENT equations and the older Pooled Cohort Equations (PCE) currently recommended.

A key difference is that PREVENT incorporates more current data on ASCVD risk factors like cholesterol levels, smoking, blood pressure, and diabetes across diverse populations. It also accounts for statin use and metabolic/kidney disease but removes the controversial inclusion of race – a social rather than biological construct.

Results

Using the PREVENT model, the average estimated 10-year ASCVD risk across all participants was just 4% – half the 8% risk predicted by the old PCE method. The gap was even more stark for certain subgroups like Black adults (5.1% vs 10.9% for PCE) and those 70-75 years old (10.2% vs 22.8%).

Based on those lower risk scores, around 17 million fewer U.S. adults would meet typical thresholds for statin therapy recommendations compared to the older equations – a drop from 45.4 million to 28.3 million.

That includes an estimated 4.1 million people currently taking statins who might no longer merit the drugs under PREVENT’s reassessment of their ASCVD risk.

Study Limitations

The analysis was based on a snapshot of data, but a person’s calculated risk inevitably changes over time as they age and develop new risk factors.

There are also outstanding questions about how to best communicate these risk recalculations to patients, particularly those who may be advised to discontinue a long-standing statin regimen they were prescribed under the old model.

StudyFinds Editor Chris Melore contributed to this report.

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