IA new study estimates that if millions of Americans no longer qualify for statins and blood pressure medications, there could be 107,000 additional heart attacks and strokes over a decade, based on a new calculator that has been updated to better predict risk.
In research papers, Published Monday in JAMAit is Number 2 In the space of two months, attention has been focused on a medicine that is widely used to prevent a leading cause of death in the United States.
The study has generated buzz in the cardiology community, while two medical societies are weighing the new risk model against existing criteria for prescribing and developing new guidelines to help inform clinical practice.
“We’re concerned that this could upend eligibility for millions of Americans,” Raj Manraj, an assistant professor of biomedical informatics at Harvard Medical School’s Blavatnik Institute and senior author of the new study, said in an interview. “We need to reexamine the other side of the equation: how patients and physicians use these risk estimates to decide who and when to receive preventive care, particularly statins and antihypertensive drugs.”
Who should take statins is at the heart of two research papers published in November 2023 analyzing a risk equation called “Predicting the Risk of Cardiovascular Disease Events (PREVENT).” modelThe model, developed by the American Heart Association, aims to improve on a version created in 2013 called the Pooled Cohort Equation (PCE). Widely criticized for Overestimating the risks.
PREVENT leverages claims and electronic health record data from a more diverse real-world population than its predecessor and incorporates current statin use, metabolic disease, and renal disease. Current guidelines used by primary care physicians are based on the PCE, but the American Heart Association and American College of Cardiology are reviewing the new PREVENT model and finalizing new guidelines.
According to the 2013 calculation-based guidelines, most people with a 10-year risk of developing cardiovascular disease of 7.5% or more are advised to take statins, but those with a 5% risk are told only that they and their doctor should consider taking them. The benchmark for hypertension treatment is blood pressure of 140/90 mmHg or higher, or blood pressure of 130/80 mmHg or higher and a 10% risk for other reasons.
Some experts say it’s more urgent to reset the thresholds used than to debate which risk calculator is better.
“It is a well-known fact that the PCE overestimates risk by about two-fold,” Sadiya Khan, a cardiologist and associate professor of medicine and preventive medicine at Northwestern University’s Feinberg School of Medicine, told STAT in an email. She was not involved in either study. Preventing the equation“The PREVENT estimates are more consistent with contemporary event rates and are about half the PCE estimates. So the question is not whether there would be more deaths or events if the thresholds were the same, but what the guidelines should consider as the new thresholds.”
Harvard’s Manray agrees: “To me, the data suggest that we should have a very important and urgent discussion about whether 7.5% is the magic number at which to start a statin, and whether that number is based on a risk-benefit calculation. I think that calculation needs to be reconsidered.”
Statins, available in the United States for about $40 per year, are very effective at lowering LDL, the “bad” cholesterol that clogs blood vessels. As arteriosclerosis worsens, the heart and brain can get less oxygen-rich blood, which can lead to heart attacks and strokes. A variety of low-cost drugs are also available to lower blood pressure, but they work by relaxing and widening blood vessels, which can lead to heart attacks and strokes if they become clogged.
The downside of statins is that they may increase the risk of type 2 diabetes. However, while the drugs have dramatically improved cardiovascular health, 40% of Americans People who could benefit from statins under current guidelines don’t take them.
“Even if we put aside the question of what is the best and most accurate model for patients in 2024 – which I think is the first fundamental question – we still know that there are large gaps in patients receiving appropriate treatment even if they are eligible,” Khan said.
Last month JAMA Internal Medicine study Using the updated PREVENT risk equation, a survey of 3,785 adults aged 40-75 years from the 2017-2020 National Health and Nutrition Examination Survey found an overall 10-year risk of developing cardiovascular disease of 4%, higher than the 8% previously predicted by the PCE. If implemented in clinics nationwide, it is estimated that 17.3 million fewer adults would be recommended statins.
Monday’s JAMA study Similarly, applying the PREVENT risk calculator to 7,765 adults ages 30 to 79 who responded to the same national survey from 2011 through 2020 (through March, when the pandemic began), they concluded that 14.3 million fewer people would no longer meet statin eligibility and 2.6 million fewer people would be eligible for blood pressure medication.
The authors then predicted the impact on heart attacks and strokes if the new risk tool reduced the number of people recommended to take statins and blood pressure medications. The answer was that being classified as low risk and thus making preventive medication ineffective would result in 107,000 additional heart attacks and strokes over 10 years. More men than women would be potentially affected, but black and white adults would be equally represented. People deemed ineligible for treatment had fewer risk factors, including lower rates of obesity, high blood pressure, and chronic kidney disease.
“This estimate is based on the assumption that fewer people will receive treatment and that the same threshold applies,” Khan said of the JAMA paper. “I think we should expect that the threshold should and will need to change now that we have more accurate models.”
Manley said he was struck by the magnitude of the potential impact of changing the risk equations. “When you look at the number of 107,000 heart attacks and strokes, we’ve looked at this 100 times. We’ve done about 15 sensitivity analyses,” he said. “I think the potential impact of changing these equations across the U.S. is a really staggering projection.”
One of the authors of the June analysis is Timothy Anderson, a primary care physician and assistant professor of medicine at the University of Pittsburgh Medical Center, who thinks there will be debate in both the primary care and cardiology communities about what the appropriate risk threshold is.
“I’ve never seen a study that says 5 percent is the perfect number, or 7 percent or 2 percent or 20 percent is the perfect number. At the end of the day, statins are safe drugs and they work very well,” he said in an interview. “Many people are willing to accept some risk and might consider taking statins and trying to control their blood pressure through exercise and weight loss.”
Manrai and his co-authors noted that both statins and blood pressure medications have drawbacks. People on statin therapy are at increased risk of type 2 diabetes, likely because the drugs interfere with insulin. Therefore, in the PREVENT model, which suggests reducing statin use, the researchers project that there would be 57,800 fewer new cases of type 2 diabetes over 10 years. People taking blood pressure medications can suffer side effects, including a sudden drop in blood pressure, reduced blood supply, and sexual dysfunction, which influences how patients and doctors judge costs and benefits.
“No risk estimation equations are perfect,” Jelani Grant, Chiadi Ndumele, and Seth Martin of Johns Hopkins wrote in an accompanying editorial. “These equations provide a starting point for risk discussions and shared decision-making in the primary prevention setting. Further risk assessment with risk-increasing factors and arterial imaging can help customize individual treatment plans.”
Manley has heard that cardiologists are already incorporating PREVENT scores into their risk estimates.
Not so with Steven Nissen, a cardiologist at the Cleveland Clinic. Nissen believes the problems arise when risk calculators are misconstrued as a requirement.
“My personal opinion is there’s no substitute for an informed physician who knows what the latest medical literature is, who looks at the patient in front of them and takes into account everything we know,” he said in an interview.
He argues that statins have lifelong benefits. Leading the collaboration with AstraZeneca to produce 5-milligram doses of the company’s drug Crestor (rosuvastatin). Available without a prescription.
“What they’re trying to say here is that getting the risk calculation wrong can be very costly,” Nissen said of the new JAMA paper, which he was not involved in. “I think they’re right that missing the mark can have societal costs. We need a more thoughtful approach to deciding who to treat and not be entirely focused on someone’s mathematical risk calculation.”
Khan said new standards of treatment should ideally be based on randomized clinical trials that follow participants to see how well risk models can predict subsequent heart attacks and strokes. This would help establish the risk levels that provide the greatest benefit and least harm from prescribing statins or blood pressure-lowering drugs.
“The guidelines don’t recommend a one-size-fits-all threshold,” she says. Instead, doctors and patients should discuss individual factors that increase risk, such as family history of heart attacks at a young age or preeclampsia, a dangerous condition during pregnancy, and imaging tests to determine calcium levels in the coronary arteries.
“One of the most important parts of this discussion is to ensure that patients do not stop taking statins without consulting their physician based on the new model until new guidelines are available indicating when to start or stop treatment,” Khan said.
STAT’s coverage of chronic health issues is supported by the following grants: Bloomberg Philanthropies. our Financial Supporters They are not involved in any decisions regarding our journalism.
