Statins may not be necessary for millions of people, research suggests

IIt’s a familiar scene for patients during a routine primary care visit. The doctor scans the blood test results, notes a high cholesterol level which is flagged by a standard calculator to assess the risk of a heart attack or stroke, and then decides – and ideally discusses – whether to recommend the use of a statin to reduce the risk in the future. reduce over time.

That conversation can take place less often if changes in the risk model presented by the American Heart Association in November translate into new guidelines for prescribing statins. Those guidelines haven’t yet been recalibrated, but a new analysis suggests that the new risk model could mean that far fewer Americans — as many as 40% fewer than current calculators say — would be candidates for cholesterol-lowering drugs to prevent cardiovascular disease.

To come to this conclusion, published Monday in a JAMA Internal Medicine studyresearchers analyzed data from 3,785 adults who were between 40 and 75 years old and who participated in the National Health and Nutrition Examination Survey from January 2017 to March 2020. Their 10-year risk of cardiovascular disease that narrows the arteries was calculated using the AHA’s Predicting Risk. of EVENTs comparisons (PREVENT) from 2023 and then compared with risk estimates using the previous tool from 2013, the Pooled Cohort Equations (PCE), on which the current guidelines are based.

Those 2013 comparisons received a lot of criticism overestimate risk. The 2023 version, based on billing and electronic health record data from a more diverse real world population, included current statin use as well as metabolic and kidney diseases.

Chiadi Ndumele, chair of the American Heart Association’s CKM Scientific Advisory Group, emphasized that actual PREVENT risk thresholds for statin use in cardiovascular prevention need to be established in clinical guidelines, and that has not yet happened. He also acknowledged criticism of the previous risk model.

“We have updated the AHA risk prediction model to PREVENT, which reflects the growing influence of interrelated metabolic risk factors (obesity, diabetes, metabolic syndrome) and chronic kidney disease on cardiovascular disease risk,” said Ndumele, director of obesity and cardiometabolic research at Johns Hopkins. University, STAT told in an email. “It is therefore not surprising that the researchers found approximately twice the predicted number of events for the PCEs versus PREVENT, reflecting this difference.”

Under current guidelines, most people with a 10-year risk of 7.5% or more of developing cardiovascular disease are advised to take a statin, while at a 5% risk they are only told that they and their doctors should consider. .

“Assessments are underway,” Ndumele said. “Guidelines will need to consider whether and how to update recommendations to include PREVENT risk thresholds to guide clinical decision-making.”

What has changed in the JAMA Internal Medicine analysis is how many people may be at risk, based on the new components entered into the calculator. Overall, 4% of people had a 10-year risk of developing cardiovascular disease, compared to the 8% previously predicted by the PCE. The number of adults recommended for statins could fall from 45.4 million to 28.3 million.

Race, now recognized as a social and not biological construct, was excluded in the newer comparisons. That meant an estimated 5.1% of black adults were at risk, compared to 10.9% from the previous calculator. For older adults ages 70 to 75, the risk rate was 10.2%, up from 22.8%.

Paradoxically, the study found that while fewer people might qualify for statins, which can now cost as little as $40 a year, the estimates also say that most people who would be advised to take them don’t do so.

“The previous risk comparisons and the PREVENT comparisons that we focus on in this study are trying to give doctors and patients some kind of starting point to say, is it worth having a conversation about statins?” lead study author Timothy Anderson, a family physician and assistant professor of medicine at the University of Pittsburgh Medical Center, told STAT. “If we see risk rates cut in half, I think that’s really something that will probably impact the way doctors and patients talk about these drugs.”

The biggest predictor of risk remains age, Anderson said. “If you run a borderline risk now, you will probably run a greater risk in five years. And that’s a complicated series of conversations for doctors and patients in primary care.”

It concerns Steven Nissen, a cardiologist at the Cleveland Clinic, who was not part of the study. “Age is the most powerful factor in the calculators, so if you wait until someone is 60 or 65, you’re playing catch-up,” he said. “I tend to treat rather than not treat if it’s borderline, but only if the patient and I have a conversation.”

Nissen has been leading an initiative in collaboration with AstraZeneca to make the 5-milligram dose of his drug, rosuvastatin, available without a prescription. He urged shared decision-making between doctor and patient, recognizing that busy GPs may be pressed for time.

“Good medicine involves judgment. And the calculator is not a substitute for good medical judgment, which may come to a different conclusion,” he said. “I’m not in favor of either calculator because I think it’s generally good to have lower LDL cholesterol,” or “bad” cholesterol.

There are a multitude of factors that influence cardiovascular health, and statins are just one part of them, says Gregg Fonarow, chief of cardiology at UCLA, citing the AHA’s recent projection that 61% of the US population is likely to have cardiovascular disease. He did not participate in the current study.

“So many cardiovascular events can be prevented, not only through medication, but also through lifestyle changes. We have to do better preventively,” said Fonarow. “This really provides an opportunity to use the new improved PREVENT risk score and better inform individuals about risk, but importantly, not just about the 10-year risk, but about their lifetime risk of disease.”

Ndumele said PREVENT will help guide the use of preventive therapies beyond statins, relevant for people with cardiovascular renal metabolic syndrome, a condition in which metabolic risk factors, chronic kidney disease and the cardiovascular system interact to cause multi-organ dysfunction and cause bad cardiovascular conditions. outcomes.

“I think the challenge of this article is the assumption that the same threshold will be used for the recommendation of statin use,” Ndumele said. “Risk estimates from PREVENT are much closer to what is actually observed than from PCEs, but there is a need for discussion about the optimal risk threshold for preventive statin use in guidelines.”

Nissen said any changes should be carefully considered, with this caveat: “The message is that each of these calculators is the best estimate of risk,” he said, “but the decision to treat is different than simply a risk calculate. .”

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