"The groundwork of all happiness is health." - Leigh Hunt

Many individuals who take statins may not need them

June 27, 2024 – If you’re taking a statin drug to stop heart disease, your doctor may inform you over the following 12 months or two that it is not any longer needed.

When and if that change occurs, it is going to reflect the usage of a brand new risk calculator that the American Heart Association released last 12 months. Using that calculator and data from a national nutrition and health surveya new study estimates that for adults aged 40 to 75, the chance of developing atherosclerotic heart disease inside 10 years is simply half as high as previous predictions.

More than 45 million Americans are allowed to take statin drugs to stop heart disease that may result in heart attacks or strokes. These guidelines are based on a 2013 risk calculator called the pooled cohort equations. In 2023, the American Heart Association released an updated calculator, the Predicting Risk of Cardiovascular Disease Events (PREVENT) equations.

In the brand new study, researchers compared the 10-year predicted risk using each calculators for 3,785 adults who participated within the CDC's National Health and Nutrition Examination Survey from 2017 to March 2020. The people within the study were all eligible for statins, but only 20% of them actually took the drugs.

After weighting the survey data to be nationally representative, the study authors found that using the calculator reduced the typical 10-year risk of heart disease in adults from 8% to 4.3% in 2023. Across all age, gender, and racial subgroups, the typical 10-year risk was lower when using these guidelines.

As a result, the variety of adults who met the standards to take statins fell from 45.4 million to twenty-eight.3 million. Based on these equations, 17.3 million adults for whom statins at the moment are really useful would not be considered eligible. This includes 4.1 million adults who currently take statins.

Update based on recent data and recent aspects

Why is there such an enormous difference between the outcomes of the 2 calculators?

One reason is that the info for the 2013 version comes from the Nineteen Sixties to Nineties, says Sadiya Khan, MD, professor of cardiovascular epidemiology and associate professor of medication at Northwestern University Feinberg School of Medicine in Chicago.

“A lot has changed since then,” says Khan, who was involved in developing the chance calculators. The larger and newer database on which the 2023 equations are based comes largely from a repository of electronic health data, in response to the brand new study.

In addition, the 2 calculators use various factors to estimate heart disease risk. For example, race is taken under consideration within the 2013 version but not within the 2023 calculator, because it is now recognized that there are not any biological differences between races. However, the baseline and decline in estimated risk were larger for blacks (from 10.9% to five.1%) than for the complete study sample.

“Black patients are at higher risk for cardiovascular disease, particularly stroke,” Khan said. “The most common reason is higher rates of hypertension and diabetes. It's a combination of many social factors coming together and probably not biological, but it's a long-standing and difficult problem to solve.”

The 2023 equations consider the extent of kidney function and statin use, which weren’t included within the previous calculator. The newer version also includes data on blood sugar, kidney health and the “social deprivation index” based on postcodes.

Not taken under consideration within the study were zip codes that didn’t appear within the nutrition survey data and LDL levels of cholesterol, which were only available for among the people surveyed.

Despite these drawbacks, Khan, who was not involved within the study, said the study's foremost conclusions on the 10-year risk of heart disease were consistent with those of other studies.

Study co-author Dr. Jeremy Sussman, an associate professor on the University of Michigan, doubts that omitting the LDL cholesterol data could have significantly affected the accuracy of the outcomes. “It certainly doesn't lower the number enough to change the basic story,” he said.

When will the rules change?

Sussman believes the study results justify a revision of the rules for stopping heart disease. “I think the change is so significant that the people who create these guidelines should at least think about what they should say about the situation.”

The study’s lead writer, Timothy S. Anderson, MD, assistant professor on the University of Pittsburgh, discussed the difficulty in an interview for News article In The Journal of the American Medical Association. Not only did he advocate for updating the rules, but he also gave a timeline for when he thinks that can occur. The American Heart Association and the American College of Cardiology are expected to release recent guidelines on hypertension and cholesterol later this 12 months and in 2025, respectively, he said, and he expects those changes to be followed by recent guidelines on primary prevention of heart problems (or disease of the guts or blood vessels).

In response to an issue, Heart Association spokeswoman Maggie Francis simply replied: “The study [on 10-year heart disease risk] will be part of the evidence considered in any review of clinical practice guidelines.”

Cast a wider net

When the brand new guidelines are written, Khan said, they need to include risk predictions for heart failure, as mortality rates from this condition are increasing. She also said it was necessary to estimate the 30-year risk of heart problems, which is liable for more deaths than every other disease. Two-thirds of individuals and not using a significant 10-year risk of heart problems have a high 30-year risk, she said.

Khan said she couldn’t estimate what number of patients currently taking statins is likely to be advised to stop taking them if primary prevention guidelines change.

“When we think about thresholds for treatment, we think about what level of risk does the benefit outweigh the harm,” she said. “And where are the studies that can show us that? There are studies that show that at lower risk levels – say 5% – the benefit [of statins] outweigh the damage.”

If there is uncertainty, a doctor can order tests. Sussman, who estimates that millions of people undergo these tests, said the lower risk level the study found could lead to fewer patients taking the tests. But whether or not the screenings are done, Khan said, the final decision to take statins is between the doctor and patient and is based on a number of factors, including family history.

Undertreatment is widespread

The most important point, Khan said, is that a minority of people who could benefit from statins actually take them, and the same is true for other forms of preventive care.

“No matter how the rules evolve, we’re treating people below average and that should be addressed. When you take a look at the treatment of blood pressure or cholesterol, or while you consider that we now have an epidemic of obesity and diabetes, we’re treating people below average,” she said.

Khan said by “we” she meant not just doctors but society as a whole. “Overall, we all know that fewer persons are being treated than could be higher from an economic and efficiency perspective,” and that this is partly related to unequal access to health care.

“Statins and antihypertensives, while incredibly cheap, could be free,” she said. “We as a society could propose that these drugs – because of their outsized benefits for prevention and because [cardiovascular disease] is the leading cause of death in this country – should be free.”