A new study suggests that a new way to determine heart disease risk could lead to millions of Americans receiving fewer statin prescriptions, but cardiologists warn that more information is needed and that patients shouldn’t stop taking their medications.
Statins such as Lipitor, Crestor and Zocor are widely used to prevent elevated LDL cholesterol, one of the causes of cardiovascular disease. Doctors prescribe the drugs, which are taken daily, based on 2013 guidelines from the American Heart Association and American College of Cardiology, which estimate a patient’s risk based on factors such as age, diabetes and blood pressure.
In the new study, Dr. Tim Anderson, assistant professor of medicine at the University of Pittsburgh, and his colleagues Heart Disease Risk Calculator, PREVENTis a new calculator released by the American Heart Association last year. Researchers looked at data from 3,785 adults ages 40 to 75 who participated in the National Health and Nutrition Examination Survey (NHANES) and compared estimates from the new calculator with previous guidelines.
The Heart Association’s new calculator was developed to more accurately assess a person’s likelihood of developing heart disease by incorporating newly recognized risk factors, such as kidney disease and obesity.
In a report published Monday in the journal JAMA Internal Medicine, the researchers found that the 10-year risk of developing heart disease among participants as determined by the new tool was about half the risk estimated by the previous tool.
When the researchers used PREVENT to calculate the 10-year risk of developing heart disease, they determined that about 40% fewer people would meet the criteria for a statin prescription.
In other words, as many as 4 million people in the United States who currently take statins for primary prevention – people who have never had a cardiovascular event such as a stroke or heart attack – may not need statins, said Anderson, lead author of the new study.
How is the new calculator different?
The new tool has a number of different elements:
- It removes race from the calculation and replaces it with an individual’s zip code, which serves as an indicator of socioeconomic status.
- These include factors that increase the risk of heart disease, such as kidney disease, obesity and a measure of poor blood sugar control (hemoglobin A1C).
- Risks are calculated separately for men and women.
Anderson said the new findings provide an opportunity for people taking statins for primary prevention to ask their doctors whether they need to continue taking the medication. While it’s important to treat heart disease risk before the first attack occurs, statins can cause side effects in some people, including muscle pain, headaches, sleep problems and digestive upset.
“Patients who are on the edge should know that there are other factors, such as family history, that these calculators don’t capture, and it’s really important to talk to your doctor about it,” Anderson said.
Cardiovascular disease experts expressed concern that the new study could lead some patients to stop taking their statins, especially since many people have already stopped taking them against their doctor’s advice.
Any new risk calculator will need new guidelines to accompany it, said Dr. Sadiya Khan, chair of the PREVENT development committee and professor of cardiovascular epidemiology at Northwestern University Feinberg School of Medicine.
“The risk model doesn’t determine who is recommended to take statins, that’s what the guidelines will determine,” Khan said. “I think the most important thing is to determine when it’s recommended to start taking statins, and that’s something that’s yet to be determined.”
Dr. Robert Robinson, director of lipids and metabolism at the Mount Sinai Health System in New York City, cautioned that the study’s small number of participants means it is not representative of the U.S. population.
“Their argument that fewer patients should be eligible for statins is based on the limited number of people in the NHANES database,” Robinson said. “This is alarming.”
Dr. Sharyn Rao, director of the heart failure service at NYU Langone Hospital on Long Island, worries that patients who actually need cholesterol-lowering drugs could get the wrong message.
“We see a lot of benefit from statins in many populations,” Rao said.