Millions of people would not be prescribed statins if physicians choose to follow U.S. Preventive Services Task Force (USPSTF) guidelines for statin use over guidelines from the American College of Cardiology and the American Heart Association (ACC/AHA), according to a study published Tuesday in JAMA.
For the study, researchers from the Duke Clinical Research Institute and McGill University Health Centre used nationally representative data collected from 3,416 people without a history of cardiovascular disease to compare statin guidelines for people ages 40 to 75 from USPSTF and ACC/AHA. Statins are cholesterol-lowering drugs used to prevent heart attacks and strokes.
The researchers noted that USPSTF in 2016 set a higher threshold for people—including those diagnosed with diabetes—to use statins, than ACC/AHA, which in 2013 had expanded the population eligible for statin therapy by basing recommendations on an elevated 10-year risk of atherosclerotic cardiovascular disease.
The 2013 ACC/AHA guidelines recommend statins for people ages 40 to 75 with at least a 7.5 percent risk of having a heart attack or stroke in the next 10 years, as well as for individuals with cardiovascular disease, diabetes, or high levels of 'bad" cholesterol.
In comparison, the 2016 USPSTF guidelines recommend statins for individuals ages 40 to 75 with at least a 10 percent or greater risk of a heart attack or stroke over the next decade and at least one cardiovascular risk factor like diabetes or high blood pressure.
Both USPSTF and ACC/AHA recommend an informed risk-benefit discussion between patients and clinicians.
Overall, the researchers found 21.5 percent of people whose data were examined were already on statins. They estimated an additional 24.3 percent would be recommended for statin initiation under the 2013 ACC/AHA guidelines, compared with an additional 15.8 percent under the USPSTF recommendations.
When they projected these findings to the entire U.S. population, the researchers estimated 26.4 million adults would be recommended for statin therapy under the ACC/AHA guidelines, compared with 17.1 million adults under the USPSTF recommendations. The difference between the two guidelines represents an estimated 9.3 million people.
Of the individuals who would not be recommended for statins under USPSTF recommendations, the researchers found:
- 55 percent would be younger adults ages 40 to 59 years with a mean 30-year cardiovascular risk greater than 30 percent; and
- 28 percent would have diabetes.
Michael Pencina, the lead study author and director of biostatistics at Duke University, said the findings indicate that "we're still searching for the perfect guidelines" when it comes to statin use.
USPSTF in a statement said its recommendations "are closely tied to the available evidence" and that "it focused on recommending statins for the people who the evidence showed were most likely to benefit, though ultimately this decision should be made through a conversation between each patient and their doctor."
Steve Nissen, chair of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine at the Cleveland Clinic who was not involved in the study, also said such decisions should be made on a case-by-case basis with patients. He said USPSTF guidelines typically are more conservative than professional organizations, but added that it would be helpful if one entity could clear up the confusion among the USPSTF, ACC/AHA, and several other statin guidelines (Seaman, Reuters, 4/18; Mulder et al., JAMA, 4/18).
On statins and more, are you leading an evidence-based organization?
Despite the shift toward broad acceptance of evidence-based practice (EBP) among medical staff, over half of physicians report not actually using guidelines day-to-day when they are available. As a result, organizations continue to see tremendous variation in clinical practice—as well as in costs and outcomes.
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