Guidelines swell ranks for statins by almost 13 million

Almost 13 million Americans between 40 and 75 years old would become eligible for statin therapy under new cholesterol guidelines, according to a study published online March 19 in the New England Journal of Medicine.

In November 2013, the American Heart Association and the American College of Cardiology published guidelines for physicians to reduce the risk of atherosclerotic disease. The guidelines veered from previous recommendations in two key ways: They eliminated the use of low-density lipoprotein (LDL) cholesterol targets and introduced a risk calculator.

The previous guidelines, the Third Adult Treatment Panel (ATP-III) of the National Cholesterol Education Program, used LDL cholesterol levels of 100 mg/dL and higher and established cardiovascular disease or diabetes as triggers for statin therapy. For primary prevention, the ATP-III focused on LDL levels and a 10-year risk of coronary heart disease based on Framingham risk calculations.

The new guidelines used 10-year predicted risk of cardiovascular disease of 7.5 percent or higher on the risk calculator and an LDL level of 70 mg/dL.

Michael J. Pencina, PhD, of the Duke Clinical Research Institute in Durham, N.C., and colleagues took a sample of 3,773 participants with fasting glucose data in the National Health and Nutrition Examination Surveys from 2005 and 2010 to estimate the number of people who would be considered appropriate for statin therapy under the new guidelines compared with ATP-III.  

They calculated that 42 percent would either receive or be eligible for statin therapy under the ATP-III guidelines and 56.6 percent under the new guidelines. Applying that to the population of adults between the ages of 40 and 75 (the age parameters in the new guidelines), a net increase of 12.8 million adults would be eligible for statin therapy under the new guidelines, with 10.4 million of them recommended for primary prevention.

“The increased number of adults who would be newly eligible for statin therapy suggests higher treatment rates among those expected to have future cardiovascular events (increased sensitivity) but also an increased number of adults receiving therapy who are not expected to have events (decreased specificity),” Pencina and colleagues wrote.

The proportion of eligible younger adults eligible was similar under both guidelines but 77.3 percent of adults between the ages of 60 and 75 would receive or be eligible for statin therapy under the new guidelines compared with 47.8 percent under ATP-III. Adding in the new guideline’s recommendations for moderate intensity statins expanded the pool to 87.4 percent of older adults.  

They noted that the new prevention guidelines include stroke as a target. Given that the prevalence of cardiovascular disease increases with age, the broadening of eligibility in older adults may be justified, they wrote. “Further research is required to determine whether more aggressive preventive strategies are needed for younger adults.”

The study equated eligibility to treatment recommendation, which could overestimate changes under the new guidelines. The authors acknowledged that physicians don’t always follow recommendations and in the past patient adherence had been low. The new guidelines also emphasize that physicians talk with patients who are deemed eligible before prescribing statins.