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Who Qualifies for Statin Treatment under the New Guidelines?

The new guidelines from the ACC and AHA would increase the number of individuals eligible for statin therapy by nearly 13 million people. 

Innovations in the new CV risk-assessment guidelines, which were released just days ago by the American College of Cardiology (ACC) and American Heart Association (AHA), reflect a focus on atherosclerosis as a chronic disease that extends beyond the heart. Compared with risk-assessment principles in earlier society-endorsed guidelines, the new document:

  • Adds stroke to the coronary events traditionally covered by the equations for predicting future risk.
  • Has a primary focus on 10-year risk of atherosclerosis-related events, plus a secondary focus on assessing lifetime risk for adults aged 59 or younger who aren’t at high shorter-term risk.
  • Provides adjunct formulas for refining risk estimates by race and gender.
  • Acknowledges selective use of coronary-artery calcium (CAC) scores and some other markers to sharpen predictions in some cases.

Among older adults, those aged 60 to 75 years old, 87.4% of men would now be eligible for the lipid-lowering medication, which is up from one-third under the old Adult Treatment Panel (ATP) III guidelines. For women of the same age, the percentage of those now eligible for statins would increase from 21.2% under ATP III to 53.6% with the new 2013 clinical guidelines.

The increase, say investigators, is the result of more patients being eligible based on their 10-year risk of cardiovascular disease.

The relative impact of age vs other risk factors is greater in the new risk-assessment model when compared with the Framingham risk score used in ATP III.

The analysis, which applied the new clinical guidelines to an estimate of the US population using data from the National Health and Nutrition Examination Surveys (NHANES), is published March 19, 2014 in the New England Journal of Medicine.

Instead of the targets published last November, the new guidelines abandon the LDL and non-HDL cholesterol targets that recommended physicians treat patients with cardiovascular disease to a target of less than 100 mg/dL (or the optional goal of less than 70 mg/dL).

The new guidelines identify four groups of primary- and secondary-prevention patients for physicians to focus their efforts to reduce cardiovascular disease events. And in these four patient groups, the new guidelines make recommendations regarding the appropriate "intensity" of statin therapy in achieving relative reductions in LDL cholesterol.

These four groups include individuals with clinical atherosclerotic cardiovascular disease, individuals with LDL-cholesterol levels >190 mg/dL, diabetic patients without cardiovascular disease aged 40 to 75 years old with LDL-cholesterol levels between 70 and 189 mg/dL, and those without evidence of cardiovascular disease, an LDL cholesterol level 70–189 mg/dL, and a 10-year risk of atherosclerotic cardiovascular disease >7.5%.

Of the 115 million adults aged 40 to 75 years old in the US, approximately 43 million (37.5%) could receive or be eligible to receive a statin using the ATP III guidelines. When the ACC/AHA cholesterol guidelines were applied, however, this number increases to 56 million (48.6%). The researchers estimate that 14.4 million adults would be newly eligible for statin therapy, a number that is higher than 12.8 million because 1.6 million adults previously eligible with ATP III would no longer be eligible for statins.

Although the new guidelines increase the number of eligible statin users across all four of the new treatment categories, the largest increase in use would be in primary prevention. Of the 12.8 million additional people treated if the ACC/AHA guidelines were applied, 10.4 million of these would be adults without evidence of atherosclerotic cardiovascular disease (but with a 10-year risk >7.5%), the primary-prevention population. The increase in statins for primary prevention is largest among men, although the number of female primary-prevention patients also increases.

The researchers also looked at patients aged 40 to 59 years and those aged 60 to 75 years old without cardiovascular disease and noted a substantial difference in statin eligibility between ATP III and the ACC/AHA guidelines. While the number of adults aged 40 to 59 years old eligible for primary-prevention therapy is similar between the two guidelines, 77% of adults aged 60 to 75 years would be treated with a statin under the ACC/AHA guidelines. This percentage is up from the 48% of older adults who would be treated with ATP III.

The number of diabetic patients eligible for statin therapy under the new guidelines would increase from 4.5 million to 6.7 million, an increase that is the result of the lower LDL-cholesterol treatment threshold.

1.Stone NJ, Robinson J, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: A report of the American College of Cardiology/American Heart Association. J Am Coll Cardiol 2013. Article. Circulation 2013. Article.

The analysis, which applied the new clinical guidelines to an estimate of the US population using data from the National Health and Nutrition Examination Surveys (NHANES), is published March 19, 2014 in the New England Journal of Medicine.