Pencina MJ, Navar-Boggan AM, D’Agostino RB, et al. Application of new cholesterol guidelines to a population-based sample. N Engl J Med 2014;370:1422–31.
Study Overview
Objective. To quantify how many people would qualify for statin treatment under the 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines [1].
Design. Descriptive, repeated cross-sectional study examining data from the 2005–2010 National Health and Nutrition Examination Surveys (NHANES). Data on the medical diagnoses and risk factors for cardiovascular disease for NHANES participants aged 40–75 years ( n = 3773) were used to extrapolate to 115.4 million US adults in the same age-range. Exclusions were for triglyceride levels > 400 mg/dL (100 participants) and missing LDL cholesterol measurement (36 participants).
Main outcome measure. Percentage of the US adult population that would be recommended statin therapy according to the 2013 ACC/AHA guidelines as compared with the 2004 guideline produced by the Third Adult Treatment Panel (ATP III) of the National Cholesterol Education Program [2,3].
Main results. Of the NHANES participants, 49% were male, 13% had cardiovascular disease, 46% had hypertension, 21% had diabetes, 21% were smokers, and 41% had obesity. Median age was 56 years (interquartile range [IQR], 41–73), median total cholesterol was 199 mg/dL (IQR, 138–272), median LDL cholesterol was 118 mg/dL (IQR, 64–182), and HDL cholesterol was 52 mg/dL (IQR, 33–86).
Overall, 2135 participants (57%) qualified for statin treatment according to the ACC/AHA guidelines as compared with 1583 (42%) under the ATP III guidelines. Additional participants qualifying under the ACC/AHA guideline were more likely to be male, older in age, have a lower LDL cholesterol, and without known cardiovascular disease, diabetes, obesity, or hypertension. Extrapolated to the US population, 56 million people (49% of the US population age 40 to 75 years, 95% CI, 46–51) would be recommended for statin treatment under the ACC/AHA guidelines compared with 43.2 million (37.5%, 95% CI, 35.3–39.7) under ATP III.
Most new candidates for statins meet criteria for primary prevention of a cardiovascular event: 2.2 million persons with diabetes and 8.2 million considered at high risk for an event in 10 years based on the new ACC/AHA risk calculator [4]. Age also was an important predictor of newly eligible statin candidates. According to ATP III, 48% of 60- to 75-year-olds would qualify for treatment, but 78% would qualify based on ACC/AHA. According to extrapolated NHANES data, 25.2 million people were taking statins from 2005 to 2010; the ACC/AHA guidelines would more than double this number.
Conclusion. The 2013 ACC/AHA cholesterol treatment guidelines would substantially increase the number of patients recommended for statin therapy.
Commentary
In November 2013, the long-awaited cholesterol treatment guidelines from the ACC/AHA hit like an earthquake [5]. The guidelines called for abandoning the traditional treat-to-target approach, in which clinicians treat patients to specific levels of LDL cholesterol [1] and instead called for statin treatment based on cardiovascular risk profile. The guideline authors made this change because of the lack of evidence supporting a treat-to-target approach; nearly all randomized controlled trials with statins used fixed doses of statins rather than trying to achieve specific LDL levels. This study by Pencina and colleagues demonstrates how implementation of the new guideline could dramatically change practice. If fully implemented, the guideline would lead to treatment for more than 12 million more patients and double the number of currently treated patients. Nearly all of the newly treated patients would receive treatment for primary prevention.