Abstract

Introduction: American College of Cardiology/American Heart Association (ACC/AHA) new cholesterol treatment guidelines recommend consideration of statin treatment for a larger proportion of population for the primary prevention of atherosclerotic cardiovascular disease (ASCVD). It is important to assess the population impact of statin treatment under these new guidelines. Hypothesis: We assessed the hypothesis that increased statin use for the primary prevention of ASCVD might be accompanied by adverse effects among population. Methods: We used 2010 US Census, Multiple Cause Mortality, Third National Health and Nutrition Examination Survey Linked Mortality File (NHANES III 1988-2006, n=7095) and NHANES 2005-2010 (n=3178) participants 40-75 years of age to estimate prevalence of statin use, annual ASCVD deaths prevented and excess adverse effects by age, sex, and race/ethnicity if everyone followed updated guidelines. Results: Among 33.0 million adults aged 40-75 years meeting new guidelines for primary prevention of ASCVD (12.4 million with diabetes and 20.6 without diabetes but with a predicted 10-year ASCVD risk ≥7.5% and 70 ≤ low-density lipoprotein (LDL) ≤189 mg/dL), 26.9% (8.8 million) were on statins, indicating an additional 24.2 million potentially eligible for statin treatment (7.7 million with diabetes and 16.5 million without). Among the 7.7 million with diabetes, assuming 100% statin use, expected annual ASCVD deaths prevented were 2,514 (95% CI 592-4,142) and number-needed-to-treat (NNT) was 3,063 (1,860-13,017). The additional cases of myopathy based on estimates from randomized clinical trials (RCT) was 482 (0-2239) and number-needed-to-harm (NNH) was 15,992 (3,440-∞), and was 11,801 (9,251-14,916) and NNH 653 (516-833) based on estimates from population-based studies. Among 16.5 million without diabetes, ASCVD deaths prevented were 5,425 (1,276-8,935) with NNT 3,039 (1,845-12,914). The additional diabetes cases were 16,406 (4,922-26,250) with NNH 1,005 (628-3,349). Additional cases of myopathy was 1,030 (0-4,791) with NNH 15,996 3,441-∞) based on RCT estimates, and 24,302 (19,363-30,292) with NNH 678 (544-851) for population-based studies. ASCVD deaths prevented increased with age and >70% of ASCVD deaths prevented would occur among adults aged ≥60 years. Conclusions: Under ACC/AHA new guidelines for primary prevention of ASCVD by statin, assuming all those eligible took a statin, up to 12.6% of annual ASCVD deaths could be prevented, but could be accompanied by additional cases of diabetes and myopathy.

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