A Long-term Benefit Approach vs Standard Risk-Based Approaches for Statin Eligibility in Primary Prevention.

IMPORTANCE: A 10-year benefit-based approach to statin therapy in primary prevention includes younger individuals with higher low-density lipoprotein cholesterol (LDL-C) and prevents more cardiovascular events than a risk-based approach. However, a 10-year treatment duration likely underestimates the expected benefits of statins. OBJECTIVE: To model the impact of a 30-year benefit approach to select individuals for statin therapy. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional analysis of the National Health and Nutrition Survey (NHANES) data set included samples of the US population from the 2009-2010, 2011-2012, and 2013-2014 data collection cycles. Individuals between 40 to 60 years old who did not have atherosclerotic cardiovascular disease, diabetes, or LDL-C levels greater than 190 mg/dL and who were not taking statins were included. Data analysis took place from November 2017 to August 2018. EXPOSURES: We calculated 10-year risk of atherosclerotic cardiovascular disease and 10-year and 30-year absolute risk reduction (10-year ARR and 30-year ARR) of atherosclerotic cardiovascular disease for each individual. MAIN OUTCOMES AND MEASURES: Number of individuals meeting eligibility for statins based on 10-year (atherosclerotic) cardiovascular disease risk, 10-year ARR, or 30-year ARR. RESULTS: A total of 1688 individuals were included, representing 56.6 million US individuals. Statin eligibility based on 7.5% CVR10 was 9.5%; based on 2.3% 10-year ARR, 13.0%, and based on 15% 30-year ARR, 17.5%. The 10-year risk, 10-year benefit, and 30-year benefit approaches all led to similar acceptable mean absolute risk reductions at 30 years, with the benefit-based approaches better able to avoid treatment of individuals with low expected benefit. Individuals who met statin eligibility based solely on the 30-year ARR threshold of 15% or greater were younger (mean age, 50 [95% CI, 48-52] years) and more likely to be women (43% [95% CI, 26%-59%]) than those recommended with a 10-year ARR threshold of 2.3% or greater (mean age, 56 [95% CI, 54-57] years; 22% [95% CI, 10%-34%] women). This group also had lower 10-year risk (mean risk, 4.7% [95% CI, 4.4%-5.1%]) and higher LDL-C levels (mean level, 149 mg/dL [95% CI, 142-155 mg/dL]) than those recommended with a 10-year ARR threshold of 2.3% or greater (mean risk, 9.3% [95% CI, 8.3%-10.2%]; mean LDL-C levels, 110 [103-118] mg/dL). Preventable atherosclerotic cardiovascular disease events in 10 and 30 years were highest using the 30-year benefit approach (296 000 at 10 years and 2.03 million at 30 years) and lowest based on 10-year risk (204 000 at 10 years and 1.18 million at 30 years). CONCLUSIONS AND RELEVANCE: A long-term benefit approach to statin eligibility identifies nearly 1 in 6 individuals as having a high degree of expected long-term benefit of statins, with a number needed to treat of less than 7. This approach identifies younger individuals with higher LDL-C levels who would not be currently recommended for treatment and may provide a more optimal approach for determining statin eligibility in primary prevention.

Duke Scholars

Author Michael J Pencina Biostatistics & Bioinformatics, Division of Biostatistics