11 million American Adults Eligible for Statin Therapy for ASCVD

Based on analysis of a nationally representative sample of US adults, 11.8 million are eligible for statin therapy with a 10-year atherosclerotic cardiovascular disease (ASCVD) risk ≥5% with the Predicting Risk of Cardiovascular Disease Events (PREVENT) equations.1

Although the 2018 Cholesterol Guideline defines increased 10-year ASCVD risk as ≥7.5% based on pooled cohort equations (PCEs), recent data have suggested that PCEs overestimate risk substantially. To that end, the American Heart Association established the PREVENT equations, which provide clinicians with risk estimates for total cardiovascular disease, as well as ASCVD and heart failure. The equations therefore represent a single multivariable risk equation for an easily implemented and simplified framework.2,3

“We examined population-level implications for statin eligibility according to different 10-year ASCVD risk estimates based on PREVENT and compared with guideline-defined thresholds based on PCEs,” wrote Sadiya Khan, MD, MSc, division of cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, and colleagues.1

Investigators collected data from the National Health and Nutrition Examination Surveys, conducted from 2011-2020. They included nonpregnant individuals between the ages of 40-75 with available data for the PREVENT-ASCVD equations. Patients already taking statins and those eligible for statins due to comorbidities, such as ASCVD and diabetes, or cholesterol levels, such as a low-density lipoprotein C (LDL-C) count ≥190 mg/dL were excluded.1

The team then calculated 10-year ASCVD risk for the remaining participants utilizing PREVENT and PCEs. 3 PREVENT-based ranges – 3%-3.9%, 4%-4.9%, and ≥5% - were evaluated based on estimated clinical benefit from statin trials. These were compared with PCE-based thresholds of borderline, intermediate, or high risk (5%-7.4% and ≥7.5%). Subgroup analyses were then conducted by age. Investigators calculated 10-year absolute risk reduction (ARR) assuming a 40% reduction in LDL-C with statins.1

A total of 5242 participants, representing 133.6 million adults, 28.1 million were already taking statins, and 15.2 million were eligible for statins for secondary prevention or high-risk primary prevention due to diabetes or LDL-C ≥190 mg/dL. The remaining 70.2 million adults were divided into the 3 PREVENT-based 10-year ASCVD risk categories, with 7.9 million at 3-3.9%, 5.3 million at 4-4.9%, and 11.8 million at ≥5%.1

Investigators noted that this translates to a mean 10-year ARR of 1.1%, 1.4%, and 2.2% for risk categories 3-3.9%, 4-4.9%, and ≥5%, respectively, if statins were recommended. Another 17 million adults were identified as having a 10-year ASCVD risk of≥7.5% with PCEs, making them eligible for statins, and 8.6 million may be considered for statins with a 10-year ASCVD risk of 5-7.4% with PCEs, with a mean 10-year ARR of 1.9% and 1.1%, respectively.1

Khan and colleagues noted that the use of a PREVENT-based threshold of 4% or greater would result in an almost equivalent number of adults eligible for statins as the current guideline-based threshold of PCE 7.5% or greater. Additionally, patients with 10-year ASCVD risk of 3-3.9% and 4-4.9% had a 10-year ARR <2%, which suggests more marginal clinical benefits at these thresholds.1

“However, given the safety and cost-effectiveness of statins, expanding eligibility may have the most favorable impact on ASCVD prevention,” Khan and colleagues wrote. “Ultimately, risk prediction is a first step in shared decision-making that incorporates risk thresholds, net benefit, and patient preferences.”1

References

1. Khan SS, Huang X, Ndumele CE, et al. Statin Eligibility According to Atherosclerotic Cardiovascular Disease Risk in the US. JAMA Cardiol. Published online August 20, 2025. doi:10.1001/jamacardio.2025.27

2. Khan SS, Matsushita K, Sang Y, et al. Development and Validation of the American Heart Association's PREVENT Equations. Circulation. 2024;149(6):430-449. doi:10.1161/CIRCULATIONAHA.123.067626

3. Khan SS, Coresh J, Pencina MJ, et al. Novel prediction equations for absolute risk assessment of total cardiovascular disease incorporating cardiovascular-kidney-metabolic health: A scientific statement from the American Heart Association. Circulation. 2023;148(24):1982-2004. doi:10.1161/cir.0000000000001191