Individualized Statin Benefit for Determining Statin Eligibility in the Primary Prevention of Cardiovascular Disease
Background—Current guidelines recommend statins in primary prevention of cardiovascular disease based on predicted cardiovascular risk without directly considering the expected benefits of statin therapy based on the available randomized trial (RCT) evidence.
Methods and Results—We included 2,134 participants representing 71.8 million American residents potentially eligible for statins in primary prevention from the National Health and Nutrition Examination Survey for years 2005-2010. We compared statin eligibilities using two separate approaches: a 10-year risk-based approach (≥7.5% 10-year risk) and an individualized benefit approach (i.e. based on predicted absolute risk reduction over 10 years [ARR10] ≥2.3% from RCT data). A risk-based approach led to the eligibility of 15.0 million (95% confidence interval 12.7-17.3 millions) Americans, whereas a benefit-based approach identified 24.6 (21.0-28.1) million. The corresponding numbers needed to treat over 10 years were 21 (range:9-44) and 25 (9-44). The benefit-based approach identified 9.5 million lower-risk (<7.5% 10-year risk) Americans not currently eligible for statin treatment, who had the same or greater expected benefit from statins (≥2.3% ARR10) as higher-risk individuals. This lower-risk/acceptable-benefit group includes younger individuals (mean age 55.2 years vs. 62.5 years; p<0.001 for benefit-based vs risk-based) with higher LDL-C (140 mg/dL vs.133 mg/dL; p=0.01). Statin treatment among this group would be expected to prevent an additional 266,508 cardiovascular events over 10 years.
Conclusions—An individualized statin benefit approach can identify lower-risk individuals who have equal or greater expected benefit from statins in primary prevention than higher-risk individuals. This may help develop guideline recommendations that better identify individuals who meaningfully benefit from statin therapy.
- risk reduction
- randomized trials
- primary prevention
- Received July 9, 2015.
- Revision received February 9, 2016.
- Accepted February 18, 2016.