Statin use and outcome risks according to predicted CVD risk in Korea: A retrospective cohort study.

Background: The validity of cardiovascular disease (CVD) risk calculators in decision for statin therapy has not been fully evaluated at a population level. This study aimed to examine the net benefits of statins according to predicted CVD risk.

Methods And Findings: A cohort of 40 to 79-year-old Korean adults without CVD was generated from the National Health Information Database 2006-2017. Major CVD event rates and all-cause mortality in 58,265 users who initiated statins during 2007-2010 were compared with those in 58,265 nonusers matched on propensity scores, from January 1, 2012 through December 31, 2017. Additionally, simulation was performed for the population-based cohort of 659,759 adults. CVD risk was predicted using the 2018 revised Pooled Cohort Equations. In propensity score-matched cohort, the CVD hazard ratios (95% CIs) in occasional, intermittent, and regular statin users were 1.06 (0.93-1.20), 0.82 (0.70-0.97), and 0.57 (0.50-0.64), respectively. The corresponding mortality hazard ratios were 1.01 (0.92-1.10), 0.87 (0.78-0.98), and 0.71 (0.66-0.77), respectively. In stratified analyses, the relative risk reductions were similar, irrespective of age, sex, or predicted CVD risk. Accordingly, absolute risk reductions were greater in higher risk categories. In 6-year follow-up simulation cohorts, regular statin use could reduce 17 CVDs and 28 deaths in 1000 adults with a 10-year risk of ≥10.0% vs 10 CVDs and 14 deaths in 1000 with ≥2 major risk factors. However, in actual adults with a risk of ≥10%, statin use was insufficient and estimated to reduce 3 CVDs and 4 deaths in 1000. Limitations of this study include assessment of medication use based on the prescription data, lack of information on the intensity of statins, and limited generalizability to individuals with very old age or other ethnicity.

Conclusions: CVD risk calculators were valid in decision-making for primary prevention statin therapy. Proper risk assessment and regular statin use in patients at high predicted risk would reduce outcome risks much more than present in Asian populations.