OBJECTIVES : To determine baseline 10-year CVD risk threshold above which net benefit of low- or moderate- dose statins outweigh net harms for a primary prevention population

METHODS : We performed a quantitative benefit-harm balance modeling based on an exponential model for estimating expected events for the benefit and harm outcomes over a 10-year horizon, which also took into account baseline risks of outcomes, patient preference weights, and competing risk for death as well as statistical uncertainty to yield the benefit-harm balance index of statins.

RESULTS : Younger men had net benefit at a lower 10-year risk for CVD than older men (14% for ages 40 to 44 years vs. 21% for ages 70 to 75 years). In women, the risk required for net benefit was higher (17% for ages 40 to 44 years vs. 22% for ages 70 to 75 years).

CONCLUSIONS : Our findings show that statins provide net benefit if the baseline CVD risk is well above 14%. This differed by age and sex due to differences in baseline risks for benefit and harm outcomes. However, the benefit-harm balance depends much on patient preferences for benefit and harm outcomes and, thus, guidelines should emphasize on making population-level recommendations and support individual-based decision-making taking to account individual risks, modifiability of risk factors and, probably most importantly, individual preferences.