Finding the Balance Between Benefits and Harms When Using Statins for Primary Prevention of Cardiovascular Disease: A Modeling Study

Abstract

Background Many guidelines use expected risk for cardiovascular disease (CVD) during the next 10 years as a basis for recommendations on use of statins for primary prevention of CVD. However, how harms were considered and weighed against benefits is often unclear. Objective To identify the expected risk above which statins provide net benefit. Design Quantitative benefit-harm balance modeling study. Data sources Network meta-analysis of primary prevention trials, a preference survey, and selected observational studies. Target population Persons aged 40 to 75 years with no history of CVD. Time horizon 10 years. Perspective Clinicians and guideline developers. Intervention Low- or moderate-dose statin versus no statin. Outcome measures The 10-year risk for CVD at which statins provide at least a 60% probability of net benefit, with baseline risk, frequencies of and preferences for statin benefits and harms, and competing risk for non-CVD death taken into account. Results of base-case analysis 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). Atorvastatin and rosuvastatin provided net benefit at lower 10-year risks than simvastatin and pravastatin. Results of sensitivity analysis Most alternative assumptions led to similar findings. Limitation Age-specific data for some harms…