Abstract
Introduction: The 2013 ACC/AHA and the 2012 European Society of Cardiology (ESC) guidelines recommend lipid-lowering treatment for primary prevention based on cardiovascular disease (CVD) risk. Randomized clinical trials for statin use in primary prevention, however, included participants with specific risk factor profiles. Hypothesis: For most individuals in the general population recommended for primary prevention of CVD with statins direct trial evidence is available. Evidence of benefit may be available for persons currently not recommended treatment. Methods: We used data from 8925 participants (57% women), aged 45-79, free of CVD from the population-based Rotterdam Study to compare treatment recommendations by the ACC/AHA and ESC guidelines, with eligibility for any of 10 major statin trials. Results: The ACC/AHA guidelines recommend statin use in 3196 (83.2%) men and 2611 (51.4%) women; the ESC guidelines in 1992 (51.8%) men and 1702 (33.4%) women (95.3% overlap with ACC/AHA). A total of 2243 (58.4%) men and 2438 (48.0%) women met the eligibility criteria for at the least one trial. Guideline recommendations and trial eligibility overlapped for 2245 (25.2%) participants (Figure). A total of 2480 (27.8%) participants would be considered for statin initiation solely by the ACC/AHA and/or ESC guidelines, while 1180 (13.2%) would have been eligible for at the least one trial and would not be recommended for statin therapy based on the guidelines (Figure). Correspondence of guideline recommendations with trial eligibility varied greatly by trial, with virtual complete alignment for trials done in individuals with diabetes, while for trials done in individuals with hypercholesterolemia alignment was poor. Conclusions: For the majority of persons recommended for lipid-lowering therapy in primary prevention, efficacy of statins has been established. Statins have been proven efficacious in many persons currently not recommended for treatment.
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