|Recommendations||NHLBI Grade||NHLBI Evidence Statements||ACC/AHA COR||ACC/AHA LOE|
|N (No recommendation)||1–4||—||—|
|E (Expert Opinion)||—||IIa||B (16,20–43)|
|Primary Prevention in Individuals ≥21 Years of Age With LDL-C ≥190 mg/dL|
|B (Moderate)||75||I‡||B (44,45)|
|E (Expert Opinion)||—||IIa||B (20,46–50)|
|E (Expert Opinion)||—||IIb||C (51)|
|Primary Prevention in Individuals With Diabetes and LDL-C 70–189 mg/dL|
|E (Expert Opinion)||—||IIa||B (49,52)|
|E (Expert Opinion)||—||IIa||C (53–62)|
|Primary Prevention in Individuals Without Diabetes and With LDL-C 70–189 mg/dL|
|E (Expert Opinion)||—||I||B (11)|
|E (Expert Opinion)||—||IIa||C (63)|
|E (Expert Opinion)||—||IIb||C (11,13)|
|Heart Failure and Hemodialysis|
|N (No Recommendation)||71,72||—||—|
ABI indicates ankle-brachial index; ACC, American College of Cardiology; AHA, American Heart Association; ASCVD, atherosclerotic cardiovascular disease; CAC, coronary artery calcium; COR, Class of Recommendation; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; LOE, Level of Evidence; NHLBI, National Heart, Lung, and Blood Institute; NYHA, New York Heart Association; RCTs, randomized controlled trials; TIA, transient ischemic attack; and —, not applicable.
↵∗ Clinical ASCVD includes acute coronary syndromes, history of MI, stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, or peripheral arterial disease presumed to be of atherosclerotic origin.
↵† Contraindications, warnings, and precautions are defined for each statin according to the manufacturer’s prescribing information (64–70).
↵‡ Individuals with secondary causes of hyperlipidemia were excluded from RCTs reviewed. A triglyceride level ≥500 mg/dL was an exclusion criterion for almost all RCTs. Therefore, ruling out secondary causes is necessary to avoid inappropriate statin therapy.
↵§ No RCTs included only individuals with LDL-C ≥190 mg/dL. However, many trials did include individuals with LDL-C ≥190 mg/dL, and all of these trials consistently demonstrated a reduction in ASCVD events. In addition, the Cholesterol Treatment Trialists meta-analyses have shown that each 39-mg/dL reduction in LDL-C with statin therapy reduced ASCVD events by 22%, and the relative reductions in ASCVD events were consistent across the range of LDL-C levels. Therefore, individuals with primary LDL-C ≥190 mg/dL should be treated with statin therapy.
↵‖ Estimated 10-year or “hard” ASCVD risk includes first occurrence of nonfatal MI, coronary heart disease death, and nonfatal and fatal stroke as used by the Risk Assessment Work Group in developing the Pooled Cohort Equations.
↵¶ These factors may include primary LDL-C ≥160 mg/dL or other evidence of genetic hyperlipidemias; family history of premature ASCVD with onset <55 years of age in a first-degree male relative or <65 years of age in a first-degree female relative; high-sensitivity C-reactive protein ≥2 mg/L; CAC score ≥300 Agatston units or ≥75th percentile for age, sex, and ethnicity (for additional information, see http://www.mesa-nhlbi.org/CACReference.aspx); ABI <0.9; or lifetime risk of ASCVD. Additional factors that might aid in individual risk assessment could be identified in the future.