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Arnett et al 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease

September 10, 2019 Circulation. 2019;140:e596–e646. DOI: 10.1161/CIR.0000000000000678 e614

CLINICAL STATEMENTS AND GUIDELINES group, the 10-year risk of “hard ASCVD” was 8.7%, and the risk of the expanded ASCVD endpoint that included coronary revascularization was 10%.S4.3-9 After 5.6 years, those assigned to rosuvastatin 10 mg per day showed significant absolute risk reduction in both co-primary endpoints, with an acceptable safety record. By comparison, after a median follow-up of 1.9 years, those assigned to a high-intensity statin dose of rosuvastatin in the JUPITER (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) RCT achieved greater LDL-C lowering and greater reductions in ASCVD outcomes.S4.3-7 This corroborates meta-analyses demonstrating that in those at risk, net benefit of LDL-C–lowering therapy is greater with greater reductions in LDL-C.S4.3-2,S4.3-10

2 If in the context of a risk discussion, maximal

ASCVD risk reduction is desired, it is reasonable to use a high-intensity statin to lower LDL-C by ≥50%. This provides increased benefit, especially when 10-year ASCVD risk is ≥20%. JUPITER enrolled men ≥50 years of age and women ≥60 years of age with high-sensitivity C-reactive protein values ≥2.0 mg/L and LDL-C <130 mg/dL. Participants randomly assigned to 20 mg per day of rosuvastatin achieved a median LDL-C reduction of 50% and a highly significant ASCVD risk reduction at 1.9 years.S4.3-7 Importantly, the magnitude of the percent LDL-C reduction achieved determined benefit.S4.3-29 The USPSTF systematic review of statin therapy in primary prevention showed a reduced risk of all-cause and cardiovascular mortality and ASCVD events and noted greater absolute benefits in those at greater baseline risk,S4.3-5 consistent with other high-quality systematic reviews and meta-analyses.S4.3-2,S4.3-8,S4.3-35 This underscores the need for aggressive and safe risk reduction in the highest-risk groups and the need for follow-up LDL-C testing to determine adherence and adequacy of effect of the statin prescribed.S4.3-1

3 Most patients 40 to 75 years of age with diabe-

tes are at intermediate or high risk (PCE ≥7.5% 10-year risk) of ASCVD events.S4.3-15,S4.3-16,S4.3-18 Three of 4 double-blinded primary-prevention RCTs of moderate statin therapy in large cohorts with diabetes in this age range showed significant reductions in ASCVD events.S4.3-11,S4.3-12,S4.3-14,S4.3-17 A meta-analysis of these trials found that moderateintensity statin therapy was associated with a risk reduction of 25%,S4.3-13 similar to people without diabetes and with no apparent difference in benefit between type 1 diabetes mellitus and T2DM. Therefore, moderate-intensity statin therapy is indicated for primary prevention in patients 40 to 75 years of age with diabetes. 4.	Patients with primary severe hypercholesterolemia (LDL-C ≥190 mg/dL [≥4.9 mmol/L]) have a high risk of ASCVDS4.3-23 and premature and recurrent coronary events. Although no randomized, placebo-controlled trials of statin therapy have been done exclusively in subjects with LDL-C ≥190 mg/ dL, a placebo-controlled primary-prevention study performed in men with a mean baseline LDL-C of 192 ± 17 mg/dL demonstrated a reduced incidence of MI and cardiovascular death in those receiving pravastatin 40 mg daily.S4.3-24 These findings were extended in a post hoc analysis of 2 560 exclusively primary-prevention subjects in that RCT and in a 20-year observational post-trial long-term follow-up study.S4.3-37 Because moderate- or high-intensity statins have been shown to reduce ASCVD risk and because high-intensity statins provide greater ASCVD risk reduction than do moderate-intensity statins or placebo,S4.3-2 maximally tolerated statin therapy should be administered to patients with LDL-C ≥190 mg/dL. Please refer to the 2018 cholesterol guidelineS4.3-1 for recommendations on the use of non-statin therapies in these patients. 5.	The occurrence of a first ASCVD event in patients 40 to 75 years of age with diabetes is associated with increased morbidity and mortality compared with those without diabetes, which places a particularly high premium on primary prevention in individuals with diabetes in that age range. Although trials using moderate-intensity statin therapy have demonstrated significant benefit in such individuals, the residual risk in the statin treatment groups in these trials remained high. (eg, 8.5% had major cardiovascular events in 3.8 years).S4.3-13 The benefit from statin therapy is related to both global risk and intensity of treatment,S4.3-2 and no RCTs of high-intensity statin therapy have been carried out in cohorts of patients exclusively with diabetes. On the basis of these considerations and the fact that patients with diabetes have a higher trajectory of lifetime risk than do those without diabetes, high-intensity statin therapy is preferred in patients with diabetes as they develop risk modifiers (Table 5). 6.	Knowledge of risk-enhancing factors (Table 3 in Section 2.2.) is useful for all individuals but particularly for those at intermediate risk (ASCVD risk of 7.5% to ≤20%). For example, in an RCT,S4.3-38 a family history of premature ASCVD identified women ≥60 years of age with elevated hsCRP and without ASCVD who benefitted from highintensity statin therapy. Those with primary LDL-C elevations of ≥160 mg/dL (≥4.1 mmol/L) have

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