ACC-AHA 2018 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol
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| 頁 | クラス | レベル | 推奨文 | 表 |
|---|---|---|---|---|
| p.7 | I | B-NR | Health Initiative, a contemporary multiethnic cohort of postmenopausal women, appeared to indicate that these pooled cohort equations overestimated ASCVD risk. However, when event surveillance was improved by data from Centers for Medicare & Medicaid Services, the authors found that the equations discriminated risk well.S2.1.3-4 Several other factors associate with ASCVD, and in the present document these are called risk-enhancing factors. Projections of future risk derived from major risk factors and risk-enhancing factors can be used to adjust the intensity of LDL-lowering therapy. | Table 2. Applying Class of Recommendation and Level of Evidence to Clinical Strategies, Interventions, Treatments, or Diagnostic Testing in Patient Care* (Updated August 2015) |
| p.8 | IIa | C-LD | Downloaded from http://ahajournals.org by on October 7, 2026 | |
| p.10 | I | A | Percent LDL-C reductions with the primary statin medications used in clinical practice (atorvastatin, rosuvastatin, simvastatin) were estimated using the median reduction in LDL-C from the VOYAGER database.S3.2.1-2 Reductions in LDL-C for other statin medications (fluvastatin, lovastatin, pitavastatin, pravastatin) were identified according to FDA-approved product labeling in adults with hyperlipidemia, primary hypercholesterolemia, and mixed dyslipidemia.S3.2.1-4 Boldface type indicates specific statins and doses that were evaluated in RCTs,S3.2.1-3,S3.2.1-5–S3.2.1-16 and the Cholesterol Treatment Trialists’ 2010 meta-analysis.S3.2.1-17 All these RCTs demonstrated a reduction in major cardiovascular events. Downloaded from http://ahajournals.org by on October 7, 2026 *Percent reductions are estimates from data across large populations. Individual responses to statin therapy varied in the RCTs and should be expected to vary in clinical practice.S3.2.1-2 †LDL-C lowering that should occur with the dosage listed below each intensity. ‡Evidence from 1 RCT only: down titration if unable to tolerate atorvastatin 80 mg in the IDEAL (Incremental Decrease through Aggressive Lipid Lowering) study.S3.2.1-3 §Although simvastatin 80 mg was evaluated in RCTs, initiation of simvastatin 80 mg or titration to 80 mg is not recommended by the FDA because of the increased risk of myopathy, including rhabdomyolysis. | |
| p.10 | I | A | BID indicates twice daily; FDA, US Food and Drug Administration; LDL-C, low-density lipoprotein cholesterol; RCT, randomized controlled trial; VOYAGER, an indiVidual patient data meta-analysis Of statin therapY in At risk Groups: Effects of Rosuvastatin, atorvastatin and simvastatin; and XL, extended release. | |
| p.10 | I | B-NR | evaluated.S3.2.1-19 Statin-associated side effects are discussed in Section 5. Common medications that may potentially interact with statins are listed in Table S5 in the Web Supplement. More information on statin drug–drug interactions can be obtained from the ACC LDL-C Manager.S3.2.1-20 3.2.2 Nonstatin Therapies | |
| p.10 | IIa | B-R | Ezetimibe is the most commonly used nonstatin agent. It lowers LDL-C levels by 13% to 20% and has a low incidence of side effects.S3.2.2-1,S3.2.2-2 Bile acid sequestrants reduce LDL-C levels by 15% to 30% depending on the dose. Bile acid sequestrants are not absorbed and do not cause systemic side effects, but they are associated with gastrointestinal complaints (eg, constipation) and can cause severe hypertriglyceridemia when fasting triglycerides are ≥300 mg/dL (≥3.4 mmol/L). PCSK9 inhibitors are powerful LDL-lowering drugs. They generally are well tolerated, but long-term safety remains to be | |
| p.11 | IIa | B-R | CLINICAL STATEMENTS AND GUIDELINES | |
| p.11 | IIb | B-R | Downloaded from http://ahajournals.org by on October 7, 2026 | |
| p.14 | IIa | B-R | 8. This recommendation is based on the observation that the age reported in clinical trials of statin therapy in patients with ASCVD represents the patient’s age at study entry. Therefore, it is reasonable to consider continuation of high-intensity therapy in patients >75 years of age with ASCVD if they are tolerating the statin and have a low risk of competing morbidities.S4.1-23,S4.1-26,S4.1-31 RCTsS4.1-32,S4.1-33,S4.1-35,S4.1-36 have not shown an adverse effect of statin therapy on cognition. 9. Although moderate-intensity statin therapy reduces ASCVD events, it is less effective than high-intensity therapy.S4.1-3 This difference presumably is due to differences in LDL-C–lowering potency. Hence, if ezetimibe were to be added to a moderate-intensity therapy to compensate for the difference in LDL-C–lowering ability between moderate- and high-intensity statins, the combination of moderate-intensity statin and ezetimibe could potentially produce a level of ASCVD risk reduction similar to that produced by high-intensity therapy alone. This hypothesis is supported by the finding that ezetimibe enhanced risk reduction when combined with moderate-intensity therapy in patients after ACS.S4.1-15 Thus, it may be reasonable to add ezetimibe to moderate-intensity therapy in patients with ASCVD for whom high-intensity therapy is indicated but cannot be used, provided their LDL-C level remains ≥70 mg/ dL (≥1.8 mmol/L) on moderate-intensity therapy. The same reasoning holds for any patient whose LDL-C level remains ≥70 mg/dL (≥1.8 mmol/L) on maximally tolerated statin therapy 10. The CORONA (Controlled Rosuvastatin Multi national Trial in Heart Failure) trialS4.1-38 (patients with ischemic HF and left ventricular ejection fraction <40%) and GISSI HF trial (Effects of n-3 PUFA and Rosuvastatin on Mortality-Morbidity of Patients With Symptomatic CHF)S4.1-39 (patients with ischemic and nonischemic HF, 9.8% with left ventricular ejection fraction >40%) evaluated the efficacy and safety of initiation of 10 mg of rosuvastatin daily compared with placebo. Neither trial met its primary outcome. Rosuvastatin reduced the risk of total hospitalizations, hospitalizations for a cardiovascular cause, and hospitalizations for worsening HF in CORONA. A subsequent analysis accounting for repeat HF hospitalizations showed significant reduction in HF hospitalizations.S4.1-46 Downloaded from http://ahajournals.org by on October 7, 2026 | |
| p.16 | IIb | C-LD | 2 404 patients with heterozygous FH (molecularly defined) taking contemporary statin with or without ezetimibe treatment regimens identified age >30 years, male sex, history of ASCVD, high blood pressure, increased waist circumference, active smoking, Lp(a) ≥50 mg/dL, and LDL-C levels ≥100 mg/dL (≥2.6 mmol/L) as independent predictors of incident ASCVD over a 5.5-year follow-up period.S4.2-14 Because other medical interventions that lower LDL-C levels via increased expression of LDL receptors reduce ASCVD risk,S4.2-9 the use of PCSK9 inhibitors in selected maximally treated patients with heterozygous FH with persistently elevated LDL-C levels may be considered after a clinician–patient discussion of the net benefits versus the cost of such therapy. 5. Regardless of whether a patient with LDL-C levels ≥190 mg/dL (≥4.9 mmol/L) is found to have a genetic mutation associated with FH, those with very high LDL-C values are most likely to achieve the greatest benefit from evidence-based LDL-C– lowering therapy. Consequently, patients who have a baseline LDL-C level ≥220 mg/dL (≥5.7 mmol/L) and an on-treatment LDL-C level ≥130 mg/dL (≥3.4 mmol/L) despite maximally tolerated statin and ezetimibe therapy may be considered for treatment with a PCSK9 inhibitor after a clinician–patient discussion of the net benefits versus the costs of such therapy. 6. The cost-effectiveness of PCSK9 inhibitors for primary prevention among patients with LDL-C levels >190 mg/dL (≥4.9 mmol/L), or with FH, has not been evaluated extensively, and their clinical effectiveness in reducing ASCVD events in these patients has also not been established. The 2 published cost-effectiveness models for primary prevention (see Online Data Supplements 44 and 45 and Section 7.) report very different results, with one suggesting an incremental costeffectiveness ratio of $503 000 per QALY added, and the other reporting $75 000 per QALY added. Because of the lack of consistent evidence, the use of PCSK9 inhibitors has uncertain value for the primary prevention of ASCVD in patients with severe hypercholesterolemia. | |
| p.16 | IIb | C-LD | Downloaded from http://ahajournals.org by on October 7, 2026 | |
| p.21 | I | A | mg/dL (particularly when accompanied by persistently elevated triglycerides), and elevated Lp(a) denote high lifetime risk for ASCVD and favor initiation of statin therapy. The presence of family history of ASCVD, premature menopause, and patients of South Asian race appear to convey a higher baseline risk and are stronger candidates for statin therapy. Conditions associated with systemic inflammation (chronic inflammatory disorders, metabolic syndrome, chronic renal disease, and elevated hsCRP) appear to predispose to atherothrombotic events, which reasonably justifies statin therapy in intermediate-risk patients. CLINICAL STATEMENTS AND GUIDELINES | |
| p.21 | I | B-NR | Downloaded from http://ahajournals.org by on October 7, 2026 | |
| p.21 | I | B-NR | 4.4.1.4. Coronary Artery Calcium Substantial advances in estimation of risk with CAC scoring have been made in the past 5 years. One purpose of CAC scoring is to reclassify risk identification of patients who will potentially benefit from statin therapy. This is especially useful when the clinician and patient are uncertain whether to start a statin. Indeed, the most important recent observation has been the finding that a CAC score of zero indicates a low ASCVD risk for the subsequent 10 years.S4.4.1.4-1–S4.4.1.4-8 Thus, measurement of CAC potentially allows a clinician to withhold statin therapy in patients showing zero CAC. There are exceptions. For example, CAC scores of zero in persistent cigarette smokers, patients with diabetes mellitus, those with a strong family history of ASCVD, and possibly chronic inflammatory conditions such as HIV, may still be associated with substantial 10-year risk.S4.4.1.4-9–S4.4.1.4-12 Nevertheless, a sizable portion of middle-aged and older patients have zero CAC, which may allow withholding of statin therapy in those intermediate risk patients who would otherwise have a high enough risk according to the PCE to receive statin therapy (Figure 2). Most patients with CAC scores ≥100 Agatston units have a 10-year risk of ASCVD ≥7.5%, a widely accepted threshold for initiation of statin therapy.S4.4.1.4-13 With increasing age, 10-year risk accompanying CAC scores of 1 to 99 rises, usually crossing the 7.5% threshold in later middle age.S4.4.1.4-13 When the CAC score is zero, some investigators favor remeasurement of CAC after 5 to 10 years.S4.4.1.4-14–S4.4.1.4-16 CAC measurement has no utility in patients already treated with statins. Statins are associated with slower progression of overall coronary atherosclerosis volume and reduction of high-risk plaque features, yet statins increase the CAC score.S4.4.1.4-17 A prospective randomized study of CAC scoring showed improved risk factor modification without an increase in downstream medical testing or cost.S4.4.1.4-18 In MESA (Multi-Ethnic Study of Atherosclerosis), CAC scanning delivered 0.74 to l.27 mSv of radiation, which is similar to the dose of a clinical mammogram.S4.4.1.4-19 CAC scans should be ordered by | |
| p.25 | I | A | benefit cannot be discounted.S4.4.2-53 The same holds for CAC score of zero and a high 10 year risk (eg, ≥20%).S4.4.2-34 For those with CAC scores of 1 to 99 Agatston units, 10-year ASCVD event rates are 3.8%, 6.5%, and 8.3% for age groups 45 to 54, 55 to 64, and 65 to 74 years,S4.4.2-23 suggesting that CAC scores in this range favor statin initiation only in adults >55 years of age and indicating that risk reclassification is modest for individuals with CAC scores of 1 to 99. Therefore, for patients with CAC scores of 1 to 99, it is reasonable to repeat the risk discussion. If these patients remain untreated, repeat CAC measurement in 5 to 10 years may have some value in reassessing for CAC progression, but data are limited.S4.4.2-12,S4.4.2-13 A systematic review and meta-analysis suggests that knowledge that a patient’s CAC score is greater than zero is beneficial.S4.4.2-38 Selected examples of candidates for CAC scoring who might benefit from knowing that their CAC score is zero are listed in Table 8. There is an increased likelihood that lifestyle therapies and drug therapy will be started or continued with significant, albeit modest, changes in risk factor levels and predicted risk levels. 8. Clinicians may need to address reducing ASCVD risk in higher-risk primary-prevention patients who either do not wish to take a statin or cannot tolerate the recommended intensity of statin therapy. In such patients, it may be reasonable to use LDL-C–lowering drugs that have been proven safe and effective in RCTs, either as monotherapy or combined with a statin.S4.4.2-9 One alternative is a cholesterol absorption inhibitor. An RCT in adults ≥40 years of age with advanced CKD and without known CHD at baseline found that the addition of ezetimibe to a moderate-intensity statin lowered LDL-C 43 mg/dL (1.1 mmol/L) at 1 year.S4.4.2-54 After a median 4.9 years, ezetimibe and simvastatin 40 mg per day resulted in a 17% proportional reduction in major atherosclerotic events compared with placebo.S4.4.2-2 Another alternative is a nonsystemic bile acid sequestrant. Bile acid sequestrants used as monotherapy reduced CHD endpoints in a large primary-prevention trial.S4.4.2-55 Bile acid sequestrants can bind other drugs, so other medications must be avoided for 1 hour before and at least 3 to 4 hours after administration. Adding psyllium can minimize constipation and can reduce the bile acid sequestrant dose.S4.4.2-56 These therapies should be considered in the context of a risk discussion that reviews potential for benefit along with tolerability and safety issues. 9. Benefit from statin therapy is seen in lower-risk individuals.S4.4.2-24 Consideration of enhancing Downloaded from http://ahajournals.org by on October 7, 2026 | |
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| p.30 | IIa | B-NR | for Cardiovascular Health and Risk Reduction in Children and Adolescents,S4.4.4.3-41 universal pediatric lipid screening has been advised in recent pediatric guidelines,S4.4.4.3-42 specifically focusing on ages 9 to 11 years and then ages 17 to 21 years because TC and LDL-C levels decrease 10% to 20% during puberty. However, the long-term benefits and harms of universal screening have not been tested in RCTs. Observational studies demonstrate that universal screening can identify severe lipid abnormalities,S4.4.4.3-18,S4.4.4.3-19 and in scant data universal screening is associated with changes in family lifestyle behaviors. Nonfasting lipid parameters are similar to fasting ones, and screening with a nonfasting non–HDL-C is a reasonable approach to population screening in childhood. Although research on this topic continues, universal screening may be reasonable given the substantial benefits of identifying severe hypercholesterolemia (see Section 4.2., “Severe Hypercholesterolemia”), including FH, and possible benefits of lifestyle counseling for multifactorial dyslipidemias.S4.4.4.3-3, S4.4.4.3-5–S4.4.4.3-9,S4.4.4.3-25,S4.4.4.3-26,S4.4.4.3-38–S4.4.4.3-40 | |
| p.31 | I | B-NR | of specificity of the term Hispanic/Latino. Race/ethnicity and country of origin, together with socioeconomic status and acculturation level, should be discussed and may explain ASCVD risk factor burden more precisely than the generic term Hispanic/Latino.S4.5.1-6–S4.5.1-11 In addition, those who identify as Native American/Alaskan natives have high rates of risk factors for ASCVD compared to non-Hispanic whites. In many ways, the increase in metabolic risk factors and propensity for diabetes mellitus resembles the risk profiles of those who identify as Mexican-Americans.S4.5.1-12 Table 10 reviews these and other racial/ethnic issues that may be useful in clinical management. | |
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| p.35 | IIa | B-NR | CLINICAL STATEMENTS AND GUIDELINES | |
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| p.36 | I | C-LD | triglycerides should preferentially be measured in the fasting state. 3. Patients with RA who are untreated or who have high disease activity generally have decreased levels of TC, triglycerides, HDL-C, and LDL-C.S4.5.5-21 These lower lipid levels are likely attributable in part to increased inflammation and may lead to functional proatherogenic changes, such as decreased cholesterol efflux capacity of HDL-C.S4.5.5-22 Treatment with anti-inflammatory medications, such as tumor necrosis factor alpha inhibitors or methotrexate, is associated with an increase in and normalization of lipid levels and a reduction in the ratio of TC to HDL-C.S4.5.5-23 Thus, to produce a more accurate risk estimate, ASCVD risk estimation should be repeated when the patient has a stable and low disease activity with normalization of their lipid levels; lower lipid levels measured during high disease activity may lead to a significant underestimation of ASCVD risk for patients with RA. | |
| p.36 | IIa | B-R | 5. STATIN SAFETY AND STATIN- ASSOCIATED SIDE EFFECTS Recommendations for Statin Safety and Statin-Associated Side Effects Referenced studies that support recommendations are summarized in Online Data Supplements 40 and 41. COR LOE Recommendations 1. A clinician–patient risk discussion is recommended before initiation of statin therapy to review net clinical benefit, weighing the potential for ASCVD risk reduction against the potential for statin-associated side effects, statin–drug interactions, and safety, while emphasizing that side effects can be addressed successfully.S5-1–S5-7 | |
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