ACC AHA guideline on the primary prevention

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Template:Hypercholesterolemia Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

2013 ACC AHA guideline on the treatment of blood cholesterol primary prevention

Primary Prevention in Adult ≥21 Years With LDL–C ≥190 mg/dL

Class I
"1. Individuals with LDL–C ≥190 mg/dL or triglycerides ≥500 mg/dL should be evaluated for secondary causes of hyperlipidemia.(Level of Evidence: B)"
"2. Adults ≥21 years of age with primary LDL–C ≥190 mg/dL should be treated with statin therapy (10-year ASCVD risk estimation is not required):
  • Use high-intensity statin therapy unless contraindicated.
  • For individuals unable to tolerate high-intensity statin therapy, use the maximum tolerated statin intensity.(Level of Evidence: B)"
Class IIa
"1. For individuals ≥21 years of age with an untreated primary LDL–C ≥190 mg/dL, it is reasonable to intensify statin therapy to achieve at least a 50% LDL–C reduction.(Level of Evidence: B)"
Class IIb
"1. For individuals ≥21 years of age with an untreated primary LDL–C ≥190 mg/dL, after the maximum intensity of statin therapy has been achieved, addition of a nonstatin drug may be considered to further lower LDL–C. Evaluate the potential for ASCVD risk reduction benefits, adverse effects, drug-drug interactions, and consider patient preferences.(Level of Evidence: C)"
Secondary Cause Elevated LDL–C Elevated Triglycerides
Diet Saturated or trans fats, weight gain, anorexia Weight gain, very low-fat diets, high intake of refined carbohydrates, excessive alcohol intake
Drugs Diuretics, cyclosporine, Glucocorticoid, amiodarone Oral estrogens, glucocorticoids, bile acid sequestrants, protease inhibitors, retinoic acid, anabolic steroids, sirolimus, raloxifene, tamoxifen, beta blockers (not carvedilol), thiazides
Diseases Biliary obstruction, nephrotic syndrome Nephrotic syndrome, chronic renal failure, lipodystrophies
Disorders and altered states of metabolism Hypothyroidism, obesity, pregnancy* Diabetes (poorly controlled), hypothyroidism, obesity; pregnancy*

* Cholesterol and triglycerides rise progressively throughout pregnancy (81); treatment with statins, niacin, and ezetimibe are contraindicated during pregnancy and lactation.

Primary Prevention in Individuals With Diabetes

Class I
"1. Moderate-intensity statin therapy should be initiated or continued for adults 40 to 75 years of age with diabetes mellitus.(Level of Evidence: A)"
Class IIa
"1. High-intensity statin therapy is reasonable for adults 40 to 75 years of age with diabetes mellitus with a ≥7.5% estimated 10-year ASCVD risk unless contraindicated.(Level of Evidence: B)"
"2. In adults with diabetes mellitus, who are <40 or >75 years of age, it is reasonable to evaluate the potential for ASCVD benefits and for adverse effects, for drug-drug interactions, and to consider patient preferences when deciding to initiate, continue, or intensify statin therapy.(Level of Evidence: C)"

Primary Prevention in Individuals Without Diabetes and With LDL–C 70 to 189 mg/dL

Class I
"1. The Pooled Cohort Equations should be used to estimate 10-year ASCVD risk for individuals with LDL–C 70 to 189 mg/dL without clinical ASCVD* to guide initiation of statin therapy for the primary prevention of ASCVD.(Level of Evidence: B)"
"2. Adults 40 to 75 years of age with LDL–C 70 to 189 mg/dL, without clinical ASCVD or diabetes and an estimated 10-year ASCV risk ≥7.5% should be treated with moderate- to high-intensity statin therapy.(Level of Evidence: A)"
Class IIa
"1. It is reasonable to offer treatment with a moderate-intensity statin to adults 40 to 75 years of age, with LDL–C 70 to 189 mg/dL, without clinical ASCVD* or diabetes and an estimated 10-year ASCVD risk of 5% to <7.5%.(Level of Evidence: B)"
"2. Before initiating statin therapy for the primary prevention of ASCVD in adults with LDL–C 70 to 189 mg/dL without clinical ASCVD or diabetes it is reasonable for clinicians and patients to engage in a discussion which considers the potential for ASCVD risk reduction benefits and for adverse effects, for drug-drug interactions, and patient preferences for treatment.(Level of Evidence: C)"
Class IIb
"1. In adults with LDL–C <190 mg/dL who are not otherwise identified in a statin benefit group, or for whom after quantitative risk assessment a risk based treatment decision is uncertain, additional factors may be considered to inform treatment decision making. In these individuals, statin therapy for primary prevention may be considered after evaluating the potential for ASCVD risk reduction benefits, adverse effects, drug-drug interactions, and discussion of patient preferences.(Level of Evidence: C)"

Initiating and Management of Statin Therapy in Individuals Without Clinical ASCVD

ACCAHA cholesterol treatment No ASCVD.jpeg

Clinical ASCVD is defined as acute coronary syndromes or history of MI, stable or unstable angina, coronary revascularization, stroke, or TIA presumed to be of atherosclerotic origin, and peripheral arterial disease or revascularization.

Risk Assessment in Primary Prevention

Rationale for the Expert Panel Approach to Primary Prevention Guidelines[1]
1. Cholesterol-lowering medications, particularly statins, are efficacious and effective for reducing risk for initial cardiovascular events.
2. Statins are associated with similar relative-risk reductions for cardiovascular events across the majority of primary-prevention patient groups studied.*
3. The extent of relative-risk reductions for ASCVD is proportional to the degree of LDL–C lowering observed on statin therapy. Therefore, more intensive statin therapy could reduce risk more than moderate- or lower-intensity statin therapy.
4. According to consistent findings, the absolute benefit in ASCVD risk reduction is proportional to the baseline risk of the patient group or individual, and to the intensity of statin therapy.
5. Patients or groups at higher baseline absolute risk, therefore, will derive greater absolute benefit from initiation of statin therapy over a period of 5 to 10 years.
6. The absolute risk for adverse outcomes, including a small excess in cases of newly diagnosed diabetes, also appears to be proportional to the intensity of statin therapy. However, the adverse outcome of incident (or earlier diagnosis of) diabetes must be weighed in the context of the potentially fatal or debilitating occurrence of MI or stroke that could be prevented by statin therapy.
7. The Expert Panel emphasizes that the occurrence of a major CVD event (MI or stroke) represents a much greater harm to health status than does an increase in blood glucose leading to a diagnosis of diabetes. The net absolute benefit of statin therapy may be considered as a comparison of the absolute risk reduction for CVD compared with the absolute excess risks including that for diabetes. Benefit also could be understood as a comparison of the number of statin-treated patients that would result in the prevention of 1 case of major ASCVD (NNT) with the number of statin-treated patients that would result in 1 excess case of diabetes (NNH).
8. Because the absolute benefit in terms of CVD risk reduction depends on the baseline absolute risk for CVD, the absolute benefit from initiation of statin therapy is lower and would approach the risk for adverse effects in patients with lower baseline levels of predicted CVD risk.
9. Available RCT evidence indicates a clear net absolute benefit of initiation of moderate-to-intensive statin therapy at a baseline estimated 10-year ASCVD risk of ≥7.5%.
10. Available RCT evidence indicates that when baseline ASCVD risk is 5.0% to <7.5%, there is still net absolute benefit with moderate-intensity statin therapy. However, the tradeoffs between the ASCVD risk reduction benefit and adverse effects are less clear. Thus, a risk-benefit discussion is even more important for individuals with this range of ASCVD risk. The net benefit of high-intensity statin therapy appears to be marginal in such individuals.
Conclusion
On the basis of the above tenets and its review of the evidence, this guideline recommends initiation of moderate or intensive statin therapy for patients who are eligible for primary CVD prevention and have a predicted 10-year “hard” ASCVD risk of ≥7.5%. This guideline recommends that initiation of moderate-intensity statin therapy be considered for patients with predicted 10-year “hard” ASCVD risk of 5.0% to <7.5% or intensive statin therapy for patients who are eligible for primary CVD prevention and have a predicted 10-year “hard” ASCVD risk of ≥7.5%. This guideline recommends that initiation of moderate-intensity statin therapy be considered for patients with predicted 10-year “hard” ASCVD risk of 5.0% to <7.5%.

References


Cardiology


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