Paper
Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Disease Risk in Adults: Synopsis of the 2013 American College of Cardiology/American Heart Association Cholesterol Guideline
Published Mar 4, 2014 · N. Stone, J. Robinson, A. Lichtenstein
Annals of Internal Medicine
174
Citations
9
Influential Citations
Abstract
Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death, decreased quality of life, and medical costs in the United States. Nearly 1 in 3 Americans die of heart disease and stroke (1). Most ASCVD is preventable through a healthy lifestyle and effective treatment of cholesterol and blood pressure. The 2013 Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults from the American College of Cardiology and American Heart Association (ACC/AHA) provides an evidence-based approach to reducing ASCVD risk (2). Guideline Development Process In 2008, the National Heart, Lung, and Blood Institute (NHLBI) convened the Adult Treatment Panel (ATP) IV to update the 2001 ATP-III cholesterol guidelines using a rigorous systematic process to identify and review randomized, controlled trials (RCTs) with cardiovascular outcomes and meta-analyses of these RCTs. The panel comprised experts and clinicians from the fields of cardiology, epidemiology, primary care, and endocrinology (2) and received support from the Lifestyle Management and Risk Assessment Work Groups (3, 4). Systematic evidence reviews conducted according to principles recommended by the Institute of Medicine (5) were performed to answer 3 questions relevant to clinical care. Two questions focused on the evidence supporting low-density lipoprotein cholesterol (LDL-C) and nonhigh-density lipoprotein cholesterol (HDL-C) levels as targets of treatment. One question examined the reduction in ASCVD events and adverse effects for each cholesterol-lowering drug class. The panel synthesized the evidence from these 3 reviews as well as from Lifestyle Management and Risk Assessment Work Groups reviews (3, 4) that addressed 5 additional critical questions. Systematic electronic searches of relevant databases of the peer-reviewed English-language literature published from 1 January 1995 through 1 December 2009 for each critical question were conducted by an NHLBI-selected independent contractor and focused on RCTs and systematic reviews and meta-analyses of RCTs assessed as fair to good quality. In addition, RCTs with ASCVD outcomes that included coronary heart disease, stroke, and cardiovascular deaths published after that date were eligible for consideration through July 2013. Evidence tables were constructed, and the strength of evidence was rated according to the NHLBI (Table 1 of the Supplement). Recommendations were graded according to criteria from the NHLBI (Table 2 of the Supplement) and ACC/AHA (Table 3 of the Supplement). Because of the inherent differences in grading systems and the clinical questions driving the recommendations, alignment between the NHLBI and ACC/AHA formats was imperfect. A complete description of the methods used and results of the evidence review are provided in the guideline (2) and the NHLBI evidence report (www.nhlbi.nih.gov/guidelines/cholesterol/ser/index.htm). Supplement. NHLBI and ACC/AHA Criteria for Rating Strength of Evidence To help clinicians estimate ASCVD risk, the risk assessment working group developed the Pooled Cohort Equations using data from 5 NHLBI-sponsored longitudinal, population-based cohorts of African American and non-Hispanic white men and women to estimate risk for a first myocardial infarction, coronary heart disease death, or fatal or nonfatal stroke on the basis of age, sex, race, smoking status, total cholesterol level, HDL-C level, systolic blood pressure, antihypertensive therapy, and diabetes (4, 6). These equations significantly advance ASCVD risk estimation by providing sex- and race-specific estimates and including stroke as an outcome. The earlier Framingham equations calculated only coronary heart disease risk for non-Hispanic whites. The draft recommendations were reviewed by 23 experts and representatives of federal agencies identified by the NHLBI. In September 2013, the recommendations developed by the panel were transitioned to the ACC/AHA and had additional review by 4 experts nominated by the ACC Foundation and the AHA. The governing bodies of the ACC and AHA approved the guideline, which also received endorsement from the American Association of Cardiovascular and Pulmonary Rehabilitation, American Pharmacists Association, American Society for Preventive Cardiology, Association of Black Cardiologists, Preventive Cardiovascular Nurses Association, and WomenHeart: The National Coalition for Women with Heart Disease. Recommendations The guideline focuses on treatment of blood cholesterol to reduce ASCVD risk in adults. Major recommendations are summarized here and in Table 1. The guideline report provides a complete listing of recommendations and supporting evidence behind each recommendation (2). Table 1. Major Recommendations for the Treatment of Blood Cholesterol to Reduce ASCVD Risk in Adults* 1. Encourage Adherence to a Healthy Lifestyle A healthy lifestyle is the foundation for cardiovascular health. The panel endorsed the 2013 ACC/AHA Lifestyle Management Guideline (3) for a diet that is low in saturated fat, trans fat, and sodium; emphasizes vegetables, fruits, whole grains, low-fat dairy products, poultry, fish, legumes, nontropical vegetable oils, and nuts; and limits sweets, sugar-sweetened beverages, and red meats and engage in regular aerobic physical activity. Adults also should maintain a healthy body weight, avoid smoking, and control hypertension and diabetes when present. 2. Statin Therapy Is Recommended for Adults in Groups Demonstrated to Benefit Strong RCT evidence shows that reduction in ASCVD events from statin therapy exceeds adverse events for 4 patient groups: those with clinical ASCVD (acute coronary syndromes, myocardial infarction, stable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease of atherosclerotic origin) when statins are used for secondary prevention, and those with LDL-C levels 190 mg/dL; those aged 40 to 75 years with diabetes and LDL-C levels 70 to 189 mg/dL; and those aged 40 to 75 years without diabetes and with a 10-year ASCVD risk 7.5% when statins are used for primary prevention. Moderate evidence supports consideration of statin therapy for primary prevention in individuals with a 10-year ASCVD risk of 5% to <7.5%. Routine initiation of statin therapy is not recommended in adults with New York Heart Association heart failure class II to IV or those receiving maintenance hemodialysis. Randomized, controlled trials in these groups showed no reduction in ASCVD. 3. Statins have an Acceptable Margin of Safety When Used in Properly Selected Individuals and Appropriately Monitored Strong RCT evidence supports safety of statins when they are used as directed in conjunction with regular follow-up assessments in properly selected patients. Adjustment of statin intensity is recommended in individuals older than 75 years with a history of statin intolerance or other characteristics (2) or those receiving drug therapy that may increase statin adverse events. Routine monitoring of hepatic aminotransferase level or creatine kinase level is not recommended unless clinically indicated by symptoms suggesting hepatotoxicity or myopathy. Given the potential for decreasing ASCVD events and death, the relationship of muscle and other symptoms to statin treatment must be confirmed. Therefore, eliciting a history of muscle symptoms before statin initiation and carefully monitoring symptoms during statin discontinuation and rechallenge is recommended. Severe myopathy, rhabdomyolysis, and possibly hemorrhagic stroke are rare complications of statin therapy. Although statin therapy modestly increases the risk for type 2 diabetes, ASCVD risk reduction outweighs the excess risk for diabetes for high-intensity statins in secondary prevention or for 10-year ASCVD risk 7.5%. Similarly, ASCVD risk reduction outweighs the excess risk for diabetes for moderate-intensity statin therapy in adults with a 10-year ASCVD risk 5%. 4. Engage in a ClinicianPatient Discussion Before Initiating Statin Therapy, Especially for Primary Prevention in Patients With Lower ASCVD Risk Decisions to initiate statin therapy in primary prevention should be based on clinical judgment and preferences of informed patients. In adults without clinical ASCVD or diabetes whose LDL-C level is <190 mg/dL, calculating the estimated 10-year ASCVD risk should be the start of the clinicianpatient discussion and should not automatically lead to statin initiation. As the absolute risk for ASCVD events decreases, so does the net benefit of the intervention. Therefore, discussion of the potential for ASCVD event reduction, adverse effects, drugdrug interactions, and patient preferences is especially important for lower-risk primary prevention. The discussion provides the opportunity to encourage healthy lifestyle habits and control other risk factors. Additional factors may be considered when a risk-based decision is uncertain, including LDL-C levels 160 mg/dL, family history of premature ASCVD, elevated lifetime ASCVD risk, high-sensitivity C-reactive protein level 2.0 mg/L, coronary artery calcification score >300 Agatston units, and anklebrachial index <0.9. After age 75 years, comorbid conditions, anticipated longevity, safety considerations, and patient preferences should play a large role in decision making. 5. Use the Newly Developed Pooled Cohort Equations for Estimating 10-Year ASCVD Risk The Pooled Cohort Equations are currently the best available method for estimating 10-year ASCVD risk to guide statin initiation (4, 6). Application of the inclusion and exclusion criteria from RCTs is cumbersome and results in underidentifying high-risk and overidentifying low-risk individuals for statin treatment. The Pooled Cohort Equations were developed using recent data from 5 NHLBI-sponsored, longitudinal, population-based cohorts of African American and white men and women (ARIC [Atherosc
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