The updated guidelines from the National

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1 BEYOND NCEP ATP III: LESSONS LEARNED AND FUTURE DIRECTIONS * Benjamin J. Ansell, MD, FACP ABSTRACT The National Cholesterol Education Program (NCEP) Third Adult Treatment Panel (ATP III) guidelines provide an important first step in identifying individuals who would most benefit from statin therapy. With heart disease as the number-one killer in the United States, prevention is crucial. The NCEP ATP III guidelines formally outline treatment goals of reducing low-density lipoprotein (LDL) cholesterol levels based on a calculated risk of coronary heart disease (CHD). Determining CHD risk is necessary to define optimal dyslipidemia treatment strategies. CHD risk is determined by a number of major risk factors: LDL cholesterol, high-density lipoprotein cholesterol, hypertension, age, sex, diabetes status, and smoking status. Those with multiple risk factors and CHD risk equivalents should be aggressively targeted for lowering LDL cholesterol with drug therapy; however, since the publication of the guidelines, important new data have been published. These data suggest additional benefit with even more aggressive LDL lowering to below 100 mg/dl in those at risk for CHD and in those with acute coronary syndromes. The metabolic syndrome is a secondary target of therapy that *Based on a presentation given by Dr Ansell at a symposium held in conjunction with the Pri-Med Midwest 2003 Conference and Exhibition. Director, UCLA Comprehensive Health Program, University of California, Los Angeles. Address correspondence to: Benjamin J. Ansell, MD, Department of Medicine, UCLA School of Medicine, 200 UCLA Medical Plaza, Suite 370, Los Angeles, CA bansell@mednet.ucla.edu. should be addressed early. Current studies will help to better define the optimal treatment target. (Adv Stud Med. 2004;4(1B):S38-S43) The updated guidelines from the National Cholesterol Education Program (NCEP) Third Adult Treatment Panel (ATP III) mark an important change in the management of dyslipidemia and coronary heart disease (CHD). Heart disease is the number-one killer in the United States. The medical community has made marked efforts to increase awareness and, therefore, prevention of the perils of CHD, yet myocardial infarction (MI) remains the first sign of heart disease in most victims. Too often, this sentinel event is fatal. The NCEP ATP III guidelines formally outline treatment goals of reducing low-density lipoprotein (LDL) cholesterol based on a calculated risk of CHD. Whereas the treatment goal is defined by LDL cholesterol, the ultimate therapeutic goal is the reduction in vascular disease. The intensity of any LDL-lowering therapy is matched to absolute CHD risk, which is defined based on lipid (LDL cholesterol, high-density lipoprotein [HDL] cholesterol) and nonlipid (hypertension, age, sex, diabetes, and smoking) factors. For cost-effective and clinical reasons, efforts toward preventing CHD have been focused on patients at highest risk. LDL cholesterol has been chosen as the treatment target because it is a universal pathway by which the associated risk for CHD S38 Vol. 4 (1B) January 2004

2 can be reduced, even in patients with normal baseline LDL cholesterol levels. The NCEP ATP III guidelines assess CHD risk based on the totality of risk factors (a global risk assessment) for a particular individual without known atherosclerosis. These risk factors are weighted based on their epidemiologic prediction of an actual risk of a CHD event in the next 10 years. A critical change in the NCEP ATP III guidelines (from the ATP II guidelines) is the inclusion of some risk factors as CHD risk equivalents (ie, they pose the same risk as having had a CHD event most notably, diabetes) and the inclusion of other forms of vascular disease (eg, significant carotid artery disease, peripheral vascular disease, abdominal aortic aneurysm, stroke). 1 CHD risk is determined via a complete history to identify risk factors and a complete fasting lipid profile. The components of a lipid profile include LDL cholesterol, HDL cholesterol, non-hdl cholesterol (total cholesterol minus HDL cholesterol), and triglycerides. Table 1 outlines the treatment goals according to CHD risk categories for both LDL cholesterol and non-hdl cholesterol. In general, non-hdl cholesterol targets are 30 points above LDL cholesterol targets and are driven predominantly by elevated triglycerides. Non-HDL cholesterol is a secondary treatment target in those with triglyceride levels of 200 mg/dl or above. 1 An LDL cholesterol level of 160 mg/dl is the highest tolerable blood level in a healthy individual; however, based on the large, randomized, controlled trials available at the time of NCEP ATP III, LDL cholesterol levels below 100 mg/dl are considered optimal. With the NCEP ATP III guidelines, the number of Americans who are eligible for lipid-lowering drug therapy has tripled to approximately 36 million persons, largely due to the inclusion of those who have CHD risk equivalents. 2 Since the publication of these guidelines nearly 3 years ago, important new data have been published. These data suggest additional benefit with even more aggressive LDL lowering to below 100 mg/dl in those at risk for CHD and in those with acute coronary syndromes. 3 Therapy may even benefit at-risk patients whose LDL is currently below 100 mg/dl. During Instability in Coronary Artery Disease II (FRISC II) study compared with 1-year mortality in patients with stable chronic angina in the Swedish Angina Pectoris Aspirin Trial (SAPAT; Figure 1). 3 In those who survive the event and return home from the hospital, there is a 10% risk of Table 1. LDL and Non-HDL Treatment Goals: NCEP ATP III LDL Cholesterol Non-HDL Cholesterol Risk Category Goal (mg/dl) Goal (mg/dl) CHD or CHD risk <100 <130 equivalent 2+ risk factors (10-year risk, 10% to 20%) <130 < risk factors (10-year risk <10%) <160 <190 0 to 1 risk factor <160 <190 LDL = low-density lipoprotein; HDL = high-density lipoprotein; NCEP = National Cholesterol Education Program; ATP III = Third Adult Treatment Panel; CHD = coronary heart disease. Adapted with permission from the Journal of the American Medical Association. 2001;285(19): Figure 1. One-Year Mortality Following Acute Coronary Syndrome Exceeds That in Stable Angina STATINS IN ACUTE CORONARY SYNDROMES CHD risk is highest in those with unstable angina or a non Q-wave MI, as evidenced by the 1-year mortality in the Fragmin and Fast Revascularization Short-term outcome for patients with unstable angina or non Q-wave MI is much worse than the outcome for patients with stable angina. MI = myocardial infarction; FRISC II = Fragmin and Fast Revascularization During Instability in Coronary Artery Disease; SAPAT = Swedish Angina Pectoris Aspirin Trial. Reproduced with permission from Elsevier. Waters et al. Am J Cardiol. 2000;86(suppl B):35J-43J. 3 Advanced Studies in Medicine S39

3 death or another MI within 2 months after the event a very high level of risk, considering that NCEP ATP III defined high risk as a 20% 10-year risk of an event. 4-6 Patients with unstable angina/non Q-wave MI are most receptive to aggressive lipid-lowering therapy because they have experienced firsthand that the risk can translate into an event and because they understand that lipid-lowering drugs are ultimately heart medications. In the original studies on which the NCEP ATP III guidelines were based, patients with unstable angina were excluded. Current guidelines recommend that patients with LDL cholesterol levels below 130 mg/dl, even with unstable angina, should try therapeutic lifestyle changes for 3 months before initiating drug therapy. New evidence from the Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) study suggests that patients can benefit clinically from statin therapy immediately following a cardiovascular event, above and beyond the long-term compliance benefit. More than 3000 patients were randomized within 24 to 96 hours from hospital admission for non Q-wave MI or unstable angina and received either atorvastatin 80 mg or placebo in addition to other usual care for 4 months. The results show the expected decreases in total cholesterol and LDL cholesterol levels in the atorvastatin group, even with baseline LDL cholesterol levels below 130 mg/dl (Table 2). By 4 months, these effects translated into a significant reduction in risk (17.4% vs 14.8%; relative risk, 0.84; P =.048) of the first cardiovascular event (ie, death due to any cause, nonfatal MI, resuscitated cardiac arrest, or worsening angina with new objective evidence requiring urgent rehospitalization) since randomization in patients taking atorvastatin. The risk of stroke was also cut in half (1.6% vs 0.8%; P <.045) by 4 months. The composite endpoint of the first cardiovascular event is broadly defined but is an expensive endpoint (in human and monetary cost). A harder endpoint, such as stroke, confirms the benefit from statin therapy and provides more direct evidence of clinical and cost effectiveness. 7 mary or secondary prevention of a CHD event, irrespective of baseline LDL cholesterol levels. The optimal LDL cholesterol appeared to be below 100 mg/dl in both primary and secondary prevention. 8 Comparing separate trials is not, however, the most scientifically sound method to determine a treatment goal. The optimal trial would select 1 group of high-risk patients and treat to at least 2 increasingly aggressive treatment goals. Only 1 study with clinical endpoints to date has been designed with 2 different treatment goals the Post-Coronary Table 2. Plasma Lipid Level Changes:The MIRACL Study Baseline End of Study Placebo, Atorvastatin, Both Groups, mg/dl mg/dl mean (mg/dl) (% change) (% change) Total cholesterol (+7) 147 (-27) LDL (+12) 72 (-40) HDL (+4) 48 (+5) Triglycerides (+9) 139 (-16) LDL = low-density lipoprotein; HDL = high-density lipoprotein. Data from Schwartz et al. 7 Figure 2. LDL Lowering with Statins: Reduced CHD Events BASELINE LDL CHOLESTEROL VERSUS LOWERING LDL CHOLESTEROL The updated recommendations in the NCEP ATP III guidelines were supported by 5 major statin trials. As shown in Figure 2, the lesson from these trials was that LDL lowering with a statin is beneficial for either pri- LDL = low-density lipoprotein; CHD = coronary heart disease. Reproduced with permission from Illingworth. Med Clin North Am. 2000;84(1): S40 Vol. 4 (1B) January 2004

4 Artery Bypass Graft (Post-CABG) study, which compared different outcomes in patients treated with lovastatin, warfarin, or placebo to target LDL cholesterol levels of approximately 130 mg/dl versus below 100 mg/dl. The study cohort consisted of approximately 1300 patients with a history of bypass surgery (ie, highrisk patients). Significant decreases in angiographic progression (in both the saphenous vein and the left main coronary artery), revascularization rate, and coronary events were observed in those with an LDL cholesterol target of below 100 mg/dl compared with those whose LDL cholesterol was moderately lowered (Figure 3) Three trials are also under way to assess conventional versus maximal doses of simvastatin and/or atorvastatin in reducing CHD events in large populations. The Treat to New Targets (TNT) study is a 5-year study of patients comparing the rates of CHD events with LDL cholesterol lowering to near 100 mg/dl versus approximately 75 mg/dl. The Incremental Decrease in Endpoints through Aggressive Lipid Lowering (IDEAL) study compares atorvastatin 80 mg versus simvastatin 20 mg or 40 mg in 8600 patients. In the Study of Effectiveness of Additional Reductions of Cholesterol and Homocysteine (SEARCH), 2 doses of simvastatin (20 mg vs 80 mg) will be compared in patients. 12 Another study is also under way to assess the benefits of LDL cholesterol lowering in patients with previous stroke or transient ischemic attack but no history of coronary problems the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL). 13 The data for these studies will be available in the next couple of years. An important early finding on this issue is found in the Heart Protection Study, which examined the rate of vascular events in adults at high risk for CHD, although not necessarily dyslipidemic. In this study population, participants had increased CHD risk due to previous MI, history of CHD, history of peripheral vascular disease, type 2 diabetes, or treated hypertension as well as a nonfasting total cholesterol level of at least 135 mg/dl (a common criteria, especially in those with a history of vascular disease). Participants received simvastatin 40 mg; a combination of vitamin E, beta-carotene, and vitamin C; both treatments; or placebo. The results after a mean of 5.5 years of follow-up showed a significant decrease in first vascular event in patients taking a statin versus placebo (19.8% vs 25.2%, P <.001), a 24% reduction in event rate. More importantly, the reduction in risk (relative and absolute) was observed irrespective of history of CHD (Figure 4) or baseline LDL cholesterol level including baseline LDL levels below 100 mg/dl (Figure 5). 14,15 The data suggest that every highrisk patient would benefit from lipid-lowering therapy. Figure 3. Post-CABG Trial: Results with Moderate vs Aggressive Treatment Goals CABG = coronary artery bypass graft; LDL = low-density lipoprotein. Data from Knatterud et al 9 ; Post-CABG Trial Investigators 10 ; White et al. 11 Figure 4. Results from HPS: Risk of Major Vascular Event Based on Baseline CHD HPS = Heart Protection Study; CHD = coronary heart disease; MI = myocardial infarction; CVD = cardiovascular disease; PVD = peripheral vascular disease. Adapted with permission from Elsevier. Lancet. 2002;360(9326): Advanced Studies in Medicine S41

5 Unanswered clinical questions now focus on whether statin treatment is sufficient to reduce the risk of CHD. Should combination therapy with a fibrate be used to address low HDL cholesterol or high triglyceride levels? Should statin treatment be based on LDL cholesterol level or strictly on global risk assessment? The NCEP ATP III provides an important first step in identifying individuals in the general population who would most benefit from statin therapy. risk factors are weighted based on epidemiology, including HDL cholesterol level and age. CHD risk is determined by the sum total of the risk factors. Those with multiple risk factors and CHD risk equivalents should be aggressively targeted for LDLlowering drug therapy. NCEP ATP III guidelines have brought important criteria for identifying those at greatest risk of CHD. Our next steps will be to further define the optimal treatment goals. THE METABOLIC SYNDROME Another group of individuals is also being closely examined for risk of CHD based on the types of markers used to calculate CHD risk. The metabolic syndrome has been known by other monikers (eg, syndrome X). The NCEP ATP III guidelines characterize the metabolic syndrome as a composite of potentially subtle abnormalities: abdominal obesity (waist circumference >40 in [men] or >35 in [women]), high triglyceride levels ( 150 mg/dl), low HDL cholesterol (<40 mg/dl [men], <50 mg/dl [women]), hypertension ( 130/ 85 mm Hg), and fasting blood glucose of 110 mg/dl or greater. The metabolic syndrome is defined by NCEP ATP III as a presence of 3 or more of these risk determinants. Patients with the metabolic syndrome often develop atherosclerosis if these risk determinants remain untreated. The prevalence of the metabolic syndrome is increasing rapidly with our concurrent epidemics of obesity and type 2 diabetes. General prevalence rates for adults older than 20 years are about 24%, with the vast majority in those older than 50 years (Figure 6). 16 The treatment approach to the metabolic syndrome is multifaceted, targeting both lipid and nonlipid risk factors primarily with weight reduction, diet, and exercise, as well as aspirin to address the prothrombotic state. Triglyceridemia is most common in people with the metabolic syndrome and can be treated with therapeutic lifestyle changes for borderline high levels ( mg/dl). For those with very high levels ( mg/dl), several drug strategies are available, including intensification of statin therapy or addition of niacin or fibrate. 1 Figure 5. Results from HPS: Risk of Vascular Events based on Baseline LDL-C HPS = Heart Protection Study; LDL = low-density lipoprotein. Reproduced with permission from the MRC/BHF Heart Protection Study Web site. Available at: 15 Figure 6. Prevalence of the Metabolic Syndrome Among US Adults CONCLUSION Determining CHD risk is necessary to define optimal dyslipidemia treatment strategies. The CHD Reproduced with permission from the Journal of the American Medical Association. 2002;287(3): S42 Vol. 4 (1B) January 2004

6 REFERENCES 1. Executive summary of the Third Report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). JAMA. 2001; 285(19): ATP III slide show. National Heart, Lung, and BIood Institue Web site. Available at: ncep_slds/atpiii/slide101.htm. Accessed November 21, Waters DW, Azar RR. Should intensive cholesterol lowering play a role in the management of acute coronary syndromes? Am J Cardiol. 2000;86(suppl B):35J-43J. 4. Juul-Moller S, Edvardsson N, Jahnmatz B, Rosen A, Sorensen S, Omblus R. Double-blind trial of aspirin in primary prevention of myocardial infarction in patients with stable chronic angina pectoris. The Swedish Angina Pectoris Aspirin Trial (SAPAT) Group. Lancet. 1992; 340(8833): Invasive compared with non-invasive treatment in unstable coronary-artery disease: FRISC II prospective randomised multicentre study. FRagmin and Fast Revascularisation during InStability in Coronary artery disease Investigators. Lancet. 1999;354(9180): Wallentin L, Lagerqvist B, Husted S, Kontny F, Stahle E, Swahn E. Outcome at 1 year after an invasive compared with a non-invasive strategy in unstable coronary-artery disease: the FRISC II invasive randomised trial. FRISC II Investigators. Fast Revascularisation during Instability in Coronary artery disease. Lancet. 2000;356(9223): Schwartz GG, Olsson AG, Ezekowitz MD, et al. Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial. JAMA. 2001;285(13): Illingworth DR. Management of hypercholesterolemia. Med Clin North Am. 2000;84(1): Knatterud GL, Rosenberg Y, Campeau L, et al. Long-term effects on clinical outcomes of aggressive lowering of lowdensity lipoprotein cholesterol levels and low-dose anticoagulation in the post coronary artery bypass graft trial. Post CABG Investigators. Circulation. 2000;102(2): The effect of aggressive lowering of low-density lipoprotein cholesterol levels and low-dose anticoagulation on obstructive changes in saphenous-vein coronary-artery bypass grafts. The Post Coronary Artery Bypass Graft Trial Investigators. N Engl J Med. 1997;336(3): White CW, Gobel FL, Campeau L, et al. Effect of an aggressive lipid-lowering strategy on progression of atherosclerosis in the left main coronary artery from patients in the post coronary artery bypass graft trial. Circulation. 2001;104(22): Jones PH. The search for superior treatment: current and future options for dyslipidemia. Available at: Accessed November 8, Deanfield JE. Clinical trials: Evidence and unanswered questions hyperlipidaemia. Cerebrovasc Dis. 2003;16 (suppl 3): Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in high-risk individuals: a randomised placebo-controlled trial. Lancet (9326);360: MRC/BHF Heart Protection Study Web site. Available at: Accessed November 24, Ford ES, Giles WH, Dietz WH. Prevalence of the metabolic syndrome among US adults: findings from the third National Health and Nutrition Examination Survey. JAMA. 2002;287(3): Advanced Studies in Medicine S43

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