Since the release of the National Cholesterol PROCEEDINGS FUTURE DIRECTIONS IN DYSLIPIDEMIA MANAGEMENT * Michael B. Clearfield, DO, FACOI ABSTRACT
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1 FUTURE DIRECTIONS IN DYSLIPIDEMIA MANAGEMENT * Michael B. Clearfield, DO, FACOI ABSTRACT Since the National Cholesterol Education Program (NCEP) Third Adult Treatment Panel (ATP III) guidelines, 3 large trials have confirmed the benefit of reducing coronary heart disease (CHD) risk with statins and that these benefits extend to elderly populations. These studies include the Prospective Study of Pravastatin in the Elderly at Risk (PROSPER), the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT), and the Anglo-Scandinavian Cardiac Outcomes Trial Lipid-Lowering Arm (ASCOT-LLA). Our total experience with statins now exceeds patients from clinical studies. Reducing cholesterol levels and, more specifically, low-density lipoprotein (LDL) cholesterol, however, does not provide the entire answer in our search for the most effective prevention of CHD. Many healthy patients without CHD and with normal LDL cholesterol levels (<130 mg/dl) who would not be treated at this time based on NCEP guidelines experience cardiovascular events, and a myocardial infarction is still the first sign of CHD in at least one half of patients. The metabolic syndrome as defined by NCEP ATP III might also be involved, especially as it is being recognized as a *Based on a presentation given by Dr Clearfield at a symposium held in conjunction with the Pri-Med Midwest 2003 Conference and Exhibition. Professor of Medicine, Associate Dean for Clinical Research, Department of Internal Medicine, University of North Texas Health Science Center, Forth Worth, Texas. Address correspondence to: Michael Clearfield, DO, FACOI, Department of Internal Medicine, University of North Texas Health Science Center, 3500 Camp Bowie Blvd, Fort Worth, TX mclearfi@hsc.unt.edu. precursor to diabetes now considered a CHD risk equivalent in many individuals. C-reactive protein (CRP) levels might also help to identify those at high risk for a cardiovascular event in the absence of any other apparent risk factors. A current, ongoing study is evaluating the effect of the most recently approved statin, rosuvastatin, on the primary prevention of cardiovascular events in individuals with low LDL cholesterol levels but high CRP levels. (Adv Stud Med. 2004;4(1B):S53-S60) Since the release of the National Cholesterol Education Program (NCEP) Third Adult Treatment Panel (ATP III) guidelines, several important, large, randomized trials have been published. Their results either confirm the findings from the previous landmark studies (upon which the guidelines were based) or introduce potentially important new markers of risk for coronary heart disease (CHD), which might be incorporated into future versions of the guidelines. As discussed by Dr Ansell (see page S38), the Heart Protection Study provided an intriguing indication that additional benefit can be gained if low-density lipoprotein (LDL) cholesterol levels are lowered below the recommended 100 mg/dl. 1 Three important new trials include the Prospective Study of Pravastatin in the Elderly at Risk (PROSPER), the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT), and the Anglo- Scandinavian Cardiac Outcomes Trial Lipid- Lowering Arm (ASCOT-LLA). Advanced Studies in Medicine S53
2 PROSPER PROSPER was designed to test the benefits of pravastatin in an elderly cohort with or at high risk for developing cardiovascular disease or stroke. Because previous studies of statins were performed predominantly in middle-aged men, the efficacy and safety of these agents in elderly men and women were not known. Safety is a particular issue because many elderly patients take several medications, and the relationship between plasma cholesterol and coronary artery disease diminishes with increasing age. 2-4 The elderly are at particular risk for stroke, and some statin trials have shown a benefit of statins for reducing risk of stroke. In PROSPER, the mean age of the 5804-person cohort was 75 years (range, years). A total of 44% had vascular disease or were at high risk for vascular disease (smoking, 27%; hypertension, 62%; diabetes, 11%). The average number of concomitant medications was 3.6; only 5% of patients were taking no other medications. Study participants received either pravastatin 40 mg once daily or placebo. Patients were followed up for an average of 3.2 years, and the primary endpoint was a composite of coronary death, nonfatal myocardial infarction (MI), and fatal or nonfatal stroke. 5 The results showed a decrease in LDL cholesterol levels of 33% in compliant patients and 27% overall. Compliance was an issue because 10% of patients taking placebo began taking a nonstudy statin during the trial. The pravastatin group had a 15% decrease in relative risk for the primary endpoint (P =.014). Those with the lowest high-density lipoprotein (HDL) cholesterol levels (<44 mg/dl) benefited the most, with a 36% reduction in the primary endpoint. Transient ischemic attacks were reduced by 25% with pravastatin, but the effect was not significant compared with placebo. No change in cognitive function was observed with pravastatin treatment, thus challenging any previous theories on the role of statins in preventing or delaying the onset of age-related cognitive decline. In the end, significant decreases were observed in the primary and secondary endpoints, CHD death or nonfatal MI (excluding silent and unrecognized events), all cardiovascular events, and CHD death (Figure 1). 5 The incidence of cancer during the trial increased by 25% in patients taking pravastatin compared with placebo. To evaluate this risk, the investigators performed a meta-analysis of cancer rates in randomized Figure 1. Outcomes from the PROSPER Study *Cardiovascular events that were primary endpoint, coronary artery bypass graft or percutaneous transluminal coronary angioplasty, or peripheral artery surgery or angioplasty. CHD = coronary heart disease; MI = myocardial infaction; CV = cardiovascular. Data from Shepherd et al. 5 Table 1. Clinical Events in Statin Trials Baseline Endpoint Statin Placebo Reduction LDL LDL Event Event in Relative Cholesterol Cholesterol Rate Rate Risk Trial (mg/dl) (mg/dl) (%) (%) (%) NNT HPS PROSPER S LIPID* CARE WOSCOPS AFCAPS/ TexCAPS 10 *Composite endpoint was nonfatal myocardial infarction, coronary heart disease death, and fatal or nonfatal stroke. LDL = low-density lipoprotein; NNT = number needed to treat. S54 Vol. 4 (1B) January 2004
3 placebo-controlled studies using pravastatin or other statins and lasting more than 3 years. The results showed that treatment with pravastatin (hazard ratio, 1.06; 95% CI, ; P =.20) or with all statins taken together (hazard ratio, 1.02; 95% CI, ; P =.32) was not associated with an excess of cancer. Ultimately, the results showed that the benefits of pravastatin extend to the elderly population and that the number needed to treat to avoid one CHD event with drug treatment is within reasonable limits, as found in other statin trials of middle-aged populations (Table 1). 1,5-10 ALLHAT-LLT The ALLHAT study was primarily a study of hypertensive patients with a lipid-lowering treatment arm. Of the total ALLHAT study population, participated in the lipid-lowering study. The patients in the lipidlowering treatment arm were aged 55 years or older (mean age, 66 years) with well-controlled hypertension and with or without CHD. The purpose of the study was to assess the effect of statin therapy on all-cause mortality and in important subgroups: women (almost half), older persons (55% 65 years of age), and those with normal LDL cholesterol levels (25% with LDL cholesterol <130 mg/dl). Participants were randomized to receive either pravastatin 40 mg or usual care, defined as LDL cholesterol lowering according to the discretion of the patient s primary care physician. Of note, the study was not blinded. The study groups were followed up for a mean of 4.8 years. The primary endpoint was all-cause mortality with secondary outcomes, including nonfatal MI or fatal CHD combined, cause-specific mortality, and cancer. 11 The results showed modest reductions in total cholesterol (17% pravastatin vs 8% usual care) and LDL cholesterol levels (28% pravastatin vs 11% usual care). The differential between the 2 treatment groups, however, was only 9% for total cholesterol and 17% for LDL cholesterol. In the final analysis, pravastatin did not significantly reduce all-cause mortality (14.9% pravastatin vs 15.3% usual care) or CHD event rates (9.3% pravastatin vs 10.4% usual care) compared with usual care. 11 The ALLHAT investigators discussed several reasons for the apparent negative results. First, the compliance rate in the pravastatin group was less than 80% at study end. More importantly, 30% of usual care patients began taking a nonstudy statin or other lipidlowering drug during the study. Because the study was conducted after the publication of the NCEP ATP III treatment guidelines, many patients were eligible for and therefore initiated statin therapy. As a result, the low differential between treatment groups in reduction of total cholesterol and LDL cholesterol was about half that seen in other clinical trials in which a statin was compared with placebo. This may explain the lack of reduction in relative risk of all-cause mortality or CHD events with pravastatin in ALLHAT compared with other statin studies (Table 2). The only true placebo group in the study might have been those without CHD and with LDL cholesterol levels below 130 mg/dl who were receiving usual care. According to the NCEP ATP III guidelines, these patients would not be eligible for lipid-lowering treatments. The reduction in risk of Table 2. Comparison of ALLHAT to Other Large Long-term Statin Trials Change in All-Cause CHD Total Mortality Events Trial Patients (N) Cholesterol (%) (OR) (OR) HPS PROSPER S LIPID CARE WOSCOPS AFCAPS/ TexCAPS ALLHAT ASCOT LIPS Post-CABG All trials Adapted with permission from the Journal of the American Medical Association. 2002; 288(23): OR = odds ratio; CHD = coronary heart disease. Advanced Studies in Medicine S55
4 CHD death plus nonfatal MI was 27% lower in the pravastatin group compared with those in the usual care group without CHD and with LDL cholesterol levels below 130 mg/dl a placebo group; this risk reduction was comparable to reductions observed in other studies. 11 Nonetheless, ALLHAT-LLT showed clinical benefit with pravastatin and that less reduction in LDL cholesterol results in less clinical benefit. As the investigators note, In the absence of evidence for increases in any category of noncardiovascular mortality, the ALLHAT-LLT results should be interpreted as consistent with current recommendations for cholesterol control in the prevention and treatment of cardiovascular disease. These results emphasize the need for obtaining an adequate reduction in LDL cholesterol in clinical practice when lipid-lowering therapy is implemented. 11 ASCOT-LLA Similar to ALLHAT, the ASCOT study was designed to assess the efficacy of atorvastatin in a subgroup of hypertensive patients as part of a larger trial. The original ASCOT study population consisted of hypertensive patients aged 40 to 79 years with at least 3 other cardiovascular risk factors. Of these, were included in the lipid-lowering arm. Patients were randomized to receive either atorvastatin 10 mg or placebo (in addition to the antihypertensive drugs in the study) with an intended follow-up of 5 years. Primary outcome measures were nonfatal MI (including silent MI) and fatal CHD. 12 As in ALLHAT, the study cohort consisted of high-risk patients with no history of MI. The study population was similar to that of ALLHAT. 11,12 The results after 3-year follow-up showed significant improvement in all parameters with atorvastatin: 36% reduction in MI and fatal CHD (P <.001), 27% reduction in stroke (P =.024), 21% reduction in total cardiovascular events (P <.001), and 29% reduction in total coronary events (P <.001). The benefit in primary outcome measure emerged in the first year. Because of the significant benefit, the study was discontinued early (after 3.5 years). 12 Compared with the other statin trials (Table 2), the results from ASCOT clearly support the benefit of statins in patients at high risk for CHD. Our total experience with statins to date is now with more than patients (Table 2). 1,5-14 DO WE HAVE FINAL GUIDELINES? Given the wealth of data now available on the benefits of statins in reducing CHD risk, it might be easy to conclude that our research has ended. The complete relationship between cholesterol levels and CHD risk, however, is not completely understood. Clearly, some other factors are involved. Castelli first noted almost 2 decades ago that many CHD patients have total cholesterol levels below or near the average of 210 mg/dl (Figure 2). 15 More recently, a study of 284 patients with MI showed that 74% would not have met criteria for drug treatment under the NCEP ATP III guidelines. The mean LDL cholesterol for the group was 126 mg/dl; only 16% had LDL cholesterol levels above 160 mg/dl. Other risk factors included overweight/obesity (82%), hypertension (40%), family history of premature CHD (42%), and smoking (60%). A total of 50% had only 0 or 1 risk factor, and of those, only 8% had LDL cholesterol levels of 160 mg/dl or above. 16 MI or death is the initial presentation of CHD in as many as 62% of men and 46% of women. 17 The search is under way for other risk determinants beyond cholesterol. NCEP ATP III has listed the following as emerging or nontraditional risk factors: lipoprotein(a), homocysteine, prothrombotic and proin- Figure 2. Many CHD Patients Have Total Cholesterol Levels Similar to the Average CHD = coronary heart disease. Reproduced with permission from Elsevier. Am J Med. 1984;76(2A): S56 Vol. 4 (1B) January 2004
5 flammatory factors, impaired fasting glucose, and evidence of subclinical atherosclerotic disease. THE METABOLIC SYNDROME The NCEP ATP III guidelines formally described the criteria for the metabolic syndrome, the currently accepted name for a syndrome also historically known as syndrome X (as defined by Reaven), 18 dyslipidemic hypertension, the deadly quartet, insulin resistance syndrome, or hazardous waist. NCEP ATP III defines the metabolic syndrome based on waist circumference, triglyceride level, HDL cholesterol level, blood pressure, and serum glucose (Table 3). 19 As with obesity and diabetes, the metabolic syndrome is common in our society, with an estimated prevalence of 22% of the population (about 47 million). 20 A study of the Health Family Tree Study and the National Heart, Lung, and Blood Institute (NHLBI) Family Heart Study showed that 72% of early cases of CHD (men < 55 years, women < 65 years) are in families with a history of premature CHD. 21 Similarly, the risk factors that contribute to the metabolic syndrome (ie, hyperinsulinemia, dyslipidemia, high fibrinogen) are higher in those with premature CHD compared with siblings without CHD. 22 Impaired fasting glucose was found to be predictive of coronary artery disease only in the presence of triglyceridemia and large waist (>40 in). 23 One area of future investigation is to examine whether a family history of diabetes should be considered a risk factor for CHD, given that diabetes is a CHD risk equivalent and CHD tends to cluster in families. Metabolic syndrome is often confused with overweight or obesity. Only 22% of those who are overweight (defined as a body mass index [BMI] of kg/m 2 ) and 60% of those who are obese (BMI >30 kg/m 2 ) have metabolic syndrome. 20 Metabolic syndrome and overweight/obesity are not synonymous, but they are very commonly associated. It is important to differentiate the metabolic syndrome from obesity; a recent study showed that the benefits of the Step II diet for reducing CHD risk is conferred only to those who are obese with metabolic syndrome. Obese persons without metabolic syndrome do not have associated decreased risk of CHD with weight loss based on reductions in plasma insulin and triglycerides, increases in HDL cholesterol, and decrease in LDL cholesterol/hdl cholesterol ratio. No significant differences were observed in these parameters in the obese group without metabolic syndrome. 24 Is metabolic syndrome a CHD risk equivalent, given that it is often a precursor to type 2 diabetes and diabetes is now a CHD risk equivalent? Future epidemiologic studies will be needed to answer this question. C-REACTIVE PROTEIN The Women s Health Study (WHS) is a prospective cohort of over middle-aged, predominantly postmenopausal American women who were free of cardiovascular disease at study entry. Table 3.The Metabolic Syndrome From NCEP ATP III, any 3 of the following: Waist circumference: >40 in (men), >35 in (women) Serum triglycerides: 150 mg/dl HDL: <40 mg/dl (men), <50 mg/dl (women) Blood pressure: 130/85 mm Hg Serum glucose: 110 mg/dl HDL = high-density lipoprotein. The ICD-9 code for metabolic syndrome is Reproduced with permission from the Journal of the American Medical Association. 2001;285(19): Figure 3. CRP in AFCAPS/TexCAPS with LDL and TC/HDL Ratio Lower than Median Levels CRP = C-reactive protein; LDL = low-density lipoprotein; TC = total cholesterol; HDL = high-density lipoprotein; NNT = number needed to treat. Data from Ridker et al. 25 Advanced Studies in Medicine S57
6 A comparison of the Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS) and the Women s Health Study 2 of the landmark primary prevention trials showed that the study cohorts were very similar. 10 LDL cholesterol levels were low or in the normal range. How can patients with low LDL cholesterol levels but who are at high risk be targeted? Levels of C-reactive protein (CRP, an inflammatory marker) may provide some insight. Analysis of CRP levels in a large subpopulation (5742 of 6605 participants) of the AFCAPS/ TexCAPS study, in which patients received either lovastatin or placebo for 5 years, showed that the risk of CHD was higher in those with either a total/hdl cholesterol ratio of less than 5.96 or LDL cholesterol level below mg/dl, if CRP was greater than 1.6 mg/l. These increased risks were attenuated with statin therapy. In patients with low CRP levels, statins did not offer risk reduction (Figure 3). 25 This also bore out in the reduced number needed to treat with high CRP, irrespective of total cholesterol/hdl cholesterol ratio. 25 In WHS, the relative risk of future vascular events increased as the level of CRP went from low-normal to high-normal (Figure 4). This trend continued for all vascular events as well as for the specific combined endpoint of MI or stroke. 26 A large study of healthy women showed the relationship between CRP and CHD risk based on the Framingham system of calculation. The results clearly show that increasing CRP levels are associated with increasingly high risk of CHD based on the Framingham estimate of 10-year risk, and even more so in those with the highest CRP levels (Figure 5). 27 CRP can help to distinguish those with high risk based on Framingham score or to define groups that are not represented by, or are underestimated by, the Framingham score. Recently, the same investigators showed that CRP level increases with an increasing number of components of the metabolic syndrome (ie, waist circumference, triglyceride and HDL cholesterol levels, blood pressure, fasting blood glucose). The risk of CHD is up to 7 times higher in those with high CRP levels and the metabolic syndrome compared with those with low CRP and without metabolic syndrome. Those without metabolic syndrome and with high CRP have only 1.5 times the relative risk of CHD. 28 The Centers for Disease Control and Prevention and the American Heart Association have published a state- Figure 4. CRP and Risk of Future Cardiovascular Events in Apparently Healthy Women: Results from the Women s Health Study CRP = C-reactive protein; MI = myocardial infarction. Data from Ridker et al. 26 Figure 5. CHD Risk with Framingham Score and CRP Level CHD = coronary heart disease; CRP = C-reactive protein. Reproduced with permission from Ridker et al. Comparison of C-reactive protein and low-density lipoprotein cholesterol levels in the prediction of first cardiovascular events. N Engl J Med. 2002;347(20): Copyright 2002 Massachusetts Medical Society. All rights reserved. S58 Vol. 4 (1B) January 2004
7 ment for healthcare professionals regarding the role of CRP in determining CHD risk. They suggest that if CRP is measured, it should be measured twice (2 weeks apart), in either a fasting or nonfasting individual. If the test results are greater than 10 mg/l, the test should be repeated in 2 to 3 weeks, and the patient should be examined for infection. CRP levels below 1 mg/l are considered low risk; 1 to 3 mg/l, intermediate risk; and above 3 mg/l, high risk. CRP can be useful in underscoring the importance of statin therapy in patients with LDL cholesterol levels below 130 mg/dl. In those with low LDL cholesterol, patients with high CRP are at high risk for metabolic syndrome and should be evaluated. Alternatively, CRP can be checked in those with a calculated 10-year risk of 10% to 20% (the intermediate-risk group) to identify any potentially high-risk individuals. 29 FUTURE STUDIES A recently initiated placebo-controlled trial is evaluating the newest statin (rosuvastatin) and its effect on the primary prevention of cardiovascular events in individuals with low LDL cholesterol but high CRP. The Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) has begun in patients older than 55 years (men) or 65 years (women). The primary endpoint will be a composite of nonfatal MI, nonfatal stroke, hospitalization for unstable angina, coronary revascularization, or cardiovascular death. 30 CONCLUSION Since the NCEP ATP III guidelines, 3 large trials of statins have confirmed the benefits of reducing CHD risk with statins and have shown that the benefits extend to elderly populations. Our total experience with statins now exceeds patients from clinical studies; however, reducing cholesterol and, more specifically, LDL cholesterol, does not provide the entire answer in our search for the most effective prevention of CHD. The metabolic syndrome might also be involved, especially as it is being recognized as a precursor to diabetes now considered a CHD risk equivalent in many individuals. CHD also tends to cluster in families. CRP levels might help to identify those at high risk for a cardiovascular event in the absence of any other apparent risk factors. The medical community should watch closely for any further developments in this area, as such developments can profoundly affect the way at-risk patients are identified and targeted for therapy. REFERENCES 1. Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in high-risk individuals: a randomised placebo-controlled trial. 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8 patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial. Lancet. 2003; 361(9364): Serruys PW, De Feyter PJ, Benghozi R, Hugenholtz PG, Lesaffre E. The Lescol Intervention Prevention Study (LIPS): a double-blind, placebo-controlled, randomized trial of the long-term effects of fluvastatin after successful transcatheter therapy in patients with coronary heart disease. Int J Cardiovasc Intervent. 2001;4(4): The Post Coronary Artery Bypass Graft Trial Investigators. 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. N Engl J Med. 1997;336(3): Castelli WP. Epidemiology of coronary heart disease: the Framingham study. Am J Med. 1984;76(2A): Akosah KO, Schaper A, Cogbill C, Schoenfeld P. Preventing myocardial infarction in the young adult in the first place: how do the National Cholesterol Education Panel III guidelines perform? J Am Coll Cardiol. 2003;41(9): Maurobito JM, Evans JC, Larson MG, Levy D. Prognosis after the onset of coronary heart disease: an investigation of differences in outcome between the sexes according to initial coronary disease presentation. Circulation. 1993;88: Reaven G. Role of insulin resistance in human disease (syndrome X): an expanded definition. Annu Rev Med. 1993;44: 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): Park YW, Zhu S, Palaniappan L, Heshka S, Carnethon MR, Heymsfield SB. The metabolic syndrome. Prevalence and associated risk factor findings in the US population from the National Health and Nutrition Examination Survey, Arch Intern Med. 2003;163(4): Williams RR, Hunt SC, Heiss G, et al. Usefulness of cardiovascular family history data for population-based preventive medicine and medical research (the Health Family Tree Study and the NHLBI Family Heart Study). Am J Cardiol. 2001;87(2): Kareinen A, Viitanen L, Halonen P, Lehto S, Laakso M. Cardiovascular risk factors associated with insulin resistance cluster in families with early-onset coronary heart disease. Arterioscler Thromb Vasc Biol. 2001;21(8): St-Pierre J, Lemieux I, Vohl MC, et al. Contribution of abdominal obesity and hypertriglyceridemia to impaired fasting glucose and coronary artery disease. Am J Cardiol. 2002;90(1): Reaven G, Segal K, Hauptman J, Boldrin M, Lucas C. Effect of orlistat-assisted weight loss in decreasing coronary heart disease risk in patients with syndrome X. Am J Cardiol. 2001;87(7): Ridker PM, Rifai N, Clearfield M, et al. Measurement of C- reactive protein for the targeting of statin therapy in the primary prevention of acute coronary events. N Engl J Med. 2001;344(26): Ridker PM, Buring JE, Shih J, Matias M, Hennekens CH. Prospective study of C-reactive protein and the risk of future cardiovascular events among apparently healthy women. Circulation. 1998;98: Ridker PM, Rifai N, Rose L, Buring JE, Cook NR. Comparison of C-reactive protein and low-density lipoprotein cholesterol levels in the prediction of first cardiovascular events. N Engl J Med. 2002;347(20): Ridker PM, Buring JE, Cook NR, Rifai N. C-reactive protein, the metabolic syndrome, and risk of incident cardiovascular events: an 8-year follow-up of initially healthy American women. Circulation. 2003;107(3): Pearson TA, Mensah GA, Alexander RW, et al. Markers of inflammation and cardiovascular disease: application to clinical and public health practice: a statement for healthcare professionals from the Centers for Disease Control and Prevention and the American Heart Association. Circulation. 2003;107(3): Ridker PM. High-sensitivity C-reactive protein and cardiovascular risk: rationale for screening and primary prevention. Am J Cardiol. 2003;92(4B):17K-22K. S60 Vol. 4 (1B) January 2004
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