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(Circulation. 1996;93:1067-1068.)
© 1996 American Heart Association, Inc.
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| Introduction |
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The proposed ACP guidelines1 and the accompanying background article by Garber et al4 recommend screening for lipid abnormalities only in men aged 35 to 65 years and women aged 45 to 65 years and using only a total cholesterol level. Even in these people, it is considered appropriate but not mandatory. Cholesterol measurement might be considered 5 to 10 years earlier if there is evidence of a familial lipoprotein disorder or two other characteristics that place the individual at increased risk of coronary heart disease. These guidelines would thus exclude many persons 65 years and older as well as men and women younger than ages 35 and 45 years, respectively. HDL cholesterol testing, as recommended in the most recent NCEP/AHA guidelines,3 is not recommended. Lipoprotein analysis is recommended only after the onset of cardiovascular disease. Thus, the proposed ACP guidelines represent a major departure from those advocated by the AHA, the National Heart, Lung, and Blood Institute, and other organizations primarily concerned with reducing our nation's burden from cardiovascular disease.
In an accompanying editorial in Annals of Internal Medicine,5 LaRosa points out a number of flaws in the rationale for changing the guidelines. These include (1) the lack of consideration of the established role of cholesterol in the pathogenesis of atherosclerosis, (2) the false implication that diet is ineffective as a means of lowering total and LDL cholesterol levels, (3) overlooking evidence that cholesterol levels in young adults in fact predict midlife coronary disease,6 (4) the neglect of data from both primary and secondary prevention trials7 8 that demonstrate that cholesterol lowering is just as effective in persons older than 60 years as in younger persons, (5) ignorance of the fact that a substantial portion of preventable coronary disease presents as sudden death or disabling myocardial infarction, (6) the mistaken impression that an elevated cholesterol level unequivocally leads to costly cholesterol-lowering drug therapy in low-risk persons, and (7) the incorrect notion that modern cholesterol-lowering drug therapy is not associated with a total mortality benefit, when recent trials of asymptomatic as well as coronary patients showed substantial improvements in overall survival in both groups.7 8
The recent review of carcinogenicity studies in rodents9 has not been accepted as credible evidence of cancer risk for cholesterol-lowering drugs in humans, as supported by a lack of cancer cases in recent studies of cholesterol-lowering drugs in more than 10 000 humans followed for 5 or more years.10
The Risk Reduction Task Force agrees with Dr LaRosa's conclusion that "the guidelines on cholesterol screening proposed in this issue are incorrect and misguided."
While a large amount of scientific evidence clearly favors the NCEP/AHA guidelines, as exhaustively reviewed,3 consideration of several practical implications of these proposed changes also should be made. Of special concern is the recommendation to exclude young adults (men below age 35 years and women below age 45 years). One group of patients potentially overlooked by these guidelines are those with familial lipid disorders, especially heterozygous familial hypercholesterolemia (hFH).11 With a prevalence of 1 in 500, this condition is more common than several other conditions for which screening is mandated by law (eg, phenylketonuria and congenital hypothyroidism) and involves tests no less sensitive, specific, or expensive. Patients with hFH have an average age of onset of myocardial infarction in their 40s,11 and a positive family history is not always present. Coronary disease is potentially preventable with current therapies if the hFH patient is identified and treated early.
Detection and treatment of elevated cholesterol levels in young adults has the potential to prevent premature coronary heart disease. Treating elevated cholesterol levels later in life only partially diminishes the risk acquired from high cholesterol levels in young adulthood. Therefore, early detection of a high level of serum cholesterol is warranted and advisable. Introduction of appropriate changes in detrimental life habits will reduce long-term risk and can be recommended. Cholesterol-lowering drug therapy will not be necessary in most young adults, except in those who have very high cholesterol levels. However, modification of life habits is fully justified for all young adults who have high cholesterol levels. Young adults deserve to know whether they have high levels of serum cholesterol.
Cholesterol testing in older adults also is warranted. The highest incidence of coronary heart disease occurs in persons older than age 65 years. Thus, older people who have high cholesterol levels are at high short-term risk for developing coronary heart disease. Recent studies7 8 demonstrate that cholesterol-lowering therapy effectively reduces coronary risk and the total mortality rate in high-risk patients. This benefit extended to the older people in these clinical trials. Thus, high-risk older patients should not be denied the benefits of cholesterol-lowering therapy.
The recommendations also overlook the use of cholesterol testing as part of a population-based strategy to lower cholesterol. This was the main reason that the Population Panel of the NCEP12 endorsed population-wide testing and was the basis for the "Know Your Cholesterol" campaign. The American College of Physicians proposal assumes no public health impact of screening, with all benefits limited to the physician's office. However, well-designed research studies have demonstrated that persons tested for total cholesterol and informed of their elevated levels increased their reading of health messages, their use of nutrition labels, and their selection of low-fat foods.13 14 The prevalence of cholesterol testing in the US population correlates temporally with the reduction in population-wide cholesterol levels.15 16
A cornerstone of the current NCEP/AHA guidelines is the incorporation of cardiovascular risk assessment, including total and HDL cholesterol measurements, into the patient's overall healthcare program. One practical concern is that cholesterol testing not obtained within the doctor-patient relationship now can be obtained elsewhere, using home cholesterol testing kits, as approved by the Food and Drug Administration and currently available in drug stores without prescriptions. HDL home testing kits are in the development and approval phases. Cholesterol testing outside the doctor-patient relationship without counseling and follow-up could lead to inappropriate actions and anxieties by the person screened. It seems ironic that the American College of Physicians should make a recommendation that does not promote the benefits of the doctor-patient relationship and does not champion the role of the internist as the primary manager of a patient's risk for chronic disease. In fact, given the widespread use of automated profiles that usually include a minimal cholesterol screen, the internist would have to decide to intentionally exclude this test.
Finally, the proposed American College of Physicians guidelines clearly put the practicing physician in an uncomfortable position. While these guidelines suggest otherwise, cholesterol-testing guidelines recommended by numerous other professional bodies and the NCEP include testing all adults 20 years and older, with interventions in those high-risk subjects identified supported directly or indirectly by clinical trials. Quality assurance programs, such as the Health Plan Employer Data and Information Set (HEDIS) "report card," prominently feature cholesterol testing as a measure of quality of care.17 Thus, the clinician faces a number of conflicting messages that could have professional, legal, and financial implications.
The Risk Reduction Task Force of the AHA concludes that there is no current evidence to support change in the NCEP/AHA guidelines on cholesterol testing. While new and convincing evidence should provide an impetus to revise guidelines, no such evidence is presented by Garber et al.4 "Evidence-based" guidelines imply a balanced, impartial review of the available evidence. The new American College of Physicians guidelines and background study represent neither.
| Footnotes |
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| References |
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This article has been cited by other articles:
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A. M. Garber and W. S. Browner Cholesterol Screening Guidelines : Consensus, Evidence, and Common Sense Circulation, March 18, 1997; 95(6): 1642 - 1645. [Full Text] |
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New Screening Guidelines Fuel Cholesterol Debate Journal Watch Cardiology, April 1, 1996; 1996(401): 6 - 6. [Full Text] |
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