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47Lowering Blood Cholesterol To Prevent Heart Disease

National Institutes of Health Consensus Development Conference Statement, December 10-12, 1984

Introduction and Conclusions


Coronary heart disease is responsible for more than 550,000 deaths in the United States each year. It is responsible for more deaths than all forms of cancer combined. There are over 5.4 million Americans with symptomatic coronary heart disease and a large number of others with undiagnosed coronary disease, many of them young and highly productive. It has been estimated that coronary heart disease costs the United States over $60 billion a year in direct and indirect costs.

Coronary heart disease is due to atherosclerosis, a slowly progressive disease of the large arteries that begins early in life but rarely produces symptoms until middle age. Often the disease goes undetected until the time of the first heart attack, and this first heart attack is often fatal. Modern methods of treatment have improved greatly the outlook for patients having heart attacks, but major progress in our battle against this number one killer must rest on finding preventive measures.

A number of risk factors have been identified as strongly associated with coronary heart disease. Cigarette smoking, high blood pressure, and high blood cholesterol are the most clearly established of these factors. Risk is greater in men, increases with age, and has a strong genetic component. Obesity, diabetes mellitus, physical inactivity, and behavior pattern are also risk factors.

A large body of evidence of many kinds links elevated blood cholesterol levels to coronary heart disease. However, some doubt remains about the strength of the evidence for a cause-and-effect relationship. Questions remain regarding the exact relationship between blood cholesterol and heart attacks and the steps that should be taken to diagnose and treat elevated blood cholesterol levels.

To resolve some of these questions, the National Heart, Lung, and Blood Institute and the NIH Office of Medical Applications of Research convened a
Consensus Development Conference on Lowering Blood Cholesterol to Prevent Heart Disease on December 10-12, 1984. After hearing a series of expert presentations and reviewing all of the available data, a consensus panel of lipoprotein experts, cardiologists, primary care physicians, epidemiologists, biomedical scientists, biostatisticians, experts in preventive medicine, and lay representatives considered the evidence and agreed on answers to the following questions:

  • Is the relationship between blood cholesterol levels and coronary heart disease causal?
  • Will reduction of blood cholesterol levels help prevent coronary heart disease?
  • Under what circumstances and at what level of blood cholesterol should dietary or drug treatment be started?
  • Should an attempt be made to reduce the blood cholesterol levels of the general population?
  • What research directions should be pursued on the relationship between blood cholesterol and coronary heart disease?

Panel's Conclusions

Elevated blood cholesterol level is a major cause of coronary artery disease. It has been established beyond a reasonable doubt that lowering definitely elevated blood cholesterol levels (specifically blood levels of low-density lipoprotein cholesterol) will reduce the risk of heart attacks due to coronary heart disease. This has been demonstrated most conclusively in men with elevated blood cholesterol levels, but much evidence justifies the conclusion that similar protection will be afforded in women with elevated levels. After careful review of genetic, experimental, epidemiologic, and clinical trial evidence, we recommend treatment of individuals with blood cholesterol levels above the 75th percentile (upper 25 percent of values). Further, we are persuaded that the blood cholesterol level of most Americans is undesirably high, in large part because of our high dietary intake of calories, saturated fat, and cholesterol. In countries with diets lower in these constituents, blood cholesterol levels are lower, and coronary heart disease is less common. There is no doubt that appropriate changes in our diet will reduce blood cholesterol levels. Epidemiologic data and over a dozen clinical trials allow us to predict with reasonable assurance that such a measure will afford significant protection against coronary heart disease.

For these reasons we recommend that:

  1. Individuals with high-risk blood cholesterol levels (values above the 90th percentile) be treated intensively by dietary means under the guidance of a physician, dietitian, or other health professional; if response to diet is inadequate, appropriate drugs should be added to the treatment regimen. Guidelines for children are somewhat different, as discussed below.
  2. Adults with moderate-risk blood cholesterol levels (values between the 75th and 90th percentiles) be treated intensively by dietary means, especially if additional risk factors are present. Only a small proportion should require drug treatment.
  3. All Americans (except children under 2 years of age) be advised to adopt a diet that reduces total dietary fat intake from the current level of about 40 percent of total calories to 30 percent of total calories, reduces saturated fat intake to less than 10 percent of total calories, increases polyunsaturated fat intake but to no more than 10 percent of total calories, and reduces daily cholesterol intake to 250 to 300 mg or less.
  4. Intake of total calories be reduced, if necessary, to correct obesity and adjusted to maintain ideal body weight. A program of regular moderate-level exercise will be helpful in this connection.
  5. In individuals with elevated blood cholesterol, special attention be given to the management of other risk factors (hypertension, cigarette smoking, diabetes, and physical inactivity).

These dietary recommendations are similar to those of the American Heart Association and the Inter-Society Commission for Heart Disease Resources.

We further recommend that:

  • 6. New and expanded programs be planned and initiated soon to educate physicians, other health professionals, and the public to the significance of elevated blood cholesterol and the importance of treating it. We recommend that the National Heart, Lung, and Blood Institute provide the focus for development of plans for a National Cholesterol Education Program that would enlist participation by and contributions from all interested organizations at national, state, and local levels.
  • 7. The food industry be encouraged to continue and intensify efforts to develop and market foods that will make it easier for individuals to adhere to the recommended diets and that school food services and restaurants serve meals consistent with these dietary recommendations.
  • 8. Food labeling should include the specific source or sources of fat, total fat, saturated and polyunsaturated fat, and cholesterol content as well as other nutritional information. The public should be educated on how to use this information to achieve dietary aims.
  • 9. All physicians be encouraged to include whenever possible a blood cholesterol measurement on every adult patient when that patient is first seen; to ensure reliability of data, we recommend steps to improve and standardize methods for cholesterol measurement in clinical laboratories.
  • 10. Further research be encouraged to compare the effectiveness and safety of currently recommended diets with that of alternative diets; to study human behavior as it relates to food choices and adherence to diets; to develop more effective, better tolerated, safer, and more economical drugs for lowering blood cholesterol levels; to assess the effectiveness of medical and surgical treatment of high blood cholesterol levels in patients with established clinical coronary artery disease; to develop more precise and sensitive noninvasive artery imaging methods; to apply basic cell and molecular biology to increase our understanding of lipoprotein metabolism (particularly the role of HDL as a protective factor) and artery wall metabolism as they relate to coronary heart disease.
  • 11. Plans be developed that will permit assessment of the impact of the changes recommended here as implementation proceeds and provide the basis for changes when and where appropriate.

Is the Relationship Between Blood Cholesterol Levels and Coronary Heart Disease Causal?

The evidence supporting a causal relationship between blood cholesterol levels and coronary heart disease comes from a wealth of congruent results of genetic, experimental pathologic, epidemiologic, and intervention studies. These data establish beyond any reasonable doubt the close relationship between elevated blood cholesterol levels (as measured in serum or plasma) and coronary heart disease. At the same time, it is equally clear that an elevated blood cholesterol level is not the only cause of coronary heart disease. Hypertension, cigarette smoking, diabetes mellitus, obesity, and physical inactivity along with a number of other risk factors such as age, sex, and family history are important contributing causes. There probably are other undiscovered contributing causes. However, we shall confine ourselves here primarily to a discussion of elevated blood cholesterol.

It is now firmly established that all cholesterol is carried in the bloodstream in several protein-lipid combinations known as lipoproteins and that most of the blood cholesterol in humans is carried by specific low-density lipoproteins (LDL). Some is also present in high-density lipoproteins (HDL) and in very low-density lipoproteins (VLDL). The LDL particles, when present in excess in the blood, are deposited in the tissues and form a major part of a buildup in the artery wall to form atherosclerotic plaque. Atherosclerosis narrows the channels of the coronary arteries, the vessels that furnish the major blood supply to the heart muscle.

Genetic Evidence

Severe coronary heart disease can result from high blood cholesterol levels in the absence of any other contributing risk factors. This is clearly demonstrated by the accelerated and clinically catastrophic coronary heart disease in children with inherited hypercholesterolemia in its most severe form. These children lack the specific receptor that normally removes LDL from the blood, and as a result, they have very high LDL cholesterol levels from birth. They frequently suffer severe coronary heart disease, and death may occur even in childhood. Careful study of these diseased arteries reveals large quantities of cholesterol in the plaques.

The LDL receptor normally plays a critical role in regulating blood cholesterol levels in all mammals, including humans. It has been purified and fully characterized.

Studies suggest that a number of cases of clinically important coronary heart disease with less severe elevations of blood cholesterol may be explained by partial deficiencies of functioning LDL receptors, deficiencies induced by dietary and lifestyle factors. Thus, the high blood cholesterol in these patients has a similar basis to that in inherited hypercholesterolemia and, while less severe, probably has the same implications.

Experimental Pathology (Animal Model) Evidence

With improved use of the many existing animal models, a number of very important relationships between blood cholesterol, atherosclerosis, and coronary heart disease have been demonstrated:

  • Many species (including several nonhuman primates) develop atherosclerosis when fed diets that raise their blood cholesterol levels.
  • Studies over time demonstrate that hypercholesterolemic monkeys (and other species) develop intimal lesions that progress from fatty streaks to typical raised plaques to complicated ulcerated plaques resembling those seen in humans suffering from coronary heart disease.
  • Hypercholesterolemia augments experimental atherosclerosis when arterial "injury" is present.
  • Severe atherosclerosis in rhesus monkeys, usually a progressive process, regresses when the blood cholesterol is lowered substantially for an extended period by diet or by drugs.

Animal studies thus offer strong and persuasive evidence supporting the causal relationship between blood cholesterol and atherosclerosis.

Epidemiologic Evidence

A large body of epidemiologic evidence supports the direct relationship between blood cholesterol levels and coronary heart disease:

  • Comparisons among various populations throughout the world reveal a direct correlation between blood cholesterol levels and the occurrence of coronary heart disease; no population has been reported with a high rate of coronary heart disease and low blood cholesterol levels.
  • People who have migrated to another country with a higher average blood cholesterol level gradually acquire the dietary habits, blood cholesterol concentration, and coronary heart disease rates of their new country of residence.
  • Severity and frequency of raised plaques in the aorta and coronary arteries are strongly correlated with blood cholesterol levels.
  • Populations experiencing severe dietary (especially fat) limitations and weight loss have been shown to have less atherosclerosis, coronary heart disease, and fewer heart attacks.
  • Prospective studies such as the Framingham study have shown that elevated blood cholesterol levels in healthy people predict the future occurrence of coronary heart disease.
  • Evidence emerging from multiple clinical trials, reviewed in the next section, clearly indicates that lowering blood cholesterol levels in patients with hypercholesterolemia decreases the likelihood of fatal and nonfatal coronary heart disease.

Thus, the evidence obtained from genetic, experimental, epidemiologic, and clinical intervention investigations overwhelmingly supports a causal relationship between blood cholesterol levels and coronary heart disease.

Will Reduction of Cholesterol Levels Help Prevent Coronary Heart Disease?

Our conclusion that reduction of blood cholesterol levels will reduce the rate of coronary heart disease is based partly on the evidence for cause-and-effect presented above and partly on the direct evidence from clinical trials noted below.

First, metabolic ward studies establish beyond reasonable doubt three dietary maneuvers that lower blood cholesterol levels: reducing the saturated fat content, increasing the polyunsaturated fat content, and reducing the cholesterol content. Second, a number of drugs have been developed that lower blood cholesterol levels. The issue of whether these interventions also influence coronary heart disease events has been more challenging.

In previous years, more than a dozen randomized trials of the effects of fat-controlled diets or drugs have been reported. Most showed some decrease in coronary heart disease event rates in the treated group, and the dietary trials carried out by Dayton et al. and by Leren et al. were particularly suggestive, producing 23 percent and 35 percent reductions in the incidence of coronary heart disease. However, no study considered individually could be regarded as conclusive: the sample sizes were too small, and there were in some cases unanticipated increases in non-cardiovascular deaths, although these were not statistically significant. An aggregate analysis of all unifactor blood-cholesterol-lowering trials, while not revealing an effect on total mortality, does indicate that coronary heart disease rates can be reduced by reduction of blood cholesterol levels.

These findings have been extended by two recently reported randomized and blinded clinical trials of the efficacy of the cholesterol-lowering drug, cholestyramine. One of these studies, the Lipid Research Clinics Coronary Primary Prevention Trial, showed a statistically significant 19 percent reduction in the combined rate of fatal and nonfatal coronary heart disease in association with a 9 percent decrease in blood cholesterol level. The other study, the NHLBI Type II Coronary Intervention Study, showed a reduction in the angiographic progression of coronary artery disease. In addition, a third trial (the Coronary Drug Project) has recently presented information extending the earlier published finding that the use of nicotinic acid lowers the rate of recurrent coronary heart disease by demonstrating in long-term followup a decrease in overall mortality.

These findings, taken in conjunction with the results of the earlier studies, permit the conclusion that reduction of blood cholesterol level in people with relatively high initial levels will reduce the rate of coronary heart disease. The clinical trials are too limited to settle the issue of effects on overall mortality. However, the complete set of evidence, which includes information derived from animal, pathophysiological, metabolic, and epidemiologic studies, makes it reasonable to presume that the reduction in coronary heart disease incidence will be accompanied by a reduction in overall mortality.

The magnitude of the reduction in coronary heart disease risk can be estimated from these clinical trials; they indicate that each 1 percent reduction in blood cholesterol level yields approximately a 2 percent reduction in coronary heart disease rates. This is remarkably similar to the magnitude of the beneficial outcome predicted from observational epidemiologic studies. Thus, for example, a 5 percent reduction in blood cholesterol level resulting from the diets recommended below should reduce coronary heart disease rates by 10 percent. The absolute magnitude of this benefit should be greater in patients at high risk because of existing coronary heart disease or the presence of other risk factors such as cigarette smoking and hypertension. Reductions in disease rates of as much as 50 percent may be achievable in high-risk cholesterol patients who adhere well to a combination of effective drug treatment and a fat-controlled diet.

Under What Circumstances and at What Level of Blood Cholesterol Should Dietary or Drug Treatment Be Started?

What Is Hypercholesterolemia?

A precise definition of hypercholesterolemia (an abnormally high blood cholesterol level) is difficult to establish. Often, an abnormally high level of a biologic substance is considered to be that level above which are found the upper 5 percent of the population (the 95th percentile). However, the use of this criterion in defining "normal" values for blood cholesterol levels in the United States is unreasonable; coronary heart disease is our major cause of death and, in part at least, because a large fraction of our population probably has too high a blood cholesterol level. A review of available data suggests that levels above 200 and 230 mg/dl are associated with an increased risk of developing premature coronary heart disease. It is staggering to realize that this represents about 50 percent of the adult population of the United States. The consensus panel has chosen to define two levels of hypercholesterolemia, both of which are associated with an increased coronary heart disease risk, and both of which should be treated.

High-Risk Blood Cholesterol (Severe Hypercholesterolemia)

This category is defined as values at approximately the 90th percentile or above as determined by the Lipid Research Clinics Prevalence Study (see table for guidelines). It will include individuals with hereditary forms of high blood cholesterol and will require the most aggressive treatment. Withholding treatment subjects these individuals to unnecessary risk.

Table 1. Table Values for Selecting Adults at Moderate and High Risk Requiring Treatment.

Table 1

Table Values for Selecting Adults at Moderate and High Risk Requiring Treatment.

Moderate-Risk Blood Cholesterol (Moderate Hypercholesterolemia)

This category is defined as values approximately between the 75th to 90th percentiles (see table for guidelines). It includes large numbers of people whose elevated blood cholesterol is due, in part, to their diet. The intensity of treatment is guided by the clinical and family history and the presence of other risk factors predisposing to coronary heart disease.

How Should Adults With Hypercholesterolemia Be Treated?

The presence of high-risk and moderate-risk blood cholesterol should be confirmed by a repeat analysis. Although the initial sample may be obtained nonfasting, the repeat analysis should be obtained after an overnight fast so that a valid triglyceride level also can be determined.

After the secondary causes for hypercholesterolemia (e.g., hypothyroidism, nephrotic syndrome, dysproteinemias, diabetes mellitus, and obstructive liver disease) have been excluded, the primary cause should be evaluated. This includes family screening to detect the hereditary forms of elevated blood cholesterol and to identify other family members needing treatment. Measurement of HDL cholesterol is often helpful to determine if the elevated blood cholesterol is due to high levels of HDL (which is associated with a lower risk of coronary heart disease). In addition, a low HDL cholesterol (an independent risk factor) might guide a physician to be more aggressive in treatment of individuals with high or moderately high blood cholesterol.

Diet Therapy

The first step in the treatment of high-risk and moderate-risk blood cholesterol is diet therapy and caloric restriction for weight normalization in the overweight. Weight loss may reduce blood cholesterol, and a moderate level of physical exercise may be helpful in this regard. The dietary approach should be to lower total fat, saturated fat, and cholesterol consumption. The following guidelines are generally consistent with those of the American Heart Association and the Atherosclerosis Study Group of the Inter-Society Commission for Heart Disease Resources. We recommend a diet composed of approximately 30 percent of the caloric intake from fats and no more than 250 to 300 mg of cholesterol a day. An essential consideration is a reduction of the total saturated fat intake to 10 percent or less of total calories. It is recommended that polyunsaturated fat intake be increased but to no more than 10 percent of total calories. These changes can be readily made while maintaining intake of protein, vitamins, and minerals to satisfy the Recommended Dietary Allowances of the Food and Nutrition Board of the National Research Council.

Insufficient response to this diet may necessitate further restrictions of total fat to 20 to 25 percent of calories with saturated fat comprising 6 to 8 percent of the calories. The dietary cholesterol should be lowered to 150 to 200 mg/day (equivalent to American Heart Association Phases II and III diets).

The use of diet as a primary mode of therapy requires a major effort on the part of physicians, nutritionists, dietitians, and other health professionals. Lifestyle changes are difficult without adequate instruction, motivation, and encouragement. Education of physicians, as well as the general public, as to the value of reductions in dietary saturated fat and cholesterol will assist not only with treatment of patients with high- or moderate-risk blood cholesterol but also in achieving the goal of reducing the blood cholesterol levels of our entire adult population to less than 200 mg/dl (less than 180 mg/dl in those under age 30).

Drug Therapy

Drug therapy should be used only after a careful trial of diet modification using the most rigorous diet appropriate for the particular individual. Even when drugs seem appropriate, it is important to stress that maximal diet therapy should be continued. Several drugs, used singly or in combination, are now available. These include the bile-acid sequestrants (cholestyramine and colestipol), nicotinic acid, probucol, and the fibric acids (clofibrate and gemfibrozil). Of these, bile-acid sequestrants and nicotinic acid have been shown to reduce coronary heart disease. Clofibrate, while effective in treating one rare familial form of lipid abnormality (Type III hyperlipoproteinemia), is not recommended because it is not effective in most individuals with a high blood cholesterol level but normal triglyceride level. Moreover, an excess overall mortality was reported in the World Health Organization trial of this drug. We still do not have direct evidence for the safety of any cholesterol-lowering drugs when given over decades; therefore, drug treatment should be undertaken cautiously and its desirability should be periodically reevaluated, particularly in children.

Individuals with high-risk blood cholesterol (severe hypercholesterolemia), especially those with the hereditary form, may well require drug therapy in addition to dietary modification. Combined drug treatment (e.g., bile-acid sequestrant plus nicotinic acid) may be particularly effective. Several combined treatment regimens are under study. Individuals with moderate-risk blood cholesterol will usually respond adequately to diet alone. Judgment on the decision to use drugs in such patients must be made on a case-by-case basis, taking into account family history of coronary heart disease, existing coronary disease in the individual, coexistence of other risk factors, and age of the individual.

Who Should Be Treated?

As described above, individuals with high- and moderate-risk cholesterol levels (greater than the 75th percentile) should be treated with diet or diet and drugs. Furthermore, it is clearly recognized that it is a goal to encourage reduction of the blood cholesterol to approximately 180 mg/dl for adults under the age of 30 years and to approximately 200 mg/dl for individuals age 30 or older. This is recognized as a realistic "target" level that should be possible to achieve and that would be predicted to have a beneficial effect on coronary heart disease risk. As will be discussed in the following section, it is recommended that all individuals in the population consume a diet composed of approximately 30 percent of the calories as fat (10 percent or less saturated fat) and 250 to 300 mg of cholesterol a day in an attempt to shift the blood cholesterol levels in our population toward the lower levels observed in populations having much lower rates of coronary heart disease.

Both men and women at high risk, as defined above, should be treated similarly, even though premenopausal women have an apparent protection, and the onset of the disease occurs later than in men. However, as in men, the leading cause of death in women is coronary heart disease, and blood cholesterol is a risk factor. Despite the fact that direct intervention studies have not been conducted in women, there is no reason to propose a separate treatment schedule for women.

Studies are available that indicate a beneficial effect of treating high cholesterol levels in individuals with preexisting clinical disease (secondary intervention) as well as in individuals without preexisting clinical disease (primary intervention). Because of their vulnerability, patients with established disease, including particularly patients with coronary bypass grafts, should be intensively treated. It is encouraging that the progression of established lesions may be retarded by appropriate dietary and drug therapy. The same may apply to the elderly patient. While there is no direct evidence on the benefit to be expected in the elderly, and while blood cholesterol becomes less important as a risk factor in old age, dietary treatment (with due attention to ensure nutritional adequacy) may still be helpful.

Special Guidelines for Management of Children

Identifying and treating children with elevated blood cholesterol levels is a subject for special consideration. It is desirable to begin prevention in childhood because patterns of lifestyle are developed in childhood. The moderate-fat and moderate-cholesterol diets recommended for the population at large in this report should be suitable for all family members, including healthy children over the age of 2 years. For children, the diets should provide all nutrients in quantities adequate to assure growth and development and meet energy requirements. Excessive gain in weight should be avoided. The diet may be inappropriate in children or in the elderly if they are malnourished or have special nutritional requirements. For others, the diet plan is safe and nutritionally adequate.

Children at "high-risk" should be identified primarily by carefully obtained family histories rather than routine screening. The history should include parents, grandparents, and all first-degree relatives. A family history of hypercholesterolemia or premature coronary heart disease should alert the physician to obtain at least two blood cholesterol determinations. If the blood cholesterol level in such "high-risk" children is above the 75th percentile (approximately 170 mg/dl for ages 2 to 19 years), total and HDL cholesterol should be obtained. Those children with blood cholesterol levels between the 75th and 90th percentile (170 to 185 mg/dl) should be counseled regarding diet and other cardiovascular risk factors and then followed at 1-year intervals. Those with levels above the 90th percentile (over 185 mg/dl) require special dietary instruction and close supervision with evaluation of other risk factors. A child with a blood cholesterol level above the 95th percentile (greater than 200 mg/dl) on two occasions is in a special category and may have one of the hereditary hypercholesterolemias. Strict dietary intervention is indicated and will be sufficient for many children. Nonresponders should be considered for treatment with a lipid-lowering agent, e.g., bile-acid sequestrant (such as cholestyramine). All family members should be screened.

Dietary management of children with elevated blood cholesterol levels should be part of total management that includes regular exercise programs, maintenance of ideal weight, avoidance of excess salt and avoidance of cigarette smoking.

What Screening Strategy Should Be Adopted for Finding Subjects With High Blood Cholesterol?

According to data from the National Center for Health Statistics, a high percentage of the American population sees a physician at least once every year. If a cholesterol level were determined on adults at these visits, many of the individuals with cholesterol levels above the 75th percentile would be identified in a relatively short time and should be evaluated and treated as described above. This physician- and clinic-oriented method for screening would be cost-effective. Obviously, some patients may not see a physician for several years, and it would be advisable to educate the public to the importance of knowing one's cholesterol level. In children, only a "family history screening" is recommended, that is, cholesterol levels should be obtained in those at higher risk because of a strong family history, as discussed above. Educational programs developed by voluntary and public health organizations in conjunction with the National Cholesterol Education Program of the National Heart, Lung, and Blood Institute, as recommended by this consensus panel, should alert all adults to the advisability of learning their cholesterol level.

While we are not at this time recommending mass screening, a feasibility study of various screening methods in adults should be considered. Screening necessitates the availability of laboratories capable of determining precisely and accurately the blood cholesterol and HDL cholesterol levels and of physicians willing and able to manage large numbers of new patients. Thus, preliminary steps are needed before mass screening can be considered.

Should an Attempt Be Made To Reduce the Blood Cholesterol of the General Population?

Rationale for Recommendations to the General Population

Many compelling lines of evidence link blood cholesterol to coronary heart disease. There is also good evidence from epidemiologic studies that the relationship between level of cholesterol and level of risk for coronary heart disease covers virtually the entire cholesterol distribution for the U.S. population. In fact, recent epidemiologic studies suggest that the relationship holds even at the lower end of the spectrum of cholesterol levels found in our population.

The Japanese population, in comparison with the U.S. population, is characterized by a much lower average cholesterol level and a much lower frequency of coronary heart disease. The Finnish, on the other hand, have a much higher average cholesterol level and a much greater risk of coronary heart disease than do U.S. citizens. Furthermore, Japanese who have migrated to Hawaii and to San Francisco have higher cholesterol levels and a higher risk of coronary heart disease than nonmigrants. Compilation of all the available data suggests that it will be beneficial to lower the blood cholesterol of the average American.

In recent years, Americans have been changing their habitual diet in the direction we recommend, that is, by reducing their intake of total fat, saturated fat, and cholesterol and by increasing intake of polyunsaturated fat. This has been accompanied by a substantial reduction in the average blood cholesterol of the population. In addition, all-cause mortality, cardiovascular mortality, and coronary heart disease mortality have also decreased, but it is difficult to determine with certainty how much, if any, of this decrease is due to changes in diet, blood pressure, cigarette usage, or improved medical care. It is hoped that improved surveillance systems will clarify these issues.


In the general population, the basic intervention should be based on diet rather than drugs. We recommend a shift from the current typical American diet to one that is lower in total fat, saturated fat, and cholesterol. Diets with these characteristics are the usual diets consumed in a number of other countries, e.g., Japan and Greece. Life expectancy in these two countries is, at virtually every age, greater than that in the United States. This applies also to the life expectancy in middle age, when mortality from coronary heart disease begins to rise sharply.

The evidence justifies for men, women, and children ages 2 years and older the reduction of calories from fat from the present average level of 40 percent to 30 percent, calories from saturated fat to 10 percent or less, and dietary cholesterol to no more than 250 to 300 mg daily. We recommend that calories from polyunsaturated fat be increased, but not exceed 10 percent of total calories. This diet is generally consistent with the most recent recommendations of the American Heart Association and the Atherosclerosis Study Group of the Inter-Society Commission on Heart Disease Resources. Equally important, individuals, health professionals, and health agencies must recognize the need to control obesity both to aid in controlling blood cholesterol levels and to reduce the other health risks of obesity. Other elements important to the prevention of cardiovascular disease, including avoidance of cigarettes, control of high blood pressure, and maintenance of reasonable levels of physical activity are recommended.

Means of Implementing Dietary Recommendations in the General Population

  • If dietary intervention in the general population is to be effective, the eating habits of the entire family must be changed. Thus, the recommended diet should be available to all family members except those under age 2.
  • Educational services that enable adults and children to make informed choices concerning their eating habits should be readily available, including ready availability of data on composition of natural and processed foods.
  • Professional educational programs for physicians, dietitians, and other health professionals should be expanded to include adequate material on diet and heart disease.
  • Specific food items consistent with the recommended diet should be available, accessible, and affordable.
  • The food industry should accelerate its current efforts to develop, produce, and market leaner meats and other foods, including dairy products, with reduced total fat, saturated fat, and cholesterol content.
  • Restaurants, including fast-food outlets, should make foods satisfying these diet recommendations available to their customers.
  • Government and school food programs should serve meals consistent with these recommendations.
  • Food labeling should include total calories, fat source and total fat, saturated fat, polyunsaturated fat, and cholesterol content as well as other essential nutritional information. If necessary, appropriate statutory or other changes to require such labeling should be seriously considered.
  • A national cholesterol education program should be implemented for physicians, other health professionals (including those in training) and the public; its effectiveness should be periodically evaluated.

What Research Directions Should Be Pursued on the Relationship Between Cholesterol and Heart Disease?

We know that blood cholesterol is causally related to coronary heart disease and that the atherosclerotic process can be influenced by intervention. However, much about lipid metabolism and about the mechanisms of the atherosclerotic process remains unknown.

  • Cellular and Molecular Biology --A better understanding of lipoprotein production and removal, lipoprotein receptors, and apolipoproteins is needed. More information is needed with regard to factors controlling the level of HDL and its role in preventing coronary heart disease. To learn whether diets very high in polyunsaturated fatty acids have any adverse effects, more information is needed regarding their biochemical and biological effects, including those of the highly unsaturated fatty acids found in fish oils. Research is also needed on the biology of vessel wall injury, on the cells that participate in atherosclerosis, and on the events that trigger thrombosis in atherosclerotic vessels.
  • Clinical Investigation --Precisely defined diets and pharmacologic interventions to reduce blood cholesterol and other lipids must be studied in individuals under carefully controlled conditions. Research on the effectiveness of regimens to lower blood cholesterol and influence atherosclerosis, including surgical intervention, should also be conducted. Evaluation of these may involve atherosclerotic plaque measurement using safe, precise imaging techniques such as ultrasound, regional radioscintigraphy, magnetic resonance, and/or computer-enhanced radiography.
  • Pharmacologic Research --New compounds that are more effective, economical, and safe for the reduction of blood cholesterol are needed. Development of improved, more palatable, and less expensive bile-acid sequestrants also is needed. Similarly, a search for pharmacologic agents that would favorably influence other elements of the atherosclerotic process is highly desirable.
  • Food Product Research --The interface of human nutrition and human disease requires collaborative efforts within the agricultural, industrial, and health research communities. More food products that are high in nutrition quality and taste, yet low in fat and cholesterol, need to be developed.
  • Research in Human Behavior --Study of how people choose their diets and how food habits can be improved is necessary. Studies designed to measure and enhance adherence to new nutritional behaviors and treatment programs are needed.
  • Epidemiologic Investigation --The search for additional factors that initiate or affect the atherosclerotic process must be continued along with further studies of risk factors in major population subgroups, including blacks. As nutritional practices of the population change and as health professionals improve management of elevated blood cholesterol levels, ongoing monitoring of nutritional patterns, blood cholesterol levels, and disease and death outcomes is essential. An important corollary will be monitoring to assess disease incidence, prevalence, and case fatality rates. Research to assess the effects of blood cholesterol reduction on cardiovascular and all-cause mortality is needed. Overall safety of long-term intervention with diet and drugs should be investigated.
  • Secondary Prevention --The effectiveness of lowering blood cholesterol by medical or surgical intervention to retard or reverse atherosclerotic lesions in arteries or bypass grafts of patients with established coronary heart disease requires further investigation.
  • Community Applications --Community demonstration research to test the effectiveness of nutrition-educational programs that influence food choices and other risk-factor behaviors of the healthy free-living population is needed.

Consensus Development Panel

  • Daniel Steinberg, M.D., Ph.D. (Chairman)
  • Professor of Medicine
  • Director, Specialized Center of Research on Arteriosclerosis
  • Department of Medicine
  • University of California, San Diego
  • La Jolla, California
  • Sidney Blumenthal, M.D.
  • Former Senior Consultant to Vice President for Health Sciences
  • Columbia University
  • New York, New York
  • Richard A. Carleton, M.D.
  • Chief of Cardiology
  • Memorial Hospital and Brown University
  • Pawtucket, Rhode Island
  • Nancy H. Chasen, A.B., J.D.
  • Public Interest Attorney
  • Chairman
  • Montgomery County Consumer Affairs Advisory Committee
  • Bethesda, Maryland
  • James E. Dalen, M.D., M.P.H.
  • Professor and Chairman
  • Department of Medicine
  • University of Massachusetts Medical School
  • Physician-in-Chief
  • University of Massachusetts Medical Center
  • Worcester, Massachusetts
  • John T. Fitzpatrick, Esq.
  • Attorney at Law
  • Law Offices of Fitzpatrick and Fray
  • Past Chairman
  • American Heart Association
  • Fairfield, Connecticut
  • Stephen B. Hulley, M.D., M.P.H.
  • Professor of Epidemiology and Medicine
  • University of California, San Francisco
  • San Francisco, California
  • Robert W. Mahley, M.D., Ph.D.
  • Director
  • Gladstone Foundation Laboratories
  • Professor of Pathology and Medicine
  • University of California, San Francisco
  • San Francisco, California
  • Gregory O'Keefe III, M.D.
  • Islands Community Medical Center
  • Vinalhaven, Maine
  • Richard D. Remington, Ph.D.
  • Vice President for Academic Affairs
  • The University of Iowa
  • Iowa City, Iowa
  • Elijah Saunders, M.D.
  • Associate Professor, Department of Medicine
  • Head, Division of Hypertension
  • University of Maryland School of Medicine
  • Baltimore, Maryland
  • Robert E. Shank, M.D.
  • Danforth Professor of Preventive Medicine and Medicine (Emeritus)
  • Washington University School of Medicine
  • St. Louis, Missouri
  • Arthur A. Spector, M.D.
  • Professor of Biochemistry
  • Director, Arteriosclerosis Specialized Center of Research
  • University of Iowa
  • Iowa City, Iowa
  • Robert W. Wissler, M.D., Ph.D.
  • Donald N. Pritzker Distinguished Service Professor of Pathology
  • Senior Scientist of Atherosclerosis
  • Specialized Center for the Research of Atherosclerosis
  • Department of Pathology
  • University of Chicago
  • Chicago, Illinois


  • E. H. Ahrens, Jr., M.D.
  • "The Lack of Appropriateness (at this time) of Public Health Measures to Change American Dietary Habits to Reduce Blood Cholesterol Levels"
  • Professor
  • The Rockefeller University
  • New York, New York
  • Edwin L. Bierman, M.D.
  • "Identification and Management of Individuals With Moderately Elevated Cholesterol"
  • Director
  • Professor of Medicine
  • Head, Division of Metabolism, Endocrinology, and Nutrition
  • Department of Medicine
  • University of Washington
  • Seattle, Washington
  • Henry Blackburn, M.D.
  • "The Appropriateness of Public Health Measures to Change American Dietary Habits to Reduce Blood Cholesterol Levels"
  • Professor and Director
  • Division of Epidemiology
  • University of Minnesota School of Public Health
  • Minneapolis, Minnesota
  • David H. Blankenhorn, M.D.
  • "Studies of Cholesterol Lowering and Lesions in Man"
  • Professor of Medicine
  • Director, Atherosclerosis Research
  • Department of Medicine
  • University of Southern California School of Medicine
  • Los Angeles, California
  • Virgil Brown, M.D.
  • "Efficacy of Drug Management and Associated Risks"
  • Professor of Medicine
  • Chief
  • Division of Arteriosclerosis and Metabolism
  • Mount Sinai School of Medicine
  • New York, New York
  • Thomas B. Clarkson, D.V.M.
  • "Evidence from Pathology and Animal Models"
  • Professor of Comparative Medicine
  • Department of Comparative Medicine
  • Wake Forest University
  • Bowman Gray School of Medicine
  • Winston-Salem, North Carolina
  • William E. Connor, M.D.
  • "Maximal Plasma Cholesterol Lowering From Diet"
  • Professor of Medicine
  • Oregon Health Sciences University
  • Portland, Oregon
  • Howard A. Eder, M.D.
  • "What Research Directions Should Be Pursued on the Relationship Between Blood Cholesterol and Heart Disease?"
  • Professor of Medicine
  • Albert Einstein College of Medicine
  • New York, New York
  • Joseph L. Goldstein, M.D.
  • "Metabolic and Genetic Evidence: How LDL Receptors Influence Cholesterol Metabolism and Atherosclerosis"
  • Chairman
  • Paul J. Thomas Professor of Genetics
  • Department of Molecular Genetics
  • University of Texas Health Science Center
  • Dallas, Texas
  • DeWitt S. Goodman, M.D.
  • "Identification and Management of Individuals With Markedly Elevated Cholesterol"
  • Tilden-Weger-Bieler Professor of Preventive Medicine
  • Columbia University College of Physicians and Surgeons
  • New York, New York
  • Antonio M. Gotto, Jr., M.D., D.Phil.
  • "What Are the Optimal Cholesterol Levels Toward Which We Should Aim for the American Public at Large?"
  • Chairman
  • Department of Medicine
  • Baylor College of Medicine
  • The Methodist Hospital
  • Scientific Director
  • National Heart, Lung, and Blood Institute
  • Houston, Texas
  • Scott M. Grundy, M.D., Ph.D.
  • "Efficacy of Dietary Management and Associated Risks"
  • Professor of Internal Medicine and Biochemistry
  • Director
  • Center for Human Nutrition
  • University of Texas Health Science Center
  • Dallas, Texas
  • David Kritchevsky, Ph.D.
  • "Dietary Management of Hypercholesterolemia"
  • Associate Director and Institute Director
  • The Wistar Institute
  • Philadelphia, Pennsylvania
  • Robert I. Levy, M.D.
  • "The Nature of Plasma Cholesterol and the Population Distribution of Cholesterol Levels"
  • Professor of Medicine
  • Columbia University College of Physicians and Surgeons
  • New York, New York
  • Kristen McNutt, Ph.D., J.D.
  • "The Role of Public Education Regarding Cholesterol and Heart Disease"
  • Associate Director
  • Good Housekeeping Institute
  • New York, New York
  • Walter H. Meyer
  • "The Role of the Food Industry"
  • Associate Director
  • Food Product Development
  • The Procter and Gamble Company
  • Cincinnati, Ohio
  • Michael F. Oliver, M.D., F.R.C.P.
  • "Screening for Hypercholesterolemia"
  • Duke of Edinburgh Professor of Cardiology
  • Cardiovascular Research Unit University of Edinburgh
  • Robert E. Olson, M.D., Ph.D.
  • "Does Lowering Blood Cholesterol Prevent Heart Disease? A Critique of the Evidence"
  • Professor of Medicine and Pharmacological Sciences
  • State University of New York,
  • Stony Brook School of Medicine
  • Stony Brook, New York
  • Richard Peto, M.Sc.
  • "Summary of Results From Dietary and Drug Intervention Trials"
  • Reader in Cancer Studies
  • Clinical Trial Service Unit
  • Radcliffe Infirmary
  • Oxford
  • Basil M. Rifkind, M.D., F.R.C.P.
  • "Evidence From the CPPT"
  • Chief Lipid Metabolism-Atherogenesis Branch
  • National Heart, Lung, and Blood Institute
  • National Institutes of Health
  • Bethesda, Maryland
  • Jeremiah Stamler, M.D.
  • "Evidence From Prospective and Other Epidemiological Studies"
  • Professor and Chairman
  • Department of Community Health and Preventive Medicine
  • Northwestern University Medical School
  • Chicago, Illinois
  • Daniel Steinberg, M.D., Ph.D.
  • "Presentation of
  • Consensus Statement"
  • Professor of Medicine
  • Director, Specialized Center of Research on Arteriosclerosis
  • Department of Medicine
  • University of California, San Diego
  • La Jolla, California
  • Herman A. Tyroler, M.D.
  • "Relationship of Clinical Trial Findings to Epidemiologic Data"
  • Professor of Epidemiology
  • University of North Carolina at Chapel Hill School of Public Health
  • Chapel Hill, North Carolina

Planning Committee

  • Basil M. Rifkind, M.D., F.R.C.P. (Chairman)
  • Associate Deputy Director for Atherogenesis Lipid Metabolism-Atherogenesis Branch
  • National Heart, Lung, and Blood Institute
  • National Institutes of Health
  • Bethesda, Maryland
  • Michael J. Bernstein
  • Director of Communications
  • Office of Medical Applications of Research
  • National Institutes of Health
  • Bethesda, Maryland
  • Larry Blaser
  • Chief
  • Research Reporting Section
  • Public Inquiries and Reports Branch
  • National Heart, Lung, and Blood Institute
  • National Institutes of Health
  • Bethesda, Maryland
  • Susan Clark
  • OMAR Coordinator
  • Social Science Analyst
  • Office of Medical Applications of Research
  • Office of the Director
  • National Institutes of Health
  • Bethesda, Maryland
  • Charles Glueck, M.D.
  • Lipid Research Clinic
  • Cincinnati General Hospital
  • Cincinnati, Ohio
  • William Hazzard, M.D.
  • Department of Medicine
  • Johns Hopkins Hospital
  • Baltimore, Maryland
  • Kenneth Lippel, Ph.D.
  • Program Coordinator
  • Health Scientist Administrator
  • Lipid Metabolism-Atherogenesis Branch
  • National Heart, Lung, and Blood Institute
  • National Institutes of Health
  • Bethesda, Maryland
  • Albert Oberman, M.D.
  • Professor and Chairman
  • Department of Preventive Medicine
  • University of Alabama Medical Center
  • Birmingham, Alabama

Conference Sponsors

  • National Heart, Lung, and Blood Institute
  • Claude Lenfant, M.D.
  • Director
  • Office of Medical Applications of Research
  • Itzhak Jacoby, Ph.D.
  • Acting Director

This statement was originally published as: Lowering Blood Cholesterol To Prevent Heart Disease. NIH Consens Statement 1984 Dec 10-12; 5(7):1-11.

For making bibliographic reference to the statement in the electronic form displayed here, it is recommended that the following format be used: Lowering Blood Cholesterol To Prevent Heart Disease. NIH Consens Statement Online 1984 Dec 10-12 [cited year month day]; 5(7):1-11.

NIH Consensus Statements are prepared by a nonadvocate, non-Federal panel of experts, based on (1) presentations by investigators working in areas relevant to the consensus questions during a 2-day public session; (2) questions and statements from conference attendees during open discussion periods that are part of the public session; and (3) closed deliberations by the panel during the remainder of the second day and morning of the third. This statement is an independent report of the consensus panel and is not a policy statement of the NIH or the Federal Government.


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