The National Cholesterol Education Program: Title and subTitle BreakProgress and Prospects

IN ITS 50 years of existence, the National Heart, Lung, and Blood Institute (NHLBI) has played a vital role in the fight against cardiovascular disease (CVD). The NHLBI has not only been the principal source of support for biomedical research in the prevention and treatment of CVD, but has also acted as a catalyst for translating research advances into meaningful improvements in clinical and public health practice. The institute has fulfilled this latter role through the development and maintenance of a set of highly focused education programs. The current portfolio includes efforts directed to the CVD risk factors of high blood cholesterol, high blood pressure, and obesity, early recognition of acute myocardial infarction, and asthma in the pulmonary area. All of these education programs adhere to the 2 guiding principles of building on a firm science base and acting in partnership with other organizations.

The National Cholesterol Education Program (NCEP) is a prime example of the NHLBI's catalytic role in promoting improved prevention and treatment of CVD. The program's goal is to reduce the prevalence of high blood cholesterol and thereby contribute to reducing coronary heart disease (CHD) morbidity and mortality in the United States. Through educational efforts directed to health professionals, patients, and the public, the NCEP aims to raise awareness and understanding of high blood cholesterol as a risk factor for CHD and the benefits of lowering cholesterol levels as a means of preventing CHD. In slightly more than a decade, the NCEP has raised the consciousness of physicians and the public and has registered substantial progress in the effort to lower blood cholesterol levels in the United States. This progress has been made possible by the program's success in meeting the 2 early and continuing challenges identified above: building the NCEP on a strong science base and establishing a set of wide-ranging partnerships with organizations in the private and public sectors.

For many years, scientific evidence has linked blood cholesterol levels to CHD. Data from the NHLBI's Framingham Heart Study¹ showed that the higher the cholesterol level, the greater the risk for developing CHD and sustaining a CHD event. Migration studies demonstrated that a shift to a diet higher in saturated fat was associated with a rise in blood cholesterol levels and CHD rates,² and international comparisons highlighted a direct relationship between dietary intakes of saturated fat, blood cholesterol levels, and CHD rates.³ Results of animal, genetic, and biochemical studies also pointed to a direct connection between cholesterol levels and CHD.^{4 - 6} However, it was not until January 1984 that the Lipid Research Clinics Coronary Primary Prevention Trial (CPPT),⁷ a multicenter study funded by the NHLBI, provided the long-sought, definitive evidence that lowering high cholesterol levels actually reduces the risk for nonfatal myocardial infarction and CHD death.

Once the CPPT results were in hand, the NHLBI convened, in December 1984, a Consensus Development Conference on Lowering Blood Cholesterol to Prevent Heart Disease⁸ to examine all of the evidence relating cholesterol and CHD. The conference concluded that (1) high blood cholesterol is a cause of CHD and (2) lowering high cholesterol levels will reduce CHD risk. The conference also voiced support for the institute's plans to develop an educational program on cholesterol, since survey results showed that neither physicians nor the public were adequately informed of the facts about cholesterol and CHD. In early 1985, the NHLBI held a series of planning meetings for the proposed cholesterol education program with potential partner organizations, and in November 1985 the institute officially launched the NCEP.

Recent clinical trials have provided conclusive evidence for the benefits of cholesterol lowering and have significantly reinforced the science base of the NCEP. Earlier studies, such as the CPPT, had used agents that reduced total cholesterol levels by an average of only about 10%. The recent studies have used newer 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins), which have typically lowered total cholesterol levels by 25% and low-density lipoprotein (LDL) cholesterol levels by 35%. This substantially greater degree of cholesterol lowering has provided a much better test of the effects of cholesterol intervention.

The recent trials have demonstrated that cholesterol lowering reduces CHD end points significantly in 4 types of patients covering the range of risk for CHD: those with CHD and high cholesterol levels in the Scandinavian Simvastatin Survival Study (4S),⁹ those with CHD and average cholesterol levels in the Cholesterol and Recurrent Events Trial (CARE)¹⁰ and the Long-Term Intervention with Pravastatin in Ischaemic Disease Study (LIPID),¹¹ those without CHD and with high cholesterol levels in the West of Scotland Coronary Prevention Study (WOSCOPS),¹² and those without CHD and with average cholesterol levels in the Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS).¹³ An overview analysis of 16 statin trials,¹⁴ which was published in mid 1997 and which included 4S, CARE, and WOSCOPS, showed that cholesterol lowering produces large and highly significant reductions in CHD deaths and all CHD (nonfatal myocardial infarctions and CHD deaths). In patients with and without CHD, the analysis showed that cholesterol lowering significantly reduces CVD deaths, does not increase non-CVD deaths or cancer mortality or incidence, and consequently produces a significant reduction in total mortality. This analysis found that lowering cholesterol levels also reduces the risk for stroke. These results provide powerful evidence for the efficacy and safety of cholesterol lowering.

From its inception, the NCEP has relied on the power of partnership to promote implementation of its strategies and guidelines. The very planning of the program was carried out in concert with potential partner organizations in the private and public sectors, including the American Medical Association, the American College of Cardiology, the American Heart Association, and a variety of consumer groups. Representatives of these organizations met with the NHLBI in a series of 4 planning workshops to identify the program elements and strategies that the NCEP would use in educating professionals, patients, and the public.

The event that launched the NCEP in November 1985 was the inaugural meeting of the program's coordinating committee, which embodies the principle of partnership. The coordinating committee membership comprises more than 40 partner organizations representing major medical and health professional associations, voluntary health organizations, community programs, and governmental agencies. The coordinating committee is the NCEP's policy-setting body and board of directors, and it has transformed what would otherwise be a federal project into a national program. The members of the coordinating committee not only make recommendations about program directions and priorities but also take these directions and priorities back to their own organizations and conduct cholesterol education activities with their constituencies. The coordinating committee has played an active role in mobilizing and coordinating the resources and energies of all interested organizations to achieve the goals of the NCEP and has significantly expanded the scope and reach of the program.

Epidemiological data demonstrate that the risk for CHD is directly related to the level of blood cholesterol. Figure 1 shows the curve, derived from more than 360,000 men screened for the Multiple Risk Factor Intervention Trial (MRFIT),¹⁵ relating CHD mortality to serum total cholesterol levels. Coronary heart disease risk rises slowly and continuously as total cholesterol levels increase from 150 to 200 mg/dL (3.9-5.2 mmol/L), and CHD risk increases more rapidly past that point. At a level of 240 mg/dL (6.2 mmol/L), the risk for CHD is twice as high as that at 200 mg/dL (5.2 mmol/L), and at levels of 240 to 300 mg/dL (6.2-7.8 mmol/L), the likelihood of CHD is more than 4-fold as high as at 150 to 200 mg/dL (3.9-5.2 mmol/L).

Based on the current distribution of blood cholesterol levels, approximately 29% of US adults require a program of medically supervised cholesterol lowering through life-habit modification (ie, by altering diet, increasing physical activity, and controlling weight) as the primary treatment, because they have either high total and LDL cholesterol levels or borderline high levels together with multiple other CHD risk factors.¹⁶ For these individuals at the upper end of the cholesterol distribution who are at significantly increased CHD risk, a high-risk or clinical approach is needed to promote the detection and treatment of their elevated cholesterol levels, so they can obtain the risk reduction clearly demonstrated in the clinical trials. However, individuals in the vast middle of the cholesterol distribution are also at increased CHD risk, because mean cholesterol levels in the United States are high by international standards. Countries in which CHD is rare have total cholesterol levels averaging about 130 to 140 mg/dL (3.4-3.6 mmol/L), whereas the mean total cholesterol level in the United States currently approximates 200 mg/dL (5.2 mmol/L) (National Center for Health Statistics, unpublished data, 1997). As a result, a population or public health approach is needed to lower average cholesterol levels by encouraging all Americans to adopt a low-saturated-fat and low-cholesterol eating pattern, be physically active, and control their weight. The high-risk and population approaches are entirely complementary in their effects on cholesterol lowering, and the strategy of combining these 2 approaches has the potential to produce the greatest impact on CHD risk.

Since 1985, the NCEP has carried out a wide array of educational activities directed to professionals, patients, and the public. Foremost among these has been the development of a series of expert panel reports, which have translated the science into guidelines for health care professionals and have served as the platform for developing recommendations and messages to patients and the public. The following panels have issued reports:

These reports have provided a strong basis for a variety of NCEP educational activities and products. For professionals, the program has developed educational kits for physicians, nurses, and dietitians to support clinical intervention and counseling; position papers on important issues; monographs and booklets; continuing medical education publications, videotapes, and programs; guidance on public cholesterol screening; and national conferences and symposia. For patients and the public, the NCEP has developed an interactive Web site providing information on cholesterol lowering for CHD patients; educational television specials; booklets for patients and fact sheets for the public; mass media campaigns, including public service announcements for television, radio, and print media to raise awareness, posters in airports and other public places, and ready-to-air educational radio segments; point-of-purchase nutrition education kits; booklets for children with high blood cholesterol and their parents; an information center for materials distribution; a toll-free telephone number to provide information on prevention and treatment of high blood cholesterol; and Cholesterol Month Kits in hard copy and electronic versions to support cholesterol education in September, which is annually designated as National Cholesterol Education Month.

In slightly more than a decade of existence, the NCEP has made significant strides toward its goal of reducing the prevalence of high blood cholesterol in the United States. Evidence of this progress is clearly visible in 4 major trends: increasing physician and public cholesterol awareness; declining dietary intakes of saturated fat, total fat, and cholesterol; falling serum cholesterol levels; and a continuing decline in CHD mortality rates. At the same time, cholesterol levels are still being undertreated, especially in patients with CHD, and there remain substantial challenges for the NCEP to address.

A central issue in cholesterol awareness is whether physicians have adopted core elements of the NCEP's clinical guidelines. The ATP guidelines^{5 - 6} recommend that total and HDL cholesterol be measured in all adults aged 20 years or older at least once every 5 years; that LDL cholesterol serve as the main index of the need for cholesterol-lowering therapy; that treatment with diet and/or drugs be initiated at levels substantially lower than had previously been the case; that similar treatment be applied to men and women; and that patients with CHD receive more aggressive treatment to achieve LDL goals that are set lower than for patients without CHD.

Cholesterol awareness surveys of physicians and the public²¹ that have been conducted by the NHLBI since 1983 demonstrate that the ATP guidelines have had a significant influence on clinical practice. More than 90% of physicians say they are aware of the guidelines, and almost 90% say they use the guidelines in their practice. In 1995, the percentage of physicians who reported that they routinely measure the blood cholesterol levels of new patients ranged from about 60% to 90%, depending on the age and sex of the patient, and 80% of physicians said they measure HDL as part of initial testing, up from 66% in 1990. From 1986 to 1995, the percentage of physicians who rated LDL cholesterol as a very important clinical marker for CHD rose from 34% to 75%, and LDL moved up from third place in importance, behind HDL and total cholesterol, to first place. In 1995, 88% of physicians said they assess LDL before deciding on treatment, compared with 80% in 1990. In 1983, the median range of cholesterol levels at which physicians reported initiating dietary therapy for high blood cholesterol was 260 to 279 mg/dL; in 1995, it had dropped to 200 to 219 mg/dL. For drug treatment, the median range at which physicians reported initiating therapy in 1983 was 340 to 359 mg/dL, a level so high that virtually no patients were being treated with cholesterol-lowering drugs; in 1995, it had fallen to 240 to 259 mg/dL. The current median levels for diet and drug therapy approximate the ATP recommendations. In addition, the mean total and LDL cholesterol levels at which physicians reported initiating treatment in 1995 were almost identical for men and women. In 1995, the median LDL level cited by physicians as desirable for patients free of CHD was 133 mg/dL, compared with the ATP II recommended goal of below 130 mg/dL. For CHD patients, the median LDL level identified as optimal was 104 mg/dL, compared with the ATP II goal of 100 mg/dL or less. There was not only striking agreement between the median goal levels cited by physicians and the ATP II recommendations, but the median LDL goal cited for CHD patients was appropriately about 30 mg/dL lower than for patients without CHD. These results demonstrate a significant impact of the ATP guidelines on physician attitudes and practices.

Cholesterol awareness of the public has also increased markedly.²¹ From 1983 to 1995, the percentage of the public who have heard of high blood cholesterol rose from 77% to 93%, and from 1986 to 1995, the proportion who know that a desirable total cholesterol is below 200 mg/dL (5.2 mmol/L) jumped from 16% to 69%. The public is aware that total cholesterol is not the whole story: 79% have heard of "good" and "bad" cholesterol, and 60% have heard of LDL and HDL. There have been important gains in the public's knowledge and practices regarding their own cholesterol levels. From 1983 to 1995, the percentage of US adults who ever had their cholesterol checked climbed from 35% to 75%; the percentage who were told their level rose from 21% to 65%; and the percentage who know their own level increased from 3% to 49%. All of these percentages show an absolute increase of 40% or more. This means that 70 to 80 million American adults who, in 1983, were unaware of their cholesterol level have since taken action to learn what it is. The NCEP message to the public to have their cholesterol measured and to "know your cholesterol numbers" appears to be having a large impact. Results of the public survey also confirm that physicians are increasing the attention they pay to cholesterol and improving their identification of hypercholesterolemic individuals: from 1983 to 1995, the percentage of the public who were told that their cholesterol is high rose from 7% to 22%.

Despite the fact that cholesterol-related attitudes and knowledge of both physicians and the public have improved markedly, adoption of and adherence to treatment recommendations on the part of both groups has been less than optimal. The shortfall is particularly noticeable in regard to patients with CHD. Despite the incontrovertible evidence that cholesterol lowering benefits patients with CHD^{9 - 11 ,14} and despite the survey results indicating that CHD patients are being treated more aggressively than those free of CHD,²¹ only one third to one half of CHD patients are receiving active dietary or pharmacological cholesterol-lowering intervention^{21 - 22} compared with about 85% of such patients who would stand to benefit from this treatment.¹⁶ The available evidence suggests that only a minority of patients with CHD are receiving sufficiently aggressive treatment. One study reported that only 9% of women with CHD achieved the recommended LDL goal of 100 mg/dL²³ ; in men with CHD, it is estimated that only about 20% are reaching the LDL goal level. These results are consistent with the observation that behavioral changes often lag behind improvements in knowledge and attitudes. Additional efforts by all the groups participating in the NCEP are needed to ensure that the documented cognitive gains are fully expressed in clinical practice and patient adherence.

A second indicator of progress in the NCEP's efforts is the decline in the public's dietary intakes of saturated fat, total fat, and cholesterol. Data from the National Health and Nutrition Examination Surveys²⁴ show that the mean adult intake of saturated fat fell from 13% of total energy intake in 1978 to 12% in 1990 and dropped further to 11% in the mid 1990s. Mean total fat intake decreased from 36% of energy intake in 1978 to 34% in 1990 and declined further to 33% in the mid 1990s.²⁴ From 1978 to 1990, mean intake of dietary cholesterol fell from 318 to 291 mg/d.²⁵ For adolescents between the ages of 12 and 17 years, the trend in dietary intakes from 1972 to 1990 was similar. Mean saturated fat intake fell from 14% of energy intake to 12%, mean total fat intake dropped from 37% of energy intake to 34%, and mean dietary cholesterol intake decreased from 350 to 265 mg/d.^{26 - 27} These trends accord with messages from the NCEP and other authoritative sources encouraging the public to adopt eating patterns lower in saturated fat, total fat, and cholesterol.

Arguably the most telling evidence of the NCEP's progress is the documented decline in measured serum cholesterol levels of the public. Results of the National Health and Nutrition Examination Surveys show that, from the survey period of 1976 to 1980 to that of 1988 to 1994, the mean serum total cholesterol level of US adults fell from 213 to 203 mg/dL (5.5-5.2 mmol/L).²⁸ Although the downward trend in serum cholesterol levels dates back to 1960,^{28 - 29} the rate of decline has recently accelerated; more than half of the decline has occurred since 1978, and cholesterol levels are continuing to decrease. The magnitude of the fall in mean serum cholesterol levels is entirely consistent with what would be predicted on the basis of the decline in dietary intakes of saturated fat, total fat, and cholesterol.²⁵ The entire distribution of cholesterol levels has shifted downward: from the survey period of 1976 to 1980 to that of 1988 to 1994, the percentage of adults with high total cholesterol levels (≥240 mg/dL [6.2 mmol/L]) has dropped from 26% to 19%,²⁸ and the percentage with desirable total cholesterol (<200 mg/dL [5.2 mmol/L]) has risen from 44% to 50% (National Center for Health Statistics, unpublished data, 1998). Moreover, the prevalence of high blood cholesterol requiring dietary therapy has fallen from 36% to 29%.^{16 ,30} These changes in serum cholesterol levels reflect the impact of both the population and high-risk strategies for cholesterol lowering.

Serum cholesterol levels of adolescents have also declined. From the survey period of 1966 to 1970 to that of 1988 to 1994, the mean serum total cholesterol level in 12-to 17-year-olds fell from 167 to 160 mg/dL(4.3-4.13 mmol/L).³¹ This decline of 7 mg/dL (0.18 mmol/L), though somewhat smaller than that observed in adults, is nevertheless significant, and like the decline in adult levels, the drop in adolescent serum cholesterol levels paralleled a decrease in adolescent intakes of saturated fat, total fat, and cholesterol.^{26 - 27}

While serum cholesterol levels have declined significantly, the prevalence of obesity in adults and children has risen.³² The factors that have been implicated in this rise are a decrease in physical activity and, despite the public's reduced fat consumption, an increase in overall energy intake. It has been said that Americans appear to be eating too much of the right foods. If not for the increase in obesity, the observed decline in cholesterol levels might have been even greater, since increased weight is associated with higher total and LDL cholesterol levels. The problem of obesity requires concerted action by all of the involved groups to focus public attention on increasing physical activity and controlling energy intake.

At the same time that these 3 trends of improving cholesterol awareness—decreasing intakes of saturated fat, total fat, and cholesterol, and falling serum cholesterol levels—have been taking place, age-adjusted CHD mortality rates have continued to decline.³³ Needless to say, many factors other than blood cholesterol affect CHD mortality rates, including improved diagnosis and treatment of CHD and reductions in the prevalence of smoking and hypertension. Nevertheless, the consistent relationship between changes in blood cholesterol levels and CHD outcomes in clinical trials³⁴ leads to the conclusion that the documented drop in serum cholesterol levels has made a major contribution to reducing the death toll from CHD. Despite this improvement, CHD remains the leading killer of both men and women in the United States.³⁵

Taken all together, the trends cited above demonstrate that cholesterol education has had a significant impact. But beyond the milestones and progress indicators, there has been what legitimately can be called a major cultural shift regarding cholesterol. Fifteen years ago, cholesterol was occasionally in the news, while today it is a consistent focus of media attention and a frequent front-page story. Fifteen years ago, cholesterol was a concern of health-food aficionados, while today low-fat products are everywhere in the supermarkets. Fifteen years ago, cholesterol was an obscure and high-brow topic for yuppies, while today it has become a familiar word that has taken its place in middle- and low-brow humor and appears fairly often in cartoons and the Sunday comic strips. This cultural shift has been influenced by many forces, including the food and pharmaceutical industries and the media. By no means least, however, cholesterol science and education have played a pivotal role in changing the public's perceptions and attitudes.

Federal expenditures for the NCEP have averaged less than $1.5 million a year since the program's inception. The NCEP has been able to achieve a large impact at a relatively modest cost because of the involvement of many other organizations, especially the members of the coordinating committee. These organizations have carried out a wide variety of cholesterol-related educational activities, including reproduction and dissemination of NCEP materials, which have leveraged the NCEP's own efforts into a broad-based national campaign. Although cholesterol education is now promoted in many quarters, it remains necessary for the NHLBI to continue its leadership role in the NCEP. The institute's scientific credibility is essential for producing guidelines and expert panel reports that are widely accepted, and these in turn are the indispensable platform for constructing sound educational messages. In addition, experience has taught that, while the institute need not do the whole educational job itself, it must continue to play the role of an active catalyst to ensure that the messages of cholesterol education remain coherent and consistent.

Despite the gratifying progress cholesterol education has achieved, important scientific and educational challenges still remain. In the scientific arena, the following are some of the developments that are likely to have a major impact on cholesterol lowering in the 21st century.

Several nontraditional risk factors have been identified as possibly contributing to CHD risk. Among these are homocysteine³⁶ and lipoprotein(a) [Lp(a)].³⁷ Although elevated plasma levels of these factors appear to be associated with increased CHD risk in some studies, more evidence is needed to gauge their independence from, vs their interaction with, elevated cholesterol levels, and their precise role in CHD. In particular, a strong need exists for clinical trials to determine whether lowering levels of homocysteine and Lp(a) reduces CHD risk before considering their incorporation into the standard assessment and treatment algorithms for CHD risk reduction.

Efforts are currently under way to develop better algorithms for predicting the future risk for CHD in diverse population subgroups on the basis of cholesterol levels and other classic and nonclassic risk factors. Crucial questions to be answered are: What influence should a risk score ideally have on treatment decisions? And, how can the clinician best use an overall risk score to improve the management of the specific risk factors that raised the CHD risk in the first place? An NHLBI workshop is scheduled for early 1999 to assess the applicability of the Framingham risk prediction algorithm³⁸ to other study populations and to clarify the issues regarding clinical utility of the risk score.

Advances in genetics and in methods of detecting subclinical disease may make it possible to identify individuals who are particularly susceptible to developing atherosclerosis and CHD. Cholesterol lowering and other risk factor reduction interventions could be targeted to such individuals. It is unlikely, however, that these methods would obviate the need for population-wide adoption of healthful life habits, including low-saturated-fat and low-cholesterol eating patterns, to reduce mean cholesterol levels.

Existing scientific evidence supports cholesterol lowering in women and the elderly. However, conclusive evidence about the magnitude of the benefit in these groups is lacking. The NHLBI is currently conducting the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) to determine the extent to which total mortality and CHD events will be reduced in women and the elderly, especially in those who are free of CHD.

Clinical trials have thus far proven the benefits of lowering LDL cholesterol levels. Trials are currently under way to demonstrate conclusively that raising HDL cholesterol levels actually reduces CHD risk, which is strongly suggested by epidemiological and clinical studies. If this effect is confirmed, it will have a strong influence on the way physicians approach cholesterol intervention.

The role of triglycerides in increasing CHD risk remains incompletely understood. Some, but not all, forms of hypertriglyceridemia impart an increased risk for CHD. Further studies will help clarify whether the elevated risk is related to high triglyceride levels themselves or, as many authorities hold, to several factors for which high triglyceride levels serve as a marker: increased levels of atherogenic triglyceride-rich lipoproteins; low levels of HDL cholesterol and small LDL particles, which, together with high triglyceride levels, are termed the lipid triad; and nonlipid metabolic factors, such as insulin resistance, hypertension, and a prothrombotic state, that frequently accompany the lipid triad, and together constitute the metabolic syndrome.³⁹ The NCEP is currently developing a position paper that will propose an approach for incorporating triglycerides into the algorithm for cholesterol management.

Research is currently being conducted to determine the role of antioxidants, such as vitamins E and C, in reducing CHD risk, and their interaction with cholesterol. If antioxidants are confirmed to be beneficial, one mechanism by which they may exert their effect is by protecting LDL cholesterol from being oxidized to a form more likely to promote atherosclerotic plaque formation.

If these research avenues yield useful results, they will present significant opportunities for enhancing cholesterol control and improving CHD risk reduction.

There is also no shortage of challenges in the area of education. As noted above, a principal set of challenges falls into the category of behavioral or adherence issues. Perhaps the most pressing need is to address the undertreatment of patients with CHD. The NCEP has mounted a series of initiatives to improve this picture, including development of a continuing medical education monograph on cholesterol lowering in patients with CHD that was distributed to 200,000 physicians, together with a patient booklet emphasizing the LDL goal of 100 mg/dL; an educational print advertisement for CHD patients, sent to high-circulation magazines and newspapers, underscoring the importance of reaching the goal LDL; an interactive Web site providing information on cholesterol lowering for CHD patients; a 1-hour television special developed for the Public Broadcasting System highlighting the benefits of lowering cholesterol levels in CHD patients and offering free copies of the patient booklet through a toll-free telephone number; and a videotape for cardiologists and other physicians who treat patients with CHD. Cholesterol lowering in patients with CHD will remain an important focus of NCEP efforts. Effective cholesterol-lowering therapy in the approximately 10 to 11 million CHD patients who require it can reduce overall CHD morbidity and mortality by about 20% to 25% because about half of all myocardial infarctions occur in patients with previous CHD.^{40 - 41}

Although cholesterol lowering in patients with established CHD will substantially reduce the toll in illness and death from this disease, such an approach is not by itself an adequate strategy for addressing cholesterol-related risk in this country. Approximately 25% of first CHD events manifest as sudden death.^{42 - 43} For these individuals, cholesterol lowering is no longer an option. For those who survive the initial episode, cholesterol lowering will greatly reduce the risk for a future CHD event, largely by stabilizing unstable plaques, but it cannot restore these patients to the much lower baseline risk of people without CHD. Thus, in 4S, CHD mortality was reduced by an impressive 42%,⁹ but this nevertheless left 58% of a quite elevated death rate untouched. If atherosclerosis in an individual or a society is far advanced, cholesterol lowering to achieve plaque stabilization can accomplish only so much. To obtain a sufficient reduction in the societal burden of CHD, a strategy of primary prevention is essential to prevent the development of CHD in the first place. The primary prevention strategy requires action both in the public health arena to lower average cholesterol levels of the population through adoption of healthful life habits and in the clinical setting to lower high cholesterol levels of individuals under medical guidance.

The NCEP will continue to emphasize primary prevention and will pursue activities to help patients and the public incorporate cholesterol-lowering habits into their lives and to make it easier for physicians to incorporate cholesterol-lowering therapies into their clinical practices.

To provide the most up-to-date clinical guidance for cholesterol lowering in patients with CHD and in primary prevention, the NCEP is planning to convene a working group on the ATP II guidelines. This group will examine several issues regarding the guidelines in light of the various statin studies that have been completed since ATP II was released in 1993 and will prepare a report, for review by the NCEP coordinating committee and other experts, that updates the guidelines to help physicians provide optimal management of elevated cholesterol levels. Since the results of the statin studies have tended to confirm the overall appropriateness of the ATP II guidelines, a whole new set of guidelines (ATP III) may not be necessary. It is anticipated, nevertheless, that the working group will clarify and update the existing guidelines to improve clinical management.

The combination of cholesterol lowering in primary prevention and in CHD patients promises to produce a marked reduction in CHD rates. Carrying out this combined strategy is both a challenge and an opportunity as the NCEP looks ahead to the 21st century.