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British Medical Journal published a review article which used a mathematical approach to reanalyze the data from several primary prevention trials on coronary heart disease. The authors found that lowering cholesterol does, in fact, decrease the number of deaths from heart attacks. However, they also noted that the number of deaths due to homicides, accidents, and suicides were increased among people being treated for high cholesterol.
We are not sure what this means for several reasons. First, this was a retrospective analysis of data not collected for the purpose of answering this question; an independent study would be needed to determine whether the finding is real or merely an artifact. Second, no increase in these "violent" deaths was found in secondary prevention trials; that is, in studies that lowered cholesterol among heart attack survivors. We do not understand why this difference between primary and secondary prevention trials exists.
It should be noted that a number of scientists dispute the interpretation of a link between "violent" deaths and lowered blood cholesterol. Nevertheless, the hypothesis is an interesting one, and warrants further investigation.
CONGESTIVE HEART FAILURE
Question. Recently we heard much about congestive heart failure. What is the status of your research in this area?
Answer. The National Heart, Lung, and Blood Institute maintains an active and growing research portfolio on congestive heart failure (CHF). Studies of cardiac pathophysiology have already provided a comprehensive description of the hemodynamic and electrical factors related to worsening function of the failing heart. New studies apply recent developments in genetic engineering, cardiac imaging and spectroscopy to fundamental questions about signals for the structural changes in CHF, the role of recently discovered vascular hormones, and changes in the availability of cellular energy in failing heart.
One promising line of research concerns the increase in autonomic nervous system (ANS) hormones that accompanies CHF. NHLBI-supported studies have clearly demonstrated an association between increased ANS hormones and clinical decline in CHF patients. The Institute supports a number of studies on the fundamental mechanism responsible for ANS activation, and much new information has been gathered that will be essential in the development of new pharmacologic treatments. Another line of NHLBI-supported research concerns the new group of drugs called angiotensin converting enzyme (ACE) inhibitors. The drugs improve clinical function and well-being among CHF patients. Preliminary evidence suggests that they may also prolong life. The NHLBI supports a major clinical trial to address the effectiveness of ACE inhibitors in patients with varying degrees of CHF.
TREATMENT OF MILD HYPERTENSION
Question. Is drug treatment safe and effective for the treatment of mild hypertension?
Answer. In April 1990, an overview, or statistical summary, of all properly designed clinical trials of antihypertensive drug treatment was published in the British journal, The Lancet. This report affirmed results of earlier, more limited reviews: cardiovascular mortality is significantly reduced by treatment. Further, the benefit to mild hypertensives was the same when compared to all hypertensive patients.
Question. What is the place of nonpharmacological treatment?
Answer. Nonpharmacologic treatments can be useful in lowering blood pressure, particularly in mild hypertension. Recent evidence from NHLBIsupported clinical trials suggests that a combination of nonpharmacologic intervention especially, modest weight reduction and a low-dose drug regimen is most beneficial, not only for lowering blood pressure, but also for minimizing drug side effects and improving some indicators of "quality-of
life". The regimens, which include moderate salt restriction, limited use of alcohol, and increased physical activity, have now been maintained for several years in selected study populations.
NATIONAL HIGH BLOOD PRESSURE EDUCATION PROGRAM
Question. Your Institute's National High Blood Pressure Education Program is almost 20 years old. Aren't physicians sufficiently well-versed by now in managing hypertension?
Answer. It is true the NHBPEP has provided guidance to the clinical community on detection, evaluation and management of hypertension for quite some time. However, as our understanding of the disease increases, treatment choices expand, our knowledge about management increases, and the challenges to educate become more complex. Two decades ago, the program advocated a simple stepped-care management approach. All patients were prescribed one class of drug and if the blood pressure remained uncontrolled, a drug from a second class was added. If blood pressure was still uncontrolled, a drug from a powerful third class was added, and so on. Patients were simply counseled to tolerate the side effects. Many were not willing to do so and dropped out of care.
Today, a wide variety of treatment options and agents are available and the program is encouraging physicians to tailor therapy to the individual patient. Thus, not all patients will or should receive the same therapy. a result, side effects from treatment will decrease and adherence to therapy will increase. Tailoring therapy means that clinicians can offer patients greater choices and options, but it also means that they must expend additional efforts to understand all the differences among rationales for these options. In summary, treatment today is much more complex than it was two decades ago because of the wider variety of choices; it is also much more effective.
NATIONAL CHOLESTEROL EDUCATION PROGRAM
Question. What is the National Cholesterol Education Program doing to improve the management of high blood cholesterol?
Answer. Since the publication of the National Cholesterol Education Program's Adult Treatment Panel (ATP) guidelines in 1988, a major effort has been made to improve high blood cholesterol management. In 1989, visits to physicians for high blood cholesterol were up over nine-fold compated to 1983. The results of a new survey of physician knowledge, attitudes, and practice conducted in 1990 will be available at the time of the National Conference on Cholesterol and High Blood Pressure Control in April, 1991. A Cholesterol Education Program for Nurses was developed in cooperation with the American Heart Association (AHA), and a Dietitian's Kit was distributed to over 17,000 dietitians. New data fact sheets were developed to highlight the striking prevalence of high blood cholesterol, A booklet of dietary advice for patients with high blood cholesterol who have low literacy skills' was prepared, and the program's very popular dietary booklet (Eating to Lower Your High Blood Cholesterol) was widely distributed. A joint NHLBI-AHA joint "white paper" demonstrating the strength of the scientific basis for cholesterol lowering has been published and is being distributed to 180,000 physicians. The Institute conducted three important workshops addressing the issues of cholesterol as a CHD risk factor in older persons and in women; the cost and health implications of cholesterol lowering; and low cholesterol and health risk. Collectively, they supported the basic program directions of the National Cholesterol Education Program (NCEP). The NEP also released the final report of its Laboratory Standardization Panel. The report of the Panel on Children and Adolescents is nearing completion and will be released at the National Conference in April.
Question. What is the future direction of the National Cholesterol Education Program?
Answer. At this point, the National Cholesterol Education Program (NCEP) is planning to continue its high-risk and population strategies, while
refining its messages in several areas. The Institute, together with the American Heart Association (AHA), will sponsor a conference to address cholesterol lowering in coronary heart disease patients. A second conference is planned on the controversial issue of high triglycerides/low HDL. The results of these two conferences will be incorporated into the work of a new Adult Treatment Panel, which will address these and other important issues as it updates the current guidelines for the detection, evaluation, and treatment of high blood cholesterol in adults. A separate working group will make recommendations on standardization of HDL, triglycerides, and LDL measurements. Industry will be encouraged to promote heart-healthy eating patterns. New booklets will be distributed to help parents in encouraging heart-healthy eating by their children. A family theme will be used to tie together the various messages of the program. New survey information on the knowledge, attitudes, and practices of physicians, nurses, dietitians, and the public, and on blood cholesterol levels will be used to guide the efforts of the NCEP as it becomes available.
NATIONAL BLOOD RESOURCE EDUCATION PROGRAM
Question. How is the National Blood Resource Education Program helping to increase the numbers of blood donors?
Answer. The National Blood Resources Education Program's (NBREP) public education campaign seeks to encourage eligible individuals to give blood regularly to help save the lives of others. A mass media campaign, consisting of radio and print public service announcements has reached approximately 8,000 radio stations and 300 magazines. The campaign has also been seen in several major airports.
Activities to help improve blood donor recruitment and retention efforts by blood centers are underway. A publication, "Together Building a Blood Supply: A Guide to Donor Recruitment and Retention" has been distributed to individual blood centers. In addition, a symposium for donor recruiters and their top administrators was held in October, 1990, to explore the current issues in effective donor recruitment. Emphasis was placed on using a marketing approach and providing customer service in donor recruitment and retention. The program is currently assessing the effectiveness of these
MINORITY BONE MARROW DONORS
Question. How are you helping to increase the number of minority donors in the bone marrow donor registry?
Answer. We are developing a mass media campaign to encourage Black and Hispanic persons to join the bone marrow donor registry of the National Marrow Donor Program. The campaign will include radio and print messages and will be localized and distributed to 13 marrow donor centers. In addition, a package will be developed to help donor centers prepare minority volunteers for recruitment efforts in their communities. The program will also include a symposium to acquaint donor centers with the available media tools and with specific techniques for reaching minority individuals in their communities. The effectiveness of this comphrehensive effort will be evaluated and the results will be used to revise the materials. Future efforts will involve the recruitment of other minority groups, such as Asians and Native Americans.
NATIONAL ASTHMA EDUCATION PROGRAM
Question. Your National Asthma Education Program is relatively new. Tell us about its goals and what are the accomplishments so far?
Answer. The National Asthma Education Program (NAEP) was launched in March 1989, to increase awareness that asthma is a serious chronic disease; to ensure that asthma symptoms are recognized by patients, families and the public and properly diagnosised by health professionals; and to ensure the effective control of asthma by encouraging a partnership among patients, physicians, and other health professionals through modern treatment and education programs. Achieving the NAEP goals will not only enhance the
quality of life for patients with asthma, but also decrease asthma-associated morbidity and mortality.
The NAEP's first major accomplishment was the development of an Expert Panel Report on the Diagnosis and Management of Asthma. The report was released to the medical and lay communities on February 5, 1991. It outlines the latest therapeutic regimens and patient education approaches available for managing and controlling asthma. The guidelines included in the report represent the collective medical wisdom of allergists, pulmonologists, nurses, and behavioral scientists. NAEP subcommittees have identified several activities that will support the goals of the program. With regard to professional education, these activites include the development of a clinician's guide to teaching patients about asthma self-management, a statement on peak flow monitoring, and an Executive Summary of the Expert Panel Report. Publications developed for patients and the public, include a pamphlet entitled "Facts About Asthma", an Asthma Quiz, and a booklet that outlines how patients can work with their doctors to receive the best asthma care. A number of products are being developed for schools that encourage school personnel to take an active role in asthma management.
NATIONAL HEART ATTACK ALERT PROGRAM
Question. Have you initiated the National Heart Attack Alert Program?
Answer. The Institute launched the National Heart Attack Alert Program (NHAAP) in January 1991. The goal of the NHAAP is to reduce premature morbidity and mortality from acute myocardial infarction (AMI), and sudden death through rapid identification and treatment. The objectives of the NHAAP are to: (1) increase awareness and knowledge of the symptoms and signs of AMI among those at increased risk and those around them, (2) promote immediate action by patients and those around them at the first symptoms and signs.of AMI, (3) promote immediate identification and treatment of patients with a suspected AMI or sudden death by health care professionals in pre-hospital and hospital emergency systems, (4) collaborate with other state and Federal agencies to promote the appropriate use of an enhanced emergency medical services system, and (5) consider, when the time is appropriate, a public education campaign to complement the objectives. Such efforts heighten the potential for an improved quality of life for patients, their relatives and friends.
Question. Who participates in it?
Answer. The NHAAP will be modeled after the four other NHLBI national educational programs. It is governed by a coordinating committee. Thus, while the NHLBI administers the program, its implementation is a collaborative effort among all of the organizations. The NHAAP Coordinating Committee will consist of members of professional and voluntary organizations and State and Federal governments who are committed to collaborative efforts to achieve the program's goal and objectives. The Coordinating Committee members will examine important issues related to early cardiac care and make recommendations concerning program direction and policies. Members will be encouraged to participate in appropriate activities and disseminate the educational materials of the program through their national networks and constituencies. Many of the NHAAP program activities will be conducted through Committee and subcommittee endeavors designed to invite and maximize active participation by all Committee members and their organizations. The NHAAP staff will also work closely with all individuals and organizations across the United States who are involved in early cardiac identification and care.
Question. Does the NHLBI provide the public with information on obesity and the need to control weight to reduce the risk of heart disease?
Answer. The Institute has recently begun the NHLBI Obesity Education Initiative. Obesity contributes to many cardiovascular risk factors and independently affects cardiovascular disease. The initiative allows the
Institute to begin a concerted effort to educate the public and health professionals of these relationships.
Up to now, obesity and weight control have been addressed only as they relate to high blood cholesterol, high blood pressure, and smoking through the existing National Cholesterol Education Program, National High Blood Pressure Education Program, and NHLBI Smoking Education Program. Both the NCEP and NHBPEP, in their expert panel reports on the detection, evaluation and treatment of high blood cholesterol and high blood pressure, respectively, emphasize the need for weight reduction among overweight individuals. Materials for patients also encourage people to reduce dietary fat, especially saturated fat, in order to reduce blood cholesterol levels and achieve weight loss in overweight individuals. For the general public, the NHLBI has assembled kits that include fact sheets addressing obesity, weight control, and exercise. Recently, an "IQ Quiz on Weight and Heart Disease" was developed to increase public awareness about the relationships between obesity and CVD risk factors and to clarify some public misconceptions regarding weight loss.
Because of its concern for minority health issues, the Institute sponsored a Conference on Obesity and Cardiovascular Disease in Minority Populations to examine the latest scientific information available and to provide directions for further research. The proceedings of the conference will be published in the June issue of the American Journal of Clinical Nutrition.
The NHLBI Obesity Education Initiative will integrate obesity-related issues as they evolve from the Institute's national education programs, and will allow for a more effective mechanism to address obesity as a separate health issue. The initiative will be directed by a group of experts who will consider the various scientific issues related to obesity and cardiovascular disease, identify issues where consensus opinions can and should be reached, convene expert ad hoc advisory panels to address certain issues, and recommend the types of educational messages that should be brought to the public and to health care professionals.
CLINICAL TRIAL ON ORAL IRON CHELATION THERAPY
Question. I understand that the NHLBI is considering a clinical trial on oral iron chelation therapy which will be useful in the treatment of Cooley's anemia. What is the status of this situation?
Answer. For over fifteen years, the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) have been supporting the development of improved therapies for Cooley's anemia. The NIDDK has been responsible for conducting animal toxicity studies of potential new iron chelators. In anticipation of a successful effort in this area, the NHLBI has prepared an initiative for a cooperative clinical trial for one or more of the new drugs that may emerge from the toxicity studies. However, to date, no non-toxic drugs have been identified. When a promising drug is eventually identified and Food and Drug, Administration approval is obtained, the NHLBI is prepared to begin human testing.
Question. Doctor, in your opening statement you briefly mentioned some recent progress that has been made in cystic fibrosis research. What were some of the other significant advances made in this area during the past year, and what are the clinical implications of these findings?
Answer. The discovery and cloning of the cystic fibrosis (CF) gene have together improved prospects for defining the pathogenesis of CF and determining the relationship between the CF gene product, called CFTR (for cystic fibrosis transmembrance conductance regulator), and the ion characteristic transport dysfunction of CF. A significant advance in this area is the recently reported finding that CFTR is probably a chloride channel. This discovery helps to explain the function of CFTR in lung cells