Lowering Cholesterol
by Marilynn Larkin

     In the last 12 years, average cholesterol levels in the United
States have dropped significantly, according to a recent report from the
National Cholesterol Education Program (NCEP). We are now closer
than ever to the Department of Health and Human Services' Year 2000
goal: a reduction in mean cholesterol level among adult Americans to
200 milligrams (mg) per deciliter (dL) of blood.
     Yet, despite the good news of an overall drop in the average
total cholesterol level--from 213 mg/dL to 205 mg/dL--an estimated 35
percent of Americans still need to lower their cholesterol to achieve a
desirable level. Approximately 29 percent--or 52 million adults--could
lower their cholesterol effectively with dietary therapy, according to the
report. About 7 percent, or 12.7 million, would require additional drug
therapy to lower cholesterol.
     The new report recommends that the type of cholesterol-
lowering therapy prescribed be based primarily on a person's risk of
coronary heart disease (CHD). People at greatest risk--those who
already have CHD or other atherosclerotic disease such as carotid
(neck) artery disease--should receive the most aggressive treatment.
This would most likely include a combination of drug and dietary
therapy, and lifestyle changes such as increasing exercise and quitting
smoking. Those at low risk would be counseled to begin making dietary
changes and to eliminate other CHD risks from their lifestyle.

Defining Cholesterol
     Cholesterol, part of the chemical group called lipids, is a
component of all body cells, and plays an important role in hormone
production and other vital body processes. Most cholesterol in the
blood is produced by the liver; some is absorbed directly from
cholesterol-rich foods, such as eggs and whole milk dairy products.
     Cholesterol is carried in blood in the form of substances called
lipoproteins. CHD risk can be assessed by measuring total blood
cholesterol, as well as the proportions of the different types of
lipoproteins. "Total" cholesterol refers to the overall level of
cholesterol in the blood. High-density lipoprotein (HDL) is often
referred to as "good" cholesterol, because high levels of HDL are
associated with lowered CHD risk. High levels of low-density
lipoprotein (LDL)--often referred to as "bad" cholesterol--and very low
density lipoprotein (VLDL) increase CHD risk.
     Fats called triglycerides are also carried in the blood in the form
of lipoproteins. The role of triglycerides in the development of CHD is
unclear. However, doctors may be concerned when patients have tests
showing very high levels of triglycerides (more than 400 mg/dL)
because fasting triglyceride tests are an indirect measure of VLDL.
Therefore, they usually will want to investigate further.

Cholesterol Testing
     The NCEP report recommends that all adults 20 years of age
and older have their total cholesterol and HDL measured at least once
every five years.
     For people without CHD, a total blood cholesterol level of less
than 200 mg/dL is considered "desirable"; from 200 to 239 mg/dL is
"borderline-high"; and 240 mg/dL or more is "high." An HDL level of
less than 35 mg/dL is defined as "low" and is considered a CHD risk 
factor.
     A lipoprotein analysis, which measures LDL as well as HDL, is
recommended for people with CHD or for those at very high risk of
developing CHD. The goal of cholesterol-lowering therapy for high-
risk individuals is an LDL cholesterol of about 130 mg/dL; for those
with established CHD, the optimum LDL cholesterol is 100 mg/dL or
lower.
     Cholesterol testing requires a small sample of blood taken with a
fingerstick. It can be done in a physician's office or at a commercial
laboratory. Because cholesterol levels vary from day to day by as much
as 20 to 40 mg/dL, at least two samples should be taken a week or
more apart.
     FDA cleared for marketing in March 1993 a device that can be
used by consumers at home for initial screening of total cholesterol. (It
is not to be used to monitor results of cholesterol-lowering therapy.) To
use this device, the person places a drop of blood in a blood well. In
approximately 10 to 15 minutes, a purple color advances up the
measuring device, and the user reads it like a thermometer, explains
FDA's Cornelia Rooks, branch chief of clinical chemistry in the Center
for Devices and Radiological Health. The test result is obtained by
comparing the height of the peak to a chart, which tells whether
cholesterol is in a desirable, borderline, or high range. The device is
used once and then discarded.
     Natural variations in cholesterol may make home test results
difficult to interpret, notes Margo Denke, M.D., assistant professor,
department of internal medicine, University of Texas Southwestern
Medical Center at Dallas, and member of the NCEP expert panel. "If
someone does the home test several times and sees a variation, the
person may [incorrectly] assume he or she is doing something 'right'
when levels are lower and 'wrong' if the level rises," she says.
     These devices may not yet be available at local pharmacies. At
press time, a quick survey of chain pharmacies in the Washington,
D.C., area found that most do not stock the product, though some will
order it for customers. One reason given for not stocking the device
was that it gives insufficient information so that consumers would be
better advised to consult doctors for advice about cholesterol.

Other CHD Risk Factors
     In addition to total and HDL cholesterol levels, doctors take
other CHD risk factors into consideration when determining how
aggressively to treat high blood cholesterol. Age is a risk factor
because CHD risk increases with age. An older person's risk is higher
than that of a younger person, even when their cholesterol levels are
the same. For men, age becomes a major risk factor at 45 years; for
most women, at 55 years.
     A family history of premature CHD is also a risk factor.
Premature CHD is defined as heart attack before age 55 in a father or
other close male relative, or before age 65 in a mother or other close
female relative.
     Other risk factors include cigarette smoking, high blood
pressure, obesity, and diabetes. Although low HDL is a risk factor, an
HDL level of 60 mg/dL or more is considered a "negative" risk factor-
-that is, it protects against CHD.

Dietary Therapy and Lifestyle Changes
     Dietary therapy is the mainstay of treatment of high blood
cholesterol at every age. Unless a young adult (men under age 35, 
premenopausal women) is at very high risk of CHD, with a total
cholesterol of more than 300 mg/dL, the NCEP recommends that drug
therapy be delayed and dietary modification and lifestyle changes be
attempted first. Moreover, even if a person with high cholesterol needs
drug therapy, following an appropriate diet may add benefits, according
to Denke.
     Dietary therapy is prescribed in two steps, called the Step I and
Step II Diets. These are designed to help reduce intake of saturated fat
and cholesterol, and to help achieve a desirable weight by eliminating
excess calories.
     The Step I Diet is similar to the NCEP recommendations for the
general public. The physician first tries to determine if the patient is
already following the guidelines. If not, the Step I Diet is usually the
starting point of dietary therapy. In the Step I Diet, no more than 8 to
10 percent of calories are in the form of saturated fat; 30 percent or
less of calories come from total fat (saturated and unsaturated); and less
than 300 mg of cholesterol are consumed each day.
     The importance of lowering saturated fat intake should not be
underestimated, according to Donald Hunninghake, M.D., professor of
medicine and pharmacology at the University of Minnesota Hospital
Center's Heart Disease Prevention Clinic and member of the NCEP
expert panel. "A tremendous source of misinformation to the public is
the emphasis by food companies that products such as vegetable oils
contain no cholesterol; this plays on the consumer's recognition of
cholesterol as a risk factor, but ignores the importance of saturated
fat," he says.
     The new food label, which lists amounts and percentages of total
and saturated fat, as well as cholesterol, in a given food, can be used in
planning palatable meals that meet the guidelines for the Step I and
Step II Diets.
     Also, FDA has authorized a health claim relating diets low in
saturated fat and cholesterol to reduced risk of heart disease for foods
that meet the criteria for being low in fat, saturated fat, and cholesterol
and which do not contain disqualifying levels of sodium. (See "Starting
This Month: Look for 'Legit' Health Claims on Foods" in the May
1993 FDA Consumer and "A Little 'Lite' Reading" in the June 1993
FDA Consumer.)
     If the patient is already following the Step I Diet, or if this diet
isn't adequate to lower cholesterol to desirable levels, then the Step II
Diet should be tried, according to the NCEP report. People with high
cholesterol who also have CHD or other atherosclerotic disease should
begin immediately on this diet, with physician guidance. The Step II
Diet calls for reducing daily saturated fat intake to less than 7 percent
of calories and cholesterol to less than 200 mg. Since these
requirements may demand some radical changes in the diet, assistance
from a registered dietitian or other qualified nutrition professional may
be helpful.
     Overweight people can cut calories and increase physical activity
under a physician's guidance to help lower total cholesterol, as well as
lower the risk of developing other CHD risk factors, such as high
blood pressure and adult-onset diabetes. Physical activity also raises
HDL levels, further reducing CHD risk. Quitting smoking lowers the
risk of developing CHD and other diseases, including emphysema and
lung cancer.
     The role of alcohol in the diet is controversial. "There is
evidence that one or two drinks daily in men and one drink daily in
women  will raise HDL by 10 percent if a person has low HDL," says
Stephen Scheidt, M.D., a cardiologist at New York Hospital-Cornell
Medical Center in New York City. He defines one drink as a glass of
wine, a can of beer, or a shot of scotch or other hard liquor.
     But "alcohol has too many side effects to be used as a
prescription to raise HDL," Denke cautions.

Drug Therapy
     Drug treatment is considered appropriate for adults who have a
high LDL level, especially if they also have other CHD risk factors,
according to the NCEP report.
     Bile acid sequestrants such as Questran and Questran Light
(cholestyramine) and Colestid (colestipol) are approved for use in
addition to dietary therapy in patients with high LDL levels who don't
respond to dietary changes alone. Constipation is the most common side
effect.
     Niacin products such as Niacor and Nicolar, are approved for
use in addition to dietary therapy in patients with high cholesterol levels
or high triglycerides who do not respond adequately to diet and weight
loss. Side effects, which may include flushing, itching, and upset
stomach, limit its use in some people. There is some evidence that
sustained-release niacin may be more likely to cause liver function
abnormalities than conventional tablets, according to Hunninghake. He
adds that people should not use niacin vitamin supplements to self-
medicate.
     Statins, including Mevacor (lovastatin), Pravachol (pravastatin),
and Zocor (simvastatin), are used in addition to dietary therapy to
reduce elevated total and LDL cholesterol. Side effects are generally
minimal, but may include constipation, abdominal pain, nausea, and
bloating. The NCEP report notes that because they have not been
proven safe over the long term, they may not be appropriate for
younger people, who might take the medication for many years.
     Fibric acids such as Lopid (gemfibrozil) are approved for use in
addition to diet in patients who have low HDL levels and high LDL
and high triglycerides in whom diet and other drugs (bile acid
sequestrants, niacin) have proven ineffective. They may also be used in
patients with very high triglyceride levels (more than 2,000 mg/dL)
who are at high risk for pancreatitis. Side effects may include
abdominal pain and upset, abnormal liver function, and possible
increased risk of gallbladder problems.
     Lorelco (probucol) may be used to reduce cholesterol in patients
with high LDL levels who have not responded to diet and weight
reduction. However, the drug's LDL-lowering effect is modest and its
long-term safety is limited. A range of adverse reactions--including
gastrointestinal distress, heart problems, dizziness, fainting, headache,
blood problems, rashes, vision disorders, and impotence--have been
associated with its use.
     When considering whether to recommend estrogen replacement
therapy for a postmenopausal woman, some doctors take into account
whether she is at high risk for CHD. At present, estrogen is not
approved by FDA for CHD risk reduction. Approved uses include
treatment of some menopausal symptoms and prevention of
osteoporosis. However, doctors may use an approved drug for
unlabeled uses if they judge that the patient may benefit from it. Studies
assessing the value of estrogen in lowering CHD risk are ongoing.
     Side effects of estrogen therapy may include abnormal vaginal
bleeding, leg or chest pains, sudden shortness of breath, headaches,
nausea, dizziness, vision changes, breast lumps, and depression. There
is some evidence that estrogen use may increase the risk for
endometrial and uterine cancer, as well as gallbladder disease.
     A doctor's decision about which drug to prescribe will be based
primarily on an assessment of a patient's risk factors and the potential
side effects of the drugs. Physicians measure patients' LDL levels four
to six weeks after starting drug therapy, and again at three months to
see whether the therapy is effective.
     Patients should report side effects of any medication to their
doctors. William Cole, M.D., director of Heartsavers Program, New
York Downtown Hospital in New York City, cautions patients never to
try to adjust dosages on their own or to self-medicate with a different
drug. He adds that drug therapy should be regarded as a "lifetime
commitment." Generally, if medication is stopped, cholesterol returns
to higher levels. Although dosages may be reduced in some instances
after improvement, it is unlikely that drug therapy can be stopped
completely.
     Roma Krause of FDA's Health Fraud Staff in the Center for
Drug Evaluation and Research notes that some "unscrupulous
marketers" have taken advantage of the public's concern about high
cholesterol to promote various products to treat or prevent high
cholesterol levels. Unless these products are approved for this purpose,
such promotion may be considered fraud.
     Consumers concerned about their cholesterol levels are best
advised to eat a balanced diet low in saturated fats and cholesterol and
to eliminate lifestyle CHD risk factors such as smoking and lack of
exercise.
     Before any other treatment is undertaken, a doctor should be
consulted and blood cholesterol levels should be determined by
laboratory tests. n

Marilynn Larkin is a medical writer in New York City.

Treatment Talk
     Here are some terms doctors often use when discussing
cholesterol, heart disease, and dietary and drug therapy.
Atherosclerosis: A thickening of the walls of arteries, causing
narrowing of the vessels and impaired blood flow.
CHD (coronary heart disease): A broad term used to describe damage
to or malfunction of the heart caused by narrowing or blockage of the
coronary arteries, which supply blood to the heart muscle.
Cholesterol: A type of fat, or lipid, produced in the body by the liver
and also absorbed directly from cholesterol-rich foods such as eggs and
whole milk dairy products. Cholesterol is transported in blood in the
form of lipoproteins.
HDL: High-density lipoprotein, or "good" cholesterol; a high HDL
level helps protect against heart disease.
Hydrogenated fat: A type of fat added during processing to such
products as crackers, cookies, and peanut butter. Hydrogenated fat, like
saturated fat, may promote the development of atherosclerosis.
LDL: Low-density lipoprotein, or "bad" cholesterol, is a risk factor for
CHD and a primary target of cholesterol-lowering therapy.
Lipoprotein: The form in which cholesterol is transported in blood.
Saturated fat: A type of fat primarily found in foods of animal origin
(meat, fish, poultry, dairy), but also in some vegetable oils, such as
coconut. Too much saturated fat in the diet may promote the
development of atherosclerosis.
Triglycerides: A type of fat that, like cholesterol, is transported in the
body in the form of lipoproteins. Their role in the development of heart
disease is unclear.
Unsaturated fat: A type of fat found in foods that does not appear to be
linked to the development of atherosclerosis. n
--M.L.

Preventing Heart Disease by Reducing Cholesterol
A Step-By-Step Guide

If you are an adult without CHD, you can expect your doctor to
measure your total blood cholesterol and HDL cholesterol at least once
every five years, and to assess other risk factors for CHD during
regular visits. Depending on the findings, you may be counseled on
ways of reducing CHD risks, including dietary changes. If you have
high blood cholesterol, additional tests will be taken.

(Adapted from "Summary of the Second Report of the National
Cholesterol Education Program (NCEP) Expert Panel on Detection,
Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult
Treatment Panel II), which appeared in Journal of the American
Medical Association, Vol. 269, 1993.)
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