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U.S. cholesterol panel backs wide drug treatment

It's been less than 10 years since the National Cholesterol Education Program (NCEP) issued their last set of guidelines, but two major thrusts have changed how we approach the treatment of heart disease. First, we've learned aggressive treatment with cholesterol-lowering drugs dramatically reduces the incidence of disease; and second, abundant research and our own experience confirm the safety, at least in the intermediate term, of statin drugs.

The data is compelling. In the 14 years since they were introduced in the U.S., the statins have revolutionized the treatment of heart disease. Study after study have shown these drugs prevent heart attacks and prolong lives, with very few side effects.

About five million people currently take statins in this country, and these new guidelines indicate even more people should be on them, including not only those who already have heart disease—or a strong propensity for developing it, like diabetics or smokers—but also those with moderately high levels of LDL cholesterol and low levels of HDL.

Statin safety issue
When they were first introduced, there were many concerns about the safety of statins. Physicians were reluctant to prescribe them because of warnings about liver disease, but after several studies, we have cumulative evidence that these drugs are safe with relatively few side effects.

Statins cause liver and muscle toxicity in far fewer than 1 percent of patients, but we don't know if there are any negative long-term effects that might manifest themselves after 20 or 30 years. We do know these drugs save lives, and because of their safety, we are now treating both younger and older patients.

If your cholesterol levels are moderate
For those with moderate cholesterol levels (LDL levels > 130 mg/dL) who are at lower risk for heart disease—10 to 20 percent according to the new NCEP formula—our approach continues to be to recommend therapeutic lifestyle changes (TLC). These changes include eating less fat and more fiber to lower LDL and control weight and increasing exercise to raise HDL and control weight.

If these measures are not successful, we would consider beginning drug therapy for those whose risk factors are in the 10 to 20 percent range. For those with a less than 10 percent risk, we might consider drug therapy if LDL levels are 160 mg/dL or higher.

New category of people to receive aggressive treatment
Probably the biggest change is that we would now treat those with a 20 percent or higher risk due to cholesterol as aggressively as those who have already had a heart attack—usually with cholesterol-lowering drugs as well as TLC. People with diabetes are automatically placed in the high-risk category because recent research identifies this disease as such a danger sign for heart disease.

New look at "good cholesterol" (HDL)
The new guidelines also underscore the fact that a total cholesterol reading doesn't tell the whole story. Adults should have a lipoprotein profile to identify LDL, total cholesterol, HDL and triglycerides every five years. We now identify low HDL levels as anything less than 40 mg/dL. The change reflects new findings about the strong link between a low HDL and an increased risk of heart disease. An HDL level of 60 mg/dL or more is considered protective against heart disease. [See: Want to lower your risk? Try raising your levels of good cholesterol, March 2000]

Statin drugs do little to raise HDL, but drug companies now have drugs in their pipelines that target HDL, so we might see something new within the decade that will make it possible to treat low HDL effectively. Exercise and smoking cessation are somewhat helpful in raising HDL levels.

Ugly triglycerides
Elevated triglycerides are also significantly linked to heart disease. The new guidelines recommend treating even borderline levels with weight control, medications and diets that exclude alcohol.

Metabolic syndrome
At least one in every four American adults has metabolic syndrome, which places them in high-risk categories for both heart disease and diabetes. This includes three of the following:

• abdominal obesity (for men that means a waist of 40 inches or larger; for women, 35 inches or more)
• triglycerides higher than 160 milligrams
• HDL less than 40
• blood pressure higher than 130/85 millimeters
• fasting blood sugar greater than 110 milligrams

Exercise and diet, as well as treatment to reduce blood pressure and lower lipid counts, are indicated.

What about hormone replacement therapy?
We have known for decades that estrogen has a protective effect on premenopausal women. Women generally develop heart disease 10 years later than men after menopause. However, recent research indicates that hormone replacement therapy is not a substitute for cholesterol-lowering drugs.

In fact, statins have beneficial effects on strengthening bone for women at risk of osteoporosis. After a woman has had a heart attack, HRT is generally not recommended because it is associated with an increased risk of blood clots.

Talk to your doctor
The new guidelines present a good opportunity for a discussion about your risk for heart disease with your physician. Ask about your risk based on the guidelines' new risk formula, and ask about your HDL, LDL and triglyceride levels and whether any changes in lifestyle or medication are indicated.

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Dr. Setaro is an attending cardiologist at Yale-New Haven Hospital and Yale-New Haven Heart Center, as well as an associate professor of medicine and director of the Cardiovascular Disease Prevention Center at the Yale University School of Medicine.