High cholesterol: Weighing drug therapy

Not everyone is ready to join hands in a statin lovefest. Some experts strongly oppose the suggestion that the drugs be used on an expanding circle of patients -- people without a sign of heart disease, even healthy people with normal cholesterol. Since the early 1990s Thomas B. Newman, a professor of epidemiology and biostatistics at the University of California at San Francisco's school of medicine, has filled medical journals with concerns about anticholesterol medications. His message is simple: People who are healthy and free of heart disease don't need the drugs. "The idea that healthy patients with normal cholesterol need to take statins is both presumptuous and arrogant," he says.

Newman and like-minded scientists feel that cholesterol can be too low. They point to the so-called J curve in mortality, which indicates that death rates are higher in average adult men whose total cholesterol falls below 160. (Some researchers dispute this analysis by asserting that certain diseases produce low cholesterol, not the other way around.) Newman also maintains that no one knows the effect the statins will have on healthy people who take them for decades. "Even if the drugs are safe and effective in the short term, we don't know what will happen if people take them for 10, 20, or 30 years. We may be trading a short-term benefit for unknown long-term risks."

And although statins are considered reasonably safe, they aren't without risks. Studies indicate that they are better tolerated than other cholesterol-lowering drugs, the statins can cause such side effects are mild gastrointestinal disturbances, muscle pain and stiffness, rash, and headache. In some cases they can cause liver damage or serious myopathic disorders such as rhabdomyolysis. One of the drugs, cerivastatin (Baycol), has even been pulled off the market because of reports of muscle destruction linked to 31 deaths in the United States. Statins can also bring about severe problems when combined with certain drugs, including oral anticoagulants, gemfibrozil, erythromycin, niacin, cyclosporine, and certain bloods used to treat high blood pressure.

(If you're a patient and are taking Baycol, your doctor will want to switch you to another cholesterol-lowering drug right away. And if you're on any statin and experience muscle pain, weakness, or tenderness, particularly in your back and calves, or muscle pain combined with weakness, fever, vomiting, or dark urine, get medical help IMMEDIATELY.)

In general, however, statins are safe and effective, according to the American Heart Association. Perhaps a bigger obstacle to them is price. The research company Source Information /PMSI tracked 6,000 patients who began taking statins in September 1996. Six months later, fewer than half were still on the drugs; at 10 months the number had fallen from 30 to 40 percent. The reason cited most often for stopping was cost. (The apparent decline in the cost of LDL-lowering drugs, however, may mean that they'll become available to more patients.)

In addition, other studies suggest that the drugs can save patients money in the long run. One analysis, for instance, found that simivastatin therapy added only 28 cents a day in net costs due to lower hospital charges and associated treatment expenses, says Roger Blumenthal, MD, director of the cardiovascular department at the Johns Hopkins School of Medicine.

The new studies on high cholesterol are a call to action, says prominent cardiologist William Castelli. When he examined the subjects in the recent Air Force trial, for example -- people who had an average LDL of 150 and no history of heart disease -- he didn't see healthy patients. He saw future heart attack victims. "We're living in a terribly dangerous society," Castelli says. "But fortunately we're learning that we have mechanisms to change the risks." The new research has focused attention on the importance of revising therapy goals, he says. "People with an LDL of 150 -- we need to treat them."

He's not the only one who feels that way. Diet and exercise are still the first lines of defense against high cholesterol, but if lifestyle changes don't work, the National Cholesterol Education Project's guidelines recommend that physicians consider drug therapy in the following categories:

Aggressive treatment is particularly important for patients with a family history of coronary artery disease, says University of Southern California atherosclerosis research director Howard Hodis. "Genes are so important in heart disease. If someone's father had a heart attack at age 50, chances are he will too."

More than a year after his alarming trip to the doctor, Louis Vida is increasingly confident that he can defy such pronouncements. He has good reason to be hopeful. By sticking to a sensible diet and trying to exercise regularly, the auto worker has lowered his weight further. And thanks to this healthier lifestyle and continued statin therapy, his cholesterol levels remain normal.

These results are much more than numbers to Louis Vida, whose father had suffered a disabling heart attack at age 49. When Vida sought medical help, his cholesterol hovered at 299. After a combined diet, exercise, and statin therapy program, the 44-year-old auto worker's cholesterol plummeted and he feels better than he has in recent memory. Perhaps most important, he's looking forward to enjoying years of good health that his father could not.

-- Thomas H. Maugh II is a science writer based in Los Angeles. An earlier version of this story appeared in Hippocrates magazine.

Editor's note: Since this article was published, the National Cholesterol Education Program (NCEP) came out with new guidelines in July 2004 recommending statins or other cholesterol-lowering drugs for everyone who is at high risk for a heart attack AND has an LDL or bad cholesterol level above 100 mg/dL. [High-risk is defined as those who have coronary heart disease or diabetes or mulitple risk factors (i.e., smoking, hypertension) that give them a greater than 20 percent chance of having a heart attack within 10 years.] The American Heart Association also came out with new guidelines in February 2004 recommending that ALL women who are at high-risk for heart attacks take statins or other cholesterol-lowering drugs, even if their LDL cholesterol is below 100.

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First published May 21, 2001
Last updated October 29, 2007