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Statins: Is This the Drug for You?

By: Source: AARP Bulletin Today Date Posted: 2003-07-29 14:11:16

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Statins—medicines that lower cholesterol levels—are so powerful in fighting heart disease that many doctors want to expand their use dramatically.

Recent studies show that statins, currently taken by an estimated 12 to 15 million Americans, cut the risk of death from heart attack or stroke by at least 25 percent. The results have prompted experts to recommend these "wonder drugs" for another 30 to 36 million people at risk for cardiovascular disease—including those with normal or low cholesterol.

"It appears the widespread use of statins will be one of the most potent weapons we have in reducing the risk of Americans dying early of heart disease," says Richard Stein, M.D., a spokesman for the American Heart Association and chief of cardiology at the Brooklyn Hospital Center in New York.

Despite near-universal agreement on the effectiveness of statins, the drugs may not be the answer for everyone trying to prevent heart disease. Effects of long-term use are still not clear, and their cost could be a barrier for some. Experts say, too, that the emphasis needs to be on lowering cholesterol through diet and exercise, not just drugs.

"The way the recommendations read, it almost sounds like you should put statins in the drinking water and everyone should have them," says Donald O. Fedder, professor of pharmacy and medicine at the University of Maryland in Baltimore who was the lead author of an analysis of cholesterol guidelines released in January.

"But you should be cautious," he says. "This is not an innocuous drug. For one, these drugs cost money, and two, just as with any other prescription, those taking the drug need to be monitored by their physicians. We've had a limited number of years with statins."

Statins are the nation's second most prescribed class of drugs. They are sold under the brand names Zocor, Lipitor, Lescol, Pravachol, Advicor and Mevacor. Lovastatin, the generic form of Mevacor, is also available.

The drugs work by blocking an enzyme in the liver that synthesizes cholesterol, a fatty substance that clogs arteries. This action reduces levels of low-density lipoprotein (LDL), the "bad" form of blood cholesterol, and prevents blockages that could cause a stroke or heart attack.

SAFETY AND SIDE EFFECTS

Statins have been in use for 15 years—long enough for most side effects to become known, but not necessarily long enough for conclusive proof of long-term safety. "There's always the possibility that very infrequent side effects won't show up for a longer period of time," says Michael A. Crouch, M.D., associate professor of medicine at Houston's Baylor College of Medicine.

One statin, Baycol, was withdrawn last year after 31 people taking it died from severe muscle cell breakdown. But a Food and Drug Administration review found that for statins still on the market, this risk is less than one in a million.

The latest guidance issued jointly by the American Heart Association, the American College of Cardiology and the National Cholesterol Education Program of the National Institutes of Health (NIH) concludes that statins, while "not entirely free" of side effects, are "extremely safe in the vast majority of patients using them."

Statins can cause occasional bloating, diarrhea and constipation. Blood tests can usually detect liver irritation, which occurs in fewer than one in a hundred cases, and muscle cell breakdown, a rare side effect. Patients are advised to have their liver enzyme levels checked a month after starting statins and then periodically.

Patients most vulnerable to complications are those who take five or more prescription drugs daily; have kidney problems; or are over age 80 and frail. Some drugs—antibiotics, antifungals, calcium-channel blockers, fibrates, HIV protease inhibitors and niacin—may cause statins to accumulate in the body.

COSTS AND BENEFITS

Specialists say that among those who could benefit from statins are older people who have conditions like diabetes or are on hormone replacement therapy (HRT) but don't know of their risk for heart disease.

"We recommend that statins be the first line of defense for heart disease rather than HRT," says Lori Mosca, M.D., director of preventive cardiology at New York-Presbyterian Hospital. The NIH Women's Health Initiative recently found that combined hormone therapy (but not estrogen alone) raises the risk of heart disease, contradicting earlier findings. [See HRT: Weighing the Risks from our September 2002 issue.]

One obstacle to taking statins may be the cost—even though in the long term, drugs are cheaper than surgery. The drugs cost from $50 to $135 a month and must be used continuously to be effective.

Yet one in four older Americans who have congestive heart failure and no drug insurance cannot fill all their prescriptions because of cost, according to a recent study by the Henry J. Kaiser Family Foundation, a health research organization. Nor can one in seven who have some drug coverage.

The question is who should be treated before heart disease is evident. "Since 30 to 40 percent of heart attacks are fatal, there's often no second chance to talk about treatment," Mosca says.

SHOULD YOU TAKE STATINS?

To answer that, you and your doctor need to assess your risk factors for heart disease. These include:

• age (45 or older for men; 55 or older for women);
• smoking in the past six months;
• high blood pressure (above 140/90);
• a family history of heart disease (before age 55 in a father or brother; before 65 in a mother or sister);
• high levels (above 130) of LDLs;
• low levels (below 40) of high-density lipoproteins (HDL), the " good " cholesterol.

"As we age, multiple risk factors are the rule, not the exception," says James I. Cleeman, M.D., coordinator of the National Cholesterol Education Program.

A physical exam can help you calculate your risk. You can also use the results of your cholesterol and blood pressure tests in a questionnaire devised by the National Heart, Lung and Blood Institute for a rough estimate of your chance of developing heart disease or having a heart attack in the next 10 years. [See box: For More Information on Cholesterol.]

In general, doctors say, those at greatest risk are individuals with diabetes or blood-vessel disease or with multiple risk factors. In the second-highest category are those with two risk factors but no known heart disease or diabetes. Those in the third category have one risk factor or none at all.

DIET, EXERCISE STILL COUNT

Statins are "great agents but only as part of a risk reduction program," says Richard C. Pasternak, M.D., director of preventive cardiology at Massachusetts General Hospital in Boston. Taking statins does not mean you can ignore diet, he says. "You can't just eat anything, because it's possible to overwhelm the benefits [of the drugs] by loading up on saturated fat."

In fact, experts say, you can cut your danger of heart disease a further 30 percent by controlling your weight, stopping smoking, eating under 10 percent saturated fat and more than five fruits and vegetables daily and exercising regularly—at least 30 minutes on most days.

Michele Meyer is a freelance writer in Texas.