Clarified on 2/11/07: An earlier version of this article implied that the elevation of liver enzymes is a cause of severe muscle deterioration and kidney malfunction when it's an additional effect of statin use.
Until a few weeks ago, Larry Cohen believed he'd finally figured out how to beat his high cholesterol and stave off heart disease. Zocor, a statin that works by blocking the production of cholesterol in the liver, had brought his levels of "bad" LDL cholesterol down from a whopping 195 milligrams per deciliter to a still-disappointing 125. Next, on Vytorin, a combination of Zocor and a nonstatin drug that reduces the absorption of cholesterol in the gut, he dropped to a desirable 98 mg/dL. Then came word that Vytorin is no better at preventing plaque buildup in the arteries than Zocor. Suddenly, Cohen and millions of other people faced two big questions: How much protection were they getting from their cholesterol meds? And how much does lowering LDL even matter?
"After hearing the news, I have doubts, absolutely," says Cohen, 68, a retired math professor in Port Jefferson Station, N.Y. And doctors are hearing them: "My office is in an uproar. I've been in the past two Saturdays just returning calls," says Nieca Goldberg, medical director of New York University's Women's Heart Program and author of Dr. Nieca Goldberg's Complete Guide to Women's Health. Not surprisingly, refills for Vytorin have fallen nearly 25 percent since the news broke; new prescriptions are off by 40 percent.
Heart experts like Goldberg are seriously concerned that the media uproar about Vytorin may be causing even patients who have had heart attacks to conclude that they no longer have to worry about treating their high cholesterol. Bottom line, the experts say: There are two types of medication users—those who definitely need them and those who don't but are taking them anyway (thanks in no small part to effective drug marketing). The first group is made up of people with known heart disease: They've had heart-related chest pain, a previous heart attack or stroke, or angioplasty or bypass surgery. These folks, according to a large body of research, will lower their 10-year risk of a cardiac event by about 25 percent and their risk of dying from heart disease by 15 to 20 percent if they stay on a statin for the rest of their lives. The second group may have cholesterol levels that make their doctors frown but otherwise are fine.
Better drugs. Until two decades ago, doctors had few effective, safe medications at their disposal to treat high cholesterol. Now, the six powerful statins on the market (Zocor, Lipitor, Crestor, Pravachol, Lescol, Mevacor) and the non-statin Zetia—the other component of Vytorin—are so good at what they do that lowering cholesterol has taken on prime importance. In 2001, the government's National Cholesterol Education Program tightened the definition of a healthy total cholesterol level to under 200 mg/dL—previously, it was 300 mg/dL—and recommended that people at high risk keep their LDL levels below 100. "Good" HDL cholesterol levels should be kept above 40 mg/dL and preferably above 60. Result: Doctors began treating millions more people with drugs—including plenty with no signs of heart disease—even though statins are approved only for high-risk people.
"Some of the lowest-risk people are given statins," says Terry Jacobson, a cardiologist who heads the office of health promotion and disease prevention at Emory University in Atlanta. Given that the drugs can sometimes elevate liver enzymes and cause muscle aches, he says, "I've taken a lot of young women with high LDL levels and no risk factors off of them."
So what should people who are offered a drug take into account as they decide? Far more than just their cholesterol levels. The decision is almost a no-brainer for those who have had a cardiovascular event or clear evidence of clogged arteries—though the drugs aren't advised for those who are pregnant, nursing, or have liver disease. The NCEP issued new guidelines in 2004 that make clear distinctions between when medications should and should not be used in those who haven't yet developed heart disease. An LDL level of, say, 120 mg/dL—which would warrant drug therapy in a heart patient—is not considered worrisome in someone without symptoms or major risks.