Statins For All?

In 2007, the Food and Drug Administration conducted an investigation into whether statins increase the risk of the fatal neurodegenerative disease amyotrophic lateral sclerosis, also known as Lou Gehrig's disease, when the agency received a higher than expected number of reports of the disease in people taking statins. Although an analysis of 41 long-term controlled clinical trials reported in September detected no such link, the FDA has said it plans to continue studying the issue.

Dr. Scott Grundy, a professor of internal medicine and director of the Center for Human Nutrition at the University of Texas Southwestern Medical Center at Dallas, says he thinks the drugs, on balance, are safe. But he adds that caution is still warranted, especially when it comes to considering a broad expansion of their use or prescribing them earlier in people's lives.

Statins have been in use only since the late 1980s, he notes, and so there hasn't been enough time yet to learn what might happen if someone were to be on the drugs for 30 or 40 years. "It is possible that some of these rare side effects might turn out to be quite important if [statins are] started early in life and continued for years and years," he says.

Whether statin use is substantially expanded may depend on how the results of the JUPITER trial and other recent research are incorporated into new cholesterol guidelines slated to be released next year by the National Heart, Lung and Blood Institute.

If CRP testing becomes part of the standard battery of tests that guide risk assessment and statin treatment decisions, millions more Americans could find themselves filling a prescription.

Currently, most doctors use CRP testing as a sort of tie-breaker when they are on the fence as to whether a patient is at high enough risk of heart disease to warrant statin therapy. Patients might, for example, have intermediate cholesterol levels but a family history of heart attacks or some other risk factor.

Dr. Mary Malloy, co-director of the adult lipid clinic and director of the pediatric lipid clinic at the UCSF Medical Center, does not think this should change, even though she characterizes the JUPITER results as "very impressive."

"I am personally not ready to corral everyone over 35 and do CRP testing," she says.

Wong says it's important that people take into account a person's absolute risk when judging whether or not a patient needs a statin.

Of the JUPITER trial, he says, "There was a 44% reduction in cardiovascular events. This sounds very dramatic, and it is." But the risk of heart attack in those patients was pretty tiny to begin with -- 2.8%. The 44% drop took it down to 1.6%.

The bottom line is that monetary cost as well as potential side effects of statins must be weighed against the potential benefits.

Wong's biggest concern is that people will get the idea that statins are a cure-all -- and they'll stop bothering about habits that could affect their heart health just as much.

"People think statins are magic pills," he says. "You can't forget about other risk factors like smoking, diabetes and blood pressure. . . . you have to make sure all these things are adequately controlled."

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