Heart Medicine for the Non-Sick?

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If my doctor told me that I had no established risk factors for coronary heart disease (CHD) but should go on prescription medication to prevent it anyway, I'd look at him like he was from another planet -- Jupiter, perhaps.

But a new analysis of data from a study known as JUPITER (Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) suggests that for certain people, the statin drug rosuvastatin (sold as Crestor) could reduce their risk of CHD.

The study might also help uncover a new risk factor for heart disease. In a review of data presented at the American Heart Association meeting last month, researchers found that women over sixty with elevated levels of C-reactive protein (CRP) but normal cholesterol who took 20 mg of Crestor had a 46% reduced risk of cardiovascular events, and men had a smaller but still significant 42% reduction. If these figures are borne out in future studies, the potential lifesaving benefit of instituting statin therapy based on nothing more than elevated CRP levels would be vast, since CHD is the developed world's leading killer. The study, funded by AstraZeneca (which markets Crestor) was a long-term, randomized, double-blind, placebo-controlled, large-scale study -- the medical "gold standard."

CRP is a marker for inflammation, and many have suggested inflammation is a risk factor for heart disease. But, until now at least, the conventional thinking was that CRP is not an independent risk factor for heart disease. In fact, in October, the U.S. Preventive Services Task Force (USPSTF) decided not to add CRP as a risk factor.

Yes, this is the same group whose study on mammography sparked so much outrage. Maybe some of that criticism should be redirected at their CRP finding. After all, women are six times more likely to die from heart disease than from breast cancer -- and women are more likely than men to die of heart disease -- yet rarely is heart disease seen as a women's issue.

Now we have growing evidence of not only a way to identify one risk of heart disease in women but a way to prevent it. Yet I haven't seen any of the excitement that came after the USPSTF mammogram findings. There was no criticism from the secretary of the Department of Health and Human Services, no attempts by the Senate to override the advice, and no angry talking heads on television.

But in terms of how this affects the health of women, how the CRP controversy plays out will likely have a far greater impact. Why? Because, finding a way to identify patients at risk for heart disease, and preventing it even before they are sick, would be a true breakthrough against a silent killer (among the approximately 450,000 coronary-related deaths in this country each year, one-third were sudden, with no prior history of heart disease).

On December 11, the FDA released a report favoring the use of elevated CRP as an indication for Crestor use. But since CRP is not yet established as a risk factor for CHD, this move by the FDA might strike some as hasty. How can the FDA say it is okay for healthy women with no established risk factors to get medicated? Shouldn't we only take medicine if we are sick? While people may believe that, we do often give medication to people who are "not sick" -- including vaccines, cholesterol-lowering statins in high-risk patients, and stomach-protective drugs for patients using anti-arthritis drugs.

So thinking of medication as something only for the sick may be a mistake. And many people who are "not yet sick" have heart attacks. So perhaps the prudent thing to do, given the growing evidence of Crestor's efficacy and its long record of safety, is to put older women (and perhaps men) who have elevated CRP on the drug while more studies are done. Indeed, it may be risky not to.

Jeff Stier is an associate director of the American Council on Science and Health (ACSH.org).