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Big news was unveiled this week at the American Heart Association annual meeting in New Orleans, and it may change the way doctors diagnose and treat heart disease.
Turns out that inflammation may be even more of a villain than high cholesterol. And people who have low cholesterol but high levels of C-reactive protein (CRP) in their blood (a kind of marker for inflammation) can benefit from taking statin drugs. As study author Paul Ridker, MD, put it, “We can no longer assume that patients with low cholesterol are at low risk.”
The JUPITER study, as it’s called, involved nearly 18,000 people worldwide, and tested statin treatment in men 50 and older and in women 60 and older who did not have high cholesterol or histories of heart disease but did have high levels of CRP. The results? Their risk of heart attack was more than cut in half. They were also 50 percent less likely to suffer a stroke or need angioplasty or bypass surgery, and they were 20 percent less likely to die over the course of the study. The results were so striking that an independent safety monitoring board stopped what was supposed to be a five-year trial after less than two years (a decision some experts disagree with).
The study was reported widely yesterday, but I needed a day to put it in perspective. Cynical me, my first reaction was, “Hmm, a study supported by the pharmaceutical company that makes the statin drug tested finds that millions of people could benefit from that drug who currently would not be considered candidates for it? Somebody’s going to get really wealthy off this!”
That’s the 800-pound gorilla in the room, of course. Apparently there are 7.4 million adult Americans who meet the criteria for this study, says James Stein, MD, of the University of Wisconsin Medical School, Madison, who crunched the numbers. And statin therapy can cost about $1,200 a year. That adds up to a lot of dollars.
Despite my cynicism, though, most experts agree that this was a well-designed study with solid results. Elizabeth G. Nabel, MD, director of the National Heart, Lung, and Blood Institute (NHLBI), says that this and some other study results released “expand our understanding of the role of inflammation in detecting early signs of cardiovascular disease and identifying adults who are at risk for heart attack or stroke. Adding CRP levels to traditional risk factors could identify millions more adults for whom treatment with statins appears to lower the risk of heart attack.”
Medical writer Linda Marsa has been working on a story on heart health that we’re running in the February issue of Reader’s Digest. She spoke this morning with Antonio M. Gotto Jr., co-author of the JUPITER study and dean of Weill Cornell Medical College in New York City. Just between us, Marsa says Dr. Gotto is “very ethical and not someone who is beholden to the drug industry.” (That’s important in light of my blog yesterday.) He had some interesting things to say:
• CRP should become a standard test as part of an overall evaluation when people get their cholesterol and blood pressure checked. It's relatively inexpensive ($40-$60). Marsa mentioned that Dr. Ridker, his co-author, has a patent on the test, but Dr. Gotto has no financial interest, which is why she chose to interview him.
• The results apply to women, too. Dr. Gotto says the study contains "an important message for women because there's been a big debate about whether there is evidence that women benefit from statins. But the evidence is there now. Women in this study benefited who had no other known risk factor other than their age and a high CRP. Women with a high CRP and a normal LDL benefited as much as men."
• All statins will work. However, he said that Crestor, which was the statin used in the trial, is proven to be more potent than others on the market. "Crestor is the most potent one. With another one, we might not have seen this dramatic effect in this short a period of time."
• This will lead to more people being on statins. "Currently, he says, “15 million people are on statins. Probably tens of millions more could benefit from the treatment."
• “If your CRP is above 2, you should think about going on a statin."
NHLBI has asked an expert panel to review the evidence and consider new clinical guidelines incorporating this research. In the meantime, however, Dr. Nabel says “we must not lose sight of the essential truth of what we already know to prevent heart disease: Cholesterol still counts, and we have proven ways to lower it and lessen its impact. The value of following a heart-healthy eating plan, being physically active, maintaining a healthy weight, and not smoking cannot be overestimated.”
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