The New York Times-20080129-Great Drug- but Does It Prolong Life-

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Great Drug, but Does It Prolong Life?

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Statins are among the most prescribed drugs in the world, and there is no doubt that they work as advertised -- that they lower not only cholesterol but also the risk for heart attack.

But in the fallout from the headline-making trial of Vytorin, a combination drug that was found to be no more effective than a simple statin in reducing arterial plaque, many people are asking a more fundamental question about statins in general: Do they prolong your life?

And for many users, the surprising answer appears to be no.

Some patients do receive significant benefits from statins, like Lipitor (from Pfizer), Crestor (AstraZeneca) and Pravachol (Bristol-Myers Squibb). In studies of middle-aged men with cardiovascular disease, statin users were less likely to die than those who were given a placebo.

But many statin users don't have established heart disease; they simply have high cholesterol. For healthy men, for women with or without heart disease and for people over 70, there is little evidence, if any, that taking a statin will make a meaningful difference in how long they live.

High-risk groups have a lot to gain, said Dr. Mark H. Ebell, a professor at the University of Georgia who is deputy editor of the journal American Family Physician. But patients at low risk benefit very little if at all. We end up overtreating a lot of patients. (Like the other doctors quoted in this column, Dr. Ebell has no ties to drug makers.)

How is this possible, if statins lower the risk of heart attack? Because preventing a heart attack is not the same thing as saving a life. In many statin studies that show lower heart attack risk, the same number of patients end up dying, whether they are taking statins or not.

You may have helped the heart, but you haven't helped the patient, said Dr. Beatrice Golomb, an associate professor of medicine at the University of California, San Francisco, and a co-author of a 2004 editorial in The Journal of the American College of Cardiology questioning the data on statins. You still have to look at the impact on the patient over all.

A 2006 study in The Archives of Internal Medicine looked at seven trials of statin use in nearly 43,000 patients, mostly middle-aged men without heart disease. In that review, statins didn't lower mortality.

Nor did they in a study called Prosper, published in The Lancet in 2002, which studied statin use in people 70 and older. Nor did they in a 2004 review in The Journal of the American Medical Association, which looked at 13 studies of nearly 20,000 women, both healthy and with established heart disease.

A Pfizer spokeswoman notes that a decline in heart disease death rates reported recently by the American Heart Association suggests that medications like statins are having an impact. But to consistently show a mortality benefit from statins in a research setting would take years of study. We've concentrated on whether Lipitor reduces risk of heart attacks and strokes, says Halit Bander, medical team leader for Lipitor. We've proven that again and again.

This month, The Journal of the American College of Cardiology published a report combining data from several studies of people 65 and older who had a prior heart attack or established heart disease. This meta-analysis showed that 18.7 percent of the placebo users died during the studies, compared with 15.6 percent of the statin users.

This translates into a 22 percent lower mortality risk for high-risk patients over 65. A co-author of the study, Dr. Jonathan Afilalo, a cardiology fellow at McGill University in Montreal, says that for every 28 patients over 65 with heart disease who take statins, one life will be saved.

If a patient has had a heart attack, Dr. Afilalo said, they generally should be on a statin.

Of course, prolonging life is not the only measure that matters. If preventing a heart attack improved the quality of life, that would be an argument for taking statins even if it didn't reduce mortality. But critics say there's no evidence that statin users have a better quality of life than other people.

If you can show me one study that people who have a disability from their heart are worse off than people who have a disability from other causes, I would find that a compelling argument, Dr. Golomb said. There's not a shred of evidence that you've mitigated suffering in the groups where there is not a mortality benefit.

One big concern is that the side effects of statins haven't been well studied. Reported side effects include muscle pain, cognitive problems and impotence.

Statins have side effects that are underrated, said Dr. Uffe Ravnskov, a retired Swedish physician and a vocal critic of statins. It's much more frequent and serious than has been reported.

Dr. Ebell acknowledges that there are probably patients with heart disease who could benefit from a statin but who aren't taking it.

But he added, There are probably more of the opposite -- patients who are taking a statin when they probably don't need one.

[Illustration]ILLUSTRATION (ILLUSTRATION BY NOLA LOPEZ)