Wednesday, May 23, 2007

What Choices Do You Have If You're Taking Avandia?

This week's New England Journal of Medicine is bound to trigger a barrage of calls to doctors from worried diabetics who have been taking Avandia, a pill that helps control blood sugar. An analysis of 42 different studies concluded that people on the drug have an unmistakably higher risk of heart attacks than do those who aren't on the drug.Why wasn't clear. The authors suggested a few possibilities, such as Avandia's tendency to increase levels of LDL cholesterol, the bad variety. What to do if you're taking it? U.S. News asked Bruce Psaty, an internist at the University of Washington Health Sciences Center and coauthor of an editorial in the New England Journal that looked closely at the analysis, to respond to questions that patients might have.

The authors of the New England Journal analysis looked at a lot of different studies. Their conclusion was that Avandia patients had a 43 percent higher chance of a heart attack. What does that mean? What was their risk of having a heart attack if they hadn't been taking Avandia?

Some diabetics who aren't taking Avandia might run a risk of heart attack of roughly 20 per 1,000 per year. This study shows that it would be 28 heart attacks in people taking Avandia, an increase of 8 heart attacks for every 1,000 people. It may not sound like much, but it's a substantially higher risk. Think about it this way: When we use lipid-lowering drugs like statins, we expect to reduce the risk of heart attack by 20 to 40 percent. So there's as much of anadverse effect from Avandia—a 43 percent higher risk—as there is a beneficial effect from statins.

What should I do if I'm taking this drug?

If you have questions about whether to continue, you should talk with your physician about the risks and benefits. Don't try to be your own physician. I myself have never prescribed these drugs. I just don't use them. They improve glucose control, but there was early evidence of weight gain and lipid problems, and it was hard for me to see how this would play out. I'm concerned about physicians who only think in terms of lowering glucose. It's a kind of tunnel vision.

What are a few other options?

The most effective treatments for diabetes are weight loss and exercise. These are difficult to accomplish, but the benefits are legion. They improve lipids, blood pressure, and even mood. They should be part of every diabetic's treatment. There are other drugs, and of course there is insulin.

Avandia is one of two diabetes drugs called glitazones. The other is Actos. Do patients taking Actos need to worry, too?

We need more information about Actos. It's clear that Actos is associated with an increased risk of heart failure. The evidence for increased risk of heart attack doesn't seem to be there, but to my knowledge there hasn't been a complete review of the evidence.

Is there a blood test or other way for my doctor to know if I'm one of the patients who are more likely to have a problem?

The data are so thin—we just know there's a concern about cardiovascular problems, so we lack sufficiently robust information to be able to identify people at higher risk.

Can I reduce the risk by cutting back on the dose?

The data weren't adequate to reach conclusions about higher or lower doses.

Should the Food and Drug Administration take Avandia off the market?

I am not aware of data the FDA and the company may know about. But I don't know of a reason for physicians to prescribe it. Physicians and patients cansuspend the use of the drug until the risks and benefits are clearer.

Source : http://www.usnews.com

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