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A drug that is widely used to treat the most common type of diabetes, type II diabetes, may cause heart attacks and even death. That news was rushed into circulation today by the New England Journal of Medicine. It came from a review of Avandia's side effects.
And as NPR's Joanne Silberner reports, it's likely to leave the million or so patients who were taking the drug, wondering what to do.
JOANNE SILBERNER: Steven Nissen heads the division of cardiovascular medicine at the Cleveland Clinic. He started investigating the oral diabetes drug Avandia after noticing a suggestion of problems in a medical article published last autumn. He and a statistician combined the results of 42 trials of the drug. They found that it increased the risk of heart attacks by 43 percent, and of death from heart problems by 64 percent.
Dr. STEVEN NISSEN (Head, Cardiovascular Medicine Division, Cleveland Clinic): This is particularly important because cardiovascular disease is the leading cause of death amongst diabetic patients. So whenever you see a drug used to treat diabetes that increases rather than decreases the risk of heart disease, it is of profound public health importance.
SILBERNER: Avandia manufacturer GlaxoSmithKline responds that it did its own study similar to Nissen's and it, too, found an increased risk. But Glaxo chief medical officer Ronald Krall says there are problems with this sort of meta-analysis, the combining of a lot of different studies.
Mr. RONALD KRALL (Chief Medical Officer, GlaxoSmithKline): They are a collection of many different trials, each of which was designed for its own purpose, but not for the purpose of this particular meta-analysis that is to study cardiovascular events.
SILBERNER: Krall says Glaxo has several other studies in which doctors looked for cardiovascular problems. He says those studies showed no problems. But David Nathan, who treats diabetes patients, is not convinced by the company's reassurance. He directs the diabetes center at Massachusetts General Hospital. He's done comparative analyses of diabetes drugs. He says Nissen's findings put patients in a bind.
Dr. DAVID NATHAN (Director, Diabetes Center, Massachusetts General Hospital): It's going to be hard. I think that patients are going to need to discuss with their physician and I think the only data we have is this imperfect analysis. There's no question that it's imperfect. The authors know it. Those of us who reviewed the paper know it. But it's the only thing we have and it's credible.
SILBERNER: Avandia is not a cheap drug, about $6 a day. And David Nathan has long relied on other drugs for treating type II diabetes, drugs that have been around for decades with clean safety records.
Dr. NATHAN: I've never been a big fan of this class of drugs, frankly, so I haven't used it very much. And this particular drug was known to worsen cholesterol levels in studies. So if I were going to choose one of these drugs, this wouldn't have been the one.
SILBERNER: Another drug in the same class, Rezulin, was pulled off the market seven years ago because it caused serious liver problems. The last drug in this class, actos, may actually protect against heart disease according to some studies. Nathan says patients with diabetes who are on Avandia should talk to their physicians. Study author Nissen concurs.
Dr. NISSEN: First of all, no patients should stop taking drugs on their own. The last thing in the world we want in publishing a manuscript like this is to induce a public panic. It's very important that patients talk to their doctors.
SILBERNER: Because, he says, it's up to individual doctors to evaluate the drug risks themselves. They may see some benefit that Nissen doesn't. There's already a mention of cardiovascular risk on the drug's label, but it's not highlighted. At an FDA press conference today, Robert Meyer said the new analysis raises concerns, but the agency has more work to do.
Dr. ROBERT MEYER (Director, Office of Drug Evaluation, Food and Drug Administration): From the FDA standpoint, we have other data that suggests that we can't make a definitive conclusion at this point, so we don't have specific recommendations.
SILBERNER: The FDA says it will hold a meeting within the next couple of months to ask its advisers whether further steps should be taken.
Joanne Silberner, NPR News, Washington.
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