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New Drug for Diabetes May Double Deadly Risks

Posted on: Friday, 21 October 2005, 15:00 CDT

By Steve Sternberg USA Today

A powerful new diabetes drug on the brink of being approved appears to double the risk of death, heart attacks or strokes, researchers reported Thursday.

The drug, muraglitazar, is a prototype of a new class of drugs that can reduce blood fats and blood sugar, a valuable combination for the 18 million diabetics who have a high risk of heart disease.

The analysis was carried out by the same Cleveland Clinic researchers who first reported the heart risks posed by the arthritis drug Vioxx, now off the market. They used data the diabetes drug's manufacturer, Bristol-Myers Squibb, gave to the Food and Drug Administration.

The study involved data from 2,374 patients who took muraglitazar, to be sold as Pargluva, and 1,351 who took either a rival drug called pioglitazone, sold as Actos, or a placebo. Death, heart attacks and strokes occurred in 35 of the muraglitazar patients and nine of the control patients, indicating that muraglitazar more than doubles patients' cardiovascular risk.

"Ten of 1,000 patients would die, have a heart attack or a stroke," says lead author Steven Nissen of the Cleveland Clinic. "Those are serious, irrevocable events."

When the researchers factored in heart failure and mini-strokes, Nissen says, they found that patients' risk of catastrophic events increased nearly threefold.

Nissen and his co-authors, cardiologist Eric Topol and statistician Kathy Wolski, published their results two days after the FDA pronounced muraglitazar "approvable." But the agency asked Bristol-Myers Squibb to address "more fully" the drug's heart- disease risk profile. The Journal of the American Medical Association rushed the study onto its Web site Thursday after independent review, citing a compelling need to make the information public.

"It's a very important and interesting finding," says Richard Kahn, of the American Diabetes Association. "I'm confident that the FDA will pursue this to the end to make sure the drug is safe."

Tony Plohoros, a spokesman for Bristol-Myers Squibb, says: "At this point, we're anxious to begin discussions with FDA to address this issue." Merck, which is marketing the drug with Bristol-Myers, echoed that response in a joint statement.

James Brophy, of McGill University in Montreal, wrote in a "JAMA "editorial Thursday that the new analysis "should focus serious attention on the cardiovascular risks of the drug."

On Sept. 9, an FDA advisory committee voted 8 to 1 to recommend the drug's approval as a treatment for type 2 diabetes. During that meeting, the FDA's analysts reported evidence of cardiac risk. But they didn't flag the risk as significant, except when the drug was used with other treatments. Bristol experts concluded there was no significant rise in heart risk.

Brophy, in his editorial, cited the disparity between the two interpretations of the data. He asked: "The question now is which safety message will the FDA buy?"

Source: Deseret News (Salt Lake City)

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