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Study: Diabetes Drug Doubles Heart Risk

Posted on: Friday, 21 October 2005, 06:00 CDT

By Steve Sternberg

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 study was carried out by the same Cleveland Clinic researchers who first reported the heart risks posed by the arthritis drug Vioxx, which has been taken off the market. They used data the diabetes drug's maker, Bristol-Myers Squibb, gave the Food and Drug Administration.

Their analysis 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.

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

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 published their results two days after the FDA pronounced muraglitazar "approvable." But the FDA asked Bristol-Myers to address the drug's heart-disease risk profile.

The Journal of the American Medical Association rushed the study onto its website Thursday, 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, 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.

Laura Alvey, an FDA spokeswoman, issued a statement that said the agency was aware of the latest findings on muraglitazar but that it couldn't comment further on the drug because its application for approval is still pending.

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

On Sept. 9, an FDA advisory committee voted 8-1 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 gulf between the two interpretations of the data. He asked: "The question now is, which safety message will the FDA buy?"

(c) Copyright 2005 USA TODAY, a division of Gannett Co. Inc.

Source: USA TODAY

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