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Diabetes and Cardiology Groups Stay Firm on Rosiglitazone

Posted: Sunday, July 04, 2010

As controversy again heats up over rosiglitazone (Avandia), the American Diabetes Association (ADA) and American Heart Association (AHA) have stood firm on their positions on the embattled drug.

In response to new Medicare data showing greater elevations in stroke, heart failure, and death risk with rosiglitazone compared with pioglitazone (Actos), the AHA issued a statement to the media reiterating its stance that there are insufficient data to support the choice of one over the other. And both the AHA and the ADA emphasized the need for patients to be informed of the new evidence, but not to panic.

"We encourage patients to not stop taking their medication until they discuss it with their provider.... But they should know about all the information that's out there," stated David M. Kendall, MD, the ADA's chief scientific and medical officer.

The debate has reached a high pitch, with an impending FDA advisory committee meeting scheduled for mid-July to hear evidence on rosiglitazone. It's widely believed that pulling rosiglitazone from the market will be among the possibilities considered.

In February, the AHA released a joint advisory statement with the American College of Cardiology saying there was not good enough data to pick pioglitazone over rosiglitazone, despite the controversy over rosiglitazone's cardiac safety. The statement came in response to a Senate Finance Committee report calling pioglitazone a safer drug.

Since then, new analyses have come down both for and against rosiglitazone.

At the ADA meeting, a post-hoc analysis of the BARI 2D trial, which included a diabetes population with established coronary disease or other high-risk characteristics, found a significant 29% reduced composite relative risk of death, myocardial infarction (MI), and stroke with nonrandomized use of rosiglitazone compared with no use of any thiazolidinedione (3.79 versus 5.81 per 100 patient-years, P=0.002).

Earlier the same day, a 56-trial meta-analysis released online in the Archives of Internal Medicine had shown MI risk elevated by 28% to 39% with rosiglitazone (P=0.04).

At the same time, an analysis of observational Medicare data by the FDA was published in the Journal of the American Medical Association showing significantly higher risk of stroke, heart failure, death, and the composite with MI with rosiglitazone versus pioglitazone.

A joint consensus group of the ADA and European Association for the Study of Diabetes pulled rosiglitazone from its recommendations for treatment of Type 2 diabetes, calling pioglitazone the more appropriate choice for second-line therapy after lifestyle changes and metformin.

However, the ADA has distanced itself from this move, saying it is not official ADA policy.

The chair of the consensus group, David Nathan, MD, of Massachusetts General Hospital in Boston, saw this as somewhat disingenuous.

"It's fair to say that it's the consensus group's opinion and we don't work for the ADA," he said in an interview. "But it is a group that they [the ADA] formed."

And it's appropriate for the association to let the FDA act on the science without taking an advocacy role, said ADA president of medicine and science Richard Bergenstal, MD, of the International Diabetes Center at Park Nicollet in Minneapolis, Minn.

The AHA, while still not coming out clearly in support of either thiazolidinedione, has provided at least slightly more guidance for clinicians.

Its new statement reiterated the suggestion in its earlier advisory that patients who have achieved successful glycemic control on either drug might be continued on that drug with close monitoring.

It reemphasized that if a thiazolidinedione is considered, "it should not be used with an expectation of benefit in reducing the occurrence of heart attack or stroke," despite the BARI 2D and Medicare analyses.

Speaking on behalf of the cardiology group, Clyde Yancy, MD, of Baylor University in Dallas and immediate past president of the AHA, characterized its stance as "expressing an appropriate amount of caution" based on the limitations of all available data.

"We're all looking to the FDA," he said in an interview. "I hope what the FDA does is evaluate databases we haven't yet seen, not just a reformulation of what we've seen."

Source:, 2010 ADA Scientific Sessions.

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