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Saturday, October, 11, 2008

Additional Avandia Anxiety

by  David Mendosa
Tuesday, July 17, 2007
David Mendosa
David Mendosa
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Medical journalist living with diabetes

After earning a B.A. with honors from the University of California...

David Mendosa

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Today we have even more bad news in two separate studies about the diabetes drug Avandia. With the bad news we get all the time about diabetes you might wonder why I report more negative stuff.

It’s because we have much better alternatives.

I have been studying a pre-print of a report scheduled to appear in the highly-respected Cochrane Library, a journal devoted to systematic reviews of health care interventions. The abstract is online. This is a publication of the Cochrane Collaboration, which has worldwide chapters in 50 medical specialties. The name comes from Archie Cochrane, who wrote a history of fatal flaws in medical practice, like the refusal by 19th century doctors to wash their hands between dissecting corpses and examining patients.

Embargoed until just this hour, The Cochrane Library reports a systematic review of data by German researchers. Led by Bernd Richter, M.D., of Heinrich-Heine University, the study pooled data from 18 randomized controlled trials including more than 8,000 participants.

The new study is unlike the sensational meta-analysis that came out in May indicating that Avandia causes some people to use it to have heart attacks. That seems to affect only a small percentage of people who take it.

The new study reports on negative side effects of Avandia that affect the average user. It seems that even if you don’t die of a heart attack while taking this drug, you will probably gain a lot of weight in the meanwhile.

The pooled data that the study looked at revealed that people who take Avandia gained up to 11 pounds in body weight and that the chance of developing swelling doubled. These changes indicate that the drug causes fluid retention, which can lead to shortness of breath and heart failure.

It was the Rosiglitazone Clinical Trials Study Group, headed by Martin St. John Sutton, that reported the 11 pound weight gain on Avandia in a 2002 issue of Diabetes Care. That was just in the first year of use.

It happens that another study, which the new review did not include, showed the same 11-pound weight gain. Kaiser Permanente Northwest members who started taking Avandia or Actos (a similar drug in the same class) between 1996 and 2002 and continued to use it for at least a year without adding any other diabetes medication gained an average of 11 pounds in the first year they used it. That’s more than any other drug that we take to control our diabetes, including insulin and the sulfonylureas. Gregory A. Nichols and Andres Gomez first reported this finding in “Weight Changes Associated with Anti-Hyperglycemic Therapies for Type 2 Diabetes,” in abstract 13-OR presented at the 65th Annual Scientific Sessions of the American Diabetes Association, San Diego in 2005.

Even without taking Avandia, people with diabetes usually have a big enough problem with weight. U.S. government statistics show that 85 percent of us are overweight or obese.

The new Cochrane study has a damning conclusion as I ever remember reading in a scientific study. "New safety data on increased rates of fractures and possibly the risk of myocardial infarction and cardiovascular disease should lead to a very cautious approach to rosiglitazone use. If possible, other antidiabetic medications should be employed."

 

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