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Friday, July, 04, 2008

Actos, Avandia and the Drugmaker Murk

by  Craig Stoltz
Wednesday, September 12, 2007
Craig Stoltz
Craig Stoltz
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A veteran health journalist, I spent six years as editor of The ...

Craig Stoltz

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It's not quite fall, yet already there are two more studies adding to the whole Avandia/Actos/heart risks debate that's been rising since spring. Let's wade into the murk and see if there's anything new here. 

 

Bottom line first

 

A pair of studies appearing in the Journal of the American Medical Association suggests that Actos, a diabetes medication in the same class as Avandia, has significantly fewer serious heart-related risks than Avandia.

 

These studies in 50 words or less

 

Study No. 1 suggets that Actos reduces risk of heart attack, stroke and death by 18 percent, but increased the risk of serious heart failure by over 50 percent. No. 2 appeared to confirm earlier studies, including a major report in May, suggesting Avandia raises risk for heart attack by 42 percent and of heart failure by 50 percent.

 

Yes, but. . .

 

  • Neither study showed an increased risk in mortality, likely because the studies were too short.
  • The two reports used different methodologies, and did not compare Actos and Avandia directly.
  • One author of the Actos study is Steven Nissen of the Cleveland Clinic, whose May report in JAMA publicized fears raised by previous research that Avandia has serious heart-related side effects.
  • The Actos study was partly funded by Takeda pharmaceuticals, the drug's maker. Takeda provided its own clincial trails data for the research team; GlaxoSmithKline, maker of Avandia, did not.
  • Nissen's original report was criticized because it was a meta-analysis, or a study of previous studies. Both of the new studies are meta-analyses, but are considered more rigorous than the previous one.
  • The fact that two meta-analyses reach the same conclusion adds credibility to the Avandia-has-heart-risks hypothesis.

 

So what are you going to do about it?

 

Not much has changed for people with diabetes since the last round of studies came out: Work closely with your physician and diabetes care team to determine whether Avandia, Actos or another class of drugs entirely is the right choice for you. 

 

Many physicians interviewed for news reports on these studies suggest a consensus is forming that doctors and patients should choose drugs with a safer side effect profile than Avandia.

 

Learn more

 

To get up to speed on the Avandia controversy, check out previous reports at MyDiabetesCentral.

 

See SharePosts by Dr. Bill Quick, one of our expert physicians, about Avandia safety. 

 

See also journalist and Type 2 patient David Mendoza's excellent report.

 

 

 

 

 

 

 

 

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