Quoted from http://online.wsj.com/article/SB10001424052748703964104575334570859778764.html
Two New Studies Cite Heart Risk in Glaxo's Avandia
JUNE 29, 2010
By ALICIA MUNDY And JENNIFER CORBETT DOOREN
Two new studies released Monday said the diabetes drug Avandia is unsafe, heating up a controversy about a drug linked in a number of studies to an increased risk of heart attack and heart failure.
Avandia Diabetes Drug Controversy Heats Up
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Two studies suggest there's an increased risk of heart attack, stroke or heart failure among those taking diabetes drug Avandia, WSJ's Alicia Mundy reports.
The reports were presented in the Journal of the American Medical Association and its sister publication, the Archives of Internal Medicine. They come two weeks before an important Food and Drug Administration meeting on Avandia's safety. In releasing the papers together, a JAMA spokeswoman said the editors "hope the peer-reviewed scientific studies will have some impact on the FDA's discussions about the safety of this medication."
The studies also coincided with the American Diabetes Association's annual meeting in Orlando.
Avandia manufacturer GlaxoSmithKline PLC said in a statement that the drug, which lowers blood glucose, is safe and effective. Glaxo said it looks forward to a "rigorous scientific discussion" about the new studies at the FDA meeting.
One study in the Archives of Internal Medicine is an update of a 2007 analysis of the clinical trials done on Avandia by Steven Nissen, a cardiologist at the Cleveland Clinic. The original analysis was based on 42 studies involving Avandia and showed a 43% increase in the risk of heart attacks. The new analysis looks at 56 clinical studies, including a Glaxo-funded study known as Record, and shows an increased heart attack risk of 28%. If the Record study is removed from the analysis, the risk of heart attacks rises to 39%.
The second study, published in JAMA, was led by FDA drug-safety scientist David Graham, and looked at the outcomes of nearly 230,000 Medicare patients who were treated with Avandia or Actos, a similar drug made by Takeda Pharmaceutical Co. The study looked at a combined endpoint of heart attack, stroke, heart failure or death and found that patients taking Avandia had an 18% increased risk compared to those taking Actos.
Dr. Graham has argued that it should be withdrawn from the market.
"I think these studies ought to weigh heavily on the advisory panel," Dr. Nissen said in an interview.
An analysis of data from a third study, called Bari 2D and funded by the government, didn't show cardiovascular risks. The results, which haven't been peer-viewed and published yet, were released early at the diabetes conference in response to the JAMA studies.