The FDA has put the controversial Avandia safety trial TIDE on “partial clinical hold.” The action means that new patients may not be enrolled in the trial until the FDA gives the green light. Patients already enrolled in the trial will continue to participate in the trial. In its statement the FDA said it had…
Search Results for: avandia
Pioglitazone beats rosiglitazone in FDA review of controlled epidemiologic studies
July 9, 2010 by Leave a Comment
Avandia critics have focused on the dearth of evidence suggesting any advantage for rosiglitazone when compared to pioglitazone. They argue that there is no good reason for anyone to take rosiglitazone instead of pioglitazone. This view receives some support from the systematic review of controlled epidemiologic studies of cardiovascular risk in patients treated with rosiglitazone or…
5 different ways of spinning RECORD
July 9, 2010 by 4 Comments
The FDA Avandia briefing document (see previous post) contains 5 separate reviews of the RECORD trial. At an FDA press briefing Janet Woodcock predicted, with perfect understatement, “there will be a long discussion of RECORD.” Thomas Marciniak, an FDA reviewer who is well-known for his skepticism, was the most critical of the trial. The other reviewers…
Guest Post: Steve Nissen and Jack Lewin debate interactions with industry
May 26, 2010 by 3 Comments
Editor’s Note: The following guest post was written by Marilyn Mann, a lawyer with a keen interest in health policy. Members of her family have familial hypercholesterolemia (and have been treated by Steve Nissen), which may account for her particular interest in cardiology and this debate. Last week I attended the American Heart Association Quality…
EHJ editors rebuffed GSK efforts to suppress Nissen editorial on rosiglitazone
April 30, 2010 by 4 Comments
The editors of the European Heart Journal rejected a request by a senior GSK executive to suppress an editorial written by Steve Nissen about rosiglitazone (Avandia). The incident is recounted in a separate editorial written by the EHJ editor-in-chief, Thomas Lüscher, and two deputy editors, Ulf Landmesser, and Frank Ruschitzka, and published online on April…
BMJ study questions “whether ongoing use of rosiglitazone is justified in any circumstance”
August 18, 2009 by 3 Comments
A large observational study has found a significantly higher risk of heart failure and death associated with rosiglitazone compared to pioglitazone. David Juurlink and colleagues in Toronto, Canada state in their conclusion: Given the accumulating evidence of harm with rosiglitazone treatment and the lack of a distinct clinical advantage for the drug over pioglitazone, questioning whether…
Rosiglitazone goes on the RECORD, but is it a hit?
June 5, 2009 by 4 Comments
A big new rosiglitazone trial, RECORD, found no increase in overall cardiovascular morbidity and mortality, the primary endpoint of the trial, but is unlikely to quiet the drug’s critics or end the controversy over the drug. The trial is being presented at the American Diabetes Association (ADA) meeting in New Orleans and simultaneously published online…
RECORD and BARI 2D to be presented this weekend at ADA
June 5, 2009 by Leave a Comment
Two much anticipated trials will be presented this weekend in New Orleans at the annual meeting of the American Diabetes Association. Late Friday afternoon (5:15 PM ET) the RECORD trial with the highly controversial drug rosiglitazone (Avandia) will be presented at a symposium. The multicenter, open-label trial randomized nearly 4,500 patients with type 2 diabetes…
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