Statement from GlaxoSmithKline: publication of update regarding thiazolidinediones to treatment guidelines for the management of type 2 diabetes mellitus by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA)
The European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) recently convened a panel of physicians to recommend updates to diabetes treatment guidelines with new information on the thiazolidinediones (TZDs). The panel developed a consensus statement published in the online edition of EASD’s Diabetologia and ADA’s Diabetes Care the week of 27 November. It is important to note that, according to the ADA, a consensus statement does not reflect the official association position, but rather the consensus opinion of the panel members.
The authors of the consensus state that, “At this time, we do not view as definitive the clinical trial data regarding increased or decreased risk of myocardial infarctions with rosiglitazone or pioglitazone, respectively.”
The U.S. Food and Drug Administration (FDA) have concluded that, “To date, no oral anti-diabetes drug has been conclusively shown to reduce cardiovascular risk” and have announced that it will be requesting that labelling of all approved oral diabetes medicines contain language describing the lack of data showing this benefit. GSK is concerned that the consensus treatment algorithm has been updated based on inconclusive study data.
It is important to note that the authors of the consensus statement finalised their update to the treatment guidelines before – but published it after – the important conclusions above were made public by the FDA on 14 November 2007, regarding risk of myocardial ischaemia associated with oral diabetes medicines.
GSK believes this consensus statement could confuse those physicians who need clear guidance on determining appropriate use of treatments for their patients with type 2 diabetes.
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