MedWire News: A US Food and Drug Administration (FDA) advisory committee has voted to keep the Type 2 diabetes drug rosiglitazone on the market, but suggested that the labeling needs to be changed to include increased warnings.
The review comes after publication of contradictory results from various studies since 2007 on the potential negative effects of rosiglitazone treatment on the risk for cardiovascular disease (CVD), as previously reported by MedWire News.
The committee voted by an overall majority (20 votes to 12) to keep the thiazolidinedione rosiglitazone on the market, and that the currently ongoing Thiazolidinedione Intervention With Vitamin D Evaluation (TIDE) trial should continue (20 votes to 10). A majority (17 of 33 members) also voted for labeling revision to reflect increased risks and improved education of doctors.
The TIDE trial is comparing the effects of treatment with rosiglitazone, pioglitazone, or placebo in addition to standard care in Type 2 diabetic patients with or at high risk for CVD and has an estimated finish date of 2015. It is also due to compare the effects of long-term supplementation with vitamin D on risks for cancer or death.
In a comment published by the American Heart Association (AHA), Ralph Sacco said that the committee decision was difficult due to limited available data, previous controversy, and multiple interpretations of the information by experienced clinicians and investigators.
He said that the AHA agrees with the US FDA that further research is necessary to answer remaining questions, and that all new clinical data regarding rosiglitazone needs to be carefully evaluated and assessed as it becomes available.
The AHA says that metformin should be the first drug of choice for patients with Type 2 diabetes, with other medications considered in the absence of good glycemic control.
It says that the rationale for choosing a thiazolidinedione (TZD) should be carefully discussed between patient and physician, but that patients who have achieved good glycemic control using a TZD should be able to continue on their medication.
The European Medicines Agency is currently carrying out a similar review of rosiglitazone and the issue is due to be discussed at its plenary meeting later this month.
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