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Enrollment Halted in Avandia TIDE Trial

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Enrollment in a controversial Avandia study has been halted by the Food & Drug Administration (FDA) over safety concerns. The trial, called TIDE (Thiazolidinedione Intervention With Vitamin D Evaluation), was designed to compare the long-term effects of Avandia with another diabetes drug called Actos.

For some time now, scientists inside and outside the FDA have opposed TIDE, saying it is unethical to compare Avandia, with its known cardiac risks, with a seemingly safer alternative. Actos has not raised as many safety concerns as Avandia.

The agency is demanding that Glaxo update physicians and ethics oversight boards involved in the trial regarding all new safety information about the drug. The agency did not say how long the enrollment halt would last. The people already participating in the trial will be allowed to continue with it, the FDA said.

The agency’s decision comes a week after an FDA advisory panels voted 20-12 to recommend that Avandia be allowed to stay on the market. However, 10 panel members voted that its sales should be restricted and that warnings on its label regarding heart risks be strengthened. Nineteen panelists said TIDE should continue, and 11 opposed it.

Since November 2007, Avandia’s label has included a black box warning – the FDA’s strongest safety alert – detailing its association with myocardial ischemia. The black box was added after the Cleveland Clinic published a meta- analysis of 42 clinical trails that showed patients taking Avandia had a 43-percent higher risk of having a heart attack. Since the addition of the black box, evidence linking Avandia to an increased risk of heart attacks has continued to accumulate.

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