GSK stated that the post-marketing study is designed to examine the comparative cardiovascular safety of Rosiglitazone (Avandia) and Pioglitazone (Actos) in patients with type 2 diabetes which was made mandatory by the FDA and is being conducted by an independent academic research group, Population Health Research Institute based at McMaster University.
GSK and TIDE steering committee are expected to work together to send a summary of recent safety data and a summary of the FDA advisory committee meeting on Avandia to all TIDE investigators and Institutional Review Boards to make sure that they have the latest information for patients.
In making its final decision on Avandia, FDA is expected to consider the recommendation of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee that the TIDE trial continue if Avandia remains available. Pending that decision, Avandia remains available to physicians and appropriate patients as an option to help control blood sugar in patients with type 2 diabetes.
Ellen Strahlman, chief medical officer of GSK, said: “This pause in enrollment is expected to give clinical trial investigators and patients time to learn about the data presented to the FDA Advisory Committee and the Committee’s recommendations.”