GlaxoSmithKline statement in response to FDA announcement on TIDE trial

GlaxoSmithKlineGlaxoSmithKline [NYSE: GSK] confirmed that it will suspend enrollment of new patients in the Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) clinical trial at the request of the U.S. Food and Drug Administration (FDA) pending FDA review of recommendations from its Advisory Committee meeting July 13-14. Patients already enrolled may continue in the trial.

This post-marketing study is designed to examine the comparative cardiovascular safety of rosiglitazone (Avandia) and pioglitazone (Actos) in patients with type 2 diabetes. It was mandated by the FDA and is being conducted by an independent academic research group, Population Health Research Institute based at McMaster University.

GSK will work with the TIDE Steering Committee 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 ensure they have the latest information for patients.

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 (20 yes, 10 no) will now be considered by the FDA in making its final decision on Avandia. 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.

"This pause in enrollment will give clinical trial investigators and patients time to learn about the data presented to the FDA Advisory Committee and the Committee's recommendations," said Dr. Ellen Strahlman, GSK's Chief Medical Officer. "We are committed to working with the FDA in the best interest of diabetic patients.

"We believe that Avandia is an important treatment option for patients with type 2 diabetes," Strahlman said. "Patients with questions about the use of Avandia should talk with their physicians."

For more information about AVANDIA, please see Medication Guide or full Prescribing Information at www.AVANDIA.com.

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

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