FDA Stops Enrollment in TIDE Trial

July 21, 2010

July 21, 2010 (Philadelphia, Pennsylvania) — Enrollment of new patients in the controversial Thiazolidinedione Intervention with Vitamin D Evaluation(TIDE) trial, a study assessing the cardiovascular effects of long-term treatment with rosiglitazone (Avandia, GlaxoSmithKline) or pioglitazone (Actos, Takeda Pharmaceuticals), has been stopped [1].

The US Food and Drug Administration (FDA) said TIDE has been placed on "partial clinical hold" pending the review of recommendations from the July 13-14 advisory panel meeting. Under a partial clinical hold, no new patients can be enrolled in the study, but those already enrolled can continue in the trial.

"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," Dr Ellen Strahlman, chief medical officer at GSK, commented in a press release [2].

Last Wednesday, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee members voted 19 to 11 that the trial should continue; there were two abstentions and one "no" vote (absent).

However, as part of the complex recommendations, 12 of 33 voting panelists also voted to remove rosiglitazone from the market. Of the remaining 20 votes--one member abstained--panelists said the drug could stay on the market with severe restrictions, while some believed the drug could remain with increased warnings.