More on Communications and the TIDE Trial

On August 20, we blogged about our July 28 communications with clinical trial investigators in TIDE, a prospective, cardiovascular outcome study comparing Avandia  (rosiglitazone) to Actos  (pioglitazone) as mandated by the U.S. Food and Drug Administration (FDA).  That July 28 communication summarized the two-day FDA Advisory Committee meeting (July 13-14) on the cardiovascular safety of Avandia. There is an update from FDA regarding the TIDE trial which we felt should be shared for the sake of transparency.

Since the post was published, GSK has received a request from the FDA that the company inform the TIDE Steering Committee to "re-issue a letter"  for trial participants that was sent prior to GSK's July 28, 2010 summary for investigators, Institutional Review Boards and Ethics Commitees  involved in the TIDE trial. 

The FDA wrote GSK that the July 16 letter to trial participants did "not accurately capture the results on all the voting questions posed to the advisory committee panel at this meeting. There is an overemphasis on the mortality findings that appears to dismiss the risk of ischemic cardiovascular events, particularly between rosiglitazone and pioglitazone.  Consequently, this information does not fully inform participants of the potential risks of the different treatments in the TIDE trial."

GSK is complying with this recent FDA request.