27-Jul-10 12:00 PM CST
FDA Suspends Enrollment in Avandia Clinical Trial
The FDA told GlaxoSmithKline last week to temporarily suspend enrollment of new participants in a mandated clinical trial to study the effects of diabetes drug Avandia on the heart.
The FDA originally ordered Avandia’s manufacturer GlaxoSmithKline to conduct the Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE) trial to definitively decide if Avandia poses any greater risk for heart complications than similar diabetes drug Actos, manufactured by Takeda Pharmaceuticals. However, concerned health officials have criticized the trial, saying that it is unethical to enroll participants in a trial with little to no perceived benefits. U.S. senators are also concerned not enough is being done to inform participants in the trial of recent studies on Avandia, according to a letter to the FDA from the Senate Finance Committee sent back in February.
“After reading these documents, we would like to know what steps the FDA has taken to protect patients in the TIDE trial, and why this trial is allowed to continue,” the Senate Finance Committee wrote in the letter addressed to FDA commissioner Margaret Hamburg.
An advisory panel to the FDA decided in a meeting held July 13-14 that while it agrees (in a 24-4 vote) that Avandia may pose a greater risk of heart complications than Actos, no definitive proof exists to warrant removing Avandia from the market (by a 20-12 vote). The panel did recommend that more warnings and stricter guidelines about the risks of heart complications be issued on the drug. It also recommended that the TIDE trial should continue if the FDA decides to keep Avandia on the market in a 19-11 vote.
GlaxoSmithKline said in a statement released on its website that it will cooperate with the FDA’s decision to suspend enrollment. Ellen Strahlman, the company’s chief medical officer, also said it will use the time the FDA takes to decide if Avandia should remain on the market to provide patients and researchers participating in TIDE with information on the drug that was presented to the FDA advisory panel.
GlaxoSmithKline said in a statement released on its website that it will cooperate with the FDA’s decision to suspend enrollment. Ellen Strahlman, the company’s chief medical officer, also said it will use the time the FDA takes to decide if Avandia should remain on the market to provide patients and researchers participating in TIDE with information on the drug that was presented to the FDA advisory panel.
“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,” Strahlman said. “We are committed to working with the FDA in the best interest of diabetic patients.”
Currently enrolled participants in the TIDE trial can still continue with the trial. The FDA has mandated that GlaxoSmithKline update officials involved in the TIDE trial on the new information presented at the advisory panel meeting and to update consent forms for current participants.
Avandia (rosiglitazone) and Actos (pioglitazone) are both part of the thiazolidinedione class of drugs that treat diabetes by reducing glucose, insulin blood concentrations and fatty acids by making the body more sensitive to insulin. Health professionals have been concerned about Avandia since a controversial meta-analysis report by Cleveland Clinic researchers Dr. Steven E. Nissen, MD and Kathy Wolski, MPH in the New England Journal of Medicine found that patients taking Avandia had a 43 percent increased risk of heart attack or other cardiovascular problems compared with patients taking a placebo.
Prior to the enrollment freeze, the recruitment goal for the trial was 16,000 participants. GlaxoSmithKline had enrolled 1,324 participants spread around 353 medical centers in 23 countries prior to the FDA mandate to suspend enrollment, according to a story on CNN Health.
The FDA is still considering whether or not to remove Avandia from the market. FDA spokesman Joshua Sharfstein said in an NPR news story that the agency hopes to finish its review by the end of the summer. Doctors have advised patients taking Avandia to discuss any concerns they have about the recent controversy with their primary care physician before they decide to stop using the drug.
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