FDA puts TIDE on “partial clinical hold”

The FDA has put the controversial Avandia safety trial TIDE on “partial clinical hold.” The action means that new patients may not be enrolled in the trial until the FDA gives the green light. Patients already enrolled in the trial will continue to participate in the trial.

In its statement the FDA said it had instructed GlaxoSmithKline to “update investigators, institutional review boards (IRBs) and ethics committees involved in the TIDE trial” with information about last week’s 2-day panel meeting.

In a statement in response to the FDA announcement, GSK said that it would suspend enrollment of patients in TIDE and “will work with the TIDE Steering Committee” to send new safety data and a summary of the panel meeting to TIDE investigators and IRBs. GSK noted that the advisory panel voted 20-10 in favor  of TIDE being allowed to continue.

Here is the FDA Statement:

FDA Statement on Avandia TIDE Trial

The U.S. Food and Drug Administration today informed GlaxoSmithKline (GSK), the manufacturer of the diabetes drug Avandia (rosiglitazone), that the postmarketing trial known as TIDE (Thiazolidinedione Intervention With Vitamin D Evaluation) has been placed on partial clinical hold.
Under the partial clinical hold no new patients may be enrolled into the trial until further notice from the FDA. Patients already enrolled in the trial will be allowed to continue to participate.
The FDA has instructed GSK to update investigators, institutional review boards (IRBs) and ethics committees involved in the TIDE trial regarding new safety information presented at the joint FDA Advisory Committee meeting held on July 13 and 14, 2010, along with information regarding the deliberations and votes of that meeting.
This information can be used by investigators and IRBs to update existing informed consent information for current trial participants.
The FDA is evaluating available information on Avandia’s safety and the discussions of the recent advisory committee meeting. The FDA will update the public on the outcome of its review and its implications for Avandia and the TIDE trial when the review is complete.

Here is the GSK statement:

GlaxoSmithKline statement in response to FDA announcement on TIDE trial

GlaxoSmithKline [NYSE: GSK] confirmed today 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.”

Important safety information for Avandia® (rosiglitazone maleate)

AVANDIA can cause or worsen heart failure.  If you have severe heart failure (very poor pumping ability of the heart) you cannot be started on AVANDIA. AVANDIA is also not recommended if you have heart failure with symptoms (such as shortness of breath or swelling) even if these symptoms are not severe.

AVANDIA may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction). This risk appeared higher in patients taking medicines called nitrates or insulin.

If you have chest pain or a feeling of chest pressure, you should seek immediate medical attention, regardless of what diabetes medicines you are taking. If you take AVANDIA, tell your doctor right away if you: have swollen legs or ankles, a rapid increase in weight or difficulty breathing, or unusual tiredness; experience changes in vision; become pregnant.

Before taking AVANDIA, review your medical history and tell your doctor if you:

  • Have heart failure or other heart problems, or are on any medicines for high blood pressure, high cholesterol or heart failure, or for prevention of heart disease or stroke.
  • Take insulin or nitrate medicines.  Taking AVANDIA with insulin or nitrate is not recommended.
  • Have a type of diabetic eye disease called macular edema.
  • Have liver problems or had liver problems while taking REZULIN® (troglitazone).
  • Are pregnant or planning to become pregnant.
  • Are breastfeeding or planning to breastfeed.

Women taking AVANDIA should know that AVANDIA may increase the risk of pregnancy. More fractures have been observed in women taking AVANDIA. Other possible side effects of AVANDIA include anemia and hypoglycaemia. Your doctor should do blood tests to check your liver before you start AVANDIA and during treatment as needed.

Prescription AVANDIA, along with diet and exercise, helps improve blood sugar control in adults with type 2 diabetes.

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

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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 visitwww.gsk.com

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