GlaxoSmithKline statement in response to FDA announcement on TIDE trial
Issued: Philadelphia U.S.
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 (19 yes, 11 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 visit www.gsk.com.
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Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2009.