FDA Reviewing Results of Avandia Cardiovascular Risk Study
This week, the FDA issued a press release to both patients and health care providers about Avandia - the popular diabetes drug manufactured by GlaxoSmithKline. The FDA says it is "now reviewing the primary data from the completed RECORD study, conducting follow-up audits, and reviewing additional studies. This work is ongoing and no new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time." For several years now, the FDA has been working to determine (1) whether Avandia should remain on the market; and (2) whether Avandia causes heart attacks. A committee formed by the FDA in 2007 voted that the drug should stay on the market, but agreed that the drug did raise the risk of heart attack.
The announcement this week only confirms that the FDA is reviewing data and has no new conclusions. The FDA says that once it "completes its review of the data from the RECORD study, the agency will present the totality of new and existing cardiovascular safety data on rosiglitazone at a joint public meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees in July 2010. At that meeting, the Advisory Committee will provide an updated assessment of the risks and benefits of rosiglitazone in the treatment of type 2 diabetes."
The RECORD Study
Results of the RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes) study were submitted to the FDA in August 2009. The 4,447 patients included in the RECORD Study were between the ages of 40 and 75, with a body-mass-index of more than 25, and had glycated hemoglobin level of more than 7.0% and less than or equal to 9.0% while receiving the maximum doses of a sulfonylurea or metformin. At a press briefing at the American Diabetes Association in June 2009, the chairman of the RECORD steering committee said that the RECORD study indicated no increased overall cardiovascular morbidity or mortality associated with Avandia, but there was twice the risk of heart failure and distal fracture in women. Critics of the RECORD trial say the trial was seriously flawed because the report does not reveal how many patients were actually still taking Avandia at the end of the clinical trial.
The TIDE Study
The TIDE study (Thiazolidinedione Intervention With Vitamin D Evaluation) is a double-blind direct comparison study comparing Avandia to Actos, a diabetes drug manufactured by Takeda Pharmaceuticals. The first issue the study addresses is the cardiovascular effects of long term treatment with rosiglitazone (Avandia) or pioglitazone (Actos), when "used as part of standard of care compared to similar standard of care without rosiglitazone or pioglitazone in patients with type 2 diabetes who have a history of or are at risk for cardiovascular disease." The second issue the study addresses is "the effects of long-term supplementation of vitamin D on death and cancer". The TIDE trial began in 2009 will not end until October 2015.
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