The Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial is a six year study that has been on-going since 2003. But due to the meta-analysis study that concluded recently that rosiglitazone (Avandia) may cause heart attacks and fatal cardiovascular conditions, the researchers for the RECORD trial have decided to publish some results in the middle of the trial. They state,
"We made the decision to publish our interim findings because in their absence, concern raised by the meta-analysis by Nissen and Wolski could well compromise the study's integrity through an increase in the dropout rate and potential biases in reporting events."
The RECORD trial involves 4447 patients with type 2 diabetes whose glucose control was not successful while taking either metformin or sulfonylurea. Approximately one half of the participants received rosiglitazone as an add-on with their regular medication, and half received a combination of both metformin and sulfonylurea.
The researchers concluded,"Our interim findings from this ongoing study were inconclusive regarding the effect of rosiglitazone on the overall risk of hospitalization or death from cardiovascular causes. There was no evidence of any increase in death from either cardiovascular causes or all causes. Rosiglitazone was associated with an increased risk of heart failure. The data were insufficient to determine whether the drug was associated with an increase in the risk of myocardial infarction."
Rosiglitazone does have a side effect of increased risk of heart failure, which appears as a "black box" warning from the FDA, on the medication. Although the data wasn't strong enough to prove that rosiglitazone does cause an increase in risk of heart attacks, it does seem to support the FDA warning of increased heart failure risk.
The RECORD Study is supported by GlaxoSmithKline.
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