"These findings are consistent with prior meta-analyses conducted by GSK, the FDA and most independent investigators demonstrating an increased risk of myocardial infarction in patients treated with rosiglitazone," they continue. "The FDA has announced that it will conduct an advisory committee meeting in July 2010 to consider whether to remove rosiglitazone from the market."

The mechanisms by which rosiglitazone may cause cardiovascular harm are not clear, the authors note, but could involve increases in low-density lipoprotein (LDL, or "bad" cholesterol) levels or genetic effects associated with the production of an enzyme linked to plaque rupture.

"The public health implications of these results are considerable. There are more than 23 million persons with diabetes in the United States alone and nearly 300 million worldwide. Cardiovascular disease is the leading cause of death in patients with type 2 diabetes, representing approximately 68 percent of all causes of mortality," the authors conclude. "Although hyperglycemia has been associated with an increased risk of microvascular adverse events, there are now 12 classes of drugs that are approved to lower blood glucose levels, including insulin. Because no unique benefits of rosiglitazone use have been identified, administration of this agent solely to lower blood glucose levels is difficult to justify."

Source: Archives of Internal Medicine