Rosiglitazone was approved in 1999 to treat hyperglycemia (high blood glucose levels) among patients with type 2 diabetes. Concerns about the cardiovascular safety of rosiglitazone first arose in 2007, when a meta-analysis demonstrated a significantly increased risk for myocardial infarction (heart attack) and a borderline significant increase for cardiovascular death.
No large, definitive cardiovascular outcomes trials have been conducted with rosiglitazone. However, as a consequence of a 2004 court settlement in New York, GSK was required to post clinical trial results on a public web site.
"An alternative analysis that included trials with no cardiovascular events found a similar hazard. Subgroups classified by study duration and comparator drug also showed elevated odds ratio estimates," the authors said.
"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.
"The FDA has announced that it will conduct an advisory committee meeting in July 2010 to consider whether to remove rosiglitazone from the market," they added.
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 study appears in the July 26 print issue of Archives of Internal Medicine.
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