Patients taking the anti-diabetes drug Avandia may be at increased risk of cardiovascular ailments compared to those taking other drugs to treat diabetes, a US government study found Monday.
The analysis by the US Food and Drug Administration was in line with a spate of recent studies which have raised concern about the blockbuster medication, which also goes by the name rosiglitazone.
The study found that rosiglitazone, which was approved in 1999 to treat hyperglycemia (high blood glucose levels) among patients with type 2 diabetes, was associated with a 28 percent to 39 percent increased risk in myocardial infarction.
Research by Steven Nissen and Kathy Wolski of The Cleveland Clinic Foundation identified 56 trials involving 35,531 patients, 19,509 of whom received rosiglitazone and 16,022 who received control medications.
"The public health implications of these results are considerable," the authors wrote.
"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," the researcher said.
"Because no unique benefits of rosiglitazone use have been identified, administration of this agent solely to lower blood glucose levels is difficult to justify."
They added in a statement that the FDA will conduct an advisory committee meeting in July 2010 to consider whether to remove rosiglitazone from the market.
The study appeared Monday in the Archives of Internal Medicine, one of the publications of the Journal of the American Medical Association. A hardcopy report is to be published on July 26.
Concerns about Avandia have grown over the past few years as an increasing number of studies have shown a link with cardiovascular ailments, prompting the Food and Drug Administration in August 2007 to require British drugmaker GlaxoSmithKline to add a "black box" warning to its label.
Given the apparent increased risk of stroke and heart attack associated with Avandia, University of Toronto physician David Juurlink suggested patients taking the medication might be well advised to consider their options.
"Accumulating concerns about rosiglitazone make it difficult to advance a cogent argument why, exactly, a patient might want to receive the drug or why a physician would choose to prescribe it when there is an available and quite possibly safer alternative," said Juurlink in an editorial accompanying the report.
More than 23 million Americans and nearly 300 million people around the world suffer from diabetes.