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The diabetes drug Avandia (rosiglitazone) has been under intense scrutiny since a study published in the New England Journal of Medicine (NEJM) in 2007 looked at over 40 clinical trials and said there was a link between the drug's use and an increased risk of heart attack and death from heart disease.

Today, in a post-trial analysis of results from an international clinical trial of 2,368 diabetes patients with cardiovascular disease, scientists at Washington University School of Medicine in St. Louis and numerous major centers across the USA report no higher risk of heart attack or death in patients taking rosiglitazone. In fact, the latest analysis found a lower combined rate of death, heart attack and stroke linked to patients taking rosiglitazone compared with those who were not taking a thiazolidinedione drug (rosiglitazone or pioglitazone).

This post-trial analysis was presented by Richard G. Bach, MD, a Washington University researcher and medical director of the Cardiac Intensive Care Unit at Barnes-Jewish Hospital, at the American Diabetes Association's Scientific Sessions in Orlando, Fla., USA.

Bach says that these new results are significant in the controversy over rosiglitazone's cardiovascular safety. In an advisory panel scheduled to meet next month, the U.S. Food and Drug Administration (FDA) will reconsider the safety of rosiglitazone and decide on whether it should remain on the market.

Bach, who is also associate professor of medicine in the Cardiovascular Division at the School of Medicine, said:

    As a result of the questions raised by the meta-analysis in the New England Journal and certain other studies, some have cautioned that rosiglitazone should not be used in patients with coronary heart disease and diabetes. Our data carefully examine use of rosiglitazone in a large cohort of patients with established coronary artery disease and suggest that treatment with rosiglitazone was not associated with an increased risk of ischemic cardiovascular events, like heart attack and stroke, and in a number of analyses it was associated with a lower rate of those events.



Rosiglitazone, made by GlaxoSmithKline (GSK) under the brand name Avandia, is an insulin-sensitizing drug. In type 2 diabetes, the pancreas continues to make insulin, but the body's tissues can't use it well. Rosiglitazone and other thiazolidinediones (TZDs) do not provide more insulin but reduce insulin-resistance, helping the body regulate blood sugar with the insulin it already makes.

http://www.medicalnewstoday.com/articles/193419.php

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