June 2007 - On June 5, 2007, the New England Journal of Medicine published results of an interim analysis of the cardiovascular safety trial of rosiglitazone (brand name, Avandia). The article was accompanied by three editorials.
Although the findings from RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes) found no significant increase in heart attack or cardiac death, but an increased risk of heart failure, this interim analysis did not have the statistical power to reach a definitive answer as to all the potential cardiovascular risks that may be associated with rosiglitazone.
As one of the accompanying editorials stated, the RECORD study demonstrated a trend toward increased cardiovascular events and, when combined with recently published data and an analysis released by the company, there is still concern about cardiovascular side effects related to this drug.
As a result of all of this information, the American Diabetes Association strongly encourages patients taking this medication to consult with their physician as to its benefits and risks. The Association also reminds patients, however, that they should not stop taking any prescribed medications without first discussing the issue with their health care provider.
The most life-threatening consequences of diabetes are heart disease and stroke, which strike people with diabetes more than twice as often as they do others. If you have diabetes, it is very important to control your blood glucose, blood pressure and cholesterol levels.
To review the recent articles published by the New England Journal of Medicine, visit www.nejm.org
Source: American Diabetes Association