Diabetes Drug Rosiglitazone Not Associated with Increased Risk of Death, Stroke or Heart Attacks in BARI 2D Study
Study Confirms Higher Incidence of Fractures
Rosiglitazone, a commonly used diabetes drug, poses no significant increased risk of death, stroke or heart attack, though it does increase the risk of fractures, according to a new analysis of thousands of patients with established cardiovascular disease and type 2 diabetes. The findings are being presented at the American Diabetes Association’s 70th Scientific Sessions®, and are part of the Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes (BARI 2D) study, a landmark multicenter trial focusing exclusively on patients with both diabetes and established heart disease.
The safety of rosiglitazone, marketed as Avandia, a medication in the class of thiazolidinedione (TZD) drugs, has been a controversial topic since a 2007 meta-analysis published in the New England Journal of Medicine concluded that rosiglitazone “was associated with a significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes.” The strength of this study, which reviewed the results of 42 previously published investigations but did no independent testing of the drug, has been questioned by others in the field but ultimately led to a review of the drug’s safety by the U.S. Food and Drug Administration (FDA). In November 2007, the FDA added a warning label to the drug regarding potential heart risks.
The following year, however, researchers conducting the Veterans Affairs Diabetes Trial (VADT), a large-scale clinical trial in which 80 percent of patients were taking rosiglitazone, added further, while still inconclusive, information to this discussion. During the American Diabetes Association’s 68th Scientific Sessions, the VADT researchers reported that a specific analysis of rosiglitazone found that it did not appear to cause excess cardiovascular events and may in fact provide protective benefits for cardiovascular health.
Now a post-hoc analysis of the BARI 2D findings also shows no increased risk of heart attack or cardiovascular death with rosiglitazone treatment. Analyzing 4.5 years of follow-up data for patients who were being treated with rosiglitazone, compared to those not taking any TZD drugs, the study found no increase in risk of death or heart attack from taking rosiglitazone. While no protective cardiovascular benefit was shown, the analysis found that the rate of death, heart attack and stroke tended to be lower —about 28 percent lower in fact— among patients taking rosiglitazone. As has been seen with other studies of TZDs, the rate of congestive heart failure was significantly higher among patients taking rosiglitazone, but this difference was not statistically significant.
As seen in previous studies, the analysis of BARI 2D reported a 45 percent increase in fracture rates for those taking rosiglitazone, compared to those not taking any TZD medications.
“I think these data are important because they suggest there is no significant cardiovascular harm posed by taking rosiglitazone for patients with type 2 diabetes and coronary heart disease,” said lead researcher Richard Bach, M.D., Associate Professor of Medicine at the Washington University School of Medicine. “There is an increase in fractures, but when one considers the dramatic morbidity and mortality associated with ischemic cardiovascular events in patients with diabetes, these data are reassuring.”
The BARI 2D study, led by principal investigator Sheryl Kelsey, Ph.D, of the University of Pittsburgh Graduate School of Public Health, evaluated both a cardiovascular treatment approach as well as a diabetes control approach in 2,368 persons with type 2 diabetes and stable coronary artery disease (CAD) to reduce deaths or deaths and cardiovascular events (heart attacks and stroke) combined. The first component compared intensive medical treatment with prompt coronary revascularization by either bypass surgery or angioplasty (which opens blocked arteries by inserting metal stents or balloons through the arteries, without recourse to surgery) to intensive medical treatment alone. The second component compared whether controlling diabetes with drugs to make insulin work better (insulin sensitization) had an advantage for heart health or survival compared to using a strategy emphasizing drugs increasing insulin itself (insulin provision).
Nearly 24 million Americans have diabetes, a group of serious diseases characterized by high blood glucose levels that result from defects in the body's ability to produce and/or use insulin. Diabetes can lead to severely debilitating or fatal complications, such as heart disease, stroke, blindness, kidney disease and amputation. It is a leading cause of death by disease in the United States. Type 2 diabetes involves insulin resistance – the body’s inability to properly use its own insulin – and occurs mainly in adults who are overweight and age 40 and older. More than 65 percent of people with diabetes die from heart disease or stroke. With diabetes, heart attacks occur earlier in life and often result in death.
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To contact American Diabetes Association communications staff June 25-29, please call the Scientific Sessions News Room at 407-685-4010.
Oral presentation, Tuesday, 8:50 a.m.
The American Diabetes Association is leading the fight to Stop Diabetes and its deadly consequences and fighting for those affected by diabetes. The Association funds research to prevent, cure and manage diabetes; delivers services to hundreds of communities; provides objective and credible information; and gives voice to those denied their rights because of diabetes. Founded in 1940, our mission is to prevent and cure diabetes and to improve the lives of all people affected by diabetes. For more information please call the American Diabetes Association at 1-800-DIABETES (1-800-342-2383) or visit www.diabetes.org. Information from both these sources is available in English and Spanish.
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