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ADA: Rosiglitazone Not Linked to Adverse Cardio Outcomes

Post-hoc analysis of BARI 2D contradicts other new research, confirms drug's link with fracture

TUESDAY, June 29 (HealthDay News) -- In contrast to other recently published research, a new study presented June 29 at the American Diabetes Association's 70th Scientific Sessions, held from June 25 to 29 in Orlando, Fla., suggests that rosiglitazone may not increase the risk of death, stroke, or heart attack -- though it does increase fracture risk -- in patients with type 2 diabetes and established cardiovascular disease.

Richard Bach, M.D., of the Washington University School of Medicine in St. Louis, and colleagues conducted a post-hoc analysis of the Angioplasty Revascularization Investigation in Type 2 Diabetes (BARI 2D) study, which assessed a cardiovascular treatment approach as well as a diabetes control approach in 2,368 patients with type 2 diabetes and stable coronary artery disease.

After analyzing 4.5 years of follow-up data comparing outcomes in patients receiving rosiglitazone and those not receiving any thiazolidinedione drugs, Bach and colleagues found that rosiglitazone was not associated with an increased risk of death or heart attack. Although the researchers did not show that rosiglitazone was associated with any protective cardiovascular benefits, their analysis showed that the rate of death, heart attack, and stroke tended to be about 28 percent lower in the rosaglitazone group. They also found that rosaglitazone was associated with a statistically nonsignificant increase in the rate of congestive heart failure, and a 45 percent increase in fracture rates.

"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," Bach said in a statement. "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."

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