FRIDAY, July 27 (HealthDay News) -- Thiazolinediones may double the risk of heart failure in patients with type 2 diabetes, according to a report in the August issue of Diabetes Care, which was first published online in May.
In June, the U.S. Food and Drug Administration (FDA) announced that it had asked that Avandia and Actos carry a "black box" warning on the potentially heightened risk of congestive heart failure in some patients. An FDA advisory committee is slated to meet to discuss the cardiovascular ischemic/thrombotic risks of thiazolidinediones on July 30.
Sonal Singh, M.D., of Wake Forest University School of Medicine in Winston-Salem, N.C., and colleagues analyzed data on more than 78,000 patients taking thiazolinediones in randomized controlled trials and observational studies, as well as case series and reports to the Canadian Adverse Events Database.
They found that the risk of heart failure was higher (odds ratio, 2.1) in randomized trials in which patients took a thiazolidinedione or a placebo. The odds ratio was 1.55 in observational studies. The effect did not appear to be dose-dependent, nor was it limited to elderly patients, the teleo-analysis found.
"Existing guidelines and package inserts may have to be revised to incorporate these risk-characteristics of thiazolinediones," the study authors concluded.
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