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ADA: Thiazolidinediones May Pose Heart Failure Risk

SAN FRANCISCO. CA —

Although thiazolidinediones (TZDs) have a broad spectrum of anti-diabetic and potential vasculoprotective properties, they may increase the risk of congestive heart failure (CHF), researchers reported here Friday at the 62nd Scientific Sessions of the American Diabetes Association (ADA). Thomas E. Delea, MBA, with Policy Analysis, Inc. in Brookline, Massachusetts, United States, and his team used a health insurance claims database with information on roughly 17 million patients annually to examine the risk of CHF in patients treated with TZD.

They selected all patients with at least one diagnosis for type 2 diabetes and at least one prescription for an oral anti-diabetic drug during a recent six -year period. Patients with at least one claim for a TZD were designated “exposed”. The date of the first TZD claim for each such patient was designated the “index date”.

Five unexposed controls were randomly selected for each TZD patient and assigned the same index date. The trial excluded all patients who were not continuously enrolled, those who had a diagnosis of CHF, or those who had a prescription for digoxin or a diuretic in the year before the index date.

A total of 5,445 patients were considered exposed to TZD and had a mean age of 57 years, while the 28,137 controls had a mean age of 59 years. Those on TZD were more likely to have the following characteristics: coronary artery disease/stroke/transient ischemic attack; diabetes complications; a recent prescription for an angiotensin-converting enzyme inhibitor or a beta blocker or insulin; and higher pre-index medical costs.

The primary outcome measure was the incidence of CHF, as defined by the occurrence of at least one claim with a primary or secondary diagnosis of CHF. Results showed that TZDs were independently associated with an increased risk of CHF after controlling for differences in baseline clinical characteristics (hazard ratio 1.7, p<0.001). Adjusted Kaplan-Meier estimates of CHF risk at 36 months were 8.2 percent for patients on TZD compared to 5.3 percent for controls.

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