Diabetes Medication's Safety Questioned

(June 30, 2010) - Two new studies claim that a certain type 2 diabetes drug (Read about "Diabetes"), rosiglitazone, increases the risks of heart problems including stoke, heart failure and heart attack. (Read about "Stroke" "Congestive Heart Failure" "Heart Attack") Rosiglitazone was approved in 1999 to treat hyperglycemia (high blood glucose levels) among patients with type 2 diabetes.

One of the studies used data from GlaxoSmithKline (GSK), the drug's manufacturer and another database through February 2010 and identified 56 trials involving 35,531 patients, 19,509 of whom received rosiglitazone and 16,022 who received control medications.

In the combined studies, rosiglitazone therapy was associated with a significantly increased risk of myocardial infarction by an estimated 28 percent to 39 percent, although the risk of cardiovascular death was not increased. "An alternative analysis that included trials with no cardiovascular events found a similar hazard," the authors write.

In the second study rosiglitazone was compared with pioglitazone, another medication for diabetes. "Rosiglitazone and pioglitazone are the only thiazolidinediones (a class of drugs for treating diabetes) currently marketed in the United States," the authors provide as background information.

Researchers evaluated data from 227,571 Medicare beneficiaries (average age, 74.4 years) who started treatment with rosiglitazone or pioglitazone through a Medicare Part D prescription drug plan from July 2006 through June 2009. The patients were followed for up to three years after the initiation of the medications.

Analysis showed no differences in the risk for heart attack between rosiglitazone and pioglitazone. However "our study found that rosiglitazone was associated with a 1.25-fold increase in risk of heart failure compared with pioglitazone," and "these data suggest that rosiglitazone was associated with a 1.27-fold increased risk of stroke and a 1.14-fold increased risk of death compared with pioglitazone," according to the authors.

The Food and Drug Administration has announced that it will conduct an advisory committee meeting in July 2010 to consider whether to remove rosiglitazone from the market.

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