Two Diabetes Drugs Double Heart Failure Risk: Study

By Steven Reinberg
HealthDay Reporter
Friday, July 27, 2007; 12:00 AM

FRIDAY, July 27 (HealthDay News) -- Patients taking either of the diabetes drugs Avandia or Actos face twice the risk of developing heart failure compared to people not on the popular medications, a new study finds.

This means for every 50 patients with type 2 diabetes taking these drugs, one patient will develop heart failure within 26 months, according to the report released Friday and published in the August issue ofDiabetes Care.

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"Both Avandia and Actos double the risk of heart failure," concluded the lead author of the first study, Dr. Sonal Singh, an assistant professor of internal medicine at Wake Forest University School of Medicine. "We know these drugs increase the risk, but we found the risk is more substantial than suspected. This occurs at even the lowest dose and among young patients."

The report follows a U.S. government review released Thursday that found Avandia's heart risks are far higher than Actos'. That report sets the stage for an advisory panel hearing Monday that will examine whether Avandia's cardiovascular risks warrant a stronger warning label.

Avandia (rosiglitazone) and Actos (pioglitazone) are from the same family of diabetes drugs and used by more than 3 million diabetic patients across the United States.

The current product label warns against using these drugs in patients with more severe cases of heart failure. The label also warns that there is an increased risk of heart failure if the drugs are used in combination with insulin.

Singh's group, however, found that the risk wasn't limited to patients on insulin, and it was present even among patients without any risk factors for heart failure.

The government study, by a medical and safety review team at the Food and Drug Administration, found that patients are at much higher risk of heart problems if they take Avandia, compared to patients taking Actos. Avandia is especially hazardous to patients who are already on insulin, the report found, whereas Actos users can take insulin as well without fearing cardiac side effects, theNew York Timesreported.

That data could help decide whether or not Avandia remains on drug store shelves, experts said.

"A critical question to be resolved in determining appropriate regulatory action is whether the anticipated therapeutic benefit of rosiglitazone outweighs the demonstrated cardiovascular risk," one FDA reviewer concluded according to theTimesreport.

In theDiabetes Carestudy, Singh's team collected data on more than 78,000 patients taking either of the drugs. These patients were included in previously published studies and in case reports.

Not only did the drugs double the risk of heart failure, but the increased risk was seen with both high and low doses, the team found.


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