Study Finds Avandia and Actos to Have Same Cardiovascular Risks

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Clinical trial data has suggested that the GlaxoSmithKline diabetes drug Avandia carries significant cardiovascular risks when compared to its competitive product Actos, made by Takeda Pharmaceuticals. A new study however, conducted at WellPoint Inc has found that both drugs are equally risky and patients should actively discuss the best therapy with their doctors.

Debra Wertz of Healthcare, a research division of Wellpoint, and colleagues studied over 36,000 patients who had submitted insurance claims to the company for either Avandia (rosiglitazone) or Actos (pioglitazone) between 2001 and 2005. The compared the risk of heart attack, heart failure, and death for an average of 14 months of diabetes treatment using information from the company’s own records and the National Death Index, a database administered by the National Center for Health Statistics.

Actos and Avandia have the same level of risks

The researchers found that the risks of death or having a heart attack, heart failure or both were about the same for both drugs – about 4 percent of patients. The study did not include deaths from stroke.

Both Avandia and Actos are members of a class of medications known as thizolidinediones, which decrease the insulin resistance of body tissues. The drug also modifies the body’s production of cholesterol.

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Avandia has been recently reviewed for safety concerns by an FDA advisory panel. One study that was reviewed as part of the panel discussion was one conducted by the US Food and Drug Administration (FDA) and the US Centers for Medicare and Medicaid Services (CMS). The research indicated that patients over the age of 65 (average age 74) were at an increased risk of heart failure, stroke, and death.

The average age of the participants in the WellPoint study was 54, indicating possibly that Avandia did not pose the same risks in younger patients.

After a 2 day hearing, the FDA advisory panel ultimately felt that there was currently not enough data to withdraw the drug from the market at this time. The panel did suggest more restrictions and warnings for the drug.

The study was published in Circulation Cardiovascular Quality and Outcomes, a journal of the American Heart Association.

For more on the FDA's review of Avandia:
FDA Considering End to Avandia Safety Study
Avandia Lawsuit Ads Hit Market After Vote
Docs Saying No to Avandia

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