New Study Further Clouds Debate over Avandia

Washington, DCIn the midst of the ongoing debate over whether or not type 2 diabetes drug Avandia will be banished by the US Food and Drug Administration (FDA) comes word about a recent study that finds that Avandia puts patients at no greater risk for heart attack than its chief rival, Actos. The study, published recently in "Circulation: Cardiovascular Quality and Outcomes," compared the results of patients enrolled in a major health care provider taking either Avandia or Actos.

It is yet another confusing addition to an already heated debate about the future of a drug that some claim raises the risk of heart attack, fracture and liver failure. While a recent expert panel commissioned by the FDA did not vote to take Avandia off the market, their discussions were not kind to the drug.

This latest finding contradicts other studies and will make it tougher for the FDA to decide what to do about Avandia.

FOX News carried a Reuters report on 8/25/10 regarding the study of 36,628 patients who submitted insurance claims to WellPoint between 2001 and 2005. The patients involved all suffered from type 2 diabetes and were assigned either Actos or Avandia to fight the disease.

Comparing the risk for heart attack, heart failure and death for an average of 14 months of treatment, followed by 18 months of continued observation, the researchers concluded that the risks for heart attack amongst Avandia patients were no worse statistically that for those on Actos.

The risk, the researchers found, was about 4 percent for both. HealthCore, the research arm of WellPoint, conducted the study at WellPoint's request, due to concerns about the safety of Avandia.

The HealthCore study findings differed sharply with those of a larger study conducted by David Graham and colleagues at the FDA and the US Centers for Medicare and Medicaid Services. The latter study found that Avandia increased the risk of heart failure, stroke and death among patients insured by Medicare, which largely covers people over the age of 65.

However, that wasn't the finding of the HealthCore study. "Within the commercially insured population that we assessed, we did not see a difference between the two agents," Mark Cziraky, a vice president at HealthCore and a contributor to the study, said in a telephone interview with Reuters.

There were other differences in the two studies, according to the Reuters report. One notable difference involves the eras for the respective studies. The HealthCore study looked at the period 2001 to 2005, before concerns about Avandia had come to light. The Graham study, meanwhile, looked at 2006 to 2009, when the risks for Avandia heart attack were just entering the public conscience. HealthCore's Cziraky suggested the cloud hanging over Avandia during the Graham study could have affected how doctors received Avandia. The average age of patients in the HealthCore study was 54.