Criticism of Avandia diabetes therapy reached its climax. The drug has been in the spotlight since 07, when it was linked to heart attacks. Yesterday, two new results analysis studies for hundreds of thousands of people have reaffirmed that the drug can be dangerous for the heart and hang the degree of risk close to the conclusion of 07. The company that makes Avandia, GlaxoSmithKline, fired back with a denial that Avandia is dangerous. But the pressure to get the market is running high, and two advisory groups to the US Food and Drug Administration (FDA) meet in a few weeks to discuss what to do.
The new studies were conducted by researchers who have long expressed concerns about Avandia, also known by its generic name rosiglitazone. The first was published online by The Journal of the American Medical Association . There, David Graham, who works in drug safety at the FDA, and colleagues turned to a database of 227.571 people on Medicare, meaning they were older than 65. each of them had been treated with either Avandia or Actos (pioglitazone), a similar drug.
Data on medication use were available through the prescription drug Medicare, which took effect in January. 06 The group of Graham found that people taking Avandia had about a 18% higher risk of heart attack, stroke, heart failure or death compared to those on Actos, which other studies have shown is just as effective.
The second study was conducted by cardiologist Steven Nissen at the Cleveland Clinic in Ohio; Nissen who was there 3 years, triggered the storm with Avandia meta-analysis of 42 trials of Avandia that he said suggested an increased risk of heart attack. In his latest article, published with his colleague Kathy Wolski, published online yesterday in Archives of Internal Medicine , Nissen has updated its previous meta-analysis by analyzing 56 trials and found an additional heart attack for every 52 patients on the drug.
Although both studies have limitations, an accompanying editorial Graham reviewed the convincing conclusions: "Accumulation concerns about rosiglitazone advance difficultto a convincing argument regarding the reason which, exactly, a patient might want to receive the drug. "FDA advisers meet July 13 to give their own judgment whether the drug is safe enough to be used.
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