Glaxo, Critics Disagree on Results of New Avandia Study
GlaxoSmithKline, the maker of the controversial diabetes pill Avandia, published preliminary results of a study that the company claims show the drug does not raise heart risks. However, experts say the results are inconclusive and even seem to suggest more risk from the drug.
More people on Avandia suffered heart problems than those on other diabetes drugs -- a bad sign even if the difference was so small that it could have occurred by chance alone, some doctors said.
"This study, which was designed to show the benefit of rosiglitazone (Avandia), if anything shows the opposite," said Dr. David Nathan, chief of diabetes care at Massachusetts General Hospital.
He wrote an editorial accompanying the study, which was published online by the New England Journal of Medicine. A congressional panel is holding a hearing Wednesday on the drug's risks and the response by the federal Food and Drug Administration, which has been criticized for being too lax about safety concerns.
The heart risk trend in patients on Avandia "is going in the wrong direction," said Dr. Steven Nissen of the Cleveland Clinic. Two weeks ago, he published in the same medical journal an analysis of 42 studies on Avandia concluding that the drug raised the risk of heart attacks by 43% and possibly heart-related deaths as well.
Avandia's maker, British-based GlaxoSmithKline , has said its own similar analysis found a 31% greater risk. However, Glaxo officials have said that more definitive studies, such as the preliminary findings released today, did not show such risk.
"Overall, we feel these results are very reassuring," said Dr. Murray Stewart, Glaxo's vice president of clinical development, said during a telephone news conference on today.
More than 6 million people worldwide have taken the drug, sold as Avandia and Avandamet, since it came on the market eight years ago to help control blood sugar in people with the most common form of diabetes. About 1 million Americans use it now.
The new study involves 4,500 people at more than 150 medical centers around the world.