New Avandia study sheds little light on heart risk

By Maggie Fox and Susan Heavey

WASHINGTON (Reuters) - An early analysis from an ongoing study of GlaxoSmithKline Plc's Avandia was unable to show whether there was any increase in heart attacks among patients, but several experts said the evidence still suggested the popular diabetes drug raised the risk of heart attack.

Glaxo and three independent heart experts had sharply different views on what the results of the study meant.

The interim analysis of the study, funded by the drugmaker and published in the New England Journal of Medicine on Tuesday, was hastily published after another report last month suggested Avandia raised the risk considerably.

The study by Dr. Steven Nissen of the Cleveland Clinic in Ohio created a stir, and a U.S. House of Representatives committee will hold a hearing on Wednesday about whether the U.S. Food and Drug Administration can properly police such drugs.

Dr. Philip Home of Britain's Newcastle University and a team from around the world looked at the ongoing study of 4,400 patients to see if they could find any evidence that patients taking Avandia, known generically as rosiglitazone, were more likely to have a heart attack.

Their conclusion: they could not tell. "Because the mean follow-up was only 3.75 years, our interim analysis had limited statistical power to detect treatment differences," Home's team wrote.

"Patients and physicians should find these data reassuring," Moncef Slaoui, Glaxo's research and development chairman, said in a statement. Millions of diabetes patients take Avandia.

But Dr. Bruce Psaty of the University of Washington in Seattle and Dr. Curt Furberg of Wake Forest University said all the trials studied so far, pooled with this one, suggest a 33 percent higher risk of heart attack.