Glaxo's Avandia study in jeopardy: official

NEW YORK (Reuters) - Drug maker GlaxoSmithKline's medical director said the company's study of the heart risk associated with its Avandia diabetes treatment may be in jeopardy because patients have dropped out following reports of the drug's risks, The New York Times reported on Saturday.

Dr. Ronald Krall told the newspaper he did not know how many of the 4,450 patients in the drug trial had withdrawn but said Glaxo diabetes was worried it may not be able to complete the trial, which is scheduled to run through 2008.

Independent research committees overseeing the study, which is designed to gauge any increased risk of heart attack or stroke for people taking it, "are concerned about the ability of the study to continue" and are "considering what to do to prevent people from dropping out of the trial," the Times quoted Krall as saying.

Safety concerns about Avandia were stoked on Monday when The New England Journal of Medicine suggested in an analysis that Avandia, a treatment for Type 2 diabetes, carries an increased risk of heart attack, estimated in excess of 40 percent, in comparison to other diabetes drugs or placebos.

The Food and Drug Administration then issued a safety alert advising patients taking Avandia, which was approved in 1999, to consult their doctors. The drug, Glaxo's No. 2 seller, has been used by some 6 million people in the United States alone.