Editorials, firm clash on Avandia risk study
WASHINGTON -- GlaxoSmithKline yesterday trumpeted the preliminary results from a study it said found its embattled diabetes drug, Avandia , causes no more heart risks than other medications typically used by patients with diabetes .
Dr. Ronald Krall , Glaxo's senior vice president , called the interim results "reassuring."
But the trial, published in the New England Journal of Medicine along with toughly worded editorials, came to less reassuring findings, saying that the overall risk of hospitalization or death from cardiovascular causes among patients taking Avandia was "inconclusive." It said there was insufficient data to determine whether the 2,220 patients whose treatment included Avandia had a higher chance of suffering heart attacks than those who were not given the drug. Patients using Avandia, however, had a more than doubled risk of suffering congestive heart failure , the trial showed.
Dr. David M. Nathan, director of the Diabetes Center at Massachusetts General Hospital , in one of three editorials published about Avandia, said the increasing number of cardiovascular side effects associated with the popular drug "must be taken seriously." "Physicians may find it difficult to explain to patients why they are starting treatment with a potentially dangerous drug when other choices with longer and better safety records are available," Nathan wrote.
The New England Journal posted the papers on its website one day before a c ongressional hearing is expected to draw incendiary comments about GlaxoSmithKline and US regulators.
Last year, Avandia, the world's top-selling oral diabetes drug, generated $3.1 billion in sales globally. But since the Journal last month published a critical review of Avandia by Dr. Steven E. Nissen, a noted Cleveland Clinic cardiologist , the diabetes drug has lost market share while prescriptions for competing medicines have risen.
Nissen, the May 21 article's lead author, pored through summaries of dozens of studies and found a 43 percent higher risk of diabetics suffering a heart attack if they took Avandia, compared with other drugs or sugar pills.
Nissen is scheduled to testify at today's hearing. Dr. Philip D. Home, the lead author of the newest Journal article about Avandia, said scientists leading the 4,447- patient clinical trial made the "unusual" decision to rush publication of its interim results to allay fears raised by Nissen's study, so the patients will continue to participate in the trial, which is expected to end in late 2008 .
"We decided this unusual course of action was, as it were, the least risky thing," said Home , a professor of diabetes at Newcastle University in the United Kingdom.
Diedtra Henderson can be reached at dhenderson@globe.com. 
