Diabetes drugmaker cites "reassuring" study

GlaxoSmithKline today trumpeted the preliminary results from a study it said found its embattled diabetes drug, Avandia, causes no more heart risks than medications that set the standard for diabetes care.

Dr. Ronald Krall, Glaxo's senior vice president, called the interim results "reassuring."

But the trial, published by the New England Journal of Medicine along with toughly worded editorials, came to less reassuring findings, saying that Avandia's impact on patients' overall risk from cardiovascular causes was "inconclusive." It noted that there was insufficient data to determine whether the approximately 2,220 study patients in the trial who took Avandia had a higher chance of suffering heart attacks than those who were not given the drug.

The Journal posted the study on its website a day before a Congressional hearing that is expected to draw incendiary comments about GlaxoSmithKline and federal regulators. Tomorrow's US House of Representatives hearing, called by a California Democrat who has been critical of drug company motives and Food and Drug Administration oversight, is expected to galvanize support for the House introduction of a sweeping FDA reform bill.

Since the Journal last month published a critical review of Avandia by Cleveland Clinic cardiologist Dr. Steven E. Nissen, Avandia -- the top-selling oral treatment for diabetes -- has lost market share while prescriptions for competing medicines rose.

Nissen, the May 21 article's lead author, pored through summaries for 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. He was unable to get enough information about the patients to determine whether the level of risk depends on how long or how much Avandia is used.

The lead author of today's journal article told the Boston Globe that scientists leading the 4,447-patient clinical trial made the "unusual" decision to rush its interim results to press to try to allay fears raised by Nissen's study and to reassure patients so they would continue to participate in the trial.

source:www.boston.com