From: Reuters
Published February 6, 2008 03:44 PM

Avandia not to blame for deaths in trial, U.S. says

By Julie Steenhuysen

CHICAGO (Reuters) - GlaxoSmithKline's diabetes drug Avandia was not to blame for heart deaths in a trial to see if treating diabetes would reduce heart disease, U.S. government-funded researchers said on Wednesday.

They said no single drug appeared to be responsible, and that they would adjust the trial, called ACCORD, so that patients' blood sugar would not be lowered so intensively.

The National Heart, Lung and Blood Institute, which funded and helped organize the trial, said it appeared to be the strict lowering of blood sugar, or glucose, that was to blame.

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However, they stressed that the death rates of patients in the study were still lower than rates for other type-2 diabetics at high risk of heart disease.

The study of 10,251 patients was designed to find the best way to prevent heart disease in older adults with type 2 diabetes for more than 10 years.

"They had diabetes plus other risk factors which placed them at even higher risk for heart disease," Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute told reporters in a telephone briefing.

Patients in one group were given aggressive treatment to lower their blood sugar levels -- a measure known as hemoglobin A1c -- to below 6 percent, far below the current target of under 7 percent and closer to what is seen in non-diabetics.

These patients died at a higher rate than a second group whose A1c levels were kept to the 7 to 7.9 percent range.

"This is an important finding which shows if you have type 2 diabetes and are at especially high risk for heart disease, very intense glucose-lowering treatment aimed at normal blood glucose of less than 6 percent may be detrimental," Nabel told the briefing.

She cautioned that the study does not apply to all type-2 diabetics, and the current target of lowering A1c to below 7 percent is likely appropriate for most patients.

NO LINK TO ANY DRUG

Doctors treating the patients in both the aggressive and standard therapy groups could use any approved diabetes drug including metformin, insulins and thiazolidinediones such as Actos or Avandia, known generically as rosiglitazone.

In May, a U.S. analysis linked Avandia to a 43 percent higher risk of heart attack. U.S. and European regulators now require strongly worded warnings about heart risks on the packages of Avandia and similar drugs.

"We specifically tried to determine whether there was any link between this particular medication and the increased deaths. At this time we have found no link," said Dr. William Friedewald of Columbia University in New York, one of the directors of the trial.

They said 257 patients in the intensive treatment group died, compared with 203 who got standard treatment. All the patients were also treated for high blood pressure and cholesterol.

Friedewald said patients in the intensive treatment group had fewer nonfatal heart problems, but they had more unexpected sudden deaths, even without a clear heart attack.

"It appeared that if a heart attack did occur, it was more likely to be fatal," he told the briefing.

The researchers said they will continue to try to understand why these people died at a higher rate. But based on their analysis, there is no evidence that any drug or combination of drugs was responsible.

The American Diabetes Association on Wednesday advised patients with diabetes to maintain good control of blood glucose and talk to their doctor before making any changes.

Glaxo said the findings appear to raise questions about how aggressively blood sugar should be reduced in managing diabetes.

"I think this study will weigh on the entire class of diabetes treatments, in that it's pointing toward less-aggressive therapy," said Damien Conover, a pharmaceutical industry analyst with Morningstar.

But Conover said the study bodes well for Avandia and "will help the company put positive data in front of doctors."

Avandia was Glaxo's second-biggest drug in 2006, with worldwide revenue of 1.6 billion pounds ($3.2 billion), but sales have plunged since May.

(Additional reporting by Ben Hirschler in London, Lewis Krauskopf in New York, Maggie Fox in Washington, editing by Dave Zimmerman, Richard Chang)

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