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International diabetes study contradicts US trial
13 Feb 2008 06:22:22 GMT
Source: Reuters
By Julie Steenhuysen

CHICAGO, Feb 13 (Reuters) - Early results from the largest study ever of aggressive measures to control blood sugar in type 2 diabetics has found no sign that intensive treatment increases the risk of death, an international team of researchers said on Wednesday.

The results contrast findings last week from a large U.S.-sponsored trial studying the effects of tightly controlling the blood sugar of high-risk patients with diabetes.

That study, dubbed Accord, showed a slight increase of death in patients with diabetes whose blood sugar had been reduced to near-normal levels.

The Accord findings contradicted conventional thinking about diabetes control -- that lowering blood glucose to the normal range would protect patients from heart attacks, as well as kidney disease, nerve damage and blindness.

The surprise findings prompted the team conducting the massive study dubbed Advance to check to see if diabetics undergoing similar intensive drug therapy also had a higher risk of death. They did not.

"The interim results from Advance provide no confirmation of the adverse mortality trend reported from the Accord study," Rory Collins of the University of Oxford, chairman the study's data monitoring and safety committee, said in a statement.

Collins said the Advance results were based on more than twice as much data and similar levels of glucose control as in the Accord study.

The U.S. National Heart Lung and Blood Institute last week said it was stopping the tight glucose control part of the Accord study and moving those patients into less-aggressive treatment.

The Advance study, run by the University of Sydney's George Institute for International Health, involved 11,140 high-risk patients with type 2 diabetes. It was designed see if intensive treatment to lower blood pressure and reduce blood glucose would improve the health of patients with type 2 diabetes.

The blood sugar arm of the Advance study was completed in January but the results had only been seen by the data and safety board.

As with the Accord study, the Advance study aimed to lower blood glucose levels to below the current recommendations.

Study director Dr. Anushka Patel from The George Institute, in a statement e-mailed to Reuters, said the Advance study results were more than 99 percent complete.

"We are confident that the interim findings communicated here are a reliable guide to the final results," Patel said.

The 10,251-patient Accord trial, led and organized by the National Heart, Lung and Blood Institute, involved older adults with an average age of 62 who had type 2 diabetes for more than 10 years.

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.

Patients in the Advance study were aiming for a slightly higher A1c treatment goal of below 6.5 percent.

It was not clear whether the patients in both trials were taking the same drugs to lower their blood sugar. (Editing by Bill Trott)
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