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Largest diabetes study contradicts U.S. trial

Early results from the largest study ever of aggressive measures to control blood sugar type 2 diabetics contradicted a U.S. trial, increasing uncertainty about the treatment.
/ Source: Reuters

Early results from the largest study ever of aggressive measures to control blood sugar in type 2 diabetics has found no signs that such 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 known as 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 to less-aggressive treatment.

Study 'magnifies the uncertainty'
The American Diabetes Association said in a statement that ADVANCE "further magnifies the uncertainty over whether intensive glucose control may harm some people with diabetes." The group noted that the studies were not identical and said it was unclear whether that could explain the discrepancy.

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.

As with the ACCORD study, the ADVANCE study aimed to lower blood glucose levels to below the current recommendations.

ADVANCE study director Dr. Anushka Patel, in a statement e-mailed to Reuters, said results were more than 99 percent complete. "We are confident that the interim findings communicated here are a reliable guide to the final results."

The 10,251-patient ACCORD trial involved adults with an average age of 62 who had diabetes for more than 10 years.

Doctors call for more research
"There are some differences between the ACCORD and the ADVANCE studies. We will need to communicate about the data with each other to understand what those differences are," Dr. Denise Simons-Morton, project officer for ACCORD at NHLBI, said in a telephone interview.

"The data I would like to see are exactly what drugs people were on, what were the mortality rates ..." she said.

Dr. James Dove, president of the American College of Cardiology, said, "Until we know more about these two trials and the patient populations, we will be doing things as we had been doing them in the past."