Data on glycemic control differ in 2 trials

The American Diabetes Assn. cautions against making treatment changes based on these preliminary findings.

By Susan J. Landers — Posted March 3, 2008

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Interim findings released Feb. 13 regarding a large international type 2 diabetes study contradict those released a week earlier showing that patients receiving intensive treatment to lower their blood glucose levels were more likely to die.

Data from the 11,140-patient Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE) trial did not show any evidence of increased deaths among participants who received aggressive treatment to lower their blood glucose levels to an A1c of 6.5% or less, which is below recommendations in some clinical guidelines.

Researchers from the National Heart, Lung and Blood Institute's Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial halted an arm of that study on Feb. 6. A data review revealed 54 more deaths occurred among patients treated to reduce A1c levels to less than 6% than in the study's standard treatment arm, which had a goal of 7% to 7.9%.

The ADVANCE trial has not yet ended. But, according to Principal Investigator Stephen MacMahon, DSc, PhD, director of the George Institute for International Health in Sydney, researchers decided to check data early after the ACCORD findings were announced.

The American Diabetes Assn. cautioned against making treatment changes based on the two studies' early findings. "There is insufficient evidence from what we've heard so far," said Richard Kahn, PhD, ADA's chief scientific and medical affairs officer.

The number of deaths in the discontinued arm of the ACCORD trial -- 14 per 1,000 patients -- also is much lower than that seen in the regular population of diabetics, about 40 or 50 per 1,000, demonstrating that driving down blood glucose levels could well be beneficial, noted Dr. Kahn. "All the more reason not to change therapeutic regimens."

Meanwhile, the ADA said it was awaiting full reports for the ACCORD and ADVANCE studies as well as the VA Diabetes Trial, which also examined the relationship between intensive glycemic control and cardiovascular outcomes in type 2 diabetes. All data are expected to be available later this year.

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