ACCORD Trial Researchers Halt Intensive Glucose-Lowering After Increased Deaths
Researchers exploring the benefits of intensive versus standard glucose-lowering therapy have decided to end the trial's intensive treatment arm after interim analyses found higher mortality there.
The ACCORD researchers randomized 10,250 patients with type 2 diabetes averaging 10 years' duration and at high risk for cardiovascular disease to one of two treatment arms: the standard arm had a hemoglobin A1c target between 7% and 7.9%, and the intensive arm targeted levels under 6%. The trial's data and safety monitoring board recommended ending the intensive arm when it found increased all-cause mortality.
In a Wednesday news conference, researchers said that although the rates of nonfatal cardiovascular events were lower during intensive treatment, "if a heart attack did occur, it was more likely to be fatal." They also said that none of the study drugs used, including rosiglitazone, was conclusively implicated in the increased mortality.
Link: National Institutes of Health press release (Free)
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