The purpose of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial was to test the hypothesis that intensive glucose-lowering therapy to target normal glycated hemoglobin levels would reduce cardiovascular events in patients with type 2 diabetes compared to standard therapy. A total of 10,251 patients (38% women) with a median glycated hemoglobin level of 8.1% were randomly assigned to either intensive or standard therapy. The goals of the treatment were to achieve a glycated hemoglobin level below 6.0% and between 7.0-7.9%, respectively, for intensive and standard treatment. After 1 year, the glycated hemoglobin levels achieved were 6.4% for the intensive therapy group and 7.5% for the standard therapy group. With the standard therapy group as the group of reference, the hazard ratio for future cardiovascular events for patients in the intensive therapy group was 0.90 (95% CI, 0.78-1.04, p=0.16). Meanwhile, 257 patients of the intensive therapy group died compared to 203 patients in the standard therapy group (p=0.04). The finding that the intensive therapy group was experiencing higher mortality rates led to a discontinuation of the intensive therapy arm after a mean follow-up of 3.5 years. According to the authors, hypoglycemia requiring assistance and weight gain of more than 10 kg might have been important factors underpinning the increased mortality rates, as they were found to be higher in the intensive therapy group. The approach used to rapidly lower glycated hemoglobin levels or the actual levels of glycated hemoglobin achieved were also singled out as possible reasons for the increased mortality rate.
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