Due to safety concerns, researchers in a large ongoing trial have stopped lowering blood glucose levels below current recommendations in patients with type 2 diabetes who are at especially high risk for stroke and myocardial infarction. Reviewing the data, they found that this treatment strategy actually harms these patients, who will now receive less-intensive standard treatment.
The ACCORD (Action to Control Cardiovascular Risk in Diabetes) study enrolled 10,251 patients. In the group receiving intensive glucose-lowering treatment, 257 patients died, compared with 203 in the standard treatment group. This is a difference of 54 deaths, or 3 per 1,000 patients per year over about 4 years of treatment.
On average, patients in the intensive treatment group achieved hemoglobin A1C (A1C) values lower than standard treatment group patients. Half of patients in the intensive treatment group achieved an A1C value of less than 6.4%. According to the 2008 American Diabetes Association revised guidelines, the A1C goal for nonpregnant adults is generally less than 7%.
All ACCORD participants will now be treated to meet standard A1C goals until the study's planned conclusion in 2009. Researchers caution that their findings shouldn't influence treatment for most patients with diabetes and that patients should never adjust their treatment plan without their health care provider's guidance.
The ACCORD trial, under way at 77 sites in the United States and Canada, is sponsored by the National Heart, Lung, and Blood Institute of the National Institutes of Health.