ACCORD was designed to evaluate the impact of different glucose and lipid-lowering strategies on cardiovascular events in more than 10,251 participants with type 2 diabetes.
According to a press release, there have been 257 deaths in the intensive-treatment group and 203 in the standard treatment group, which is an excess of 54 deaths, or three per 1,000 participants each year, over an average of fours years of treatment.
The NHBLI said, however, that the death rates in both groups were lower than mortality seen in similar populations in other studies.
Patients in the intensive-glucose lowering arm received a number of medications, including rosiglitazone (Avandia), a drug that has been linked to excess events in studies published over the past year.
"Because of the recent concerns with rosiglitazone, our extensive analysis included a specific review to determine whether there was any link between this particular medication and the increased deaths. We found no link," Dr. William Friedewald, clinical professor of medicine and public health at Columbia University in New York and one of the directors of the trial, said in a statement.
"A thorough review of the data shows that the medical treatment strategy of intensively reducing blood sugar below current clinical guidelines causes harm in these especially high-risk patients with type 2 diabetes," said Elizabeth G. Nabel, M.D., director of the NHLBI.
"Though we have stopped this part of the trial, we will continue to care for these participants, who now will receive the less-intensive standard treatment. In addition, we will continue to monitor the health of all participants, seek the underlying causes for this finding, and carry on with other important research within ACCORD."
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