Intensive glucose lowering arm of diabetes trial is stopped after excess deaths

BMJ 2008; 336 doi: (Published 21 February 2008) Cite this as: BMJ 2008;336:407
  1. Susan Mayor
  1. 1London

The National Heart, Lung, and Blood Institute, part of the US National Institutes of Health, has stopped the intensive glucose lowering arm of a major trial in type 2 diabetes after more patients died than in the standard treatment group.

The action to control cardiovascular risk in diabetes (ACCORD) study involved 10 251 adults aged 40-82 years with type 2 diabetes who had two or more additional risk factors for heart disease or who already had a diagnosis of heart disease.

They were randomised to intensive glucose lowering treatment, in which the target haemoglobin A1c (HbA1c) concentration was <6%, or to less intensive, standard treatment to reach the average HbA1c (7% to 7.9%) currently achieved in the United States by such treatment.

The Data and Safety Monitoring Board, the independent group that was monitoring the trial, recommended that the trial be stopped when it found that more deaths occurred in the intensive treatment group. A total of 257 patients died in the intensive treatment arm over an average of four years of treatment, whereas 203 in the standard treatment group died. This …

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