The British Medical Journal has published an analysis of the ACCORD Study. This analysis aimed to determine whether there is a link between hypoglycaemia and mortality among participants in the study.
ACCORD was stopped early when it became apparent that all-cause and cardiovascular mortality was higher in the intensively managed group (HbA1c < 6%) compared to the standard therapy group (HbA1c 7-7.9%). The analysis reviewed rates of self reported hypoglycaemia, hypoglycaemia requiring assistance from another individual and the more restrictive definition of hypoglycaemia requiring medical assistance and correlated these with mortality.
The analysis found that hypoglycaemia was associated with an increased risk of death in both arms of the study but that the increased risk of death in individuals in the intensive arm of the study could not be attributed to hypoglycaemia. A statistical difference in the rates of death was only apparent in individuals who had never previously experienced a hypoglycaemic episode requiring medical assistance. Overall, there was an increased relative risk of death in participants from both arms of the study who had already experienced at least one symptomatic, severe hypoglycaemic episode.
The authors conclude that, "susceptibility to severe hypoglycaemia may be a marker for an underlying disorder that increases the risk for death in patients with diabetes".
Action: This analysis indicates that patients with diabetes who experience a severe hypoglycaemia episode may benefit from a clinical review to ensure optimal management of risk factors for mortality. This study provides no justification for intensive glucose control while the reasons for the increased death rate found in the ACCORD trial remain unexplained.