Hypoglycemia not to blame for mortality finding in ACCORD trial

January 01, 0001

Hypoglycemia not to blame for mortality finding in ACCORD trial

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial was a large study that looked at intensive versus normal blood sugar control regimens in uncontrolled diabetics. One striking finding from the study was increased mortality in the intensive control arm. These US investigators sought to examine whether there was a link between hypoglycemia and mortality in this study using a retrospective epidemiological analysis.

The researchers found: "10,194 of the 10,251 participants enrolled in the ACCORD study who had at least one assessment for hypoglycaemia during regular follow-up for vital status were included in this analysis. Unadjusted annual mortality among patients in the intensive glucose control arm was 2.8% in those who had one or more episodes of hypoglycaemia requiring any assistance compared with 1.2% for those with no episodes (53 deaths per 1,924 person years and 201 deaths per 16,315 person years, respectively; adjusted hazard ratio (HR) 1.41). A similar pattern was seen among participants in the standard glucose control arm (3.7% (21 deaths per 564 person years) v 1.0% (176 deaths per 17,297 person years), adjusted HR 2.30). On the other hand, among participants with at least one hypoglycaemic episode requiring any assistance, a non-significantly lower risk of death was seen in those in the intensive arm compared with those in the standard arm (adjusted HR 0.74). A significantly lower risk was observed in the intensive arm compared with the standard arm in participants who had experienced at least one hypoglycaemic episode requiring medical assistance (adjusted HR 0.55). Of the 451 deaths that occurred in ACCORD up to the time when the intensive treatment arm was closed, one death was adjudicated as definitely related to hypoglycaemia."

The investigators concluded: "Symptomatic, severe hypoglycaemia was associated with an increased risk of death within each study arm. However, among participants who experienced at least one episode of hypoglycaemia, the risk of death was lower in such participants in the intensive arm than in the standard arm. Symptomatic, severe hypoglycaemia does not appear to account for the difference in mortality between the two study arms up to the time when the ACCORD intensive glycaemia arm was discontinued."

This analysis does not find hypoglycemia, an otherwise likely suspect, as being to blame for the increased mortality seen with intensive control in the ACCORD trial and the mystery its cause remains.

For the full abstract, click here.

BMJ 340:b4909, 8 January 2010
© 2010 Bonds et al.
The association between symptomatic, severe hypoglycaemia and mortality in type 2 diabetes- retrospective epidemiological analysis of the ACCORD study. Denise E Bonds, Michael E Miller, Richard M Bergenstal et al.. Correspondence to: DE Bonds: bondsde@nhlbi.nih.gov

Category: T. Endocrine/Metabolic/Nutritional. Keywords: diabetes, intensive control, hypoglycemia, mortality, ACCORD study, retrospective epidemiological analysis, journal watch.
Synopsis edited by Dr Paul Schaefer, Toledo, Ohio. Posted on Global Family Doctor 26 January 2010

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