"Effects of intensive glucose lowering in type 2
diabetes," by the
ACCORD Study Group (H.C. Gerstein, et al.), New England
Journal of Medicine, 358(24): 2545-59, 12 June 2008.
[Authors' affiliations: For the Writing Group, 10 U.S. and Canadian
institutions]
Abstract: "Background: Epidemiologic
studies have shown a relationship between glycated hemoglobin levels and
cardiovascular events in patients with type 2 diabetes. We investigated
whether intensive therapy to target normal glycated hemoglobin levels would
reduce cardiovascular events in patients with type 2 diabetes who had
either established cardiovascular disease or additional cardiovascular risk
factors. Methods: In this randomized study, 10,251
patients (mean age, 62.2 years) with a median glycated hemoglobin level of
8.1% were assigned to receive intensive therapy (targeting a glycated
hemoglobin level below 6.0%) or standard therapy (targeting a level from
7.0 to 7.9%). Of these patients, 38% were women, and 35% had had a previous
cardiovascular event. The primary outcome was a composite of nonfatal
myocardial infarction, nonfatal stroke, or death from cardiovascular
causes. The finding of higher mortality in the intensive-therapy group led
to a discontinuation of intensive therapy after a mean of 3.5 years of
follow-up. Results: At 1 year, stable median glycated
hemoglobin levels of 6.4% and 7.5% were achieved in the intensive-therapy
group and the standard-therapy group, respectively. During follow-up, the
primary outcome occurred in 352 patients in the intensive-therapy group, as
compared with 371 in the standard-therapy group (hazard ratio, 0.90; 95%
confidence interval [CI], 0.78 to 1.04; P=0.16). At the same time, 257
patients in the intensive-therapy group died, as compared with 203 patients
in the standard-therapy group (hazard ratio, 1.22; 95% CI, 1.01 to 1.46;
P=0.04). Hypoglycemia requiring assistance and weight gain of more than 10
kg were more frequent in the intensive-therapy group (P<0.001).
Conclusions: As compared with standard therapy, the use of
intensive therapy to target normal glycated hemoglobin levels for 3.5 years
increased mortality and did not significantly reduce major cardiovascular
events. These findings identify a previously unrecognized harm of intensive
glucose lowering in high-risk patients with type 2 diabetes.
This 2008 report from the New England Journal of Medicine was
cited 62 times in current journal articles
indexed by Clarivate during January-February 2009. No other medicine
paper published in the last two years, aside from reviews, attracted a
higher citation total during that two-month period. Prior to the most
recent bimonthly count, citations to the paper have accrued as follows:
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