Nejm Glucosa

a new england
j ournal of m edicine
The

established in 1812

june 12, 2008

vol. 358

no. 24

Effects of Intensive Glucose Lowering in Type 2 Diabetes
The Action to ControlCardiovascular Risk in Diabetes Study Group*

A bs t r ac t
Background

Epidemiologic studies have shown a relationship between glycated hemoglobin
levels and cardiovascular events in patients with type 2diabetes. We investigated
whether intensive therapy to target normal glycated hemoglobin levels would reduce
cardiovascular events in patients with type 2 diabetes who had either establishedcardiovascular 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 toreceive 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 previouscardiovascular event. The primary outcome was a composite of nonfatal myocardial
infarction, nonfatal stroke, or death from cardiovascular causes. The finding of
higher mortality in theintensive-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
inthe 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 thestandard-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 inthe standardtherapy 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...