|
Clinical Update
ACCORD Study Group presents unexpected findings
 Results
of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Group
were released at the recent American Diabetes Association's 68th Scientific
Sessions. The findings, published in the New England Journal of Medicine, identify
a previously unrecognised harm of intensive glucose lowering in high-risk patients
with type 2 diabetes.
Based on epidemiologic studies showing a relationship between glycated haemoglobin
levels and cardiovascular events in patients with type 2 diabetes, the researchers
investigated whether intensive therapy to target normal glycated haemoglobin
levels would reduce cardiovascular events in patients with type 2 diabetes who
had either established cardiovascular disease or additional cardiovascular risk
factors.
In this randomised study, 10,251 patients (mean age, 62.2 years) with a median
glycated haemoglobin level of 8.1 percent were assigned to receive intensive
therapy (targeting a glycated haemoglobin level below six percent) or standard
therapy (targeting a level from 7.0 to 7.9 percent). Of these patients, 38 percent
were women, and 35 percent 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.
After one year, stable median glycated haemoglobin levels of 6.4 percent and
7.5 percent 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 percent 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 percent CI, 1.01 to 1.46; P=0.04). Hypoglycaemia requiring assistance and
weight gain of more than 10 kg were more frequent in the intensive-therapy group
(P<0.001).
The Group concluded that as compared with standard therapy, use of intensive
therapy to target normal glycated haemoglobin levels for 3.5 years increased
mortality and did not significantly reduce major cardiovascular events.
|
