Using basal insulin to normalize glucose levels in patients with early diabetes and pre-diabetes doesn't affect cardiovascular
event or cancer rates, a new study found.
The trial randomized more than 12,000 people with a mean age of
63.5 years who had cardiovascular risk factors plus impaired
fasting glucose, impaired glucose tolerance or type 2 diabetes
to receive daily basal insulin glargine or standard care, defined
as treatment based on local guidelines or the investigator's
best judgment. Insulin was titrated to a target fasting blood
glucose level of ≤95 mg/dL in the glargine treatment group; in
the standard care group, only 11% were treated with insulin,
with a majority of patients (60%) being treated with metformin,
and 19% not receiving any glucose-lowering agents. Median
length of follow-up was 6.2 years. The study was presented at
the American Diabetes Association annual meeting and published online by the New England Journal of Medicine on June 11.
The insulin and control groups had similar rates of myocardial
infarction, stroke or death from cardiovascular causes (2.94
with insulin vs. 2.85 without per 100 person-years) and of a
combined outcome of those events plus revascularization or
hospitalization
for heart failure (5.52 vs. 5.28 per 100 person-years). The
incidence of new diabetes in the pre-diabetic patients, measured
about three months after insulin was discontinued, was lower in
the insulin group (30% vs. 35%; odds ratio, 0.80; P=0.05). However, insulin was associated with more weight gain (1.6 kg vs. −0.5 kg) and severe hypoglycemia (1.00 vs.
0.31 per 100 person-years). The rate of cancer did not differ between groups.
Researchers concluded that insulin glargine had a neutral
effect on cardiovascular outcomes and cancer but increased hypoglycemia
and weight. As the largest and longest study of its kind, this
trial provides reassurance about previously suspected links
between insulin and cardiovascular problems and cancer, the
authors said. They attributed the extended benefit of diabetes
reduction after insulin was discontinued to resting of the
pancreas, although they noted that the durability of the effect
is unknown.
The study also randomized patients to receive n-3 fatty acids or placebo, and results of that investigation, also published in the New England Journal of Medicine, showed no benefit or harm from the supplementation.
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