Early Use of Basal Insulin Does Not Reduce Cardiovascular RiskWednesday, June 13, 2012
Yesterday, I posted on the results of an randomised controlled trial of n-3 fatty acids, which failed to show any positive effect on cardiovascular complications or death.
In the same trial (ORIGIN), published in the New England Journal of Medicine, the over 12,000 participants with cardiovascular risk factors plus impaired fasting glucose, impaired glucose tolerance, or type 2 diabetes were also randomised to either insulin glargine (with a target fasting blood glucose level of ≤95 mg per deciliter [5.3 mmol per liter]) or standard care.
Over the median follow-up of 6.2 years rates of incident cardiovascular outcomes were similar in the insulin-glargine and standard-care groups with no differences in primary or secondary endpoints.
New diabetes was diagnosed approximately 3 months after therapy was stopped among 30% versus 35% of 1456 participants without baseline diabetes, suggesting that there was also minimal impact on diabetes prevention.
As may be expected, rates of severe hypoglycemia were about three times higher in the insulin group than in placebo.
Also of note, median weight increased by 1.6 kg in the insulin-glargine group and fell by 0.5 kg in the standard-care group.
It is also comforting to note that insulin treatment did not increase rates of cancer (an issue that has not been carefully studied before).
From these findings the authors conclude:
“When used to target normal fasting plasma glucose levels for more than 6 years, insulin glargine had a neutral effect on cardiovascular outcomes and cancers. Although it reduced new-onset diabetes, insulin glargine also increased hypoglycemia and modestly increased weight.”
As the authors further point out:
“…the findings of the ORIGIN trial do not support changing standard therapies for early dysglycemia.”
As readers may be well aware, these therapies do not normally include the use of insulin in such patients.