medwireNews: A number of factors are associated with severe hypoglycemia risk in people with type 2 diabetes treated with insulin or sulfonylureas, suggests research reported at the 58th EASD Annual Meeting in Stockholm, Sweden.
These variables were used to create a clinical prediction tool that could be used identify those at high risk.
The retrospective cohort study included 23,016 people with type 2 diabetes treated with insulin or sulfonylureas between 2008 and 2016 in the Tayside and Fife regions of Scotland.
Presenting author Ruth Cordiner (University of Dundee, UK) told delegates that individuals on insulin had higher rates of severe hypoglycemia – defined as events requiring third-party assistance due to cognitive dysfunction – than those on sulfonylureas, at incidence rates of 17.9 versus 5.5 per 1000 person–years.
When the sulfonylureas were analyzed separately, the highest incidence of severe hypoglycemia was seen in people taking glibenclamide (13.6 per 1000 person–years) and the lowest in those on gliclazide modified release (1.66 per 1000 person–years). The incidence ranged from 4.38 to 6.32 per 1000 person–years among those on glimepiride, gliclazide, or glipizide.
These findings suggest “that low sustained concentrations of sulfonylureas are in fact protective against severe hypoglycemia,” said Cordiner.
The team then looked at factors associated with severe hypoglycemia risk in sulfonylurea-treated individuals, finding that previous severe hypoglycemia was “a very strong predictor of future events,” with an incidence rate ratio (IRR) of 1.82.
Older age, longer diabetes duration, and lower glycated hemoglobin (HbA1c) levels were also identified as significant predictors of greater risk for severe hypoglycemia among people on sulfonylureas, whereas higher BMI, male sex, and use of gliclazide modified release were significant predictors of reduced risk.
On the other hand, for insulin-treated type 2 diabetes, men had a significantly higher risk for severe hypoglycemia than women. Previous severe hypoglycemia was associated with a significantly increased risk in the insulin-treated population, albeit to a lesser degree than in sulfonylurea-treated individuals (IRR=1.02). Older age, longer diabetes duration, and lower HbA1c were also significant predictors of increased severe hypoglycemic risk in people treated with insulin.
Using these factors in a model to predict an individual’s annual risk for severe hypoglycemia, Cordiner gave some examples of how it would work in everyday clinical practice.
For instance, for a 75-year-old man without overweight or obesity who developed type 2 diabetes 5 years ago and had a degree of renal impairment and one previous severe hypoglycemic episode, she said that the annual risk would be 0.1% with gliclazide modified release, 1.0% with glibenclamide, and 9.1% with insulin
And for another man aged 40 years with type 2 diabetes duration of 5 years who was overweight with no renal impairment and no prior episodes of severe hypoglycemia, the annual risk with these agents would be 0.009%, 0.06%, and 1.9%, respectively.
This clinical prediction tool requires further validation, but “may provide valuable clinical application in primary and secondary care,” said Cordiner.
She added that the model has also been expanded to include predictors of severe hypoglycemia risk using data from 4800 people with type 1 diabetes, and these predictors “are similar to those for insulin-treated type 2 diabetes.”
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