medwireNews: Researchers find diminished cardiovascular gains and an increased risk for severe hypoglycemia in frail people with type 2 diabetes given intensive glycemic and blood pressure treatment.
“Thus, the balance of risk and benefit became less favorable with increasing frailty,” say Tu Nguyen (University of Sydney, New South Wales, Australia) and study co-authors.
The researchers used baseline data from 11,140 participants of the ADVANCE trial to construct a frailty index. The 34 variables used included cardiovascular risk factors such as blood pressure and adiposity, pre-existing medical conditions, and quality of life indicators.
Using this index, they defined 25.7% of the participants (25.1% of men and 26.5% of women) as being frail.
These people were significantly more likely than nonfrail people to experience poor outcomes, with hazard ratios ranging from 1.57 for severe hypoglycemia to 3.01 for cardiovascular mortality, after accounting for age, sex, and whether they received intensive or standard glucose-lowering treatment.
“Most of the evidence base for the management of cardiometabolic diseases is from those individuals who were robust enough to participate in previous clinical trials,” write the researchers in Diabetes Care.
“The evidence gap for older people may mask important differences in response to standard treatments, responses that might be particularly relevant in the presence of frailty.”
ADVANCE participants were randomly assigned to receive blinded blood pressure treatment with perindopril/indapamide versus placebo and to undergo open-label intensive glucose lowering with modified-release gliclazide versus a standard regimen.
Intensive versus standard glucose treatment was significantly more beneficial in nonfrail than frail participants, at a significant 16% reduction in micro- and macrovascular events, including cardiovascular death, in the former, but no change, at a nonsignificant 3% increase, in the latter group.
This was also the case for major microvascular events and for major macrovascular events considered separately.
And the same was true for intensive versus standard blood pressure treatment, at a significant 14% reduction in micro- and macrovascular events in nonfrail participants but only a nonsignificant 3% reduction in frail people.
Moreover, among those randomized to intensive glucose control, frail participants were significantly more likely to experience severe hypoglycemia than those who were not frail, at rates of 8.39 versus 4.80 per 1000 person–years. By contrast, there was no significant difference in the group receiving standard glucose control.
The researchers call for frailty to be routinely assessed in clinical trials, saying: “In an aging population, we should have more reliable evidence to know whether our usual treatments are still effective in the large numbers of older and frailer patients.”
They add: “As such evidence accumulates, routine clinical assessment of frailty will become more important in personalizing treatment for older people.”
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