medwireNews: Researchers find a reduced cardiovascular gain and an increased risk of severe hypoglycaemia in frail people with type 2 diabetes who are exposed to intensive blood sugar and blood pressure treatment.
“The balance between risk and benefit became less favorable with increasing frailty,” say Tu Nguyen (University of Sydney, New South Wales, Australia) and co-authors of the study.
The researchers used basic data from 11,140 participants in the ADVANCE study to create a frailty index. The 34 variables used included cardiovascular risk factors such as blood pressure and obesity, pre-existing medical conditions, and indicators of quality of life.
Using this index, they defined 25.7% of the participants (25.1% of the men and 26.5% of the women) as frail.
These people were significantly more likely to get poor results than those without frailty. Risk ratios ranged from 1.57 for severe hypoglycemia to 3.01 for cardiovascular mortality, after considering age, gender, and whether they received intensive or standard glucose-lowering treatment.
“Most of the evidence base for treating cardiometabolic disease comes from individuals robust enough to participate in previous clinical trials,” write Diabetes Care researchers.
“The evidence gap for the elderly can mask important differences in response to standard treatments that can be particularly relevant in the presence of frailty.”
The ADVANCE participants were randomly given a blinded blood pressure treatment with perindopril / indapamide versus placebo and an open intensive glucose lowering with gliclazide with modified release versus a standard regimen.
Intensive glucose treatment compared to standard glucose treatment was significantly more beneficial in non-frail participants than in frail participants, with micro- and macrovascular events, including cardiovascular death, significantly decreasing by 16% in the former, but no change in the latter significant increase of 3% group.
This was also the case for major microvascular events and for major macrovascular events, which were considered separately.
The same applies to intensive treatment compared to standard blood pressure treatment with a significant reduction in micro- and macrovascular events by 14% in non-frail participants, but only a non-significant reduction in frail people by 3%.
Among the randomized patients with intensive glucose control, the likelihood of severe hypoglycemia in frail participants was significantly higher than in non-frail participants at a rate of 8.39 versus 4.80 per 1000 person-years. In contrast, there was no significant difference in the group that received a standard glucose control.
Calling for routine frailty assessment in clinical trials, the researchers say, “In an aging population, we should have more reliable evidence that our usual treatments are still effective in large numbers of elderly and frail patients.”
They add, “As such evidence accumulates, routine clinical frailty assessment will become more important in personalizing the care of the elderly.”
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Diabetes Care 2021; doi: 10.2337 / dc20-2664