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T2DM risk

Intensive glucose control for T2DM can increase the risk of mortality

Neither randomised trials nor observational studies have been able to demonstrate a consistent pattern of association between levels of glucose control and adverse outcome, without any explanation as to why

The common approach of intensive glucose control to achieve low blood sugar targets in type 2 diabetes can increase the risk of mortality, according to a study by researchers from Cardiff University, UK. The findings of the study also suggest that neither randomised trials nor observational studies have been able to demonstrate a consistent pattern of association between levels of glucose control and adverse outcome, without any explanation as to why.

"Treatment guidelines generally recommend therapeutic strategies that aim for low levels of glucose control, on the understanding that it reduces risk of macrovascular complications such as coronary artery disease and stroke,” said Professor Craig Currie from Cardiff University's School of Medicine. Contrary to this belief, our findings show persuasively that there is an association with increased mortality risk and what is considered to be good glucose control, or low HbA1c."

The study, ‘The impact of differing glucose-lowering regimens on the pattern of association between glucose control and survival’, was published in the journal - Diabetes, Obesity and Metabolism.

The investigators sought to characterise survival in relation to achieved HbA1c within alternative glucose-lowering regimens with differing risks of hypoglycaemia. They extracted data from the UK Clinical Practice Research Datalink and the Hospital Episode Statistics. Over 300,000 patients with type 2 diabetes prescribed glucose-lowering therapy in monotherapy or dual therapy with metformin were identified between 2004 and 2013. Risk of all-cause mortality within treatment cohorts was evaluated using the Cox proportional hazards model, introducing mean HbA1c as a quarterly updated, time-dependent variable.

Outcomes

They reported that there were 6,646 deaths with follow-up of 374,591 years. Survival for lower (<7%) versus moderate HbA1c (≥7%, <8.5%) differed by cohort: metformin, aHR=1.03 (95% CI 0.95–1.12); sulfonylurea, 1.11 (0.99–1.25); insulin, 1.47 (1.25–1.72); combined regimens with low hypoglycaemia risk, 1.02 (0.94–1.10); and combined regimens with higher hypoglycaemia risk excluding insulin, 1.24 (1.13–1.35) and including insulin, 1.28 (1.18–1.37).

In addition, higher HbA1c levels were associated with increased mortality in regimens with low hypoglycaemia risk. Post hoc analysis by HbA1c decile revealed an elevated risk of all-cause mortality for the lowest deciles across all cohorts, but particularly in those regimens associated with hypoglycaemia. High HbA1c was associated with no difference or a small increase in mortality risk in regimens with increased risk of hypoglycaemia.

“Thus, the optimal target for glucose control in patients with type 2 diabetes remains uncertain,” added Currie. "Serious questions remain about the safety of some glucose lowering drugs, with scientific evidence and opposing opinions being largely ignored. Of most concern was an increase in mortality risk in those with 'good control' with type 2 diabetes who were treated with insulin and other glucose lowering drugs that induce hypoglycaemia.”

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