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| |  Intensive Glucose Control for Diabetes Can Lead to Hypoglycaemia and Increase Mortality Risk NEW YORK -- January 26, 2010 -- Uncontrolled hyperglycaemia in patients with diabetes is known to increase mortality. But new research shows that intensive treatment to control blood glucose can lead to hypoglycaemia, which also increases mortality. Thus blood glucose level targets should have lower as well as upper limits, to lower the risk to patients, according to a study published online first and in an upcoming edition of The Lancet. Furthermore, patients with type 2 diabetes given insulin-based regimens have a 50% increased mortality risk compared with those given combination oral therapy. Reports of potentially raised mortality rates associated with intensive glycaemic control have triggered discussion about recommendations for treatment of type 2 diabetes, specifically relating to the optimum target for haemoglobin (Hb A1C). Researchers have suggested that hypoglycaemia contributes to a heightened risk of mortality in patients with diabetes. Because intensive glycaemic control increases risk of hypoglycaemia with some drugs more than with others, assessment of risks associated with the different blood glucose-lowering regimens is important. In this study, Craig Currie, MD, School of Medicine, Cardiff University, United Kingdom, and colleagues assessed the association between all-cause mortality and Hb A1C in patients with type 2 diabetes in a primary-care setting, and established whether any evident association was independent of the diabetes treatment regimen. Two cohorts of patients aged 50 years and older with type 2 diabetes were generated from the UK General Practice Research Database from November 1986 to November 2008. The researchers identified 27,965 patients whose treatment had been intensified from oral monotherapy to combination therapy with oral blood-glucose lowering agents (metformin plus sulphonylurea), and 20,005 who had changed to regimens that included insulin. Those with diabetes secondary to other causes were excluded. All-cause mortality was the primary outcome. Age, sex, smoking status, cholesterol, cardiovascular risk, and general morbidity were identified as important confounding factors, and the data were subsequently adjusted for these factors. Using the glycated Hb A1C level with the lowest mortality risk (7.5%) as a reference point, the researchers found that for the 2 combined cohorts, mortality risk in the lowest Hb A1C decile (6.4%) was 52% higher, and in the highest Hb A1C decile (10.6%) was 79% higher. The typical Hb A1C target for diabetes treatment is 7.0%. Results showed a similar U-shaped curve for both oral combination therapy and insulin therapy. However, all-cause mortality in people given insulin-based regimens (2,834 deaths) was 49% higher than those give combination oral agents (2,035 deaths). The authors said that while the data suggest that insulin could increase the risk of death in type 2 diabetes, differences in the baseline characteristics of the insulin treated patients (older, more comorbidities, longer duration of diabetes) could be one reason behind this risk; they also pointed out a possible link between use of insulin and cancer progression that has been reported in a previous study. However, the authors wish to make clear they are not suggesting diabetes patients who are prescribed insulin should stop taking their medication. “Whether intensification of glucose control with insulin therapy alone further heightens risk of death in patients with diabetes needs further investigation and assessment of the overall risk balance,” they said. “Low and high mean Hb A1C values were associated with increased all-cause mortality and cardiac events. If confirmed, diabetes guidelines might need revision to include a minimum Hb A1C value,” the authors concluded.
SOURCE: The Lancet
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