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Severe hypoglycemia linked to macrovascular events regardless of intensity of glucose control
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ADA 70th Scientific Sessions
ORLANDO — Severe hypoglycemia was strongly associated with greater risk for macrovascular events and death in patients with type 2 diabetes, according to a re-analysis of the ADVANCE trial presented here.
Sophia Zoungas, MD, PhD, said the link between severe hypoglycemia, macrovascular events and death “may be directly causal, but it is equally likely a marker of vulnerability to a wide range of adverse clinical outcomes.”
Zoungas and colleagues examined the relationship between severe hypoglycemia, vascular complications and mortality with baseline characteristics of patients who participated in the Action in Diabetes and Vascular Disease (ADVANCE) study.
ADVANCE was a multicenter, factorial, randomized trial that enrolled 11,140 patients with type 2 diabetes. Researchers randomly assigned patients to perindopril/indapamide vs. placebo and intensive glucose control with a gliclazide MR-based regimen vs. standard glucose control. As previously reported in Endocrine Today, ADVANCE data showed independent vascular benefits of blood pressure lowering with perindopril/indapamide after 4.3 years of follow-up, and of intensive glucose control with a gliclazide MR-based regimen after 5 years of follow-up.
Results of the latest analysis indicate that severe hypoglycemia was clearly associated with an increased risk for both macrovascular and non-vascular events and death. After adjustment, these results remained significant for the majority of outcomes.
Further, both the standard and intensive glucose control groups experienced a comparable association between severe hypoglycemia and risk.
The researchers did not find a close sequential or dose-response relationship.
“Plausible mechanisms by which severe hypoglycemia may cause cardiovascular morbidity or mortality include sympatho-adrenal activation, abnormal cardiac repolarization, and increased thrombogenesis, inflammation and vasoconstriction,” Zoungas said. – by Matthew Brannon
The ADVANCE data are complementary and affirm what we believed to have understood in the ACCORD analyses — that is, severe hypoglycemia in any individual, not solely intensively treated individuals, is of significant risk. Here, it was temporally dissociated, but that suggests that these are individuals with other significant health concerns may be at risk for these events if therapy is further intensified. The data also suggest that these are individuals who should look for alternative hyperglycemic therapies, rather than hypoglycemic therapies, given the profound risks that seem to be associated.
– David M. Kendall, MD
Chief Scientific
& Medical Officer
American Diabetes Association
For more information:
- Zoungas S. Late breaking clinical studies. Presented at: American Diabetes Association 70th Scientific Sessions; June 25-29, 2010; Orlando.
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