Starting this month,
a paper from
The New England Journal of Medicine published December 17, 2008 (10.1056/NEJMoa0808431) entitled "Glucose Control and Vascular Complications in Veterans with Type 2 Diabetes"
After the "Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation" (ADVANCE) trial and the "Action to Control Cardiovascular Risk in Diabetes" (ACCORD) trial, a third study, the Veterans Affairs Diabetes Trial (VADT) reports no benefit of intensive glucose control over standard care in patients with Type 2 diabetes.
In this study authors randomly assigned 1,791 military veterans affected by type 2 diabetes with suboptimal response to therapy to receive either intensive (with a goal of reaching 1.5 percentage points in the glycated hemoglobin level) or standard glucose control. The primary outcome of interest was the composite of myocardial infarction, stroke, death from cardiovascular causes, congestive heart failure, surgery for vascular disease, inoperable coronary coronary artery disease and amputation for ischemic gangrene. After a median follow-up of 5.6 years, median glycated hemoglobin levels were 8.4% in the standard therapy group and 6.9% in the intensive-therapy group. However there was no significant difference between the two groups in the primary endpoint nor in any component of the primary endpoint or in the rate of death from any cause. Similarly, there was no difference between the two groups for microvascular complications. The rates of adverse events, predominantly hypoglycemia, were 17.6% in the standard-therapy group and 24.1% in the intensive-therapy group.
Thus authors concluded that intensive glucose control in patients with poorly controlled type 2 diabetes had no significant effect on the rates of major cardiovascular events, death or microvascular complications.
Finally authors emphasize in the text that while intensive glucose control does not appear an appealing strategy to reduce cardiovascular burden in patients with type 2 diabetes, blood pressure, cholesterol and platelet activity control does. Thus, clinicians should not be discouraged by these findings and they should focus on those modified risk factors which are known to module prognosis in such high risk individuals.
Changes in Median Glycated Hemoglobin Levels from Baseline through 78 Months.
Kaplan–Meier Curves for the Time until the First Occurrence of a Primary or Secondary Outcome
Panel A shows the time until the first occurrence of a major cardiovascular event (the primary outcome), which was a composite of myocardial infarction, stroke, death from cardiovascular causes, congestive heart failure, surgery for vascular disease, inoperable coronary disease, and amputation for ische mic gangrene, in the standard-therapy group and the intensive therapy group, with a hazard ratio in the intensive-therapy group of 0.88 (95% confidence interval [CI], 0.74 to 1.05). Panel B shows the time until death from a cardiovascular cause (a component of the primary outcome), with a hazard ratio of 1.32 (95% CI, 0.81 to 2.14). Panel C shows the time until death from any cause (a secondary outcome), with a hazard ratio of 1.07 (95% CI, 0.81 to 1.42).