:: November 2009

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Highlighted Article

How Much Evidence Do We Need to Change Practices in Which We Firmly Believe? “In the first major trial (done in the 1960s) of tight glucose control in patients with type 2 diabetes, oral glucose-lowering agents were associated with higher cardiovascular mortality and no differences in microvascular complications compared with placebo.1 Insulin also was not associated with clinical benefit. In three recent large randomized trials (ACCORD,2 ADVANCE,3 and VADT4), tight control in patients with long-standing type 2 diabetes did not lower overall mortality, cardiovascular-related mortality, stroke, amputations, or even clinical (as opposed to surrogate) microvascular endpoints. Differences in specific outcomes in these trials might be related to different treatments or to duration of diabetes in participants. In some studies, fewer intensively treated patients reached composite outcomes (such as "any diabetes complications"), but the bulk of improvement was in nonclinical outcomes (e.g., incident albuminuria). Tight control was associated with severe hypoglycemia and weight gain. In the UKPDS study,5 published a decade ago, nonobese intensively treated participants with newly diagnosed type 2 diabetes were less likely to reach microvascular endpoints (including "need for photocoagulation," but not visual loss) but showed no difference in mortality (cardiovascular, diabetes-related, or all-cause) compared with nonobese control patients. Among obese participants, metformin alone lowered long-term mortality and myocardial infarction rate, but sulfonylureas and insulin did not; tight control did not lessen risk for microvascular complications. Metformin and sulfonylureas in combination were associated with excess diabetes-related deaths and all-cause mortality. Because trials do not support tight control and because of the cost, burden, and harms associated with tight control, we should be emphasizing cardiovascular risk reduction (particularly control of blood pressure and cholesterol levels) and healthy lifestyles for patients with type 2 diabetes.6 “