Judith Fradkin, M.D.
Director, Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute for Diabetes and Digestive and Kidney Diseases

Thank you. I've been asked to address the implications of these new findings from the ACCORD study for diabetes patients. I will focus my remarks on type 2 diabetes, the form of diabetes being studied in ACCORD.

• Type 2 diabetes is by far the most common form of diabetes in the United States. It accounts for about 95 percent of the nearly 21 million diabetes cases in this country.
  
  
• Type 2 diabetes is most common in adults age 40 and older. It is strongly associated with obesity, inactivity, a family history of diabetes, and racial or ethnic background. Minority groups are at particularly high risk.
  
  
• As Dr. Nabel noted earlier, type 2 diabetes is a complex metabolic disease that results in elevated blood sugar levels. It usually begins as insulin resistance, a disorder in which cells in fat, liver, and muscle do not respond to or use insulin properly. As the need for insulin rises, the pancreas gradually loses its ability to secrete enough insulin to meet the body's needs. At diagnosis, many patients do not need medication, and most patients do well with oral medications such as metformin. Over time, however, they have a progressive loss in insulin production, and they need additional medications to control their diabetes.
  
  
• Eventually, especially if it is not well controlled, type 2 diabetes causes damage to the eyes, nerves, kidneys, heart and blood vessels. Many people with diabetes also have high blood pressure and lipid or cholesterol problems-conditions that further add to their risk for cardiovascular disease. About 65 percent of people with diabetes die from heart disease or stroke. Diabetes is an increasingly important cause of cardiovascular disease in the U.S.

I would now like to briefly review how ACCORD is different from earlier studies. One crucial way in which ACCORD differed from earlier clinical studies is that it studied the effects of lowering glucose to a near-normal level, a lower level than that targeted in earlier studies.

ACCORD also differed in another critical way from earlier studies aimed at preventing complications through intensive glucose control. At enrollment, ACCORD participants were older - they were, on average, 62 years old; they had lived with diabetes for a longer time (an average of 10 years); and they were at especially high risk for cardiovascular disease. In contrast, participants in the earlier studies of intensive glucose control were younger, had recently been diagnosed with diabetes, and were not at a similar high risk for CVD. It is not yet known whether controlling glucose to near normal levels will prevent heart disease and extend life in other groups such as younger people with diabetes, those earlier in the course of disease and in whom glucose is easier to control, and those without established cardiovascular disease.

So what have we learned from ACCORD so far?

These new findings give us important information. They show that a medical strategy to intensively lower blood glucose to a goal of near normal, or non-diabetic levels, increases the risk of death and outweighs the potential benefits of such therapy for this specific group of patients-those with established or longstanding type 2 diabetes who have cardiovascular disease or are at especially high risk for it. In this group of patients, and with the treatments currently available to us, clinicians should be wary of striving for intensive glucose control to near-normal levels.

The ACCORD trial tells us that patients with diabetes and a high likelihood of established heart disease should not aim for near normal levels of blood glucose-levels that are rarely achieved with current medical care in comparable patients.

We've learned that a one-size approach does not fit all in treating diabetes, and the ACCORD findings reinforce this message. The National Diabetes Education Program, which is sponsored by the National Institutes of Health and the Centers for Disease Control and Prevention, promotes the American Diabetes Association's guidelines for diabetes care. Under these guidelines, the A1C goal for most people with diabetes is less than 7 percent. The guidelines also state that treatment should be tailored to individual needs. For example, a less stringent A1C goal should be considered for people with severe or frequent hypoglycemia or those with a limited life expectancy. In tailoring therapy to determine an individual patient's A1C goal, physicians should now consider whether the patient has established cardiovascular disease or additional CVD risk factors.

I want to stress that ACCORD is studying the effects of intensive glucose control in type 2 diabetes. We cannot extrapolate its results to patients with type 1 diabetes, which is a different form of diabetes.

Last updated: February 6, 2008