Intensive glycemic management leads to higher mortality in type 2 diabetes mellitus patients

April 1, 2011

The management of type 2 diabetes mellitus needs to change in response to the evolving evidence base now available. Research from the ADVANCE and the ACCORD trials was presented during the American Diabetes Association 58th annual advanced postgraduate course in New York City.

Key Points

The incidence of T2DM is increasing in prevalence for patients 65 years of age and older, from 20% for the years 1988 to 1994, to 27% for the years 2005 to 2008, according to statistics from the Centers for Disease Control and Prevention (CDC). The incidence of T2DM overall is increasing with a greater percentage of people with undiagnosed diabetes in the range of 24% to 40%.

"The old treatment paradigm was 'more is better,'" Patrick J. O'Connor, MD, MPH, senior clinical investigator at HealthPartners Research Foundation, told attendees at the ADA course. "But in ACCORD, intensive glycemic management led to higher total mortality and higher cardiovascular mortality in all pre-specified patient subgroups. Moreover, microvascular benefits of intensive glycemic control were observed for a minority of microvascular measures in the study, and did not reduce rates of renal failure or reduce visual deterioration within the study period. In addition to increased mortality, those in the intensive glycemic control arm of ACCORD had greater weight gain, and more episodes of serious hypoglycemia. In ADVANCE and other recent studies, serious hypoglycemic episodes have been related to increased mortality risk and impaired cognitive function."

"Recent changes in the NCQA [National Committee for Quality Assurance] accountability measures are commendable," added Dr O'Connor, "but more adjustments in the ADA Standards of Care are needed, in my opinion."

NEW RECOMMENDATIONS FOR GDM

Some recent major changes to the ADA's clinical practice recommendations were reviewed at the meeting, including a major new recommendation for screening and diagnosis of gestational diabetes mellitus (GDM)

It is anticipated that by using this new criteria, the incidence of GDM will increase because only 1 abnormal value (not 2, as in previous guidelines) are needed to establish the diagnosis. These new criteria were established due to the increased risk of worldwide obesity and diabetes rates, with the goal of optimizing gestational outcomes. A 75-gm oral glucose tolerance test (OGTT) is now recommended to be obtained at 24 to 28 weeks gestation along with plasma glucose (BG) measurements at 1 hour and 2 hours, in women not previously diagnosed with diabetes. The OGTT should be done in the morning following an overnight fast of at least 8 hours. GDM should be diagnosed when any of the following plasma glucose values are surpassed:

The 2011 ADA Standards of Care now recommend that blood pressure goals should be individualized based on patient age, comorbidities, number of antihypertensive agents, and the presence of side effects. Antiplatelet agent and dyslipidemia agent recommendations have not changed, despite newer data. The hemoglobin A1c goal should be below or near 7%, but it also should be individualized.

The American Association of Clinical Endocrinologists/ADA consensus statement on inpatient glycemic control recommends BG levels of 140 to 180 mg/dL for most critically ill patients, and <140 mg/dL in non-critically ill patients, with a goal of rational glycemia management using intravenous insulin infusions. New guidelines recently published by the American College of Physicians recommends BG levels of 140 to 200 mg/dL, in critically ill patients, but not using "intensive" insulin therapy. All groups agree that oral antidiabetic agents are not appropriate for managing hyperglycemia in hospitalized patients.

Dr Kaufman is a clinical pharmacist at New York Downtown Hospital in New York City.