Native participants encouraged to continue glucose control
BETHESDA, M.D. – Results of a medical study revealed that lowering blood sugar to normal levels in Type 2 diabetes patients suffering from cardiovascular disease might not always be the best plan of action, according to a press conference held by the National Heart, Lung and Blood Institute, Feb. 6.
In the Action to Control Cardiovascular Risk in Diabetes trial study, patients who were randomly assigned to lower their blood sugar to nearly normal levels, had 54 more deaths than the group with a less stringent regimen.
There are more than 10,000 participants in the study. Deaths occurred in three out of 1,000 participants per year, over an average of 4 years of treatments.
Elizabeth G. Nabel, M.D., director of the NHLBI, said about 257 deaths occurred in the group of patients involved in the intensive treatment to lower their blood sugar, when compared to 203 deaths in the standard patient population.
”Because of this difference, the increased risk between the two groups outweighed potential benefits of the intensive treatment strategy on nonfatal events,” she said. ”Accordingly, the NHLBI has made the decision to stop this intensive treatment approach of the trial.”
Yvette Roubideaux, M.D., M.P.H., assistant professor at the University of Arizona College of Public Health and College of Medicine, cautions patients not to balk at controlling their glucose levels as a result of the study.
Roubideaux, Sicangu Lakota, said that the older patients with cardiovascular disease may be able to live with higher blood sugar, but cautions all Type 2 diabetes sufferers not to alter their prescribed regimen without the advice of their physician. ”Indian people should work closely with their doctor and get their blood sugar in control the best way that they can,” she said.
Dr. Rex Quaempts, the diabetes program coordinator for the IHS White Swan Health Clinic in Toppenish Wash., said that his clinic has about 15 Native patients involved in the ACCORD study and they come in every two weeks for their check-ups. From his observations, the group seems to show noteworthy improvements due to their involvement in the study.
Quaempts, an enrolled member of the Yakama Indian Nation, also said that patients in the study, as a whole, are comprised of high-risk individuals that on the average are 62 years old, have a 10-year history of diabetes, and two cardiovascular risk factors.
The drugs being used in the study are FDA-approved and regularly prescribed to patients; so drugs were not linked to the increase of deaths. ”When you look at the people in this study, they were already a high risk group,” he said.
He said that Natives made up only 2 percent of the study population.
In light of the recent findings, Quaempts said the study group had fewer deaths when compared to the general population of diabetes sufferers with cardiovascular diseases. ”When you take the sickest of the group, they are still doing better than the general population,” he said.
In order to monitor blood sugar, Quaempts said doctors base it on the results of an A1c test, also known as glycated hemoglobin test. It gives doctors a snapshot of a patient’s average blood glucose control for the past 2 to 3 months.
He said that A1c levels between 6.5 and 7.5 percent are favorable, but that patients’ needs vary. ”I am still going to shoot for the usual control,” he said, referring to the care of his patients.
The American Diabetes Association recommends a glucose level of 7 percent. Complications resulting in uncontrolled blood glucose levels include an increased risk for heart disease and stroke, kidney disease, eye complications, nerve damage and more.
When the ACCORD study began in 2001, NHLBI formed the Data and Safety Monitoring Board to review its data every 6 months. It was during their latest meeting when experts discovered that the data revealed a higher than expected death rate among the participants involved in the intensive blood sugar lowering phase of the study.
Nabel said that researchers reported that the median A1c level achieved in the intensive treatment group was 6.4 percent, while the median A1c level in the standard treatment group was 7.5 percent.
”This is an important finding which shows that if you have Type 2 diabetes and are at especially high risk for heart disease, very intensive glucose lowering treatments aimed at normalizing blood glucose to an A1c of less than 6 percent may be detrimental,” she said.
On the whole, according to the ADA, American Indians and Alaska Natives lead the way in new cases of Type 2 diabetes. American Indians and Alaska Natives are 2.2 times more likely to have diabetes than non-Hispanic whites.
Clinically-based reports and regional studies revealed that Type 2 diabetes is being diagnosed more frequently in children and adolescents, particularly in American Indians, African Americans and Hispanic/Latino Americans.
The prevalence of diabetes is at least 2 to 4 times higher among American Indian women than among non-Hispanic white women.
For more information on diabetes, visit the ADA Web site: www.diabetes.org. For information about the ACCORD study, visit www.accordtrial.org/public/index.cfm.