NIH: Deaths in Intensive Therapy Group Alter Trial
All patients will receive less-intensive standard treatment in ongoing ACCORD trial
WEDNESDAY, Feb. 6 (HealthDay News) -- One arm of a clinical trial to determine whether intensively lowering blood glucose in type 2 diabetes patients would lower the risk of cardiovascular events in high-risk patients has been halted due to excessive deaths, according to the U.S. National Institutes of Health (NIH). All patients will now receive the less-intensive standard treatment.
The ACCORD trial involved 10,251 patients in the United States and Canada with type 2 diabetes who had two or more risk factors for heart disease or had been diagnosed with heart disease. Patients were assigned to either standard or intensive treatment to lower their blood glucose.
The trial was altered when it was determined that 257 patients in the intensive treatment group died compared with 203 patients in the standard treatment group. The specific cause is currently unclear; however, study researchers report no association with the use of any one or combination of medications, including rosiglitazone.
"A thorough review of the data shows that the medical treatment strategy of intensively reducing blood sugar below current clinical guidelines causes harm in these especially high-risk patients with type 2 diabetes," Elizabeth G. Nabel, M.D., director of the National Heart, Lung, and Blood Institute in Bethesda, Md., stated. She noted that the ACCORD researchers will continue monitoring participants and analyzing the results in search of explanation.