Deaths Prompt Halt in Diabetes Study
Study of Intensive Treatment of Diabetes Curtailed Because of Increased Death Rates
Intensive Blood Sugar Treatment continued...
Patients also got drug treatment for high blood pressure, high cholesterol, and other problems.
Despite the higher death rate in the intensive-treatment group, researchers stressed that those rates were still lower than in the general diabetes population.
The results raised concerns that the diabetes drug Avandia my have played a role in the increased deaths. The drug has been under intense scrutiny by the FDA because of recent evidence that it may boost the risk of cardiovascular events.
Avandia was used in the trial, but Friedewald says a preliminary analysis could not connect the drug to increased deaths.
"At this time we have found no link, and thus the use of rosiglitazone does not seem to explain the increased mortality," he says.
Message for Type 2 Diabetes Patients
Researchers say the results to not apply to patients with type 1 diabetes.
In a statement, the American Diabetes Association says it continues to advise diabetes patients to strive for an A1c under 7%.
The importance of glucose control in diabetes is firmly established," the group states. "Recent data indicates that more than half of the population with diabetes in the U.S. have an A1C less than 7 percent and this overall level of glucose control appears to be of great benefit rather than harm."
But patients in ACCORD were considered high risk because they were on average 62 years old, had a 10-year history of diabetes, and had at least two cardiovascular risk factors such as high blood pressure or cholesterol, obesity, or were smokers.
"Care should be taken not to intensively lower blood sugar levels to near-normal levels," Nabel says. For patients with high risk for heart disease, very intensive treatment aimed at lowering blood glucose to an A1c below 6% "may be detrimental."
Researchers say patients should not alter any treatments without speaking with their doctors.