Deaths Halt Part of Large Diabetes Trial

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Officials stressed that it's not clear why people in the intensive therapy group were at higher risk of death. But the researchers did not find that the combination of medications used for the trial -- and approved by the U.S. Food and Drug Administration to lower blood sugar -- was responsible for the increased risk.

The halting of the trial segment follows recent reports that one of those medications, Avandia (rosiglitazone), has been linked to an increased risk of heart attack. But Friedewalt said the drug was not responsible for the deaths.

"Because of the recent concerns raised with regard to rosiglitazone, we specifically analyzed the data to try and determine whether there was any link between this particular medication and the increased deaths we were seeing in the ACCORD intensive treatment group," Friedewald said. "At this time, we have found no link, and thus the use of rosiglitazone does not seem to explain the increased mortality."

Most of the people in the intensive treatment group were taking high doses of several medications to lower their blood sugar. Other drugs used in the trial included metformin, thiazolidinediones, insulins, sulfonylureas, exenatide, and acarbose.

Reaction to the news was generally cautious.

One federal health expert said the findings should not affect the current treatment of type 2 diabetes.

"The ACCORD findings are important, but will not change therapy for most patients with type 2 diabetes. Few patients with high cardiovascular risk like those studied in ACCORD are treated to blood sugar levels as low as those tested in this study, " Dr. Judith Fradkin, director of the National Institute of Diabetes and Digestive and Kidney Diseases' division of diabetes, endocrinology, and metabolic diseases, said in a prepared statement. "People with diabetes should never adjust their treatment plan or goals without consulting their health care providers."

Nabel also urged those with diabetes " to consult with their health-care professional before making any changes to their treatment."