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These results from ACCORD do not apply to patients with type 1 (juvenile) diabetes, according to Fradkin. It is also unclear whether the results apply to patients with recently diagnosed type 2 diabetes or those whose cardiovascular risk is lower than the participants studied in ACCORD.

Extensive analyses by ACCORD researchers have not determined a specific cause for the increased deaths among the intensive treatment group. Based on analyses conducted to date, there is no evidence that any medication or combination of medications is responsible.

Most participants in the intensive treatment group achieved their lower blood sugar goals with combinations of Food and Drug Administration-approved diabetes medications. For both the intensive and standard treatment groups, study clinicians could use all major classes of diabetes medications available: metformin, thiazolidinediones (TZDs, primarily rosiglitazone), insulins, sulfonylureas, exanatide, and acarbose.

Because of the recent concerns with rosiglitazone, our extensive analysis included a specific review to determine whether there was any link between this particular medication and the increased deaths. We found no link, said William T. Friedewald, M.D., ACCORD Steering Committee Chair and Clinical Professor of Medicine and Public Health at Columbia University.

ACCORD researchers will continue to monitor participants and conduct additional analyses to try and explain the findings. Investigators are preparing a report of the findings for a peer-reviewed publication.

An estimated 21 million Americans have diabetes and 284,000 die from it each year. Sixty-five percent of the deaths are related to cardiovascular causes. Type 2 diabetes increases the risk for heart disease 2 to 4 times.

The National Diabetes Education Program, a program of the NIDDK and the Centers for Disease Control and Prevention (CDC), promotes the diabetes care gu
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