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Diabetes Care 28:761-762, 2005
© 2005 by the American Diabetes Association, Inc.

Letters: Comments and Responses

The Burden of Treatment Failure in Type 2 Diabetes

Response to Brown et al.

Denise G. Simons-Morton, MD, PHD1, Saul Genuth, MD2, Robert P. Byington, PHD3, Hertzel C. Gerstein, MD, MSC4 and William T. Friedewald, MD5

1 Division of Epidemiology and Clinical Applications, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland
2 Division of Clinical and Molecular Endocrinology, Case Western Reserve University, Cleveland, Ohio
3 Department of Public Health Sciences, Wake-Forest University, Winston Salem, North Carolina
4 Department of Medicine, McMaster University, Hamilton, Ontario, Canada
5 Departments of Biostatistics and Epidemiology, Mailman School of Public Health, Columbia University, New York, New York

Address correspondence to Denise G. Simons-Morton, MD, PhD, National Institutes of Health, National Heart, Lung, and Blood Institute, Division of Epidemiology and Clinical Applications, 6701 Rockledge Dr., MSC 7936, Room 8130, Bethesda, MD 20892-7936. E-mail: simonsd{at}nhlbi.nih.gov

In the July 2004 issue of Diabetes Care, Brown et al. (1) conclude by stating, "our results strongly suggest that the recommended [HbA1c] threshold for [treatment] action should be 7.0% or lower" and "an even stronger signal would be provided by a treatment threshold of 6.0%, which has proved widely achievable in the test phase of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study."

We would like to point out that the ACCORD Vanguard ("test phase") results have not been published or presented and are not available in the citation given. (Brown et al. referenced a URL [http://apps.nhlbi.nih.gov/clinicaltrials/background.asp] that cannot be directly reached but can be accessed via http://apps.nhlbi.nih.gov/clinicaltrials/, selecting "Diabetes Mellitus," clicking on "submit," clicking on the ACCORD trial, and then clicking on "background.") More importantly, however, Brown et al. fail to acknowledge that treatment targeting HbA1c <6.0% (or, in the authors’ words, a "treatment threshold of 6.0%") has not been proven to improve health outcomes, either microvascular or macrovascular. Not only is such a treatment strategy extremely difficult, but there are potential adverse consequences, such as hypoglycemia and drug-specific side effects. There is currently no sound basis to recommend such targets in clinical practice.

The ACCORD trial is designed to determine whether a therapeutic strategy that targets HbA1c <6.0% reduces cardiovascular disease events in type 2 diabetes. Microvascular events are a secondary outcome. Results from ACCORD and other pending studies are needed to inform clinical practice on this issue.

Footnotes

H.C.G. has received a research grant from Aventis.

References

  1. Brown JB, Nichols GA, Perry A: The burden of treatment failure in type 2 diabetes. Diabetes Care 27:1535–1540, 2004[Abstract/Free Full Text]

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