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Correspondence

Intensive Diabetes Treatment and Cardiovascular Disease

N Engl J Med 2006; 354:1751-1752April 20, 2006

Article

To the Editor:

The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study research group (Dec. 22 issue)1 reports that intensive therapy for diabetes reduced the risk of cardiovascular events by 42 percent without any mention of the adverse events associated with such therapy. The article from the DCCT research group2 published in the Journal in 1993 reported the incidence of severe hypoglycemia to be 62 episodes per 100 patient-years in the intensive-therapy group, as compared with 19 such episodes per 100 patient-years in the conventional-therapy group. The cardiovascular-event rates were 0.80 per 100 patient-years and 0.38 per 100 patient-years, respectively. The reported hypoglycemic episodes were not trivial, since approximately 25 percent resulted in coma or seizure, and it was speculated that one resulted in two fatalities from a motor vehicle accident. Although the DCCT/EDIC study showed a significant beneficial effect on the cardiovascular complications of diabetes, the magnitude of this benefit needs to be considered in light of the risk of hypoglycemia.

Andrew J. Weissman, M.D.
Lenox Hill Hospital, New York, NY 10021

2 References
  1. 1

    The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type I diabetes. N Engl J Med 2005;353:2643-2653
    Full Text | Web of Science | Medline

  2. 2

    The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977-986
    Full Text | Web of Science | Medline

To the Editor:

In the editorial accompanying the DCCT/EDIC study,1 Dr. Cefalu details the continuing accumulation of evidence in favor of tight glycemic control. However, no evidence will be of any benefit if the resultant recommendations cannot be implemented. Sadly, that is exactly the case. Now, more than 12 years after the publication of the initial results of the DCCT study, reimbursement for the care of children with type 1 diabetes has only deteriorated. Until payers accept some other way to compensate for care provided outside the face-to-face office visit, the only providers capable of giving adequate care will be those subsidized by their grants or institutions, such as the providers at the study sites in the DCCT trial.

Peter S. Ross, M.D.
Inova Hospital System, Fairfax, VA 22031

1 References
  1. 1

    Cefalu WT. Glycemic control and cardiovascular disease -- should we reassess clinical goals? N Engl J Med 2005;353:2707-2709
    Full Text | Web of Science | Medline

Author/Editor Response

Dr. Weissman suggests that the 42 percent reduction in cardiovascular disease we observed in the original DCCT intensive-therapy group, as compared with the conventional-treatment group, should be reconsidered in light of the heightened risk of severe hypoglycemia accompanying intensive therapy. The risk of hypoglycemia was three times as high in the intensive-therapy group as in the conventional-therapy group (16 vs. 5 episodes of seizure or transient coma per 100 patient-years); nevertheless, intensive therapy has been adopted internationally as the standard of care for type 1 diabetes since 1993.1 The rationale for intensive therapy was not predicated on a reduction in cardiovascular disease but on the major reduction in retinopathy, nephropathy, and neuropathy as demonstrated during the mean DCCT follow-up of 6.5 years. The salutary effects of intensive therapy have been projected to add, on average, 5.6 to 7.7 years in which patients are free from blindness, renal failure, and amputations and to increase life span by 5 years,2 even before its very welcome additional beneficial effects on cardiovascular disease are taken into account. Thus, the risk–benefit ratio of intensive therapy has become even more favorable.

David M. Nathan, M.D.
Massachusetts General Hospital, Boston, MA 02114

Saul Genuth, M.D.
Case Western Reserve University, Cleveland, OH 44106

John Lachin, D.Sc.
George Washington University, Rockville, MD 20852

2 References
  1. 1

    American Diabetes Association. Implications of the Diabetes Control and Complications Trial. Diabetes Care 2003;26:Suppl 1:S25-S27
    CrossRef | Medline

  2. 2

    The Diabetes Control and Complications Trial Research Group. Lifetime benefits and costs of intensive therapy as practiced in the Diabetes Control and Complications Trial. JAMA 1996;276:1409-1415[Erratum, JAMA 1997;278:25.]
    CrossRef | Web of Science

Author/Editor Response

In response to my editorial, Dr. Ross writes that “no evidence will be of any benefit if the resultant recommendations cannot be implemented.” Specifically, he is referring to the reimbursement for the care of children with type 1 diabetes. I commented in the editorial that the medical community will need a different mind-set in order to maintain and improve glycemic control in persons with diabetes. I think that Dr. Ross has noted a major limitation and hurdle in our medical system pertaining to the care not only of persons with type 1 diabetes but also of people with chronic diseases in general. Management of type 1 diabetes is very labor-intensive and requires substantial time from numerous health care providers, including physicians, educators, and nutritionists. Unfortunately, providers who do spend the considerable time required to address all the needs of the patient with a complicated disorder are not adequately compensated. Fair reimbursement for time spent educating and caring for patients not only makes sense but also is a policy that should have been in place years ago.

William T. Cefalu, M.D.
Pennington Biomedical Research Center, Baton Rouge, LA 70808

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