Background Epidemiologic studies have shown a relationship betweenglycated hemoglobin levels and cardiovascular events in patientswith type 2 diabetes. We investigated whether intensive therapyto target normal glycated hemoglobin levels would reduce cardiovascularevents in patients with type 2 diabetes who had either establishedcardiovascular disease or additional cardiovascular risk factors.
Methods In this randomized study, 10,251 patients (mean age,62.2 years) with a median glycated hemoglobin level of 8.1%were assigned to receive intensive therapy (targeting a glycatedhemoglobin level below 6.0%) or standard therapy (targetinga level from 7.0 to 7.9%). Of these patients, 38% were women,and 35% had had a previous cardiovascular event. The primaryoutcome was a composite of nonfatal myocardial infarction, nonfatalstroke, or death from cardiovascular causes. The finding ofhigher mortality in the intensive-therapy group led to a discontinuationof intensive therapy after a mean of 3.5 years of follow-up.
Results At 1 year, stable median glycated hemoglobin levelsof 6.4% and 7.5% were achieved in the intensive-therapy groupand the standard-therapy group, respectively. During follow-up,the primary outcome occurred in 352 patients in the intensive-therapygroup, as compared with 371 in the standard-therapy group (hazardratio, 0.90; 95% confidence interval [CI], 0.78 to 1.04; P=0.16).At the same time, 257 patients in the intensive-therapy groupdied, as compared with 203 patients in the standard-therapygroup (hazard ratio, 1.22; 95% CI, 1.01 to 1.46; P=0.04). Hypoglycemiarequiring assistance and weight gain of more than 10 kg weremore frequent in the intensive-therapy group (P<0.001).
Conclusions As compared with standard therapy, the use of intensivetherapy to target normal glycated hemoglobin levels for 3.5years increased mortality and did not significantly reduce majorcardiovascular events. These findings identify a previouslyunrecognized harm of intensive glucose lowering in high-riskpatients with type 2 diabetes. (ClinicalTrials.gov number, NCT00000620
[ClinicalTrials.gov]
.)
Source Information
The members of the writing group (Hertzel C. Gerstein, M.D., M.Sc., McMaster University and Hamilton Health Sciences, Population Health Research Institute, Hamilton, ON, Canada; Michael E. Miller, Ph.D., Robert P. Byington, Ph.D., and David C. Goff, Jr., M.D., Ph.D., Wake Forest University School of Medicine, Winston-Salem, NC; J. Thomas Bigger, M.D., Columbia University College of Physicians and Surgeons, New York; John B. Buse, M.D., Ph.D., University of North Carolina School of Medicine, Chapel Hill; William C. Cushman, M.D., Memphis Veterans Affairs Medical Center, Memphis, TN; Saul Genuth, M.D., and Faramarz Ismail-Beigi, M.D., Ph.D., Case Western Reserve University, Cleveland; Richard H. Grimm, Jr., M.D., Ph.D., Berman Center for Outcomes and Clinical Research, Minneapolis; Jeffrey L. Probstfield, M.D., University of Washington, Seattle; Denise G. Simons-Morton, M.D., Ph.D., National Heart, Lung, and Blood Institute, Bethesda, MD; and William T. Friedewald, M.D., Columbia University Mailman School of Public Health, New York) assume responsibility for the overall content and integrity of this article. This article (10.1056/NEJMoa0802743) was published at www.nejm.org on June 6, 2008.
Address reprint requests to Dr. Byington at the Division of Public Health Sciences, Wake Forest University School of Medicine, Medical Center Blvd., Winston-Salem, NC 27157, or at bbyingto{at}wfubmc.edu.
Intensive Glucose Control in Type 2 Diabetes
Jenny-Avital E. R., Luan F. L., Nguyen K., Tobey T. A., Parashar A., Byington R. P., Gerstein H. C., Friedewald W. T., Patel A., MacMahon S., Chalmers J.
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N Engl J Med 2008;
359:1519-1521, Oct 2, 2008.
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