Effect of intensive compared with standard glycemia treatment strategies on mortality by baseline subgroup characteristics: The ACCORD trial
- Jorge Calles-Escandón, MD (jcalles{at}wfubmc.edu)1,
- Laura C. Lovato, MS2,
- Denise G. Simons-Morton, MD, PhD3,
- David M. Kendall, MD4,
- Rodica Pop-Busui, MD5,
- Robert M. Cohen, MD, PhD6,
- Denise E. Bonds, MD3,
- Vivian Fonseca, MD7,
- Faramarz Ismail-Beigi, MD8,
- Mary Ann Banerji, MD9,
- Alan Failor, MD10 and
- Bruce Hamilton, MD11
- 1 Wake Forest University Health Sciences, Department of Internal Medicine, Winston-Salem, NC
- 2 Wake Forest University Health Sciences, Department of Biostatistical Sciences, Winston-Salem, NC
- 3 National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD
- 4 International Diabetes Center, Minneapolis, Minnesota
- 5 University of Michigan Medical School, Department of Endocrinology, Metabolism and Nutrition, Ann Arbor, Michigan
- 6 University of Cincinnati Medical Center, Division of Endocrinology, Diabetes & Metabolism, Cincinnati, Oh
- 7 Tulane University Medical Center, Section of Endocrinology, New Orleans, LA
- 8 University of Cleveland, VA Medical Center, Section of Endocrinology, Cleveland, OH
- 9 State University New York, Downstate Medical Center, Section of Endocrinology, NY, NY
- 10 University of Washington, Division of Endocrinology, Nutrition and metabolism, Seattle, WA
- 11 VA Medical Center and University of Maryland School of Medicine, Baltimore, Md
Abstract
Objective: To determine if baseline subgroups in the ACCORD trial can be identified for whom intensive compared with standard glycemia treatment had different effects on all-cause mortality.
Research Design and Methods: Exploratory post-hoc intention-to-treat comparisons between intensive and standard glycemia groups on all-cause mortality by subgroups defined by baseline characteristics.
Results: There were few significant interactions between baseline characteristics and effects of intensive vs standard glycemia treatment on mortality: self-reported history of neuropathy (HR=1.95, 95% CI 1.41-2.69 versus no history of neuropathy (HR 0.99, 95% CI 0.79 – 1.26; p-value for interaction 0.0008), higher A1c (A1c > 8.5%: HR=1.64, 95% CI 1.22-2.22; A1c 7.5-8.4%, HR=1.00, 95% CI 0.75-1.34; A1c < 7.5%: HR=1.00, 95% CI 0.67-1.50; p-value for interaction 0.04), and aspirin use (HR = 1.45, 95% CI: 1.13–1.85, compared to HR=0.96 (0.72-1.27) in non-users; p-value for interaction 0.03).
Conclusions: We found a remarkable similarity of effect from intensive compared with standard glycemia treatment on mortality across most baseline subgroups. No differential effect was found in subgroups defined by variables anticipated to have an interaction: age, duration of diabetes, previous history of cardiovascular disease. The 3 baseline characteristics that defined subgroups for which there was a differential effect on mortality may help identify patients with type 2 diabetes at higher risk of mortality from very intensive regimens for glycemia control. Further research is warranted.
Footnotes
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- Received August 11, 2009.
- Accepted January 12, 2010.
- Copyright © American Diabetes Association
