Author + information
- Received May 12, 2018
- Revision received June 25, 2018
- Accepted July 2, 2018
- Published online September 3, 2018.
- Seth A. Berkowitz, MD, MPHa,b,∗ (, )@UNC_SOM@Stanford,
- Jeremy B. Sussman, MD, MSc,d,
- Daniel E. Jonas, MD, MPHa,b and
- Sanjay Basu, MD, PhDe,f
- aDivision of General Medicine and Clinical Epidemiology, Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina
- bCecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
- cDivision of General Medicine, University of Michigan, Ann Arbor, Michigan
- dCenter for Clinical Management Research, Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan
- eCenter for Primary Care and Outcomes Research, Center for Population Health Sciences, Departments of Medicine and of Health Research and Policy, Stanford University, Palo Alto, California
- fCenter for Primary Care, Harvard Medical School, Boston, Massachusetts
- ↵∗Address for correspondence:
Dr. Seth A. Berkowitz, Division of General Medicine and Clinical Epidemiology, University of North Carolina School of Medicine, 5034 Old Clinic Building, CB 7110, Chapel Hill, North Carolina 27599.
Background Controversy over blood pressure (BP) treatment targets for individuals with diabetes is in part due to conflicting perspectives about generalizability of available trial data.
Objective The authors sought to estimate how results from the largest clinical trial of intensive BP treatment among adults with diabetes would generalize to the U.S. population.
Methods The authors used transportability methods to reweight individual patient data from the ACCORD (Action to Control Cardiovascular Risk in Diabetes) BP trial (N = 4,507) of intensive (goal systolic BP <120 mm Hg) versus standard (goal systolic BP <140 mm Hg) treatment to better represent the demographic and clinical risk factors of the U.S. population of adults with diabetes (data from NHANES [National Health and Nutrition Examination Survey] 2005 to 2014, n = 1,943). The primary outcome was the first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Analysis used weighted Cox proportional hazards regression models with robust standard errors.
Results The ACCORD BP sample had less racial/ethnic diversity and more elevated cardiovascular risk factors than the NHANES participants. Weighted results significantly favored intensive BP treatment, unlike unweighted results (hazard ratio for primary outcome in intensive versus standard treatment in weighted analyses: 0.67, 95% confidence interval: 0.49 to 0.91; in unweighted analyses: hazard ratio: 0.88, 95% confidence interval: 0.73 to 1.07). Over 5 years, the weighted results estimate a number needed to treat of 34, and number needed to harm of 55.
Conclusions After reweighting to better reflect the U.S. adult population with diabetes, intensive BP therapy was associated with significantly lower risk for cardiovascular events. However, data were limited among racial/ethnic minorities and those with lower cardiovascular risk.
Research reported in this publication was supported by the National Institute for Diabetes and Digestive and Kidney Disease of the National Institutes of Health, and the National Institute on Minority Health and Health Disparities of the National Institutes of Health under Award Numbers K23DK109200 (Dr. Berkowitz), K08HL121056 (Dr. Basu), DP2MD010478 (Dr. Basu), and U54MD010724 (Dr. Basu). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. This paper was prepared using ACCORD research materials obtained from the NHLBI Biologic Specimen and Data Repository Information Coordinating Center and does not necessarily reflect the opinion or views of the ACCORD trial or the NHLBI. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received May 12, 2018.
- Revision received June 25, 2018.
- Accepted July 2, 2018.
- 2018 American College of Cardiology Foundation
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