Blood Pressure Control and the Association With Diabetes Mellitus Incidence Results From SPRINT Randomized Trial

• Type of Material: Article
• Authors: Christianne L. Roumie, VA Tennessee Valley Healthcare System; Adriana M. Hung, VA Tennessee Valley Healthcare System; Gregory B. Russell, Wake Forest University; Jan Basile, Ralph H Johnson VA Medical Center; Kathryn E. Kreider, Duke University; John Nord, Salt Lake City VA Medical Center; Thomas M. Ramsey, University of Alabama Birmingham; Anjay Rastogi, University of California Los Angeles; Mary Sweeney, Emory University; Leonardo Tamariz, University of Miami; William J. Kostis, Rutgers State University; Jonathan Williams, VA Boston Healthcare System; Athena Zias, Northport Veteran Affairs Medical Center; William C. Cushman, Memphis Veteran Affairs Medical Center
• Language: English
• Date: 2020-02-01
• Publisher: Lippincot Williams & Wilkins
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2019 American Heart Association, Inc.
• Final Published Version (URL): http://dx.doi.org/10.1161/HYPERTENSIONAHA.118.12572
• Title of Journal or Parent Work: Hypertension
• Volume: 75
• Issue: 2
• Start Page: 331
• End Page: 338
• Grant/Funding Information: University of Utah: UL1TR000105-05, Vanderbilt University: UL1 TR000445, George Washington University: UL1TR000075, University of CA, Davis: UL1 TR000002,; University of Florida: UL1 TR000064, University of Michigan: UL1TR000433, Tulane University: P30GM103337 COBRE Award NIGMS, Wake Forest University: UL1TR001420.; The Systolic Blood Pressure Intervention Trial is funded with Federal funds from the National Institutes of Health (NIH), including the National Heart, Lung, and Blood Institute (NHLBI); Boston: UL1RR025771, Stanford: UL1TR000093, Tufts: UL1RR025752, UL1TR000073 UL1TR001064, University of Illinois: UL1TR000050, University of Pittsburgh: UL1TR000005, UT Southwestern: 9U54TR000017-06,; We also acknowledge the support from the following CTSAs funded by NCATS: CWRU: UL1TR000439, OSU: UL1RR025755, U Penn: UL1RR024134& UL1TR000003,; It was also supported in part with resources and use of facilities through the Department of Veterans Affairs.; he SPRINT investigators acknowledge the contribution of study medications (azilsartan and azilsartan combined with chlorthalidone) from Takeda Pharmaceuticals International, Inc.; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute on Aging (NIA), and the National Institute of Neurological Disorders and Stroke (NINDS), under Contract Numbers HHSN268200900040C, HHSN268200900046C, HHSN268200900047C, HHSN268200900048C, HHSN268200900049C, and Inter-Agency Agreement Number A-HL-13-002-001.
• Keywords: Cardiovascular System & Cardiology; United States; Blockers; Risk; Veterans; Therapy; Life Sciences & Biomedicine; Chronic kidney disease; Insulin resistance; glucose; Peripheral Vascular Disease; random allocation; diabetes mellitus; Health; Hypertensive patients; blood pressure; Metaanalysis; Science & Technology; cardiovascular diseases
• Research Categories: Biology, Biostatistics; Health Sciences, Public Health; Health Sciences, Health Care Management; Biology, Bioinformatics

Abstract

The SPRINT (Systolic Blood Pressure Intervention Trial) demonstrated reduced cardiovascular outcomes. We evaluated diabetes mellitus incidence in this randomized trial that compared intensive blood pressure strategy (systolic blood pressure <120 mm Hg) versus standard strategy (<140 mm Hg). Participants were ≥50 years of age, with systolic 130 to 180 mm Hg and increased cardiovascular risk. Participants were excluded if they had diabetes mellitus, polycystic kidney disease, proteinuria >1 g/d, heart failure, dementia, or stroke. Postrandomization exclusions included participants missing blood glucose or ≥126 mg/dL (6.99 mmol/L) or on hypoglycemics. The outcome was incident diabetes mellitus: fasting blood glucose ≥126 mg/dL (6.99 mmol/L), diabetes mellitus self-report, or new use of hypoglycemics. The secondary outcome was impaired fasting glucose (100-125 mg/dL [5.55-6.94 mmol/L]) among those with normoglycemia (<100 mg/dL [5.55 mmol/L]). There were 9361 participants randomized and 981 excluded, yielding 4187 and 4193 participants assigned to intensive and standard strategies. There were 299 incident diabetes mellitus events (2.3% per year) for intensive and 251 events (1.9% per year) for standard, rates of 22.6 (20.2-25.3) versus 19.0 (16.8-21.5) events per 1000 person-years of treatment, respectively (adjusted hazard ratio, 1.19 [95% CI, 0.95-1.49]). Impaired fasting glucose rates were 26.4 (24.9-28.0) and 22.5 (21.1-24.1) per 100 person-years for intensive and standard strategies (adjusted hazard ratio, 1.17 [1.06-1.30]). Intensive treatment strategy was not associated with increased diabetes mellitus but was associated with more impaired fasting glucose. The risks and benefits of intensive blood pressure targets should be factored into individualized patient treatment goals. Clinical Trial Registration - URL: http://www.clinicaltrials.gov. Unique identifier: NCT01206062.