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    Original Investigation
    June 28, 2016

    Intensive vs Standard Blood Pressure Control and Cardiovascular Disease Outcomes in Adults Aged ≥75 Years: A Randomized Clinical Trial

    Author Affiliations
    • 1Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Department of Internal Medicine, Winston-Salem, North Carolina
    • 2Division of Geriatrics, School of Medicine, University of Utah, Salt Lake City
    • 3Veterans Affairs Salt Lake City, Geriatric Research, Education, and Clinical Center, Salt Lake City, Utah
    • 4Bedford Veterans Affairs Hospital, Bedford, Massachusetts
    • 5School of Public Health, Boston University, Boston, Massachusetts
    • 6Department of Medicine, Medical University of South Carolina, Charleston
    • 7Department of Medicine, Stanford University School of Medicine, Palo Alto, California
    • 8Clinical Applications and Prevention Branch, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland
    • 9Department of Nephrology and Hypertension, Mayo Clinic, Jacksonville, Florida
    • 10Section on Nephrology, Wake Forest School of Medicine, Winston-Salem, North Carolina
    • 11Division of Nephrology and Hypertension, Department of Medicine, University of California, San Diego
    • 12Division of Preventive Medicine, Department of Family Medicine and Public Health, University of California, San Diego
    • 13Department of Medicine, Nephrology Section, Veterans Affairs San Diego Healthcare System, San Diego, California
    • 14Section on Cardiovascular Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina
    • 15Cardiovascular Institute at Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey
    • 16Department of Medicine, Tulane University School of Medicine, New Orleans, Louisiana
    • 17Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana
    • 18Center for Applied Health Research, Ochsner Clinic Foundation, New Orleans, Louisiana
    • 19Intramural Research Program, National Institute on Aging, Bethesda, Maryland
    • 20Division of Cardiovascular Disease, Department of Medicine, University of Alabama, Birmingham
    • 21Division of Public Health Sciences, Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, North Carolina
    • 22Veterans Health Administration-Tennessee Valley Healthcare System Geriatric Research Education Clinical Center, HSR&D Center, Nashville
    • 23Department of Medicine, Vanderbilt University, Nashville, Tennessee
    • 24Department of Epidemiology, University of Florida, Gainesville
    • 25Geriatric Research, Education, and Clinical Center, Malcom Randall Veterans Administration Medical Center, Gainesville, Florida
    • 26Department of Medicine, University of Alabama, Birmingham
    • 27Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana
    • 28Department of Medicine, Medical College of Wisconsin, Milwaukee
    • 29Primary Care Division, Clement J. Zablocki Veterans Affairs Medical Center, Milwaukee, Wisconsin
    • 30Division of Nephrology and Hypertension, Department of Medicine, Case Western Reserve University, Cleveland, Ohio
    • 31Division of Public Health Sciences, Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina
    JAMA. 2016;315(24):2673-2682. doi:10.1001/jama.2016.7050
    Abstract

    Importance  The appropriate treatment target for systolic blood pressure (SBP) in older patients with hypertension remains uncertain.

    Objective  To evaluate the effects of intensive (<120 mm Hg) compared with standard (<140 mm Hg) SBP targets in persons aged 75 years or older with hypertension but without diabetes.

    Design, Setting, and Participants  A multicenter, randomized clinical trial of patients aged 75 years or older who participated in the Systolic Blood Pressure Intervention Trial (SPRINT). Recruitment began on October 20, 2010, and follow-up ended on August 20, 2015.

    Interventions  Participants were randomized to an SBP target of less than 120 mm Hg (intensive treatment group, n = 1317) or an SBP target of less than 140 mm Hg (standard treatment group, n = 1319).

    Main Outcomes and Measures  The primary cardiovascular disease outcome was a composite of nonfatal myocardial infarction, acute coronary syndrome not resulting in a myocardial infarction, nonfatal stroke, nonfatal acute decompensated heart failure, and death from cardiovascular causes. All-cause mortality was a secondary outcome.

    Results  Among 2636 participants (mean age, 79.9 years; 37.9% women), 2510 (95.2%) provided complete follow-up data. At a median follow-up of 3.14 years, there was a significantly lower rate of the primary composite outcome (102 events in the intensive treatment group vs 148 events in the standard treatment group; hazard ratio [HR], 0.66 [95% CI, 0.51-0.85]) and all-cause mortality (73 deaths vs 107 deaths, respectively; HR, 0.67 [95% CI, 0.49-0.91]). The overall rate of serious adverse events was not different between treatment groups (48.4% in the intensive treatment group vs 48.3% in the standard treatment group; HR, 0.99 [95% CI, 0.89-1.11]). Absolute rates of hypotension were 2.4% in the intensive treatment group vs 1.4% in the standard treatment group (HR, 1.71 [95% CI, 0.97-3.09]), 3.0% vs 2.4%, respectively, for syncope (HR, 1.23 [95% CI, 0.76-2.00]), 4.0% vs 2.7% for electrolyte abnormalities (HR, 1.51 [95% CI, 0.99-2.33]), 5.5% vs 4.0% for acute kidney injury (HR, 1.41 [95% CI, 0.98-2.04]), and 4.9% vs 5.5% for injurious falls (HR, 0.91 [95% CI, 0.65-1.29]).

    Conclusions and Relevance  Among ambulatory adults aged 75 years or older, treating to an SBP target of less than 120 mm Hg compared with an SBP target of less than 140 mm Hg resulted in significantly lower rates of fatal and nonfatal major cardiovascular events and death from any cause.

    Trial Registration  clinicaltrials.gov Identifier: NCT01206062

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