Cited by 1,261Blood Pressure and Hypertension StudiesCardiovascular Health and Disease PreventionSodium Intake and Health

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

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Williamson, Jeff D., Supiano, Mark A., Applegate, William B., Berlowitz, Dan R., Campbell, Ruth C., Chertow, Glenn M., Fine, Larry J., Haley, William E. +18 more·2016·JAMA

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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  • The SPRINT trial was stopped early because intensive blood pressure treatment produced significantly fewer cardiovascular events and deaths than standard treatment.

    “The US and Puerto Rico Systolic Blood Pressure Intervention Trial (SPRINT) in 9361 hypertensive adults aged 50 years and older, was stopped early because of significantly fewer cardiovascular events and deaths occurring in the intensive treatment arm (aiming for systolic <120 mm Hg, n=4678) in comparison with standard treatment (systolic <140 mm Hg, n=4683).”

    From Dementia prevention, intervention, and care: 2020 report of the Lancet Commission (2020) · cites this paper as [78]

    The Methods (Statistical Analysis) say the SPRINT intervention was stopped on August 20, 2015, and the Results (Clinical Outcomes) report significantly fewer cardiovascular composite events and deaths with intensive treatment. But this paper reports those outcomes for 2,636 participants aged 75 or older, not the cited sentence’s full trial of 9,361 adults aged 50 or older, and it does not explicitly say the outcome differences were the reason for stopping. (LLM, conf=0.85)

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Authors
Williamson, J. D., Supiano, M. A., Applegate, W. B., Berlowitz, D. R., Campbell, R. C., Chertow, G. M., Fine, L. J., Haley, W. E., Hawfield, A. T., Ix, J. H., Kitzman, D. W., Kostis, J. B., Krousel-Wood, M. A., Launer, L. J., Oparil, S., Rodriguez, C. J., Roumie, C. L., Shorr, R. I., Sink, K. M., Wadley, V. G., Whelton, P. K., Whittle, J., Woolard, N. F., Wright, J. T., Pajewski, N. M., & for the SPRINT Research Group
Affiliations
  • Wake Forest University (US)
  • University of Utah (US)
  • Boston University (US)
  • Medical University of South Carolina (US)
  • Stanford Medicine (US)
  • National Heart, Lung, and Blood Institute (US)
  • Mayo Clinic in Florida (US)
  • Wake Forest University Health Sciences (US)
  • University of California San Diego (US)
  • Rutgers, The State University of New Jersey (US)
  • Tulane University (US)
  • National Institutes of Health (US)
  • University of Alabama (US)
  • Division of Public Health Sciences, Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, North Carolina
  • Vanderbilt University (US)
  • University of Florida (US)
  • University of Alabama at Birmingham (US)
  • Department of Medicine, Medical College of Wisconsin, Milwaukee29Primary Care Division, Clement J. Zablocki Veterans Affairs Medical Center, Milwaukee, Wisconsin
  • Case Western Reserve University (US)
Corresponding author
Williamson, Jeff D.
Venue
JAMA
Published
2016-06-28
Volume
315
Issue
24
Pages
2673
ISSN
  • 0002-9955 (ISSN-L)
  • 0098-7484
OpenAlex
W2402203869
Cited by
1,261
References
40
Citations by year
2026: 62 · 2025: 93 · 2024: 101 · 2023: 106 · 2022: 112 · 2021: 112 · 2020: 122 · 2019: 155 · 2018: 150 · 2017: 187 · 2016: 59
FWCI
150.31
Type
journal article
Language
en
Open access
Locations
  • JAMA (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • U.S. Department of Veterans Affairs
  • National Institutes of Health (UL1TR000093, UL1TR000050, UL1TR001427, UL1TR000073, UL1TR001064, UL1TR001085, UL1TR000002, UL1TR001070, UL1TR000075, UL1TR000064, UL1TR000005, UL1TR000433, UL1TR000003, UL1TR000445, UL1TR000439, UL1TR000105)
  • U.S. Public Health Service (HHSN268200900040C, HHSN268200900049C, HHSN268200900046C, HHSN268200900047C, HHSN268200900048C)
  • National Institute on Aging (P30AG021332)
  • National Heart, Lung, and Blood Institute (R01HL107257, HHSN268200900040C, A-HL-13-002-001, HHSN268200900049C, R01HL107241, HHSN268200900048C, HHSN268200900047C, R01HL130500, 01-HL10741, HHSN268200900046C)
  • National Institute of General Medical Sciences (P30GM103337)
  • National Center for Research Resources (UL1RR025755, UL1RR024134, UL1RR025752, UL1RR025771)
  • National Center for Advancing Translational Sciences (9U54TR000017‐06)
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Health and Disease Prevention
  • Health Sciences › Nursing › Nutrition and Dietetics › Sodium Intake and Health
Keywords
intensive blood pressure control, systolic blood pressure target, hypertension, older adults, cardiovascular outcomes, all-cause mortality, acute coronary syndrome, stroke, heart failure, hypotension, SPRINT trial, antihypertensive therapy, serious adverse events, cardiovascular risk reduction, antihypertensive drugs, anticoagulation, antithrombotic therapy, antihypertensive drug discontinuation, antihypertensive drug switching
MeSH terms
Aged, Aged, 80 and over, Antihypertensive Agents, Blood Pressure, Blood Pressure Determination, Cause of Death, Female, Heart Failure, Humans, Hypertension, Male, Myocardial Infarction, Acute Coronary Syndrome

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