TY - JOUR
T1 - Intensive vs standard blood pressure control and cardiovascular disease outcomes in adults aged ≥75 years a randomized clinical trial
AU - Williamson, Jeff D.
AU - Supiano, Mark A.
AU - Applegate, William B.
AU - Berlowitz, Dan R.
AU - Campbell, Ruth C.
AU - Chertow, Glenn M.
AU - Fine, Larry J.
AU - Haley, William E.
AU - Hawfield, Amret T.
AU - Ix, Joachim H.
AU - Kitzman, Dalanew
AU - Kostis, John B.
AU - Marie, A. Krousel Wood
AU - Launer, Lenore J.
AU - Oparil, Suzanne
AU - Rodriguez, Carlos J.
AU - Roumie, Christianne L.
AU - Shorr, Ronald I.
AU - Sink, Kaycee M.
AU - Gwadley, Virginia
AU - Whelton, Paul K.
AU - Whittle, Jeffrey
AU - Wright, Jackson T.
AU - Pajewski, Nicholas M.
N1 - Funding Information:
The SPRINT study was funded by the National Institutes of Health (including the National Heart, Lung, and Blood Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute on Aging, and the National Institute of Neurological Disorders and Stroke) under contracts HHSN268200900040C,HHSN268200900046C, HHSN268200900047C,HHSN268200900048C, and HHSN268200900049C and interagency agreement A-HL-13-002-001. It was also supported in part with resources and use of facilities through the Department of Veterans Affairs. Azilsartan and chlorthalidone (combined with azilsartan) were provided by Takeda Pharmaceuticals International Inc. Additional support was provided by grants P30-AG21332 and R01-HL10741 from the Wake Forest Claude Pepper Older Americans Independence Center; through the following National Center for Advancing Translational Sciences clinical and translational science awards: UL1TR000439 (awarded to Case Western Reserve University); UL1RR025755 (Ohio State University); UL1RR024134 and UL1TR000003 (University of Pennsylvania); UL1RR025771 (Boston University); UL1TR000093 (Stanford University); UL1RR025752, UL1TR000073, and UL1TR001064 (Tufts University); UL1TR000050 (University of Illinois); UL1TR000005 (University of Pittsburgh); 9U54TR000017-06 (University of Texas Southwestern Medical Center); UL1TR000105-05 (University of Utah); UL1TR000445 (Vanderbilt University); UL1TR000075 (GeorgeWashington University); UL1TR000002 (University of California, Davis); UL1TR000064 (University of Florida); and UL1TR000433 (University of Michigan); and by National Institute of General Medical Sciences, Centers of Biomedical Research Excellence award NIGMS P30GM103337 (awarded to Tulane University).
Publisher Copyright:
Copyright 2016 American Medical Association. All rights reserved.
PY - 2016/6/28
Y1 - 2016/6/28
N2 - IMPORTANCE The appropriate treatment target for systolic blood pressure (SBP) in older patients with hypertension remains uncertain. OBJECTIVE To evaluate the effects of intensive (<120mmHg) compared with standard (<140mmHg) 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 120mmHg (intensive treatment group, n = 1317) or an SBP target of less than 140mmHg (standard treatment group, n = 1319). MAIN OUTCOMES AND MEASURES The primary cardiovascular disease outcomewas a composite of nonfatalmyocardial 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 120mmHg compared with an SBP target of less than 140mmHg resulted in significantly lower rates of fatal and nonfatal major cardiovascular events and death from any cause.
AB - IMPORTANCE The appropriate treatment target for systolic blood pressure (SBP) in older patients with hypertension remains uncertain. OBJECTIVE To evaluate the effects of intensive (<120mmHg) compared with standard (<140mmHg) 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 120mmHg (intensive treatment group, n = 1317) or an SBP target of less than 140mmHg (standard treatment group, n = 1319). MAIN OUTCOMES AND MEASURES The primary cardiovascular disease outcomewas a composite of nonfatalmyocardial 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 120mmHg compared with an SBP target of less than 140mmHg resulted in significantly lower rates of fatal and nonfatal major cardiovascular events and death from any cause.
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U2 - 10.1001/jama.2016.7050
DO - 10.1001/jama.2016.7050
M3 - Article
C2 - 27195814
AN - SCOPUS:84976367394
SN - 0002-9955
VL - 315
SP - 2673
EP - 2682
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
IS - 24
ER -