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Intensive vs Standard Blood Pressure Control and Cardiovascular Disease Outcomes in Adults Aged ≥75 Years: A Randomized Clinical Trial.
JAMA. 2016 Jun 28; 315(24):2673-82.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.

Links

PMC Free PDF

Authors+Show Affiliations

Williamson JD
Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Department of Internal Medicine, Winston-Salem, North Carolina.
Supiano MA
Division of Geriatrics, School of Medicine, University of Utah, Salt Lake City3Veterans Affairs Salt Lake City, Geriatric Research, Education, and Clinical Center, Salt Lake City, Utah.
Applegate WB
Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Department of Internal Medicine, Winston-Salem, North Carolina.
Berlowitz DR
Bedford Veterans Affairs Hospital, Bedford, Massachusetts5School of Public Health, Boston University, Boston, Massachusetts.
Campbell RC
Department of Medicine, Medical University of South Carolina, Charleston.
Chertow GM
Department of Medicine, Stanford University School of Medicine, Palo Alto, California.
Fine LJ
Clinical Applications and Prevention Branch, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland.
Haley WE
Department of Nephrology and Hypertension, Mayo Clinic, Jacksonville, Florida.
Hawfield AT
Section on Nephrology, Wake Forest School of Medicine, Winston-Salem, North Carolina.
Ix JH
Division of Nephrology and Hypertension, Department of Medicine, University of California, San Diego12Division of Preventive Medicine, Department of Family Medicine and Public Health, University of California, San Diego13Department of Medicine, Nephrology.
Kitzman DW
Section on Cardiovascular Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.
Kostis JB
Cardiovascular Institute at Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey.
Krousel-Wood MA
Department of Medicine, Tulane University School of Medicine, New Orleans, Louisiana17Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana18Center for Applied Health Research, Ochsner Clinic F.
Launer LJ
Intramural Research Program, National Institute on Aging, Bethesda, Maryland.
Oparil S
Division of Cardiovascular Disease, Department of Medicine, University of Alabama, Birmingham.
Rodriguez CJ
Division of Public Health Sciences, Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, North Carolina.
Roumie CL
Veterans Health Administration-Tennessee Valley Healthcare System Geriatric Research Education Clinical Center, HSR&D Center, Nashville23Department of Medicine, Vanderbilt University, Nashville, Tennessee.
Shorr RI
Department of Epidemiology, University of Florida, Gainesville25Geriatric Research, Education, and Clinical Center, Malcom Randall Veterans Administration Medical Center, Gainesville, Florida.
Sink KM
Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Department of Internal Medicine, Winston-Salem, North Carolina.
Wadley VG
Department of Medicine, University of Alabama, Birmingham.
Whelton PK
Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.
Whittle J
Department of Medicine, Medical College of Wisconsin, Milwaukee29Primary Care Division, Clement J. Zablocki Veterans Affairs Medical Center, Milwaukee, Wisconsin.
Woolard NF
Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Department of Internal Medicine, Winston-Salem, North Carolina.
Wright JT
Division of Nephrology and Hypertension, Department of Medicine, Case Western Reserve University, Cleveland, Ohio.
Pajewski NM
Division of Public Health Sciences, Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.
SPRINT Research Group
No affiliation info available

MeSH

Acute Coronary SyndromeAgedAged, 80 and overAntihypertensive AgentsBlood PressureBlood Pressure DeterminationCause of DeathFemaleHeart FailureHumansHypertensionMaleMyocardial Infarction

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

27195814

Clinical Trial Links

Clinical trial which this article describes

Citation

Williamson, Jeff D., et al. "Intensive Vs Standard Blood Pressure Control and Cardiovascular Disease Outcomes in Adults Aged ≥75 Years: a Randomized Clinical Trial." JAMA, vol. 315, no. 24, 2016, pp. 2673-82.
Williamson JD, Supiano MA, Applegate WB, et al. Intensive vs Standard Blood Pressure Control and Cardiovascular Disease Outcomes in Adults Aged ≥75 Years: A Randomized Clinical Trial. JAMA. 2016;315(24):2673-82.
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., ... Pajewski, N. M. (2016). Intensive vs Standard Blood Pressure Control and Cardiovascular Disease Outcomes in Adults Aged ≥75 Years: A Randomized Clinical Trial. JAMA, 315(24), 2673-82. https://doi.org/10.1001/jama.2016.7050
Williamson JD, et al. Intensive Vs Standard Blood Pressure Control and Cardiovascular Disease Outcomes in Adults Aged ≥75 Years: a Randomized Clinical Trial. JAMA. 2016 Jun 28;315(24):2673-82. PubMed PMID: 27195814.
* Article titles in AMA citation format should be in sentence-case
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,Dalane W, AU - Kostis,John B, AU - Krousel-Wood,Marie A, AU - Launer,Lenore J, AU - Oparil,Suzanne, AU - Rodriguez,Carlos J, AU - Roumie,Christianne L, AU - Shorr,Ronald I, AU - Sink,Kaycee M, AU - Wadley,Virginia G, AU - Whelton,Paul K, AU - Whittle,Jeffrey, AU - Woolard,Nancy F, AU - Wright,Jackson T,Jr AU - Pajewski,Nicholas M, AU - ,, PY - 2016/5/20/entrez PY - 2016/5/20/pubmed PY - 2016/7/14/medline SP - 2673 EP - 82 JF - JAMA JO - JAMA VL - 315 IS - 24 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 (<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. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/27195814/Intensive_vs_Standard_Blood_Pressure_Control_and_Cardiovascular_Disease_Outcomes_in_Adults_Aged_≥75_Years:_A_Randomized_Clinical_Trial_ DB - PRIME DP - Unbound Medicine ER -