Jeff D Williamson1, Mark A Supiano2, William B Applegate1, Dan R Berlowitz3, Ruth C Campbell4, Glenn M Chertow5, Larry J Fine6, William E Haley7, Amret T Hawfield8, Joachim H Ix9, Dalane W Kitzman10, John B Kostis11, Marie A Krousel-Wood12, Lenore J Launer13, Suzanne Oparil14, Carlos J Rodriguez15, Christianne L Roumie16, Ronald I Shorr17, Kaycee M Sink1, Virginia G Wadley18, Paul K Whelton19, Jeffrey Whittle20, Nancy F Woolard1, Jackson T Wright21, Nicholas M Pajewski22. 1. Section on Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Department of Internal Medicine, Winston-Salem, North Carolina. 2. 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. 3. Bedford Veterans Affairs Hospital, Bedford, Massachusetts5School of Public Health, Boston University, Boston, Massachusetts. 4. Department of Medicine, Medical University of South Carolina, Charleston. 5. Department of Medicine, Stanford University School of Medicine, Palo Alto, California. 6. Clinical Applications and Prevention Branch, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland. 7. Department of Nephrology and Hypertension, Mayo Clinic, Jacksonville, Florida. 8. Section on Nephrology, Wake Forest School of Medicine, Winston-Salem, North Carolina. 9. 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. 10. Section on Cardiovascular Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina. 11. Cardiovascular Institute at Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey. 12. 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. 13. Intramural Research Program, National Institute on Aging, Bethesda, Maryland. 14. Division of Cardiovascular Disease, Department of Medicine, University of Alabama, Birmingham. 15. Division of Public Health Sciences, Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, North Carolina. 16. Veterans Health Administration-Tennessee Valley Healthcare System Geriatric Research Education Clinical Center, HSR&D Center, Nashville23Department of Medicine, Vanderbilt University, Nashville, Tennessee. 17. Department of Epidemiology, University of Florida, Gainesville25Geriatric Research, Education, and Clinical Center, Malcom Randall Veterans Administration Medical Center, Gainesville, Florida. 18. Department of Medicine, University of Alabama, Birmingham. 19. Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana. 20. Department of Medicine, Medical College of Wisconsin, Milwaukee29Primary Care Division, Clement J. Zablocki Veterans Affairs Medical Center, Milwaukee, Wisconsin. 21. Division of Nephrology and Hypertension, Department of Medicine, Case Western Reserve University, Cleveland, Ohio. 22. Division of Public Health Sciences, Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.
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.
RCT Entities:
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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