Kaycee M Sink1, Gregory W Evans2, Ronald I Shorr3,4, Jeffrey T Bates5,6, Dan Berlowitz7,8,9, Molly B Conroy10, Deborah M Felton2, Tanya Gure11, Karen C Johnson12, Dalane Kitzman13, Mary F Lyles1, Karen Servilla14, Mark A Supiano15,16, Jeff Whittle17,18, Alan Wiggers19, Lawrence J Fine20. 1. Department of Medicine, Section on Department of Geriatric Medicine, School of Medicine, Wake Forest University, Winston-Salem, North Carolina. 2. Division of Public Health Sciences, School of Medicine, Wake Forest University, Winston-Salem, North Carolina. 3. Malcom Randall Veterans Affairs Medical Center, Gainesville, Florida. 4. Department of Epidemiology, University of Florida, Gainesville, Florida. 5. Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas. 6. Baylor College of Medicine, Houston, Texas. 7. Bedford Veterans Affairs Hospital, Bedford, Massachusetts. 8. School of Medicine, Boston University, Boston, Massachusetts. 9. School of Public Health, Boston University, Boston, Massachusetts. 10. Division of General Internal Medicine, School of Medicine, University of Utah, Salt Lake City, Utah. 11. Division of General Internal Medicine and Geriatrics, Wexner Medical Center, Ohio State University, Columbus, Ohio. 12. Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, Tennessee. 13. Department of Cardiology, School of Medicine, Wake Forest University, Winston-Salem, North Carolina. 14. Renal Section, New Mexico VA Health Care System, Albuquerque, New Mexico. 15. Division of Geriatrics, School of Medicine, University of Utah, Salt Lake City, Utah. 16. Department of Veterans, Geriatric Research, Education and Clinical Center, Salt Lake City, Utah. 17. Primary Care Division, Clement J. Zablocki Veterans Affairs Medical Center, Milwaukee, Wisconsin. 18. Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin. 19. Department of Primary Care, Heritage College of Osteopathic Medicine, Ohio University Cleveland Campus, Cleveland, Ohio. 20. National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
Abstract
OBJECTIVE: To determine predictors of serious adverse events (SAEs) involving syncope, hypotension, and falls, with particular attention to age, in the Systolic Blood Pressure Intervention Trial. DESIGN: Randomized clinical trial. SETTING:Academic and private practices across the United States (N = 102). PARTICIPANTS: Adults aged 50 and older with a systolic blood pressure (SBP) of 130 to 180 mmHg at high risk of cardiovascular disease events, but without diabetes, history of stroke, symptomatic heart failure or ejection fraction less than 35%, dementia, or standing SBPless than 110 mmHg (N = 9,361). INTERVENTION: Treatment of SBP to a goal of less than 120 mmHg or 140 mmHg. MEASUREMENTS: Outcomes were SAEs involving syncope, hypotension, and falls. Predictors were treatment assignment, demographic characteristics, comorbidities, baseline measurements, and baseline use of cardiovascular medications. RESULTS:One hundred seventy-two (1.8%) participants had SAEs involving syncope, 155 (1.6%) hypotension, and 203 (2.2%) falls. Randomization to intensive SBP control was associated with greater risk of an SAE involving hypotension (hazard ratio (HR) = 1.67, 95% confidence interval (CI) = 1.21-2.32, P = .002), and possibly syncope (HR = 1.32, 95% CI = 0.98-1.79, P = .07), but not falls (HR = 0.98, 95% CI = 0.75-1.29, P = .90). Risk of all three outcomes was higher for participants with chronic kidney disease or frailty. Older age was also associated with greater risk of syncope, hypotension, and falls, but there was no age-by-treatment interaction for any of the SAE outcomes. CONCLUSIONS: Participants randomized to intensive SBP control had greater risk of hypotension and possibly syncope, but not falls. The greater risk of developing these events associated with intensive treatment did not vary according to age.
RCT Entities:
OBJECTIVE: To determine predictors of serious adverse events (SAEs) involving syncope, hypotension, and falls, with particular attention to age, in the Systolic Blood Pressure Intervention Trial. DESIGN: Randomized clinical trial. SETTING: Academic and private practices across the United States (N = 102). PARTICIPANTS: Adults aged 50 and older with a systolic blood pressure (SBP) of 130 to 180 mmHg at high risk of cardiovascular disease events, but without diabetes, history of stroke, symptomatic heart failure or ejection fraction less than 35%, dementia, or standing SBP less than 110 mmHg (N = 9,361). INTERVENTION: Treatment of SBP to a goal of less than 120 mmHg or 140 mmHg. MEASUREMENTS: Outcomes were SAEs involving syncope, hypotension, and falls. Predictors were treatment assignment, demographic characteristics, comorbidities, baseline measurements, and baseline use of cardiovascular medications. RESULTS: One hundred seventy-two (1.8%) participants had SAEs involving syncope, 155 (1.6%) hypotension, and 203 (2.2%) falls. Randomization to intensive SBP control was associated with greater risk of an SAE involving hypotension (hazard ratio (HR) = 1.67, 95% confidence interval (CI) = 1.21-2.32, P = .002), and possibly syncope (HR = 1.32, 95% CI = 0.98-1.79, P = .07), but not falls (HR = 0.98, 95% CI = 0.75-1.29, P = .90). Risk of all three outcomes was higher for participants with chronic kidney disease or frailty. Older age was also associated with greater risk of syncope, hypotension, and falls, but there was no age-by-treatment interaction for any of the SAE outcomes. CONCLUSIONS:Participants randomized to intensive SBP control had greater risk of hypotension and possibly syncope, but not falls. The greater risk of developing these events associated with intensive treatment did not vary according to age.
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