Volume 66, Issue 4 p. 679-686
Clinical Investigation

Syncope, Hypotension, and Falls in the Treatment of Hypertension: Results from the Randomized Clinical Systolic Blood Pressure Intervention Trial

Kaycee M. Sink MD, MAS

Corresponding Author

Kaycee M. Sink MD, MAS

Department of Medicine, Section on Department of Geriatric Medicine, School of Medicine, Wake Forest University, Winston-Salem, North Carolina

Address correspondence to Kaycee M. Sink, E-mail: [email protected]Search for more papers by this author
Gregory W. Evans MA

Gregory W. Evans MA

Division of Public Health Sciences, School of Medicine, Wake Forest University, Winston-Salem, North Carolina

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Ronald I. Shorr MD

Ronald I. Shorr MD

Malcom Randall Veterans Affairs Medical Center, Gainesville, Florida

Department of Epidemiology, University of Florida, Gainesville, Florida

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Jeffrey T. Bates MD

Jeffrey T. Bates MD

Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas

Baylor College of Medicine, Houston, Texas

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Dan Berlowitz MD

Dan Berlowitz MD

Bedford Veterans Affairs Hospital, Bedford, Massachusetts

School of Medicine, Boston University, Boston, Massachusetts

School of Public Health, Boston University, Boston, Massachusetts

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Molly B. Conroy MD, MPH

Molly B. Conroy MD, MPH

Division of General Internal Medicine, School of Medicine, University of Utah, Salt Lake City, Utah

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Deborah M. Felton BS

Deborah M. Felton BS

Division of Public Health Sciences, School of Medicine, Wake Forest University, Winston-Salem, North Carolina

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Tanya Gure MD

Tanya Gure MD

Division of General Internal Medicine and Geriatrics, Wexner Medical Center, Ohio State University, Columbus, Ohio

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Karen C. Johnson MD, MPH

Karen C. Johnson MD, MPH

Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, Tennessee

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Dalane Kitzman MD

Dalane Kitzman MD

Department of Cardiology, School of Medicine, Wake Forest University, Winston-Salem, North Carolina

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Mary F. Lyles MD

Mary F. Lyles MD

Department of Medicine, Section on Department of Geriatric Medicine, School of Medicine, Wake Forest University, Winston-Salem, North Carolina

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Karen Servilla MD

Karen Servilla MD

Renal Section, New Mexico VA Health Care System, Albuquerque, New Mexico

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Mark A. Supiano MD

Mark A. Supiano MD

Division of Geriatrics, School of Medicine, University of Utah, Salt Lake City, Utah

Department of Veterans, Geriatric Research, Education and Clinical Center, Salt Lake City, Utah

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Jeff Whittle MD, MPH

Jeff Whittle MD, MPH

Primary Care Division, Clement J. Zablocki Veterans Affairs Medical Center, Milwaukee, Wisconsin

Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin

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Alan Wiggers DO

Alan Wiggers DO

Department of Primary Care, Heritage College of Osteopathic Medicine, Ohio University Cleveland Campus, Cleveland, Ohio

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Lawrence J. Fine MD, DrPH

Lawrence J. Fine MD, DrPH

National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland

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First published: 30 March 2018
Citations: 57
Trial Registration: Clinicaltrials.gov identifier: NCT01206062
See related editorial by Michael W. Rich.

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 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.