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Randomized Controlled Trial
. 2018 Apr;66(4):679-686.
doi: 10.1111/jgs.15236. Epub 2018 Mar 30.

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

Kaycee M Sink  1 , Gregory W Evans  2 , Ronald I Shorr  3   4 , Jeffrey T Bates  5   6 , Dan Berlowitz  7   8   9 , Molly B Conroy  10 , Deborah M Felton  2 , Tanya Gure  11 , Karen C Johnson  12 , Dalane Kitzman  13 , Mary F Lyles  1 , Karen Servilla  14 , Mark A Supiano  15   16 , Jeff Whittle  17   18 , Alan Wiggers  19 , Lawrence J Fine  20
Affiliations
Randomized Controlled Trial

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

Kaycee M Sink et al. J Am Geriatr Soc. 2018 Apr.

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.

Keywords: antihypertensive; falls; hypotension; older adults; syncope.

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Conflict of interest statement

Conflicts of Interest: Greg Evans reports receiving salary support on an institutional grant from AstraZeneca Investments (China) Co. All other authors declare they have no conflicts to report. Kaycee Sink was employed by Wake Forest School of Medicine at the time of submission of this manuscript. However, at the time of publication she is employed by Genentech, a Member of the Roche Group. Genentech had no involvement in the study design, data collection, interpretation of data, or preparation of this manuscript.

Figures

Figure 1:
Figure 1:
Cumulative incidence of syncope, hypotension, and falls by randomized group
Figure 2:
Figure 2:
Forest Plot of SAE outcomes by treatment arm and age subgroups
See this image and copyright information in PMC

Comment in

References

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