Syncope, Hypotension, and Falls in the Treatment of Hypertension: Results from the Randomized Clinical Systolic Blood Pressure Intervention Trial : SYNCOPE, HYPOTENSION, AND FALLS IN THE SPRINT TRIAL

Abstract

<div class="section"> <a class="named-anchor" id="S1"> <!-- named anchor --> </a> <h5 class="section-title" id="d2879644e334">Background:</h5> <p id="P3">SPRINT found that treatment of systolic hypertension to a goal of &lt;120 mmHg reduces risk of cardiovascular events and mortality, even in older adults. But concern remains that older adults will have excess serious adverse events (SAEs). </p> </div><div class="section"> <a class="named-anchor" id="S2"> <!-- named anchor --> </a> <h5 class="section-title" id="d2879644e339">Objective:</h5> <p id="P4">To determine predictors of SAEs for syncope, hypotension, and falls, with particular attention to age, in the Systolic Blood Pressure Intervention Trial. </p> </div><div class="section"> <a class="named-anchor" id="S3"> <!-- named anchor --> </a> <h5 class="section-title" id="d2879644e344">Design:</h5> <p id="P5">Randomized clinical trial.</p> </div><div class="section"> <a class="named-anchor" id="S4"> <!-- named anchor --> </a> <h5 class="section-title" id="d2879644e349">Setting:</h5> <p id="P6">102 practices across the US and Puerto Rico.</p> </div><div class="section"> <a class="named-anchor" id="S5"> <!-- named anchor --> </a> <h5 class="section-title" id="d2879644e354">Participants:</h5> <p id="P7">9361 adults aged ≥50 years with SBP 130–180 mmHg and increased risk for cardiovascular disease events, but without diabetes, history of stroke, symptomatic heart failure or ejection fraction &lt;35%, dementia, or standing SBP &lt;110 mmHg. </p> </div><div class="section"> <a class="named-anchor" id="S6"> <!-- named anchor --> </a> <h5 class="section-title" id="d2879644e359">Intervention:</h5> <p id="P8">Treatment of SBP to a goal of &lt;120 vs &lt;140 mmHg.</p> </div><div class="section"> <a class="named-anchor" id="S7"> <!-- named anchor --> </a> <h5 class="section-title" id="d2879644e364">Measurements:</h5> <p id="P9">Outcomes were SAEs for syncope, hypotension, and falls. Predictors were treatment assignment, demographics, comorbidities, baseline measurements, and baseline use of cardiovascular medications. </p> </div><div class="section"> <a class="named-anchor" id="S8"> <!-- named anchor --> </a> <h5 class="section-title" id="d2879644e369">Results:</h5> <p id="P10">172 (1.8%) participants had SAEs for syncope, 155 (1.6%) for hypotension, and 203 (2.2%) for falls. Randomization to intensive SBP control was associated with greater risk of an SAE involving hypotension (HR 1.67 (1.21–2.32), p=.002), and possibly syncope (HR 1.32 (0.98–1.79), p=.07), but not falls (HR 0.98 (0.75–1.29), p=.90). Risk of all 3 outcomes was higher for participants with chronic kidney disease or frailty. Older age was also associated with greater risk of syncope, hypotension, and falls. However, there was no age by treatment interaction for any of the SAE outcomes. </p> </div><div class="section"> <a class="named-anchor" id="S9"> <!-- named anchor --> </a> <h5 class="section-title" id="d2879644e374">Conclusions:</h5> <p id="P11">Compared to the standard group, participants randomized to intensive systolic BP control were at higher risk for hypotension and possibly syncope, but not falls. The increased risk of developing these events associated with intensive treatment did not vary by age. </p> </div>