Abstract MP59: Effects Of Sodium Reduction And Weight Loss On Lightheadedness And Falls In Older Adults: Results From TONE

Abstract

Background: The Trial of Nonpharmacologic Interventions in the Elderly (TONE) demonstrated the efficacy of sodium reduction and weight loss to reduce hypertension medication use in older adults. However, adverse events related to lightheadedness and falls have not been reported. Objective: To determine whether sodium reduction and weight loss are associated with greater risk of lightheadedness and falls among older adults. Methods: TONE was a randomized trial of 60-80 year-old adults with systolic BP (SBP) and diastolic BP (DBP) below 145 and 85 mm Hg, respectively, while receiving treatment with a single antihypertensive medication. Participants were randomized to behavioral interventions focused on sodium reduction, weight loss, both, or neither (usual care); 3 months after randomization, the antihypertensive medication was withdrawn and only restored later during the study if needed for uncontrolled hypertension. Total follow-up was 36 months post-randomization. Two physicians independently adjudicated adverse event logs, masked to intervention assignment. The primary outcome was a composite of the first occurrence of adverse event related to falls (total N=95): 72 involved orthostatic symptoms (lightheadedness, dizziness, vertigo), while 23 involved hard events (fall or syncope). Hazard ratios were determined via Cox proportional hazards models. Results: Among the 975 participants (mean age 66 yrs, 48% women, 24% black), mean SBP and DBP were 128 and 71 mm Hg. The cumulative incidence of adverse events at 30 months was 0.08, 0.13, 0.11, and 0.14 for usual care, reduced sodium, weight loss, or both, respectively ( Figure ). In adjusted multi-variable analyses, sodium reduction was associated with higher risk of an adverse event (HR 1.52; 95% CI: 1.02, 2.27), while weight loss was not associated with adverse events (HR 1.18; 0.77, 1.79). Conclusions: In the context of antihypertensive medication withdrawal, sodium reduction was associated with a higher risk of fall-related adverse events, predominantly symptoms.