#4139 effects of empagliflozin on fluid overload in chronic kidney disease: an empa-kidney bioimpedance substudy
Abstract
The EMPA-KIDNEY trial showed that, compared to placebo, empagliflozin 10 mg once daily reduced the risk of kidney disease progression or cardiovascular death in 6609 patients with chronic kidney disease at risk of progression. We aimed to assess effects of empagliflozin on bioimpedance-measured fluid overload and adiposity in a subset to better understand the mechanisms of cardiovascular benefits of sodium glucose co-transporter-2 inhibitors.
This EMPA-KIDNEY substudy added Body Composition Monitor (BCM) measurements at randomization and the 2 and 18 month follow-up visits to the trial's main protocol-specified procedures. The primary outcome was Absolute Fluid Overload (a parameter reflecting overhydration, derived from extracellular and intracellular resistance). Pre-specified subgroup analyses of the primary outcome were by sex, diabetes status, estimated glomerular filtration rate (eGFR) and N-terminal pro-brain-type natriuretic peptide (NT-proBNP) at baseline. The key secondary analysis was a composite of death from heart failure, heart failure hospitalisation or development of new moderate (>7%, ≤15%) or severe (>15%) BCM-measured Relative Fluid Overload. Tertiary outcomes included weight, anthropometry, and other BCM-measurements of body water and adiposity. The primary outcome was analysed used mixed-model repeated measures (MMRM) methods. The key secondary outcome used time-to-first event methods.
A total of 660 EMPA-KIDNEY participants were recruited into this…
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