Effects of Empagliflozin on Urine Biomarkers in EMPA-KIDNEY.
Abstract
RATIONALE & OBJECTIVE: Sodium/glucose cotransporter 2 (SGLT2) inhibitors substantially slow progression of chronic kidney disease and reduce the risk of acute kidney injury, but their effects on kidney physiology are incompletely understood. This study assessed the effects of empagliflozin on a comprehensive set of urinary tubular and glomerular biomarkers.
STUDY DESIGN: Randomized controlled trial.
SETTING & PARTICIPANTS: 2,752 participants from EMPA-KIDNEY.
EXPOSURE: Empagliflozin, 10 mg daily, versus placebo.
OUTCOME: Urine biomarkers indexed to urinary creatinine and averaged across on-study time points. Urine biomarkers included markers of glomerular disease (albumin, total protein); proximal tubular reabsorption (α1-microglobulin [A1M]); functional tubular reserve (epidermal growth factor [EGF], uromodulin [UMOD]); tubular injury/inflammation (kidney injury molecule-1 [KIM-1], neutrophil gelatinase-associated lipocalin [NGAL]); and tubular ischemia/stress (dickkopf-3 [DKK-3], monocyte chemoattractant protein-1 [MCP-1]).
ANALYTICAL APPROACH: Mixed model repeated measures.
RESULTS: Allocation to empagliflozin reduced urinary albumin by 19% (95% CI, -24% to -14%), total protein by 7% (-11% to -2%), and UMOD by 63% (-65% to -61%). It increased A1M by 29% (25%-34%), DKK-3 by 22% (16%-29%), and NGAL by 7% (0-13%). Overall, there were no significant effects on EGF (1% [-1% to 4%]), KIM-1 (2% [-1% to 6%]), and MCP-1 (0 [-4% to 3%]). The magnitude of effects on biomarker levels…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 2,752 participants or records.
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