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Empagliflozin Reduces Risk of Hospitalization in Patients With Chronic Kidney Disease in the EMPA-KIDNEY Trial

Uster A, Desai N, Navaneethan SD, Pfarr E, Mazo AR

Clinical therapeutics, 2025

6,609 participants

Abstract

Purpose: Chronic kidney disease (CKD) increases hospitalization risk. In the randomized, phase III, EMPA-KIDNEY trial, empagliflozin significantly reduced risk of all-cause hospitalizations (ACH; first and recurrent) vs placebo. This post hoc analysis of the EMPA-KIDNEY trial examines the burden of ACH in CKD and the effects of empagliflozin on ACH.

Methods: Participants with CKD (n = 6609) were randomized to empagliflozin 10 mg or placebo. Reasons for hospitalizations were derived from adverse events leading to hospitalization, assessed by system organ class.

Findings: Overall, 1995 participants (1035 placebo, 960 empagliflozin) had ≥1 ACH (1895 ACH in placebo and 1611 in the empagliflozin 10-mg groups). The estimated mortality rate after first hospitalization in participants with ≥1 hospitalization was 12% after 1 year and 18% after 2 years, and risk of death was ∼10 times higher vs those without (hazard ratio [HR] 9.53; 95% confidence interval [CI], 7.18-12.64; P < 0.0001). The most common reasons for hospitalization were infections and infestations, surgical and medical procedures, investigations, cardiac disorders, renal and urinary disorders, and metabolic disorders. Risk of ACH was significantly reduced for empagliflozin vs placebo (HR: 0.86, 95% CI, 0.78-0.95, P = 0.003). This was consistent regardless of baseline diabetes status, estimated glomerular filtration rate, or urinary albumin-to-creatinine ratio. Mean cumulative incidence of ACH in empagliflozin and…

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: 6,609 participants or records.

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