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

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 placebo groups diverged shortly after randomization and separated further over time. Risk of hospital admissions from cardiovascular (CV), renal, or metabolic conditions was significantly lower with empagliflozin vs placebo (P < 0.05).

Implications: Treatment with empagliflozin significantly reduced risk of ACH, including those attributed to CV, renal, or metabolic conditions.

Clinicaltrials:

Gov number: NCT03594110.