Empagliflozin in Patients with Chronic Kidney Disease

Background This study, the EMPA-KIDNEY trial, was designed to assess the effects of empagliflozin in a broad range of patients with chronic kidney disease (CKD) at risk of progression. Methods We randomly assigned 6609 participants to empagliflozin (10mg once daily) versus matching placebo. Eligibility required an estimated glomerular filtration rate (eGFR) of ≥20 to <45 ml/minute/1.73m2; or ≥45 to <90 ml/minute/1.73m2 with a urinary albumin-to-creatinine ratio (ACR) of ≥200 mg/g. The primary outcome was a composite of kidney disease progression (end-stage kidney disease, a sustained eGFR <10 ml/minute/1.73m2, a sustained decline in eGFR of ≥40%, or a renal death) or death from cardiovascular causes. Results During a median of 2.0 years follow-up, a primary outcome event occurred in 432 of 3304 patients (13.1%) in the empagliflozin group and in 558 of 3305 patients (16.9%) in the placebo group (hazard ratio, 0.72; 95% CI 0.64 to 0.82; P<0.001), with consistent results in those with or without diabetes and across the range of eGFR studied. There were fewer hospitalizations from any cause in the empagliflozin group (0.86; 0.78 to 0.95, P=0.003), but no statistically significant effect on hospitalization for heart failure or cardiovascular death (4.0% vs 4.6%), or death from any cause (4.5% vs 5.1%). The rates of serious adverse events were broadly similar in the two groups. Conclusions Empagliflozin reduced the risk of the composite outcome of kidney disease progression or cardiovascular death in a wide range of patients at risk of CKD progression. (Funding:Boehringer Ingelheim, Eli Lilly and others; Clinicaltrials.gov:NCT03594110, EuDRACT: 2017-002971-24).