Empagliflozin in Patients with Chronic Kidney Disease
Empagliflozin in Patients with Chronic Kidney Disease
- 2023-01-12.
/pmc/articles/PMC7614055/ /pubmed/36331190
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/1.73m(2); or ≥45 to <90 ml/minute/1.73m(2) 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/1.73m(2), 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).
https://creativecommons.org/licenses/by-nd/4.0/This work is licensed under a CC BY-ND 4.0 (https://creativecommons.org/licenses/by-nd/4.0/) International license.
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/pmc/articles/PMC7614055/ /pubmed/36331190
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/1.73m(2); or ≥45 to <90 ml/minute/1.73m(2) 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/1.73m(2), 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).
https://creativecommons.org/licenses/by-nd/4.0/This work is licensed under a CC BY-ND 4.0 (https://creativecommons.org/licenses/by-nd/4.0/) International license.
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