Effects of empagliflozin on progression of chronic kidney disease: a prespecified secondary analysis from the EMPA-KIDNEY trial
In a prespecified secondary analysis of the EMPA-KIDNEY trial, empagliflozin slowed the chronic rate of eGFR decline across a broad range of CKD patients, including those without diabetes and with lower albuminuria where benefit had been less certain.
Background
SGLT2 inhibitors reduce CKD progression and cardiovascular risk, but their effect on kidney disease progression in some patient subgroups had remained unclear because few kidney outcome events occurred among such patients in earlier trials. Some guidelines stratify the strength of their SGLT2 inhibitor recommendation by diabetes status and albuminuria, motivating a closer look at eGFR slope across the full EMPA-KIDNEY population.
Study design
EMPA-KIDNEY was a randomised, controlled, phase 3 trial conducted at 241 centres in eight countries that enrolled 6609 adults with an eGFR of 20 to less than 45 mL/min/1.73 m2, or 45 to less than 90 with a urinary albumin-to-creatinine ratio of at least 200 mg/g. Participants received empagliflozin 10 mg once daily or placebo and were followed for a median of 2.0 years. This prespecified analysis examined the annualised rate of change in eGFR, studying the acute slope (randomisation to 2 months) and chronic slope (from 2 months onward) separately.
Key findings
Empagliflozin caused an acute initial dip in eGFR (about 2.12 mL/min/1.73 m2) followed by a slower long-term (chronic) rate of eGFR decline compared with placebo. Prespecified subgroups spanned a wide range of baseline eGFR and albuminuria, including participants with a uACR below 30 mg/g and those with eGFR below 30 mL/min/1.73 m2, allowing assessment of treatment effects across the CKD spectrum.
Clinical implications
The analysis supports a consistent benefit of empagliflozin on preserving kidney function across diverse CKD patients, reinforcing use of SGLT2 inhibitors in CKD irrespective of diabetes status and across albuminuria categories. The findings are relevant to guideline recommendations that had previously stratified treatment by diabetes and albuminuria.
Category
Research
Source
The Lancet Diabetes & Endocrinology
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