Type 2 & other diabetes

Effects of empagliflozin on progression of chronic kidney disease: a prespecified secondary analysis from the empa-kidney trial

Lancet Diabetes EndocrinolPublished Prespecified secondary analysis of the EMPA-KIDNEY randomised trial

Errata to this article were published (Lancet Diabetes Endocrinol, Mar 2024 ↗ · Nov 2024 ↗)

Primary result · Chronic eGFR slopeResult — go to the resultRelative difference 50% 95% CI 42–58

Authors' conclusion

Empagliflozin slowed the rate of progression of chronic kidney disease among all types of participant in the EMPA-KIDNEY trial, including those with little albuminuria. Albuminuria alone should not be used to determine whether to treat with an SGLT2 inhibitor.

Study context

Population
Adults ≥18 years with estimated glomerular filtration rate (eGFR) 20 to <45 mL/min per 1.73 m², or eGFR 45 to <90 mL/min per 1.73 m² with urinary albumin-to-creatinine ratio (uACR) ≥200 mg/g; 241 centres in 8 countriesmedian follow-up 2.0 years
Participants
6,609 adults
Comparison
Empagliflozin 10 mg once daily vs placebo
Primary endpoint
Annualised rate of change in eGFR (eGFR slope; tertiary outcome): acute slope (randomisation to 2 months) and chronic slope (from 2 months onwards)
Methodological detailscontrolled, phase 3, multicentre (241 centres, 8 countries), intention-to-treat, shared parameter models, Randomised May 15, 2019 to April 16, 2021; median follow-up 2.0 years (IQR 1.5-2.4)
  • Controlled
  • Phase 3
  • Multicentre (241 centres, 8 countries)
  • Intention-to-treat
  • Shared parameter models
  • Randomised May 15, 2019 to April 16, 2021; median follow-up 2.0 years (IQR 1.5-2.4)

Primary result

Chronic eGFR slope · from 2 months onwards

Relative difference

50%

95% CI 42–58

Empagliflozinvs Placebo
relative difference 50% (95% CI 42–58)

As reported in the abstract

Further findings

OutcomeReduction in eGFR (mL/min per 1.73 m²) (95% CI)
Acute eGFR change · first 2 monthsEquivalent to a 6% (5-6) dip2.12 (1.83–2.41)

Chronic slope reduction by baseline uACR subgroup

Relative reduction in chronic slope, uACR <30 mg/g
86% [36-136]
Relative reduction in chronic slope, uACR ≥2000 mg/g
29% [19-38]
Trend across uACR
P for trend < 0.0001
Absolute and relative benefits on chronic slope varied significantly by diabetes status and baseline eGFR and uACR; absolute difference lower with lower baseline uACR

Original publication

Effects of empagliflozin on progression of chronic kidney disease: a prespecified secondary analysis from the empa-kidney trial. Lancet Diabetes Endocrinol. Published 4 December 2023. doi:10.1016/s2213-8587(23)00321-2

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