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Abstract: FR-PO228

Change in Albuminuria and Renal Risk: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Waijer, Simke W., University Medical Center Groningen, Groningen, Netherlands
  • Xie, Di, University Medical Center Groningen, Groningen, Netherlands
  • Inzucchi, Silvio E., Yale University School of Medicine, New Haven, Connecticut, United States
  • Zinman, Bernard, Mount Sinai Hospital, Toronto, Ontario, Canada
  • Koitka-Weber, Audrey, Boehringer Ingelheim International GmbH, Mainz-Drais, Germany
  • von Eynatten, Maximilian, Boehringer Ingelheim International GmbH, Mainz-Drais, Germany
  • Wanner, Christoph, Wurzburg University Clinic, Wurzburg, Germany
  • L Heerspink, Hiddo Jan, University Medical Center Groningen, Groningen, Netherlands
Background

Previous studies have shown that an early reduction in albuminuria (UACR) during RAAS inhibition is associated with improved renal outcomes. Empagliflozin is a SGLT2 inhibitor that decreases UACR. We assessed the association between an early reduction in UACR during treatment with empagliflozin or placebo and long-term renal risk in a post-hoc analysis from the EMPA-REG OUTCOME trial.

Methods

We calculated UACR change as the percentage difference from baseline to week 12 in 6820 participants who did not experience a renal outcome (>40% decrease in eGFR, end-stage renal disease or renal death) during the first 12 weeks. Cox regression models were used to estimate the hazard ratio (HR) for each 30% reduction in UACR with renal outcome after adjustment for treatment assignment, laboratory measurements and medication use.

Results

Empagliflozin, compared to placebo, reduced UACR by 18% (95%CI 14-22%) and increased the likelihood of a ≥30% reduction in UACR at week 12 (odds ratio 1.42 [95%CI 1.27-1.58]). Over a median follow-up of 2.9 years, 168 renal endpoints were observed. Each 30% reduction in UACR from baseline to week 12 was associated with an average 18% lower hazard for the renal outcome (HR 0.82 [95%CI 0.76-0.88]). The adjusted HR for each 30% reduction in UACR in patients with normo-, micro-, or macroalbuminuria at baseline was 0.87 (95%CI 0.78-0.98), 0.82 (95%CI 0.69-0.97) and 0.65 (95%CI 0.54-0.79), respectively (p for interaction 0.24). The association between change in UACR and renal outcomes was consistent in various subgroups and similar in the placebo and empagliflozin groups (Figure).

Conclusion

An early reduction in albuminuria was more common with empagliflozin and was independently associated with a reduced renal risk in patients with type 2 diabetes and cardiovascular disease.

Funding

  • Commercial Support –