Kidney Week

Abstract: SA-PO142

Reduction in Weight and Adiposity Indices and Kidney Outcomes with Empagliflozin in Patients with Type 2 Diabetes (T2D): Results from the EMPA-REG OUTCOME® Trial

Session Information

• Diabetic Kidney Disease: Clinical - II
  October 27, 2018 | Location: Exhibit Hall, San Diego Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Diabetic Kidney Disease

• 602 Diabetic Kidney Disease: Clinical

Authors

• Ikizler, Talat Alp, Vanderbilt University Medical Center, Nashville, Tennessee, United States

Talat Alp Ikizler,

• Stenvinkel, Peter, Karolinska University Hospital Huddinge, Stockholm, Sweden

Peter Stenvinkel,

• Neeland, Ian J., UT Southwestern Medical Center, Dallas, Texas, United States

Ian J. Neeland,

• Hantel, Stefan, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany

Stefan Hantel,

• Johansen, Odd Erik, Boehringer-Ingelheim, Asker, Norway

Odd Erik Johansen,

• von Eynatten, Maximilian, Boehringer Ingelheim, Ingelheim, Germany

Maximilian von Eynatten,

• Wanner, Christoph, University Hospital, Wuerzburg, Germany

Christoph Wanner,

• Koitka-Weber, Audrey, Boehringer Ingelheim, Ingelheim, Germany

Audrey Koitka-Weber,

Background

Empagliflozin (EMPA), a sodium-glucose co-transporter-2 inhibitor, significantly reduced the risk of prespecified kidney outcomes by 39% when added to standard of care in patients with T2D and established cardiovascular disease (CVD) in the EMPA-REG OUTCOME^® trial. As obesity increases the risk for chronic kidney disease (CKD) and its progression to end-stage kidney disease, we explored the potential interaction between changes in weight/adiposity and the kidney-protective effects of EMPA .

Methods

In EMPA-REG OUTCOME^®, 7020 patients were randomized (1:1:1) to daily EMPA 10 or 25 mg or placebo (PBO). Background glucose-lowering therapy was unchanged for the first 12 weeks. We analyzed kidney outcomes in subgroups based on change in weight and adiposity markers from baseline to week 12. Differences in risk for pooled EMPA vs PBO were assessed using a Cox proportional hazards model adjusting for clinical covariates.

Results

Median observation time was 3.1 years. At baseline, the EMPA and PBO groups had similar mean weight (86.6 vs 86.2 kg, respectively), body mass index (30.7 vs 30.6 kg/m²), waist circumference (105.0 vs 104.7 cm), and estimated total body fat (33.4% vs 33.5%). Changes in these parameters from baseline to week 12 did not significantly affect the reduced risk of incident or worsening nephropathy observed after week 12 with EMPA vs PBO (Figure; treatment by subgroup interaction p-value >0.05 for all).

Conclusion

The beneficial effect of EMPA on kidney outcomes was consistent irrespective of changes in weight or body fat in T2D patients with established CVD. The EMPA-KIDNEY trial will provide further insight into the effects of EMPA on adiposity and kidney outcomes in CKD patients with or without diabetes.

Funding

• Commercial Support – Boehringer Ingelheim & Eli Lilly and Company Diabetes Alliance