Kidney Week

Abstract: TH-OR46

Finerenone in Patients with Type 2 Diabetes and CKD by SGLT2 Inhibitor and Glucagon-Like Peptide 1 Receptor Agonists Receptor Agonist Use: A FIDELITY Analysis

Session Information

• Diabetic Kidney Disease - Clinical: Novel Insights into Precision Medicine
  October 24, 2024 | Location: Room 33, Convention Center
  Abstract Time: 04:30 PM - 04:40 PM

Category: Diabetic Kidney Disease

• 702 Diabetic Kidney Disease: Clinical

Authors

• Singh, Ajay K., Harvard Medical School, Renal Division, Brigham and Women’s Hospital/Dana Farber Cancer Institute, Boston, Massachusetts, United States

Ajay K. Singh, MD

• Anker, Stefan D., Department of Cardiology (CVK) of German Heart Center Charité; German Centre for Cardiovascular Research (DZHK) partner site Berlin, Charité Universitätsmedizin, Berlin, Germany

Stefan D. Anker, MD, PhD

• Pitt, Bertram, Department of Medicine, University of Michigan School of Medicine, Ann Arbor, Michigan, United States

Bertram Pitt, MD

• Rossing, Peter, Steno Diabetes Center Copenhagen, Herlev, Denmark

Peter Rossing, MD, DrMed

• Ruilope, Luis M., Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain

Luis M. Ruilope, MD, PhD

• Ahlers, Christiane, Statistics and Data Insights, Bayer AG, Berlin, Germany

Christiane Ahlers, MD

• Farag, Youssef MK, Postgraduate Medical Education, Harvard Medical School, Boston, Massachusetts, United States

Youssef MK Farag, MD, PhD, MPH, FASN

• Lambelet, Marc, Chrestos Concept GmbH & Co. KG, Essen, Germany

Marc Lambelet

• Brinker, Meike Daniela, Cardiology and Nephrology Clinical Development, Bayer AG, Berlin, Germany

Meike Daniela Brinker, DrMed, MD

• Rohwedder, Katja, Cardio-Renal Medical Affairs Department, Bayer AG, Berlin, Germany

Katja Rohwedder, MD

• Filippatos, Gerasimos, National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens, Greece

Gerasimos Filippatos, MD

• Bakris, George L., Department of Medicine, University of Chicago Medicine, Chicago, Illinois, United States

George L. Bakris, MD, MA, FASN

Background

Finerenone significantly reduced the risk of cardiovascular and kidney outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) in FIDELITY, a prespecified pooled analysis of the FIDELIO-DKD and FIGARO-DKD trials. Here, we explored the treatment effect of finerenone in concomitant use with sodium-glucose co-transporter-2 inhibitor (SGLT-2i) + glucagon-like peptide-1 receptor agonist (GLP-1RA).

Methods

Patients in FIDELITY were on optimized renin–angiotensin system inhibition and randomized 1:1 to finerenone or placebo. Key outcomes in this analysis were change in urine albumin-to-creatinine ratio (UACR) over time and treatment-emergent adverse events (including serum potassium [K⁺]).

Results

Of 12,990 patients analyzed, 167 received concomitant use of finerenone with SGLT-2i+GLP-1RA at baseline. Baseline characteristics were similar despite concomitant use of finerenone with SGLT2i±GLP-1RA. Finerenone led to a greater reduction in UACR from baseline to month 4 vs placebo; at month 12, reduction was 49%, 45%, 35% and 40% with concomitant use of finerenone with SGLT-2i+GLP-1RA, GLP-1RA, SGLT-2i, and finerenone alone, respectively (Fig 1A). Safety profile of finerenone was not modified by concomitant SGLT2i±GLP-1RA use. Overall, the risk of hyperkalemia leading to treatment discontinuation or hospitalization with finerenone were low. There were fewer patients with serum [K+] of >5.5/>6 mmol/l in the treatment group with concomitant use of finerenone with SGLT-2i+GLP-1RA vs finerenone alone (Fig 1B).

Conclusion

In FIDELITY, concomitant use of finerenone with SGLT-2i+GLP-1RA at baseline may have additive kidney benefits vs placebo in patients with T2D and CKD.

Funding

• Commercial Support – Bayer AG