Bayer Ag · XETR:BAYN
Bayer — Technical Presentation (June 2025)
11 slides from Bayer's technical presentation, June 2025
Slide 1: Effect of finerenone on eGFR slope across different levels of baseline albuminuria and eGFR
Effect of finerenone on eGFR slope across different levels of baseline albuminuria and eGFR: Insights from FINEARTS-HF Finnian R. Mc Causland1*; Hiddo J. L. Heerspink2*; Muthiah Vaduganathan1; Brian L. Claggett1; Akshay S. Desai1; Pardeep S. Jhund3; Martina M. McGrath1; Katja Rohwedder4; Flaviana Am
Slide 2: Background
Background • Finerenone reduces the risk of kidney disease progression and slows the decline in eGFR among patients with type 2 diabetes (T2DM), chronic kidney disease (CKD), and albuminuria. • Finerenone did not modify the risk of kidney outcomes or eGFR decline among patients with heart failure (H
Slide 3: FINEARTS-HF Study Design
FINEARTS-HF Study Design Randomized, double-blind, placebo-controlled trial of patients with HFmrEF/HFpEF Key Inclusion Criteria Key Exclusion Criteria • Symptomatic HF with LVEF ≥ 40% • Age ≥40 yrs • eGFR <25 mL/min/1.73 m² • Elevated natriuretic peptide levels • Potassium >5.0 mmol/L • Structural
Slide 4: Patient Flow
Patient Flow Assessed for eligibility N = 7463 Screen failures N = 1447 Randomized N = 6016 Randomized to finerenone Randomized to placebo N = 3011 N = 3005 Excluded due to invalid Excluded due to invalid randomization or GCP violations randomization or GCP violations N=8 N=7 Full analysis set, N =
Slide 5: UACR and eGFR measurements
UACR and eGFR measurements Exposures – UACR and eGFR • UACR was measured from spot urine collections at baseline in 5,797 participants. • Categories: <30 mg/g, 30 to <300 mg/g, and ≥300 mg/g. • eGFR was calculated using the CKD-EPI 2009 equation • Categories: <45, 45 to <60, and ≥60 mL/min/1.73 m2.
Slide 6: Analytic Approach
Analytic Approach • Changes in eGFR (continuous) over time were assessed with repeated measures mixed-effect models, using available data from central laboratory measurements. • Models were adjusted for treatment assignment, trial visit, geographic region, left ventricular ejection fraction (<60 or
Slide 7: Baseline Characteristics
Baseline Characteristics Categories of UACR Categories of eGFR UACR <30 mg/g UACR 30 - <300 mg/g UACR ≥300 mg/g eGFR ≥60 eGFR 45-<60 eGFR <45 mL/min/1.73 m2 mL/min/1.73 m2 mL/min/1.73 m2 n=3511 n=1712 n=574 n=3012 n=1520 n=1265 Age, years 71 ± 10 73 ± 9 70 ± 10 Age, years 68 ± 10 74 ± 8 77 ± 8 Femal
Slide 8: Results: Categories of UACR
Results: Categories of UACR P-interaction=0.09
Slide 9: Results: Categories of eGFR
Results: Categories of eGFR P-interaction=0.48
Slide 10: Conclusions
Conclusions • Finerenone appears to slow eGFR decline relative to placebo to a clinically meaningful degree among patients with higher baseline UACR • There was no suggestion of heterogeneity according to categories of baseline eGFR • Overall, consistent with data from FIDELITY, the present data sup
Slide 11: Acknowledgements
Acknowledgements Steering Committee Scott D. Solomon, MD & John J.V. McMurray, MD, Co-Chairs Carolyn S.P. Lam, MD, Bertram Pitt, MD, Michele Senni, MD, Sanjiv Shah, MD, Adriaan Voors, MD, Faiez Zannad, MD Sponsor Leadership National Lead Investigators Bayer Argentina Felipe Martinez Japan Naoki Sato