Bayer Ag · XETR:BAYN
Bayer — ERA Congress 2026
13 slides from Bayer's conference presentation, June 2026
Slide 1: Dose-exposure-response analysis of finerenone on serum potassium and cardiovascular outcomes
Dose-exposure-response analysis of finerenone on serum potassium and cardiovascular outcomes among patients with heart failure: Insights from FINEARTS-HF Thomas Eissing1*, Finnian R. Mc Causland2*, Sebastiaan C. Goulooze3, Eleonora Marostica3, Jan Berkhout3, Paul van den Berg3, Nelleke Snelder3, Dir
Slide 2: Background
Background • Finerenone reduces the risk of total heart failure events and cardiovascular death among patients with HF with mildly reduced or preserved ejection fraction • Finerenone is also known to reduce NT-proBNP and raise serum potassium, compared with placebo • Whether the effects of finereone
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: FINEARTS-HF Dosing Algorithm – serum K
FINEARTS-HF Dosing Algorithm – serum K
Slide 5: Analytic Approach
Analytic Approach • For data visualization, finerenone dose was considered as the dose administered before the respective PD measurement • Non-linear mixed effects models were fit to explore relationships of repeated measures of dose/exposure with outcomes • Serum potassium • Thresholds of >5.5 and
Slide 6: Results
Results N=6,001 Finerenone concentrations n=6,658 measurements Mean eGFR 62 ±20 mL/min/1.73 m2 Serum K+ n=123,720 measurements n=3,168 eGFR >60 n=2,833 eGFR ≤60 Serum NT-proBNP Finerenone 20 -> 40 mg/day Finerenone 10 -> 20 mg/day n=16,971 measurements Mean prescribed dose Mean prescribed dose CV de
Slide 7: Pharmacokinetics of finerenone
Pharmacokinetics of finerenone
Slide 8: Finerenone dose and serum K
Finerenone dose and serum K Post-baseline central lab data
Slide 9: Simulation studies – dose and serum K
Simulation studies – dose and serum K Without dose titration With dose titration
Slide 10: Dose-exposure and NT-proBNP
Dose-exposure and NT-proBNP
Slide 11: Dose-exposure and CV events
Dose-exposure and CV events Hazard ratio 1.0 0.8 0.6 0.4 0 1000 2000 3000 AUCr,md (ug*h/L) 63° ERA CONGRESS GLASGOW & VIRTUAL JUNE 3-6, 2026 ChelLenge Your Thinting
Slide 12: Conclusions
Conclusions • The major determinants of higher finerenone exposure were lower body weight and lower eGFR • Due to protocolized finerenone dose titration, higher doses did not lead to higher serum potassium concentrations • Higher finerenone exposure was associated with a non-significant lower freque
Slide 13: 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