Finerenone and effects on mortality in chronic kidney disease and type 2 diabetes: a FIDELITY analysis

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  • Gerasimos Filippatos
  • Stefan D. Anker
  • Phyllis August
  • Andrew J.S. Coats
  • James L. Januzzi
  • Boris Mankovsky
  • Rossing, Peter
  • Luis M. Ruilope
  • Bertram Pitt
  • Pantelis Sarafidis
  • John R. Teerlink
  • Chris J. Kapelios
  • Martin Gebel
  • Meike Brinker
  • Amer Joseph
  • Andrea Lage
  • George Bakris
  • Rajiv Agarwal

AIMS: Finerenone reduces the risk of cardiovascular events in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). We investigated the causes of mortality in the FIDELITY population. METHODS AND RESULTS: The FIDELITY prespecified pooled data analysis from FIDELIO-DKD and FIGARO-DKD excluded patients with heart failure and reduced ejection fraction. Outcomes included intention-to-treat and prespecified on-treatment analyses of the risk of all-cause and cardiovascular mortality. Of 13 026 patients [mean age, 64.8 years; mean estimated glomerular filtration rate (eGFR), 57.6 mL/min/1.73 m2], 99.8% were on renin-angiotensin system inhibitors. Finerenone reduced the incidence of all-cause and cardiovascular mortality vs. placebo (8.5% vs. 9.4% and 4.9% vs. 5.6%, respectively) and demonstrated significant on-treatment reductions [hazard ratio (HR), 0.82; 95% confidence interval (CI), 0.70-0.96; P = 0.014 and HR, 0.82; 95% CI, 0.67-0.99; P = 0.040, respectively]. Cardiovascular-related mortality was most common, and finerenone lowered the incidence of sudden cardiac death vs. placebo [1.3% (incidence rate 0.44/100 patient-years) vs. 1.8% (0.58/100 patient-years), respectively; HR, 0.75; 95% CI, 0.57-0.996; P = 0.046]. The effects of finerenone on mortality were similar across all Kidney Disease: Improving Global Outcomes risk groups. Event probability with finerenone at 4 years was consistent irrespective of baseline urine albumin-to-creatinine ratio, but seemingly more pronounced in patients with higher baseline eGFR. CONCLUSION: In FIDELITY, finerenone significantly reduced the risk of all-cause and cardiovascular mortality vs. placebo in patients with T2D across a broad spectrum of CKD stages while on treatment, as well as sudden cardiac death in the intention-to-treat population. CLINICAL TRIALS REGISTRATION: FIDELIO-DKD and FIGARO-DKD are registered with ClinicalTrials.gov, numbers NCT02540993 and NCT02545049, respectively (funded by Bayer AG).

Original languageEnglish
JournalEuropean heart journal. Cardiovascular pharmacotherapy
Volume9
Issue number2
Pages (from-to)183-191
Number of pages9
ISSN2055-6837
DOIs
Publication statusPublished - 2023

Bibliographical note

Publisher Copyright:
© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.

    Research areas

  • All-cause mortality, Cardiovascular mortality, Chronic kidney disease, Finerenone, Non-steroidal MRA, Type 2 diabetes

ID: 366827673