Evidence map›Paper›PMID 36251465›Full record

Trial reportEuropean heart journal. Cardiovascular pharmacotherapy2022

Finerenone efficacy in patients with chronic kidney disease, type 2 diabetes and atherosclerotic cardiovascular disease.

Gerasimos Filippatos, Stefan D Anker, Bertram Pitt, Darren K McGuire, Peter Rossing, Luis M Ruilope, Javed Butler, Ewa A Jankowska, Erin D Michos, Dimitrios Farmakis and 6 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial
In one paragraph

Trial report in European heart journal. Cardiovascular pharmacotherapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02540993 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate the Safety and Efficacy of Finerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

TypeinterventionalSponsorBayerRan2015 to 2020Enrolled5,734ConditionsChronic Kidney DiseaseArmsFinerenone (BAY94-8862), Placebo
NCT02545049 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate Efficacy and Safety of Finerenone on the Reduction of Cardiovascular Morbidity and Mortality in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease in Addition to Standard of Care.

TypeinterventionalSponsorBayerRan2015 to 2021Enrolled7,352ConditionsDiabetic Kidney DiseaseArmsFinerenone (BAY94-8862), Placebo
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
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  14. Combination therapy: an upcoming paradigm to improve kidney and cardiovascular outcomes in chronic kidney disease.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025
    Review
  15. Finerenone: a breakthrough mineralocorticoid receptor antagonist for heart failure, diabetes and chronic kidney disease.The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology · 2024
    Review
  16. The Role of Finerenone in Optimizing Cardiovascular-Kidney-Metabolic Health: Everything PCPs Should Know.Federal practitioner : for the health care professionals of the VA, DoD, and PHS · 2024
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 13 institutions in 8 countries.

Gerasimos FilippatosDepartment of Cardiology, School of Medicine, National and Kapodistrian University of Athens, Attikon University Hospital, Athens, Chaidari 12462, Greece.ORCID 0000-0002-5640-0332
Stefan D AnkerDepartment of Cardiology (CVK), and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, 10117 Berlin, Germany.ORCID 0000-0002-0805-8683
Bertram PittDepartment of Medicine, University of Michigan School of Medicine, Ann Arbor, MI 48109, USA.
Darren K McGuireThe Division of Cardiology, University of Texas Southwestern Medical Center, and Parkland Health and Hospital System, Dallas, TX 75390, USA.ORCID 0000-0002-6412-7989
Peter RossingSteno Diabetes Center Copenhagen, 2730 Herlev, Denmark.ORCID 0000-0002-1531-4294
Luis M RuilopeCardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, s/n, 28041, Madrid, Spain.
Javed ButlerBaylor Scott and White Research Institute, Dallas, TX 75204, USA.ORCID 0000-0001-7683-4720
Ewa A JankowskaInstitute of Heart Diseases, Wrocław Medical University, Borowska 213, 50-556 Wrocław , Poland.
Erin D MichosDivision of Cardiology, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.ORCID 0000-0002-5547-5084
Dimitrios FarmakisStatistics and Data Insights, University of Cyprus Medical School, Nicosia 2029, Cyprus.ORCID 0000-0001-8364-3447
Alfredo E FarjatResearch and Development, Statistics and Data Insights, Bayer PLC, Reading, RG2 6AD, UK.
Peter KolkhofResearch and Development, Cardiovascular Precision Medicines, Bayer AG, 42117, Wuppertal, Germany.ORCID 0000-0003-3425-7528
Andrea ScalisePharmaceutical Development, Bayer Hispania, S.L., 08970 Barcelona, Spain.
Amer JosephCardiology and Nephrology Clinical Development, Bayer AG, Berlin 13353, Germany.
George L BakrisDepartment of Medicine, University of Chicago Medicine, Chicago, IL 60637, USA.
Rajiv AgarwalRichard L. Roudebush VA Medical Center and Indiana University, Indianapolis, IN 46202, USA.
Bayer (Germany) · DEWroclaw Medical University · PLCentro de Investigación en Red en Enfermedades Cardiovasculares · ESHealth Data Research UK · GBJohns Hopkins University · USNational and Kapodistrian University of Athens · GRParkland Health & Hospital System · USRichard L. Roudebush VA Medical Center · USUniversity of Chicago · USUniversity of Copenhagen · DKUniversity of Cyprus · CYUniversity of Michigan · USUniversity of Mississippi · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsFinerenone, a selective, non-steroidal mineralocorticoid receptor antagonist, improves cardiovascular (CV) and kidney outcomes in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). This subgroup analysis of FIDELITY, a pre-specified, pooled, individual patient-data analysis of FIDELIO-DKD (NCT02540993) and FIGARO-DKD (NCT02545049), compared finerenone vs. placebo in patients with and without baseline history of atherosclerotic CV disease (ASCVD). METHODS AND

resultsOutcomes included a composite CV outcome [CV death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure (HHF)]; CV death or HHF; a composite kidney outcome (kidney failure, sustained estimated glomerular filtration rate decrease ≥57%, or kidney-related death); all-cause mortality; and safety by baseline history of ASCVD.Of 13 026 patients, 5935 (45.6%) had a history of ASCVD. The incidence of the composite CV outcome, CV death or HHF, and all-cause mortality was higher in patients with ASCVD vs. those without, with no difference between groups in the composite kidney outcome. Finerenone consistently reduced outcomes vs. placebo in patients with and without ASCVD (P-interaction for the composite CV outcome, CV death or HHF, the composite kidney outcome, and all-cause mortality 0.38, 0.68, 0.33, and 0.38, respectively). Investigator-reported treatment-emergent adverse events were consistent between treatment arms across ASCVD subgroups.

conclusionFinerenone reduced the risk of CV and kidney outcomes consistently across the spectrum of CKD in patients with T2D, irrespective of prevalent ASCVD.

Indexed as

AtherosclerosisCardiovascular DiseasesDiabetes Mellitus, Type 2Heart FailureRenal Insufficiency, ChronicDouble-Blind MethodHumansNaphthyridinesfinerenoneNaphthyridinesAtherosclerotic cardiovascular diseaseChronic kidney diseaseFinerenoneMineralocorticoid receptor antagonistType 2 diabetes

Identifiers

PMID36251465
PMCPMC9753093
OpenAlexW4306632750

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.