Evidence map›Paper›PMID 38046911›Full record

ArticleKidney medicine2023

Finerenone in Black Patients With Type 2 Diabetes and CKD: A Post hoc Analysis of the Pooled FIDELIO-DKD and FIGARO-DKD Trials.

John M Flack, Rajiv Agarwal, Stefan D Anker, Bertram Pitt, Luis M Ruilope, Peter Rossing, Sharon G Adler, Linda Fried, Kenneth Jamerson, Robert Toto and 7 more

2 registry-linked trialsAbstract read
In one paragraph

Article in Kidney medicine, 2023. 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 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

6 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. Article
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

17 authors.

John M FlackDepartment of Medicine, Division of General Internal Medicine, Hypertension Section Southern Illinois University School of Medicine, Illinois, IL.
Rajiv AgarwalRichard L. Roudebush VA Medical Center and Indiana University, Indianapolis, IN.
Stefan D AnkerDepartment of Cardiology (CVK) of German Heart Center Charité; Institute of Health Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) partner site Berlin, Charité Universitätsmedizin, Berlin, Germany.
Bertram PittDepartment of Medicine, University of Michigan School of Medicine, Ann Arbor, MI.
Luis M RuilopeCardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain.
Peter RossingSteno Diabetes Center Copenhagen, Gentofte, Denmark.
Sharon G AdlerDivision of Nephrology and Hypertension, Harbor-UCLA Medical Center, Torrance, CA.
Linda FriedDepartment of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA.
Kenneth JamersonCardiology Clinic, University of Michigan, Ann Arbor, Michigan, MI.
Robert TotoDepartment of Internal Medicine, University of Texas Southwestern Medicine, Dallas, TX.
Meike BrinkerCardiology and Nephrology Clinical Development, Bayer AG, Wuppertal, Germany.
Alfredo E FarjatResearch and Development, Statistics and Data Insights, Bayer PLC, Reading, United Kingdom.
Peter KolkhofResearch and Development Cardiovascular Precision Medicines, Bayer AG, Wuppertal, Germany.
Robert LawatscheckCardiology and Nephrology Clinical Development, Bayer AG, Berlin, Germany.
Amer JosephCardiology and Nephrology Clinical Development, Bayer AG, Berlin, Germany.
George L BakrisDepartment of Medicine, University of Chicago Medicine, Chicago, IL.
FIDELIO-DKD and FIGARO-DKD Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Rationale & Objective: In FIDELITY, finerenone improved cardiorenal outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). This analysis explored the efficacy and safety of finerenone in Black patients. Study Design: Subanalysis of randomized controlled trials. Setting & Participants: Patients with T2D and CKD. Intervention: Finerenone or placebo. Outcomes: Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure; composite of kidney failure, sustained ≥57% estimated glomerular filtration rate (eGFR) decline from baseline maintained for ≥4 weeks, or renal death. Results: Of the 13,026 patients, 522 (4.0%) self-identified as Black. Finerenone demonstrated similar effects on the cardiovascular composite outcome in Black (HR, 0.79 [95% CI, 0.51-1.24]) and non-Black patients (HR, 0.87 [95% CI, 0.79-0.96; Limitations: Small number of Black patients; analysis was not originally powered to determine an interaction effect based on Black race. Conclusions: The efficacy and safety of finerenone appears consistent in Black and non-Black patients with CKD and T2D. Funding: Bayer AG. Trial Registration: ClinicalTrials.gov NCT02540993, NCT02545049. Plain-Language Summary: Diabetes is a major cause of chronic kidney disease (CKD), affecting more Black adults than White adults. Most adults with CKD ultimately die from heart and vascular complications (eg, heart attack and stroke) rather than kidney failure. This analysis of 2 recent trials shows that the drug finerenone was beneficial for patients with diabetes and CKD. Along with reducing kidney function decline and protein in the urine, it also decreased heart and vascular issues and lowered blood pressure in both Black and non-Black adults with diabetes and CKD. These findings have promising implications for slowing the progression of CKD and protecting against cardiovascular problems in diverse populations.

Indexed as

Cardiorenalchronic kidney diseaseclinical trialfinerenoneracetype 2 diabetes

Identifiers

PMID38046911
PMCPMC10692708

What OpenQuestion holds

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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.