Trial reportBMJ open2024
Finerenone cardiovascular and kidney outcomes by age and sex: FIDELITY post hoc analysis of two phase 3, multicentre, double-blind trials.
Trial report in BMJ open, 2024. 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 16 papers, 2 of them syntheses that pooled 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.
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.
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
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.
Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.
- 2026 AHA/ACC/ADA/ASN Guideline for the Prevention, Detection, Evaluation, and Management of Cardiovascular-Kidney-Metabolic Syndrome: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.Journal of the American College of Cardiology · 2026Guideline
- Causal insights into major risk factors for diabetic kidney disease: a comprehensive meta-analysis and Mendelian randomization study.Renal failure · 2025Pooled it
- A study on risk factors for the progression from T2DM to end-stage renal disease based on Mendelian randomization and logistic regression analysis.Renal failure · 2026Article
- Lost in Stratification: Age Subgroup Analyses in CKD Progression Trials.Kidney international reports · 2026Article
- Efficacy and Safety of Finerenone in Patients Aged 65 Years or Older with Diabetic Kidney Disease: Subgroup Analysis of the FINDKDLATAM Study.Medicina (Kaunas, Lithuania) · 2026Observational
- Unveiling the role of aldosterone in metabolic dysfunction-associated steatotic liver disease.Reviews in endocrine & metabolic disorders · 2026Review
- [Sex and gender-specific aspects in prediabetes and diabetes mellitus - Clinical recommendations (Update 2026)].Wiener klinische Wochenschrift · 2026Review
- Effect of Finerenone Treatment Discontinuation on Kidney and Cardiovascular Outcomes: A Fidelity Analysis.American journal of nephrology · 2026Article
- Finerenone in mildly reduced or preserved ejection fraction and chronic kidney disease: a narrative review.The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology · 2026Review
- The nonsteroidal MR antagonist finerenone reverses Western diet-induced kidney disease by regulating mitochondrial and lipid metabolism and inflammation.American journal of physiology. Renal physiology · 2025Article
- Dosing, treatment patterns and safety of finerenone use in routine care: an interim analysis of the prospective, real-world and observational FINE-REAL study.Clinical kidney journal · 2025Article
- Review
- Sex differences in diagnosis and treatment of heart failure: toward precision medicine.The Korean journal of internal medicine · 2025Review
- Finerenone: A Third-Generation MRA and Its Impact on Cardiovascular Health-Insights from Randomized Controlled Trials.Journal of clinical medicine · 2024Review
- Review
- Sex-related differences in heart failure patients: physiological mechanisms of cardiovascular ageing and evidence-based sex-specific medical therapies.Therapeutic advances in cardiovascular diseaseReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 11 institutions in 8 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThis study aimed to evaluate the efficacy and safety of finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist, on cardiovascular and kidney outcomes by age and/or sex.
designFIDELITY post hoc analysis; median follow-up of 3 years.
settingFIDELITY: a prespecified analysis of the FIDELIO-DKD and FIGARO-DKD trials.
participantsAdults with type 2 diabetes and chronic kidney disease receiving optimised renin-angiotensin system inhibitors (N=13 026).
interventionsRandomised 1:1; finerenone or placebo. PRIMARY AND SECONDARY OUTCOME MEASURES: Cardiovascular (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for heart failure (HHF)) and kidney (kidney failure, sustained ≥57% estimated glomerular filtration rate (eGFR) decline or renal death) composite outcomes.
resultsMean age was 64.8 years; 45.2%, 40.1% and 14.7% were aged <65, 65-74 and ≥75 years, respectively; 69.8% were male. Cardiovascular benefits of finerenone versus placebo were consistent across age (HR 0.94 (95% CI 0.81 to 1.10) (<65 years), HR 0.84 (95% CI 0.73 to 0.98) (65-74 years), HR 0.80 (95% CI 0.65 to 0.99) (≥75 years); P
conclusionsFinerenone improved cardiovascular and kidney composite outcomes with no significant heterogeneity between age and sex subgroups; however, the effect on HHF appeared more pronounced in males. Finerenone demonstrated a similar safety profile across age and sex subgroups. TRIAL REGISTRATION NUMBERS: NCT02540993, NCT02545049.
Indexed as
Identifiers
What Socratic holds
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 Socratic graph.