Finerenone in patients with chronic kidney disease and type 2 diabetes with and without heart failure: a prespecified subgroup analysis of the FIDELIO-DKD trial
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Dokumenter
- Fulltext
Forlagets udgivne version, 599 KB, PDF-dokument
Aims: This prespecified analysis of the FIDELIO-DKD trial compared the effects of finerenone, a selective non-steroidal mineralocorticoid receptor antagonist, on cardiorenal outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) by history of heart failure (HF). Methods and results: Patients with T2D and CKD (urine albumin-to-creatinine ratio ≥30–5000 mg/g and estimated glomerular filtration rate [eGFR] ≥25–<75 ml/min/1.73 m2), without symptomatic HF with reduced ejection fraction (New York Heart Association II–IV) and treated with optimized renin–angiotensin system blockade were randomized to finerenone or placebo. The composite cardiovascular (CV) outcome (CV death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for HF) and composite kidney outcome (kidney failure, sustained ≥40% decrease in eGFR from baseline, or renal death) were analysed by investigator-reported medical history of HF. Of 5674 patients, 436 (7.7%) had a history of HF. Over a median follow-up of 2.6 years, the effect of finerenone compared with placebo on the composite CV outcome was consistent in patients with and without a history of HF (hazard ratio [HR] 0.73, 95% confidence interval [CI] 0.50–1.06 and HR 0.90, 95% CI 0.77–1.04, respectively; interaction p = 0.33). The effect of finerenone on the composite kidney outcome did not differ by history of HF (HR 0.79, 95% CI 0.52–1.20 and HR 0.83, 95% CI 0.73–0.94, respectively; interaction p = 0.83). Conclusion: In FIDELIO-DKD, finerenone improved cardiorenal outcome in patients with CKD and T2D irrespective of baseline HF history.
Originalsprog | Engelsk |
---|---|
Tidsskrift | European Journal of Heart Failure |
Vol/bind | 24 |
Udgave nummer | 6 |
Sider (fra-til) | 996-1005 |
Antal sider | 10 |
ISSN | 1388-9842 |
DOI | |
Status | Udgivet - 2022 |
Bibliografisk note
Funding Information:
This work, and the FIDELIO-DKD study was conducted and funded by Bayer AG. The funder participated in study design, data collection, data analysis, data interpretation, and approval of the manuscript. Analyses were conducted by the sponsor, and all authors had access to and participated in the interpretation of the data. Conflict of interest: G.F. reports lectures fees and/or that he is a committee member of trials and registries sponsored by Amgen, Bayer, Boehringer Ingelheim, Medtronic, Novartis, Servier, and Vifor Pharma; he is a Senior Consulting Editor for JACC Heart Failure and has received research support from the European Union. B.P. reports consultant fees for Ardelyx, AstraZeneca, Bayer, Boehringer Ingelheim, Brainstorm Medical, Cereno Scientific, G3 Pharmaceuticals, KBP Biosciences, PhaseBio, Sanofi/Lexicon, Sarfez, scPharmaceuticals, SQ Innovation, Tricida, and Vifor/Relypsa; he has stock options for Brainstorm Medical, Cereno Scientific, G3 Pharmaceuticals, KBP Biosciences, Sarfez, scPharmaceuticals, SQ Innovation, Tricida, and Vifor/Relypsa; he also holds a patent for site-specific delivery of eplerenone to the myocardium (US patent #9931412) and a provisional patent for histone-acetylation-modulating agents for the treatment and prevention of organ injury (provisional patent US 63/045784). R.A. reports personal fees and non-financial support from Bayer Healthcare Pharmaceuticals Inc. during the conduct of the study; he also reports personal fees and non-financial support from Akebia Therapeutics, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Fresenius Kabi, Janssen, Relypsa, Sanofi, and Vifor Pharma; he has received personal fees from Ironwood Pharmaceuticals, Lexicon Pharmaceuticals, Merck & Co., and Reata, and non-financial support from E. R. Squibb & Sons, Opko Health, and Otsuka Pharmaceuticals America; he is a member of data safety monitoring committees for Amgen, AstraZeneca, and Celgene, a member of steering committees of randomized trials for Akebia Therapeutics, Bayer, Janssen, and Relypsa and a member of adjudication committees for AbbVie, Bayer, Boehringer Ingelheim, and Janssen; he has served as Associate Editor of the American Journal of Nephrology and Nephrology Dialysis and Transplantation and has been an author for UpToDate, and he has received research grants from the U.S. Veterans Administration and the National Institutes of Health. D.F. has received personal fees for lectures and/or consultation from Abbott Laboratories, Bayer, Boehringer Ingelheim, Leo, Novartis, Orion, and Roche Diagnostics outside the submitted work. L.M.R. reports receipt of consultancy fees from Bayer. P.R. reports personal fees from Bayer during the conduct of the study; he has received research support and personal fees from AstraZeneca and Novo Nordisk, and personal fees from Astellas Pharma, Boehringer Ingelheim, Eli Lilly, Gilead Sciences, Mundipharma, Sanofi, and Vifor Pharma; all fees are given to Steno Diabetes Center, Copenhagen; he has an equity interest in Novo Nordisk. J.B. received honoraria for lectures/consulting from Abiomed, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Cardior, CVRx, Daiichi-Sankyo, Medtronic, MSD, Novartis, Orion, Pfizer, Servier, and Vifor Pharma; and research support from Abiomed, CVRx, Vifor Pharma, and Zoll unrelated to this paper. R.J.M. has received research support and honoraria from Abbott, American Regent, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim/Eli Lilly, Boston Scientific, Cytokinetics, Fast BioMedical, Gilead, Innolife, Medtronic, Merck, Novartis, Relypsa, Respicardia, Roche, Sanofi, Vifor Pharma, and Windtree Therapeutics. P.K. is a full-time employee of Bayer AG, Division Pharmaceuticals, Germany. He is the co-inventor of finerenone and holds US and European patents relating to finerenone (US8436180B2 and EP2132206B1). C.S. is a full-time employee of Bayer PLC, Division Pharmaceuticals, United Kingdom. A.J. is a full-time employee of Bayer AG, Division Pharmaceuticals, Germany. G.L.B. reports research funding paid to the University of Chicago Medicine from Bayer, during the conduct of the study; he also reports research funding paid to the University of Chicago Medicine from Novo Nordisk and Vascular Dynamics; he acted as a consultant for and received personal fees from Merck, Relypsa, and Alnylam Pharmaceuticals; he is an Editor of the American Journal of Nephrology, Nephrology and Hypertension, and Section Editor of UpToDate, he is also an Associate Editor of Diabetes Care and Hypertension Research. S.D.A. has received research support from Abbott Vascular and Vifor Pharma, and personal fees from Abbott Vascular, Boehringer Ingelheim, Bayer, BRAHMS, Novartis, Servier, Vifor Pharma, Impulse Dynamics, and Cardiac Dimensions. We are indebted to the patients, investigators, and centres who supported FIDELIO-DKD. The Executive Committee designed the study in conjunction with the sponsor. Prof. Filippatos wrote the first draft of the report and assumes responsibility for the integrity and accuracy of the data. All authors had access to study results and were involved in data analysis, interpretation, drafting and revising the report. All authors reviewed and approved the final version. Additional statistical review/assistance was provided by Christoph Tasto and Luke Roberts (Bayer AG). Medical writing assistance was provided by Richard Starke, of Chameleon Communications International, and was funded by Bayer AG. This work, and the FIDELIO-DKD study was conducted and funded by Bayer AG. The funder participated in study design, data collection, data analysis, data interpretation, and approval of the manuscript. Analyses were conducted by the sponsor, and all authors had access to and participated in the interpretation of the data. Conflict of interest: G.F. reports lectures fees and/or that he is a committee member of trials and registries sponsored by Amgen, Bayer, Boehringer Ingelheim, Medtronic, Novartis, Servier, and Vifor Pharma; he is a Senior Consulting Editor for JACC Heart Failure and has received research support from the European Union. B.P. reports consultant fees for Ardelyx, AstraZeneca, Bayer, Boehringer Ingelheim, Brainstorm Medical, Cereno Scientific, G3 Pharmaceuticals, KBP Biosciences, PhaseBio, Sanofi/Lexicon, Sarfez, scPharmaceuticals, SQ Innovation, Tricida, and Vifor/Relypsa; he has stock options for Brainstorm Medical, Cereno Scientific, G3 Pharmaceuticals, KBP Biosciences, Sarfez, scPharmaceuticals, SQ Innovation, Tricida, and Vifor/Relypsa; he also holds a patent for site-specific delivery of eplerenone to the myocardium (US patent #9931412) and a provisional patent for histone-acetylation-modulating agents for the treatment and prevention of organ injury (provisional patent US 63/045784). R.A. reports personal fees and non-financial support from Bayer Healthcare Pharmaceuticals Inc. during the conduct of the study; he also reports personal fees and non-financial support from Akebia Therapeutics, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Fresenius Kabi, Janssen, Relypsa, Sanofi, and Vifor Pharma; he has received personal fees from Ironwood Pharmaceuticals, Lexicon Pharmaceuticals, Merck & Co., and Reata, and non-financial support from E. R. Squibb & Sons, Opko Health, and Otsuka Pharmaceuticals America; he is a member of data safety monitoring committees for Amgen, AstraZeneca, and Celgene, a member of steering committees of randomized trials for Akebia Therapeutics, Bayer, Janssen, and Relypsa and a member of adjudication committees for AbbVie, Bayer, Boehringer Ingelheim, and Janssen; he has served as Associate Editor of the American Journal of Nephrology and Nephrology Dialysis and Transplantation and has been an author for UpToDate, and he has received research grants from the U.S. Veterans Administration and the National Institutes of Health. D.F. has received personal fees for lectures and/or consultation from Abbott Laboratories, Bayer, Boehringer Ingelheim, Leo, Novartis, Orion, and Roche Diagnostics outside the submitted work. L.M.R. reports receipt of consultancy fees from Bayer. P.R. reports personal fees from Bayer during the conduct of the study; he has received research support and personal fees from AstraZeneca and Novo Nordisk, and personal fees from Astellas Pharma, Boehringer Ingelheim, Eli Lilly, Gilead Sciences, Mundipharma, Sanofi, and Vifor Pharma; all fees are given to Steno Diabetes Center, Copenhagen; he has an equity interest in Novo Nordisk. J.B. received honoraria for lectures/consulting from Abiomed, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Cardior, CVRx, Daiichi-Sankyo, Medtronic, MSD, Novartis, Orion, Pfizer, Servier, and Vifor Pharma; and research support from Abiomed, CVRx, Vifor Pharma, and Zoll unrelated to this paper. R.J.M. has received research support and honoraria from Abbott, American Regent, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim/Eli Lilly, Boston Scientific, Cytokinetics, Fast BioMedical, Gilead, Innolife, Medtronic, Merck, Novartis, Relypsa, Respicardia, Roche, Sanofi, Vifor Pharma, and Windtree Therapeutics. P.K. is a full-time employee of Bayer AG, Division Pharmaceuticals, Germany. He is the co-inventor of finerenone and holds US and European patents relating to finerenone (US8436180B2 and EP2132206B1). C.S. is a full-time employee of Bayer PLC, Division Pharmaceuticals, United Kingdom. A.J. is a full-time employee of Bayer AG, Division Pharmaceuticals, Germany. G.L.B. reports research funding paid to the University of Chicago Medicine from Bayer, during the conduct of the study; he also reports research funding paid to the University of Chicago Medicine from Novo Nordisk and Vascular Dynamics; he acted as a consultant for and received personal fees from Merck, Relypsa, and Alnylam Pharmaceuticals; he is an Editor of the American Journal of Nephrology, Nephrology and Hypertension, and Section Editor of UpToDate, he is also an Associate Editor of Diabetes Care and Hypertension Research. S.D.A. has received research support from Abbott Vascular and Vifor Pharma, and personal fees from Abbott Vascular, Boehringer Ingelheim, Bayer, BRAHMS, Novartis, Servier, Vifor Pharma, Impulse Dynamics, and Cardiac Dimensions.
Publisher Copyright:
© 2022 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.
Antal downloads er baseret på statistik fra Google Scholar og www.ku.dk
ID: 328547892