Finerenone cardiovascular and kidney outcomes by age and sex: FIDELITY post hoc analysis of two phase 3, multicentre, double-blind trials

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 analys...

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Published inBMJ open Vol. 14; no. 3; p. e076444
Main Authors Bansal, Shweta, Canziani, Maria E F, Birne, Rita, Anker, Stefan D, Bakris, George L, Filippatos, Gerasimos, Rossing, Peter, Ruilope, Luis M, Farjat, Alfredo E, Kolkhof, Peter, Lage, Andrea, Brinker, Meike, Pitt, Bertram
Format Journal Article
LanguageEnglish
Published England British Medical Journal Publishing Group 19.03.2024
BMJ Publishing Group LTD
BMJ Publishing Group
SeriesOriginal research
Subjects
Adult
Age
Blood pressure
cardiovascular disease
Clinical outcomes
Clinical trials
Diabetes
diabetes & endocrinology
Diabetes and Endocrinology
Diabetes Mellitus, Type 2 - complications
diabetic nephropathy & vascular disease
Double-Blind Method
Female
Females
Heart Failure - complications
Hormones
Humans
Kidney
Kidney diseases
Male
Males
Middle Aged
Naphthyridines - therapeutic use
Patients
Potassium
Renal Insufficiency, Chronic - complications
Renal Insufficiency, Chronic - drug therapy
risk factors
cardiovascular disease
risk factors
diabetic nephropathy & vascular disease
diabetes & endocrinology
Online AccessGet full text
ISSN2044-6055
2044-6055
DOI10.1136/bmjopen-2023-076444

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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 measuresCardiovascular (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); Pinteraction=0.42) and sex categories (HR 0.86 (95% CI 0.77 to 0.96) (male), HR 0.89 (95% CI 0.35 to 2.27) (premenopausal female), HR 0.87 (95% CI 0.73 to 1.05) (postmenopausal female); Pinteraction=0.99). Effects on HHF reduction were not modified by age (Pinteraction=0.70) but appeared more pronounced in males (Pinteraction=0.02). Kidney events were reduced with finerenone versus placebo in age groups <65 and 65–74 but not ≥75; no heterogeneity in treatment effect was observed (Pinteraction=0.51). In sex subgroups, finerenone consistently reduced kidney events (Pinteraction=0.85). Finerenone reduced albuminuria and eGFR decline regardless of age and sex. Hyperkalaemia increased with finerenone, but discontinuation rates were <3% across subgroups. Gynaecomastia in males was uncommon across age subgroups and identical between treatment groups.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 numbersNCT02540993, NCT02545049.
AbstractList This 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.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.FIDELITY post hoc analysis; median follow-up of 3 years.DESIGNFIDELITY post hoc analysis; median follow-up of 3 years.FIDELITY: a prespecified analysis of the FIDELIO-DKD and FIGARO-DKD trials.SETTINGFIDELITY: a prespecified analysis of the FIDELIO-DKD and FIGARO-DKD trials.Adults with type 2 diabetes and chronic kidney disease receiving optimised renin-angiotensin system inhibitors (N=13 026).PARTICIPANTSAdults with type 2 diabetes and chronic kidney disease receiving optimised renin-angiotensin system inhibitors (N=13 026).Randomised 1:1; finerenone or placebo.INTERVENTIONSRandomised 1:1; finerenone or placebo.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.PRIMARY AND SECONDARY OUTCOME MEASURESCardiovascular (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.Mean 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); Pinteraction=0.42) and sex categories (HR 0.86 (95% CI 0.77 to 0.96) (male), HR 0.89 (95% CI 0.35 to 2.27) (premenopausal female), HR 0.87 (95% CI 0.73 to 1.05) (postmenopausal female); Pinteraction=0.99). Effects on HHF reduction were not modified by age (Pinteraction=0.70) but appeared more pronounced in males (Pinteraction=0.02). Kidney events were reduced with finerenone versus placebo in age groups <65 and 65-74 but not ≥75; no heterogeneity in treatment effect was observed (Pinteraction=0.51). In sex subgroups, finerenone consistently reduced kidney events (Pinteraction=0.85). Finerenone reduced albuminuria and eGFR decline regardless of age and sex. Hyperkalaemia increased with finerenone, but discontinuation rates were <3% across subgroups. Gynaecomastia in males was uncommon across age subgroups and identical between treatment groups.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); Pinteraction=0.42) and sex categories (HR 0.86 (95% CI 0.77 to 0.96) (male), HR 0.89 (95% CI 0.35 to 2.27) (premenopausal female), HR 0.87 (95% CI 0.73 to 1.05) (postmenopausal female); Pinteraction=0.99). Effects on HHF reduction were not modified by age (Pinteraction=0.70) but appeared more pronounced in males (Pinteraction=0.02). Kidney events were reduced with finerenone versus placebo in age groups <65 and 65-74 but not ≥75; no heterogeneity in treatment effect was observed (Pinteraction=0.51). In sex subgroups, finerenone consistently reduced kidney events (Pinteraction=0.85). Finerenone reduced albuminuria and eGFR decline regardless of age and sex. Hyperkalaemia increased with finerenone, but discontinuation rates were <3% across subgroups. Gynaecomastia in males was uncommon across age subgroups and identical between treatment groups.Finerenone 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.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.NCT02540993, NCT02545049.TRIAL REGISTRATION NUMBERSNCT02540993, NCT02545049.
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 measuresCardiovascular (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); Pinteraction=0.42) and sex categories (HR 0.86 (95% CI 0.77 to 0.96) (male), HR 0.89 (95% CI 0.35 to 2.27) (premenopausal female), HR 0.87 (95% CI 0.73 to 1.05) (postmenopausal female); Pinteraction=0.99). Effects on HHF reduction were not modified by age (Pinteraction=0.70) but appeared more pronounced in males (Pinteraction=0.02). Kidney events were reduced with finerenone versus placebo in age groups <65 and 65–74 but not ≥75; no heterogeneity in treatment effect was observed (Pinteraction=0.51). In sex subgroups, finerenone consistently reduced kidney events (Pinteraction=0.85). Finerenone reduced albuminuria and eGFR decline regardless of age and sex. Hyperkalaemia increased with finerenone, but discontinuation rates were <3% across subgroups. Gynaecomastia in males was uncommon across age subgroups and identical between treatment groups.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 numbersNCT02540993, NCT02545049.
This 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. FIDELITY post hoc analysis; median follow-up of 3 years. FIDELITY: a prespecified analysis of the FIDELIO-DKD and FIGARO-DKD trials. Adults with type 2 diabetes and chronic kidney disease receiving optimised renin-angiotensin system inhibitors (N=13 026). Randomised 1:1; finerenone or placebo. 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. Mean 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 =0.42) and sex categories (HR 0.86 (95% CI 0.77 to 0.96) (male), HR 0.89 (95% CI 0.35 to 2.27) (premenopausal female), HR 0.87 (95% CI 0.73 to 1.05) (postmenopausal female); P =0.99). Effects on HHF reduction were not modified by age (P =0.70) but appeared more pronounced in males (P =0.02). Kidney events were reduced with finerenone versus placebo in age groups <65 and 65-74 but not ≥75; no heterogeneity in treatment effect was observed (P =0.51). In sex subgroups, finerenone consistently reduced kidney events (P =0.85). Finerenone reduced albuminuria and eGFR decline regardless of age and sex. Hyperkalaemia increased with finerenone, but discontinuation rates were <3% across subgroups. Gynaecomastia in males was uncommon across age subgroups and identical between treatment groups. Finerenone 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. NCT02540993, NCT02545049.
Objectives This 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.Design FIDELITY post hoc analysis; median follow-up of 3 years.Setting FIDELITY: a prespecified analysis of the FIDELIO-DKD and FIGARO-DKD trials.Participants Adults with type 2 diabetes and chronic kidney disease receiving optimised renin–angiotensin system inhibitors (N=13 026).Interventions Randomised 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.Results Mean 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); Pinteraction=0.42) and sex categories (HR 0.86 (95% CI 0.77 to 0.96) (male), HR 0.89 (95% CI 0.35 to 2.27) (premenopausal female), HR 0.87 (95% CI 0.73 to 1.05) (postmenopausal female); Pinteraction=0.99). Effects on HHF reduction were not modified by age (Pinteraction=0.70) but appeared more pronounced in males (Pinteraction=0.02). Kidney events were reduced with finerenone versus placebo in age groups <65 and 65–74 but not ≥75; no heterogeneity in treatment effect was observed (Pinteraction=0.51). In sex subgroups, finerenone consistently reduced kidney events (Pinteraction=0.85). Finerenone reduced albuminuria and eGFR decline regardless of age and sex. Hyperkalaemia increased with finerenone, but discontinuation rates were <3% across subgroups. Gynaecomastia in males was uncommon across age subgroups and identical between treatment groups.Conclusions Finerenone 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.
Author Farjat, Alfredo E
Anker, Stefan D
Lage, Andrea
Kolkhof, Peter
Filippatos, Gerasimos
Brinker, Meike
Bansal, Shweta
Bakris, George L
Rossing, Peter
Pitt, Bertram
Canziani, Maria E F
Birne, Rita
Ruilope, Luis M
AuthorAffiliation 11 CIBER-CV , Hospital Universitario 12 de Octubre , Madrid , Spain
17 Department of Medicine , University of Michigan School of Medicine , Ann Arbor , Michigan , USA
10 Cardiorenal Translational Laboratory and Hypertension Unit , Institute of Research imas12 , Madrid , Spain
2 Nephrology Division , Federal University of São Paulo , São Paulo , Brazil
16 Cardiology and Nephrology Clinical Development , Bayer AG , Wuppertal , Germany
3 Department of Nephrology , Centro Hospitalar Lisboa Ocidental , Lisbon , Portugal
13 Research and Development, Clinical Data Sciences and Analytics , Bayer PLC , Reading , UK
7 National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital , Athens , Greece
14 Research and Early Development, Cardiovascular Precision Medicines , Bayer AG , Wuppertal , Germany
5 Department of Cardiology (CVK) of German Heart Center Charité; German Centre for Cardiovascular Research (DZHK) partner Site Berlin , Charité Univer
AuthorAffiliation_xml – name: 15 Cardiology and Nephrology Clinical Development , Bayer SA , São Paulo , Brazil
– name: 17 Department of Medicine , University of Michigan School of Medicine , Ann Arbor , Michigan , USA
– name: 3 Department of Nephrology , Centro Hospitalar Lisboa Ocidental , Lisbon , Portugal
– name: 6 Department of Medicine , University of Chicago Medicine , Chicago , Illinois , USA
– name: 12 Faculty of Sport Sciences , European University of Madrid , Madrid , Spain
– name: 13 Research and Development, Clinical Data Sciences and Analytics , Bayer PLC , Reading , UK
– name: 4 Nova Medical School , University of Lisbon , Lisbon , Portugal
– name: 2 Nephrology Division , Federal University of São Paulo , São Paulo , Brazil
– name: 7 National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital , Athens , Greece
– name: 9 Department of Clinical Medicine , University of Copenhagen , Copenhagen , Denmark
– name: 11 CIBER-CV , Hospital Universitario 12 de Octubre , Madrid , Spain
– name: 14 Research and Early Development, Cardiovascular Precision Medicines , Bayer AG , Wuppertal , Germany
– name: 8 Steno Diabetes Center Copenhagen , Gentofte , Denmark
– name: 10 Cardiorenal Translational Laboratory and Hypertension Unit , Institute of Research imas12 , Madrid , Spain
– name: 5 Department of Cardiology (CVK) of German Heart Center Charité; German Centre for Cardiovascular Research (DZHK) partner Site Berlin , Charité Universitätsmedizin , Berlin , Germany
– name: 1 Division of Nephrology, Department of Medicine , University of Texas Health San Antonio , San Antonio , Texas , USA
– name: 16 Cardiology and Nephrology Clinical Development , Bayer AG , Wuppertal , Germany
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  givenname: Shweta
  surname: Bansal
  fullname: Bansal, Shweta
  email: bansals3@uthscsa.edu
  organization: Division of Nephrology, Department of Medicine, University of Texas Health San Antonio, San Antonio, Texas, USA
– sequence: 2
  givenname: Maria E F
  surname: Canziani
  fullname: Canziani, Maria E F
  organization: Nephrology Division, Federal University of São Paulo, São Paulo, Brazil
– sequence: 3
  givenname: Rita
  surname: Birne
  fullname: Birne, Rita
  organization: Nova Medical School, University of Lisbon, Lisbon, Portugal
– sequence: 4
  givenname: Stefan D
  surname: Anker
  fullname: Anker, Stefan D
  organization: Department of Cardiology (CVK) of German Heart Center Charité; German Centre for Cardiovascular Research (DZHK) partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany
– sequence: 5
  givenname: George L
  surname: Bakris
  fullname: Bakris, George L
  organization: Department of Medicine, University of Chicago Medicine, Chicago, Illinois, USA
– sequence: 6
  givenname: Gerasimos
  surname: Filippatos
  fullname: Filippatos, Gerasimos
  organization: National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens, Greece
– sequence: 7
  givenname: Peter
  surname: Rossing
  fullname: Rossing, Peter
  organization: Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
– sequence: 8
  givenname: Luis M
  surname: Ruilope
  fullname: Ruilope, Luis M
  organization: Faculty of Sport Sciences, European University of Madrid, Madrid, Spain
– sequence: 9
  givenname: Alfredo E
  surname: Farjat
  fullname: Farjat, Alfredo E
  organization: Research and Development, Clinical Data Sciences and Analytics, Bayer PLC, Reading, UK
– sequence: 10
  givenname: Peter
  surname: Kolkhof
  fullname: Kolkhof, Peter
  organization: Research and Early Development, Cardiovascular Precision Medicines, Bayer AG, Wuppertal, Germany
– sequence: 11
  givenname: Andrea
  surname: Lage
  fullname: Lage, Andrea
  organization: Cardiology and Nephrology Clinical Development, Bayer SA, São Paulo, Brazil
– sequence: 12
  givenname: Meike
  surname: Brinker
  fullname: Brinker, Meike
  organization: Cardiology and Nephrology Clinical Development, Bayer AG, Wuppertal, Germany
– sequence: 13
  givenname: Bertram
  surname: Pitt
  fullname: Pitt, Bertram
  organization: Department of Medicine, University of Michigan School of Medicine, Ann Arbor, Michigan, USA
BackLink https://www.ncbi.nlm.nih.gov/pubmed/38508632$$D View this record in MEDLINE/PubMed
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DOI 10.1136/bmjopen-2023-076444
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Issue 3
Keywords cardiovascular disease
risk factors
diabetic nephropathy & vascular disease
diabetes & endocrinology
Language English
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Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
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Snippet ObjectivesThis study aimed to evaluate the efficacy and safety of finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist, on...
This study aimed to evaluate the efficacy and safety of finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist, on cardiovascular and...
Objectives This study aimed to evaluate the efficacy and safety of finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist, on...
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StartPage e076444
SubjectTerms Adult
Age
Blood pressure
cardiovascular disease
Clinical outcomes
Clinical trials
Diabetes
diabetes & endocrinology
Diabetes and Endocrinology
Diabetes Mellitus, Type 2 - complications
diabetic nephropathy & vascular disease
Double-Blind Method
Female
Females
Heart Failure - complications
Hormones
Humans
Kidney
Kidney diseases
Male
Males
Middle Aged
Naphthyridines - therapeutic use
Patients
Potassium
Renal Insufficiency, Chronic - complications
Renal Insufficiency, Chronic - drug therapy
risk factors
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Title Finerenone cardiovascular and kidney outcomes by age and sex: FIDELITY post hoc analysis of two phase 3, multicentre, double-blind trials
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