Finerenone and left ventricular hypertrophy in chronic kidney disease and type 2 diabetes
Abstract Aims Left ventricular hypertrophy (LVH) has been associated with an increased risk of cardiovascular (CV) disease and linked to increased morbidity and mortality. In patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), hypertension is common, and patients with these co‐morb...
Saved in:
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2025-02-01
|
| Series: | ESC Heart Failure |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/ehf2.14962 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850186466376810496 |
|---|---|
| author | Gerasimos Filippatos Stefan D. Anker George L. Bakris Peter Rossing Luis M. Ruilope Andrew J.S. Coats Stephan vonHaehling Piotr Ponikowski Giuseppe M.C. Rosano Meike Brinker Alfredo E. Farjat Luke Roberts Bertram Pitt the FIDELIO‐DKD and FIGARO‐DKD investigators |
| author_facet | Gerasimos Filippatos Stefan D. Anker George L. Bakris Peter Rossing Luis M. Ruilope Andrew J.S. Coats Stephan vonHaehling Piotr Ponikowski Giuseppe M.C. Rosano Meike Brinker Alfredo E. Farjat Luke Roberts Bertram Pitt the FIDELIO‐DKD and FIGARO‐DKD investigators |
| author_sort | Gerasimos Filippatos |
| collection | DOAJ |
| description | Abstract Aims Left ventricular hypertrophy (LVH) has been associated with an increased risk of cardiovascular (CV) disease and linked to increased morbidity and mortality. In patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), hypertension is common, and patients with these co‐morbidities additionally have a high prevalence of LVH. This analysis of the prespecified pooled FIDELITY analysis comprising the randomized, double‐blind, placebo‐controlled, multicentre FIDELIO‐DKD and FIGARO‐DKD phase III studies aimed to explore the CV and kidney effects of finerenone, a nonsteroidal mineralocorticoid receptor antagonist, in patients with CKD and T2D stratified by a diagnosis of LVH at baseline. Methods and results A diagnosis of LVH in the FIDELITY patient population was determined at baseline using investigator‐reported electrocardiogram (ECG) findings. The two efficacy outcomes, assessed by baseline LVH, were the composite CV outcome of time to CV death, non‐fatal myocardial infarction, non‐fatal stroke, or hospitalization for heart failure (HHF), and a composite kidney outcome of time to onset of kidney failure, a sustained decrease in estimated glomerular filtration rate (eGFR) ≥57% from baseline over ≥4 weeks, or kidney‐related death. Safety outcomes by baseline LVH were reported as treatment‐emergent adverse events. At baseline out of 13 026 patients in FIDELITY, 96.5% had hypertension and 9.6% had investigator‐reported LVH. The relative risk reduction for the composite CV and kidney outcomes with finerenone versus placebo was lower in the LVH subgroup; however, the treatment effect of finerenone was not modified by baseline LVH for either outcome (Pinteraction = 0.1075 for composite CV outcome and Pinteraction = 0.1782 for composite kidney outcome). Analysis of the composite CV outcome components showed a greater reduction in the risk of HHF versus placebo for patients with baseline LVH compared with those without (Pinteraction = 0.0024). Overall safety events were comparable between the LVH subgroups and treatment arms. Treatment‐emergent hyperkalaemia was observed more frequently with finerenone versus placebo, but discontinuation rates were low in both treatment arms and between LVH subgroups. Conclusions In conclusion, the overall CV and kidney benefits of finerenone versus placebo were not modified by the presence of LVH at baseline, with overall safety findings being similar between LVH subgroups. A greater benefit was observed for HHF in patients with versus without LVH, suggesting that LVH may be a predictor of the treatment effect of finerenone on HHF. |
| format | Article |
| id | doaj-art-1910be4cba174c97aaef8e7f1fbcbb31 |
| institution | OA Journals |
| issn | 2055-5822 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Wiley |
| record_format | Article |
| series | ESC Heart Failure |
| spelling | doaj-art-1910be4cba174c97aaef8e7f1fbcbb312025-08-20T02:16:21ZengWileyESC Heart Failure2055-58222025-02-0112118518810.1002/ehf2.14962Finerenone and left ventricular hypertrophy in chronic kidney disease and type 2 diabetesGerasimos Filippatos0Stefan D. Anker1George L. Bakris2Peter Rossing3Luis M. Ruilope4Andrew J.S. Coats5Stephan vonHaehling6Piotr Ponikowski7Giuseppe M.C. Rosano8Meike Brinker9Alfredo E. Farjat10Luke Roberts11Bertram Pitt12the FIDELIO‐DKD and FIGARO‐DKD investigatorsNational and Kapodistrian University of Athens, School of Medicine Department of Cardiology Attikon University Hospital Athens GreeceDepartment of Cardiology (CVK) of German Heart Center Charité; German Centre for Cardiovascular Research (DZHK) partner site Berlin Charité Universitätsmedizin Berlin GermanyDepartment of Medicine University of Chicago Medicine Chicago IL USASteno Diabetes Center Copenhagen Herlev DenmarkCardiorenal Translational Laboratory and Hypertension Unit Institute of Research imas12 Madrid SpainHeart Research Institute Sydney AustraliaDepartment of Cardiology and Pneumology University Medical Center Göttingen (UMG) Göttingen GermanyInstitute of Heart Diseases, Medical University University Hospital Wroclaw PolandDepartment of Cardiology San Raffaele Cassino Cassino ItalyDepartment of Research and Development Bayer AG Wuppertal GermanyDepartment of Data Science and Analytics Bayer PLC Reading UKDepartment of Clinical Development Bayer PLC Reading UKDepartment of Medicine University of Michigan School of Medicine Ann Arbor MI USAAbstract Aims Left ventricular hypertrophy (LVH) has been associated with an increased risk of cardiovascular (CV) disease and linked to increased morbidity and mortality. In patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), hypertension is common, and patients with these co‐morbidities additionally have a high prevalence of LVH. This analysis of the prespecified pooled FIDELITY analysis comprising the randomized, double‐blind, placebo‐controlled, multicentre FIDELIO‐DKD and FIGARO‐DKD phase III studies aimed to explore the CV and kidney effects of finerenone, a nonsteroidal mineralocorticoid receptor antagonist, in patients with CKD and T2D stratified by a diagnosis of LVH at baseline. Methods and results A diagnosis of LVH in the FIDELITY patient population was determined at baseline using investigator‐reported electrocardiogram (ECG) findings. The two efficacy outcomes, assessed by baseline LVH, were the composite CV outcome of time to CV death, non‐fatal myocardial infarction, non‐fatal stroke, or hospitalization for heart failure (HHF), and a composite kidney outcome of time to onset of kidney failure, a sustained decrease in estimated glomerular filtration rate (eGFR) ≥57% from baseline over ≥4 weeks, or kidney‐related death. Safety outcomes by baseline LVH were reported as treatment‐emergent adverse events. At baseline out of 13 026 patients in FIDELITY, 96.5% had hypertension and 9.6% had investigator‐reported LVH. The relative risk reduction for the composite CV and kidney outcomes with finerenone versus placebo was lower in the LVH subgroup; however, the treatment effect of finerenone was not modified by baseline LVH for either outcome (Pinteraction = 0.1075 for composite CV outcome and Pinteraction = 0.1782 for composite kidney outcome). Analysis of the composite CV outcome components showed a greater reduction in the risk of HHF versus placebo for patients with baseline LVH compared with those without (Pinteraction = 0.0024). Overall safety events were comparable between the LVH subgroups and treatment arms. Treatment‐emergent hyperkalaemia was observed more frequently with finerenone versus placebo, but discontinuation rates were low in both treatment arms and between LVH subgroups. Conclusions In conclusion, the overall CV and kidney benefits of finerenone versus placebo were not modified by the presence of LVH at baseline, with overall safety findings being similar between LVH subgroups. A greater benefit was observed for HHF in patients with versus without LVH, suggesting that LVH may be a predictor of the treatment effect of finerenone on HHF.https://doi.org/10.1002/ehf2.14962Cardiorenal outcomesChronic kidney diseaseFinerenoneHospitalization for heart failureLeft ventricular hypertrophyType 2 diabetes |
| spellingShingle | Gerasimos Filippatos Stefan D. Anker George L. Bakris Peter Rossing Luis M. Ruilope Andrew J.S. Coats Stephan vonHaehling Piotr Ponikowski Giuseppe M.C. Rosano Meike Brinker Alfredo E. Farjat Luke Roberts Bertram Pitt the FIDELIO‐DKD and FIGARO‐DKD investigators Finerenone and left ventricular hypertrophy in chronic kidney disease and type 2 diabetes ESC Heart Failure Cardiorenal outcomes Chronic kidney disease Finerenone Hospitalization for heart failure Left ventricular hypertrophy Type 2 diabetes |
| title | Finerenone and left ventricular hypertrophy in chronic kidney disease and type 2 diabetes |
| title_full | Finerenone and left ventricular hypertrophy in chronic kidney disease and type 2 diabetes |
| title_fullStr | Finerenone and left ventricular hypertrophy in chronic kidney disease and type 2 diabetes |
| title_full_unstemmed | Finerenone and left ventricular hypertrophy in chronic kidney disease and type 2 diabetes |
| title_short | Finerenone and left ventricular hypertrophy in chronic kidney disease and type 2 diabetes |
| title_sort | finerenone and left ventricular hypertrophy in chronic kidney disease and type 2 diabetes |
| topic | Cardiorenal outcomes Chronic kidney disease Finerenone Hospitalization for heart failure Left ventricular hypertrophy Type 2 diabetes |
| url | https://doi.org/10.1002/ehf2.14962 |
| work_keys_str_mv | AT gerasimosfilippatos finerenoneandleftventricularhypertrophyinchronickidneydiseaseandtype2diabetes AT stefandanker finerenoneandleftventricularhypertrophyinchronickidneydiseaseandtype2diabetes AT georgelbakris finerenoneandleftventricularhypertrophyinchronickidneydiseaseandtype2diabetes AT peterrossing finerenoneandleftventricularhypertrophyinchronickidneydiseaseandtype2diabetes AT luismruilope finerenoneandleftventricularhypertrophyinchronickidneydiseaseandtype2diabetes AT andrewjscoats finerenoneandleftventricularhypertrophyinchronickidneydiseaseandtype2diabetes AT stephanvonhaehling finerenoneandleftventricularhypertrophyinchronickidneydiseaseandtype2diabetes AT piotrponikowski finerenoneandleftventricularhypertrophyinchronickidneydiseaseandtype2diabetes AT giuseppemcrosano finerenoneandleftventricularhypertrophyinchronickidneydiseaseandtype2diabetes AT meikebrinker finerenoneandleftventricularhypertrophyinchronickidneydiseaseandtype2diabetes AT alfredoefarjat finerenoneandleftventricularhypertrophyinchronickidneydiseaseandtype2diabetes AT lukeroberts finerenoneandleftventricularhypertrophyinchronickidneydiseaseandtype2diabetes AT bertrampitt finerenoneandleftventricularhypertrophyinchronickidneydiseaseandtype2diabetes AT thefideliodkdandfigarodkdinvestigators finerenoneandleftventricularhypertrophyinchronickidneydiseaseandtype2diabetes |