A prespecified exploratory analysis from FIDELITY examined finerenone use and kidney outcomes in patients with chronic kidney disease and type 2 diabetes

Abstract

In FIDELITY, a prespecified pooled analysis of the FIDELIO-DKD and FIGARO-DKD studies, finerenone was found to improve cardiorenal outcomes in patients with type 2 diabetes, a urine albumin-to-creatinine ratio of 30–5000 mg/g, an estimated glomerular filtration rate (eGFR) of 25 ml/min per 1.73 m2 or more and also receiving optimized renin-angiotensin system blockade treatment. This present analysis focused on the efficacy and safety of finerenone on kidney outcomes. Among 13,026 patients with a median follow-up of three years, finerenone significantly reduced the hazard of a kidney composite outcome (time to kidney failure, sustained 57% or more decrease in eGFR from baseline, or kidney death) by 23% versus placebo (hazard ratio, 0.77; 95% confidence interval, 0.67–0.88), with a three-year absolute between-group difference of 1.7% (95% confidence interval, 0.7–2.6). Hazard ratios were directionally consistent for a prespecified baseline eGFR and urine albumin-to-creatinine ratio categories (Pinteraction = 0.62 and Pinteraction = 0.67, respectively), although there was a high degree of uncertainty in the 30–300 mg/g subgroup. Finerenone significantly reduced the hazard of end-stage kidney disease (ESKD) by 20% versus placebo (0.80; 0.64–0.99). Adverse events were similar between treatment arms, although hyperkalemia leading to treatment discontinuation occurred significantly more frequently with finerenone versus placebo (2.4% vs 0.8% and 0.6% vs 0.3% in patients with eGFR less than 60 vs. greater than or equal to 60 ml/min per 1.73 m2, respectively). Thus, finerenone improved kidney outcomes, reduced the hazard of ESKD, and is well tolerated in patients with chronic kidney disease and type 2 diabetes. In FIDELITY, a prespecified pooled analysis of the FIDELIO-DKD and FIGARO-DKD studies, finerenone was found to improve cardiorenal outcomes in patients with type 2 diabetes, a urine albumin-to-creatinine ratio of 30–5000 mg/g, an estimated glomerular filtration rate (eGFR) of 25 ml/min per 1.73 m2 or more and also receiving optimized renin-angiotensin system blockade treatment. This present analysis focused on the efficacy and safety of finerenone on kidney outcomes. Among 13,026 patients with a median follow-up of three years, finerenone significantly reduced the hazard of a kidney composite outcome (time to kidney failure, sustained 57% or more decrease in eGFR from baseline, or kidney death) by 23% versus placebo (hazard ratio, 0.77; 95% confidence interval, 0.67–0.88), with a three-year absolute between-group difference of 1.7% (95% confidence interval, 0.7–2.6). Hazard ratios were directionally consistent for a prespecified baseline eGFR and urine albumin-to-creatinine ratio categories (Pinteraction = 0.62 and Pinteraction = 0.67, respectively), although there was a high degree of uncertainty in the 30–300 mg/g subgroup. Finerenone significantly reduced the hazard of end-stage kidney disease (ESKD) by 20% versus placebo (0.80; 0.64–0.99). Adverse events were similar between treatment arms, although hyperkalemia leading to treatment discontinuation occurred significantly more frequently with finerenone versus placebo (2.4% vs 0.8% and 0.6% vs 0.3% in patients with eGFR less than 60 vs. greater than or equal to 60 ml/min per 1.73 m2, respectively). Thus, finerenone improved kidney outcomes, reduced the hazard of ESKD, and is well tolerated in patients with chronic kidney disease and type 2 diabetes. Patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) are at high risk of CKD progression and cardiovascular (CV) events, despite available therapies.1Brenner B.M. Cooper M.E. de Zeeuw D. et al.Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy.N Engl J Med. 2001; 345: 861-869Crossref PubMed Scopus (6385) Google Scholar, 2Lewis E.J. Hunsicker L.G. Clarke W.R. et al.Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes.N Engl J Med. 2001; 345: 851-860Crossref PubMed Scopus (5228) Google Scholar, 3Perkovic V. de Zeeuw D. Mahaffey K.W. et al.Canagliflozin and renal outcomes in type 2 diabetes: results from the CANVAS Program randomised clinical trials.Lancet Diabetes Endocrinol. 2018; 6: 691-704Abstract Full Text Full Text PDF PubMed Scopus (443) Google Scholar The current standard of care in patients with CKD and T2D primarily focuses on glucose and blood pressure control, and guidelines recommend treatment with renin-angiotensin system (RAS) inhibitors and sodium-glucose cotransporter-2 inhibitors (SGLT-2i) in most patients.4Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work GroupKDIGO 2020 clinical practice guideline for diabetes management in chronic kidney disease.Kidney Int. 2020; 98: S1-S115Abstract Full Text Full Text PDF PubMed Scopus (653) Google Scholar, 5Agarwal R. Anker S.D. Bakris G. et al.Investigating new treatment opportunities for patients with chronic kidney disease in type 2 diabetes: the role of finerenone.Nephrol Dial Transplant. 2022; 37: 1014-1023Crossref PubMed Scopus (36) Google Scholar, 6Draznin B. Aroda V.R. et al.American Diabetes Association Professional Practice Committee11. Chronic kidney disease and risk management: standards of medical care in diabetes-2022.Diabetes Care. 2022; 45: S175-S184Crossref PubMed Scopus (170) Google Scholar Mineralocorticoid receptor (MR) overactivation causes inflammation and fibrosis, contributing to progressive kidney and CV injury and CKD in T2D disease progression; therefore, MR blockade is a potential therapeutic target to reduce cardiorenal risk in patients with CKD and T2D.5Agarwal R. Anker S.D. Bakris G. et al.Investigating new treatment opportunities for patients with chronic kidney disease in type 2 diabetes: the role of finerenone.Nephrol Dial Transplant. 2022; 37: 1014-1023Crossref PubMed Scopus (36) Google Scholar,7Agarwal R. Kolkhof P. Bakris G. et al.Steroidal and non-steroidal mineralocorticoid receptor antagonists in cardiorenal medicine.Eur Heart J. 2021; 42: 152-161Crossref PubMed Scopus (206) Google Scholar,8Kintscher U. Bakris G.L. Kolkhof P. Novel non-steroidal mineralocorticoid receptor antagonists in cardiorenal disease.Br J Pharmacol. 2022; 179: 3220-3234Crossref PubMed Scopus (51) Google Scholar The selective, nonsteroidal MR antagonist finerenone, on top of maximum tolerated RAS inhibition, was evaluated in 2 complementary phase 3 trials, Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease (FIDELIO-DKD) and Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD), in patients with T2D and CKD. Together, both trials covered a large breadth of patients with different stages and severity of CKD.9Bakris G.L. Agarwal R. Anker S.D. et al.Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes.N Engl J Med. 2020; 383: 2219-2229Crossref PubMed Scopus (935) Google Scholar,10Pitt B. Filippatos G. Agarwal R. et al.Cardiovascular events with finerenone in kidney disease and type 2 diabetes.N Engl J Med. 2021; 385: 2252-2263Crossref PubMed Scopus (484) Google Scholar In FIDELIO-DKD, finerenone significantly reduced the hazard of the primary kidney composite outcome in patients with predominantly advanced CKD.9Bakris G.L. Agarwal R. Anker S.D. et al.Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes.N Engl J Med. 2020; 383: 2219-2229Crossref PubMed Scopus (935) Google Scholar In FIGARO-DKD, finerenone significantly reduced the primary CV composite outcome hazard in a patient population with less advanced CKD than that studied in FIDELIO-DKD.10Pitt B. Filippatos G. Agarwal R. et al.Cardiovascular events with finerenone in kidney disease and type 2 diabetes.N Engl J Med. 2021; 385: 2252-2263Crossref PubMed Scopus (484) Google Scholar Finerenone in Chronic Kidney Disease and Type 2 Diabetes: Combined FIDELIO-DKD and FIGARO-DKD Trial Programme Analysis (FIDELITY) is a prespecified, individual patient data pooled analysis of the FIDELIO-DKD and FIGARO-DKD studies.11Agarwal R. Filippatos G. Pitt B. et al.Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis.Eur Heart J. 2022; 43: 474-484Crossref PubMed Scopus (241) Google Scholar The aim of this FIDELITY analysis is to evaluate the kidney benefits and kidney safety of finerenone in patients with CKD stage 1 to with to and FIDELITY individual patient data from FIDELIO-DKD and FIGARO-DKD were 2 phase trials of finerenone versus G.L. Agarwal R. Anker S.D. et al.Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes.N Engl J Med. 2020; 383: 2219-2229Crossref PubMed Scopus (935) Google Scholar,10Pitt B. Filippatos G. Agarwal R. et al.Cardiovascular events with finerenone in kidney disease and type 2 diabetes.N Engl J Med. 2021; 385: 2252-2263Crossref PubMed Scopus (484) Google Scholar The with the efficacy and safety outcomes for FIDELIO-DKD, FIGARO-DKD, and the FIDELITY analysis G.L. Agarwal R. Anker S.D. et al.Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes.N Engl J Med. 2020; 383: 2219-2229Crossref PubMed Scopus (935) Google Scholar, B. Filippatos G. Agarwal R. et al.Cardiovascular events with finerenone in kidney disease and type 2 diabetes.N Engl J Med. 2021; 385: 2252-2263Crossref PubMed Scopus (484) Google Scholar, R. Filippatos G. Pitt B. et al.Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis.Eur Heart J. 2022; 43: 474-484Crossref PubMed Scopus (241) Google Scholar patients were with T2D and CKD with a of an or receptor with to CKD were albumin-to-creatinine ratio with estimated glomerular filtration rate (eGFR) to ml/min per 1.73 m2 and of (FIDELIO-DKD) or eGFR to ml/min per 1.73 m2 or with eGFR to ml/min per 1.73 m2 (FIDELIO-DKD) or eGFR ml/min per 1.73 m2 G.L. Agarwal R. Anker S.D. et al.Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes.N Engl J Med. 2020; 383: 2219-2229Crossref PubMed Scopus (935) Google Scholar, B. Filippatos G. Agarwal R. et al.Cardiovascular events with finerenone in kidney disease and type 2 diabetes.N Engl J Med. 2021; 385: 2252-2263Crossref PubMed Scopus (484) Google Scholar, R. Filippatos G. Pitt B. et al.Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis.Eur Heart J. 2022; 43: 474-484Crossref PubMed Scopus (241) Google Scholar were in to that the patient in FIDELIO-DKD and FIGARO-DKD were at high risk of kidney disease progression and CV events, Patients with or were with at both kidney a of for kidney the or a kidney in or of and a of chronic with reduced a for treatment with MR R. Filippatos G. Pitt B. et al.Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis.Eur Heart J. 2022; 43: 474-484Crossref PubMed Scopus (241) Google Scholar patients were to finerenone of or or G.L. Agarwal R. Anker S.D. et al.Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes.N Engl J Med. 2020; 383: 2219-2229Crossref PubMed Scopus (935) Google Scholar,10Pitt B. Filippatos G. Agarwal R. et al.Cardiovascular events with finerenone in kidney disease and type 2 diabetes.N Engl J Med. 2021; 385: 2252-2263Crossref PubMed Scopus (484) Google Scholar of treatment and safety follow-up G.L. Agarwal R. Anker S.D. et al.Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes.N Engl J Med. 2020; 383: 2219-2229Crossref PubMed Scopus (935) Google Scholar,10Pitt B. Filippatos G. Agarwal R. et al.Cardiovascular events with finerenone in kidney disease and type 2 diabetes.N Engl J Med. 2021; 385: 2252-2263Crossref PubMed Scopus (484) Google Scholar the or the and eGFR the of patients were to to the G.L. Agarwal R. Anker S.D. et al.Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes.N Engl J Med. 2020; 383: 2219-2229Crossref PubMed Scopus (935) Google Scholar,10Pitt B. Filippatos G. Agarwal R. et al.Cardiovascular events with finerenone in kidney disease and type 2 diabetes.N Engl J Med. 2021; 385: 2252-2263Crossref PubMed Scopus (484) Google Scholar The efficacy outcomes in this analysis a composite kidney outcome of to of kidney end-stage kidney disease or a sustained eGFR ml/min per 1.73 sustained decrease in eGFR from baseline or renal kidney disease was the of chronic or kidney The sustained of the composite kidney outcome ml/min per 1.73 m2 and a decrease in eGFR from eGFR to the a of kidney were by an clinical of to treatment outcomes in this analysis are individual of the kidney composite outcome and in in the population and to categories at were prespecified in FIDELITY, the kidney outcomes a the of patients with a mg/g to with finerenone to outcome and rate of hyperkalemia to eGFR at are are and for were the analysis patients with Practice were from events were from to the Patients an were at the of with on of outcomes. outcomes, were on the of a In the were for the of treatment outcomes are hazard ratios with confidence from a were and a of CV disease or eGFR at and ml/min per 1.73 and mg/g and at treatment were for for are on and The ratio of from baseline to was evaluated by an analysis of with the of treatment eGFR at type of at CV disease baseline and the between and treatment. were the safety analysis of patients Practice of the of 13,026 patients from the FIDELIO-DKD and FIGARO-DKD were in the were available for of of were and a of patients the the were of were The median follow-up was R. Filippatos G. Pitt B. et al.Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis.Eur Heart J. 2022; 43: 474-484Crossref PubMed Scopus (241) Google Scholar Full patient and baseline for the FIDELITY analysis population R. Filippatos G. Pitt B. et al.Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis.Eur Heart J. 2022; 43: 474-484Crossref PubMed Scopus (241) Google Scholar In and of a baseline eGFR of and ml/min per 1.73 m2, and and a baseline of and mg/g, The were and in the and ml/min per 1.73 m2 with a median of mg/g and mg/g of and and versus of patients with at the and mg/g the were and ml/min per 1.73 m2, the median were and mg/g, the were and and versus of patients of patients in baseline eGFR and categories are in baseline and by eGFR and ml/min per 1.73 m2 = ml/min per 1.73 m2 = mg/g = mg/g = blood blood of diabetes, ml/min per 1.73 ml/min per 1.73 m2, median mg/g, of at baseline, receptor inhibitors and cardiovascular estimated glomerular filtration receptor sodium-glucose cotransporter-2 urine albumin-to-creatinine in a new cardiovascular estimated glomerular filtration receptor sodium-glucose cotransporter-2 urine albumin-to-creatinine the 13,026 patients versus patients receiving placebo a kidney composite to a 23% hazard with finerenone versus placebo 0.77; 95% = R. Filippatos G. Pitt B. et al.Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis.Eur Heart J. 2022; 43: 474-484Crossref PubMed Scopus (241) Google Scholar Finerenone reduced the of of the kidney composite outcome with placebo The hazard of end-stage kidney disease by patients in the finerenone and of patients in the placebo was reduced by 20% with finerenone versus placebo 95% = Analysis of the sustained decrease in eGFR a hazard with finerenone with placebo 95% renal were a between treatment and patients in the finerenone and placebo respectively). The of patients to with finerenone to kidney outcome was 60 (95% on an absolute between-group risk difference of 1.7% (95% at of R. Filippatos G. Pitt B. et al.Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis.Eur Heart J. 2022; 43: 474-484Crossref PubMed Scopus (241) Google Scholar analysis by baseline eGFR and categories that patients at the risk of a kidney outcome were with a baseline eGFR ml/min per 1.73 m2 and with a baseline In the placebo with an per were and in patients with an eGFR to 25 to and ml/min per 1.73 m2, in patients with a to and mg/g, were 0.62 and were directionally consistent for prespecified baseline and eGFR and for the treatment effect of finerenone versus placebo baseline eGFR categories and for eGFR and ml/min per 1.73 m2, Pinteraction = and baseline categories and for patients with a and mg/g, Pinteraction = eGFR and were In the of patients with a mg/g, the of patients to with finerenone to kidney outcome was (95% to on an absolute between-group risk difference of (95% to at Finerenone consistent to reduce the hazard of the composite kidney outcome versus placebo prespecified for and for Pinteraction = and for and for Pinteraction = well baseline treatment with an and for patients with and at baseline, Pinteraction = was by baseline (Pinteraction = with a in patients with 95% versus 95% kidney a estimated glomerular filtration rate (eGFR) decrease in prespecified confidence receptor blood sodium-glucose the in from baseline to was with finerenone versus placebo in the population of from baseline, 95% R. Filippatos G. Pitt B. et al.Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis.Eur Heart J. 2022; 43: 474-484Crossref PubMed Scopus (241) Google the ratios to baseline at of the in were and in the finerenone and placebo In the patient with a baseline to and mg/g, finerenone to a similar in at to baseline with ratios to baseline at of were versus and versus with finerenone versus placebo in patients with to and mg/g, and In the the in eGFR from baseline to of treatment was similar between treatment ml/min per 1.73 m2 with finerenone vs. ml/min per 1.73 m2 with The eGFR from to of treatment was reduced in patients with finerenone with placebo vs. ml/min per 1.73 m2, analysis by baseline eGFR that patients a chronic eGFR versus of baseline eGFR the rate of events was in patients with an eGFR ml/min per 1.73 m2 with patients with an eGFR ml/min per 1.73 m2 was similar between treatment in both the eGFR and ml/min per 1.73 m2 categories The of to a of renal and kidney injury was and occurred in similar of patients between treatment In the ml/min per 1.73 m2 the of renal leading to was and with finerenone and with and of patients in treatment of renal similar was in the ml/min per 1.73 m2 were the ml/min per 1.73 m2 the of to renal leading to were and and leading to discontinuation were and with finerenone and The most in patients was was more frequently in patients with eGFR ml/min per 1.73 m2 at The of discontinuation or due to hyperkalemia in patients was in both The of discontinuation due to hyperkalemia was with finerenone versus 0.8% with placebo in patients with an eGFR ml/min per 1.73 m2 95% in patients with an eGFR ml/min per 1.73 m2, the were 0.6% versus 0.3% 95% = The of hyperkalemia leading to was with finerenone versus 0.3% with placebo in patients with an eGFR ml/min per 1.73 m2 95% and 0.3% versus in patients with an eGFR ml/min per 1.73 m2 95% = and The of was in patients with finerenone than in receiving placebo in both eGFR vs. 0.8% in patients with eGFR ml/min per 1.73 m2 and vs. in patients with eGFR ml/min per 1.73 m2, respectively). events to treatment discontinuation occurred more in patients than in placebo vs. in patients with eGFR ml/min per 1.73 m2 and vs. in patients with eGFR ml/min per 1.73 m2, respectively), treatment discontinuation due to was in outcomes by baseline eGFR with a ml/min per 1.73 ml/min per 1.73 = = = = to to with outcome renal events to to discontinuation of kidney failure, blood glomerular filtration rate failure, failure, renal failure, and renal kidney to to hyperkalemia is for to to estimated glomerular filtration discontinuation of kidney failure, blood glomerular filtration rate failure, failure, renal failure, and renal is for in a new estimated glomerular filtration FIDELITY kidney benefits and safety of finerenone in patients with T2D the of CKD with finerenone reduced the hazard of the kidney composite outcome by 23% versus well the of of the kidney composite The benefits of finerenone on the kidney composite outcome were primarily by a hazard of a sustained decrease in eGFR from baseline and a 20% hazard of end-stage kidney analysis by baseline eGFR and categories that the of kidney outcomes occurred in patients with a baseline eGFR ml/min per 1.73 m2 and with a baseline The absolute hazard were greater with finerenone versus placebo in the with the subgroup. of patients with a mg/g an eGFR ml/min per 1.73 m2, data the to patients for and the of treatment to improve outcomes in CKD and the for kidney outcomes were directionally consistent baseline and eGFR that treatment with finerenone is to CKD progression the of CKD there is a high degree of uncertainty in the hazard for the kidney composite outcome in the to mg/g subgroup. in this the CV rate is than the kidney rate CV events per vs. kidney events per in the placebo the effect of finerenone on CV events was by baseline categories 30–300 95% 95% Pinteraction = a cardiorenal of finerenone in patients with a to R. Filippatos G. Pitt B. et al.Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis.Eur Heart J. 2022; 43: 474-484Crossref PubMed Scopus (241) Google Scholar The of in CKD progression with finerenone in patients with a of an RAS in this analysis are consistent with trials of kidney outcome trials, the and in Diabetes and the and of Adverse Outcomes in Chronic Kidney Disease cardiorenal outcomes for patients with CKD and and in patients with CKD with or T2D in the V. B. et al.Canagliflozin and renal outcomes in type 2 diabetes and nephropathy.N Engl J Med. PubMed Scopus Google Scholar, et al.Effects of on kidney and cardiovascular events in patients with and chronic kidney disease: a prespecified analysis from the Endocrinol. 2021; Full Text Full Text PDF PubMed Scopus Google Scholar, R. et in patients with chronic kidney Engl J Med. 2020; 383: PubMed Scopus Google Scholar of in the primary and patient patients with CKD and T2D from FIDELIO-DKD and FIGARO-DKD 30–5000 mg/g with mg/g from the the trials to with G.L. Agarwal R. Anker S.D. et al.Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes.N Engl J Med. 2020; 383: 2219-2229Crossref PubMed Scopus (935) Google Scholar,10Pitt B. Filippatos G. Agarwal R. et al.Cardiovascular events with finerenone in kidney disease and type 2 diabetes.N Engl J Med. 2021; 385: 2252-2263Crossref PubMed Scopus (484) Google V. B. et al.Canagliflozin and renal outcomes in type 2 diabetes and nephropathy.N Engl J Med. PubMed Scopus Google Scholar, et al.Effects of on kidney and cardiovascular events in patients with and chronic kidney disease: a prespecified analysis from the Endocrinol. 2021; Full Text Full Text PDF PubMed Scopus Google Scholar, R. et in patients with chronic kidney Engl J Med. 2020; 383: PubMed Scopus Google Scholar, R. Anker S.D. Filippatos G. et al.Effects of versus finerenone on cardiorenal from FIDELIO-DKD to Dial Transplant. 2022; 37: PubMed Scopus Google Scholar This is by an analysis of the FIDELIO-DKD for in between the FIDELIO-DKD and trials in and eGFR and composite and for in baseline of The analysis that similar of cardiorenal hazard were with finerenone with R. Anker S.D. Filippatos G. et al.Effects of versus finerenone on cardiorenal from FIDELIO-DKD to Dial Transplant. 2022; 37: PubMed Scopus Google Scholar In both FIDELIO-DKD and FIGARO-DKD, patients were to with an RAS treatment with an was the kidney and CV benefits of finerenone, in both the current and R. Filippatos G. Pitt B. et al.Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis.Eur Heart J. 2022; 43: 474-484Crossref PubMed Scopus (241) Google P. Filippatos G. Agarwal R. et in predominantly advanced CKD and type 2 diabetes with or sodium-glucose cotransporter-2 2021; Full Text Full Text PDF PubMed Scopus Google Scholar to of a of both is and for patients with CKD and In this the of kidney injury and events to of renal were and similar between the finerenone and placebo The clinical of in of renal was with of events leading to and discontinuation treatment The of kidney injury was in patients with an eGFR ml/min per 1.73 m2 at baseline in both treatment and difference was between patients with finerenone with In the in Diabetes patients with with an and an receptor was with an risk of kidney injury occurred in of patients receiving losartan and with of patients receiving losartan et for the treatment of nephropathy.N Engl J Med. PubMed Scopus Google Scholar In the Mineralocorticoid patients with CKD and with reduced of renal occurred in versus of patients in the finerenone and placebo with of patients in the 25 to B. P. et and of the non-steroidal mineralocorticoid receptor antagonist in patients with chronic and or chronic kidney disease: a Heart J. PubMed Scopus Google Scholar of of finerenone treatment is to MR R. Kolkhof P. Bakris G. et al.Steroidal and non-steroidal mineralocorticoid receptor antagonists in cardiorenal medicine.Eur Heart J. 2021; 42: 152-161Crossref PubMed Scopus (206) Google Scholar In FIDELITY, hyperkalemia was more with finerenone than with the clinical of hyperkalemia was were due to and the of hyperkalemia leading to treatment discontinuation was in patients vs. 0.3% in with an eGFR ml/min per 1.73 m2 and vs. 0.8% in with an eGFR ml/min per 1.73 m2 with finerenone vs. respectively). of treatment discontinuation were significantly between treatment in patients with an eGFR ml/min per 1.73 m2, that finerenone is well tolerated in Patients in FIDELITY to on RAS inhibition, and there were on or patients with at and were at In the finerenone and and was with a in from baseline to with 25 or and and significantly reduced the of hyperkalemia with and = B. P. et and of the non-steroidal mineralocorticoid receptor antagonist in patients with chronic and or chronic kidney disease: a Heart J. PubMed Scopus Google Scholar The of of renal and hyperkalemia with finerenone versus due to in in a of in the kidney with the finerenone to the kidney and the a than B. P. et and of the non-steroidal mineralocorticoid receptor antagonist in patients with chronic and or chronic kidney disease: a Heart J. PubMed Scopus Google P. of the mineralocorticoid for Endocrinol. PubMed Scopus Google Scholar in and for the MR with also the clinical of finerenone with a MR U. Bakris G.L. Kolkhof P. Novel non-steroidal mineralocorticoid receptor antagonists in cardiorenal disease.Br J Pharmacol. 2022; 179: 3220-3234Crossref PubMed Scopus (51) Google Scholar FIDELITY, a prespecified individual patient data pooled a large patient population with T2D a of are that patients with CKD were in the analysis and a of patients were In the were in and were for is also to that FIDELITY data are from 2 trials with and follow-up and that the of finerenone in practice by the the of Finerenone in a the FIDELITY analysis that the hazard of the kidney composite outcome and of the kidney composite outcome was reduced with finerenone with This analysis that finerenone kidney efficacy and safety benefits the of CKD in T2D and the benefits of treatment to CKD progression in patients with to the of from the of the also to the of from and a and from and is an of the of and of and an of Diabetes and of from from and and from and that is a of trials and by and is a for Heart Failure and from the for and for and also a for of to the and a for for the treatment and of injury from the of the and from and and from and are to Diabetes from and for a of data safety for and is a for and is also the and of is an to and is a for and from and is a of and for and is an for the of and for and and are of and from the of the also and from and from and and from R. and is a of data safety for and a of of trials for and and a of for and of the of and and and an for and from the and the of The data the of this are available in at The data were from the available in the The and are to the patients and well the and in the was by of and was by This was by the FIDELIO-DKD and FIGARO-DKD and This was by the FIDELIO-DKD and FIGARO-DKD and

Topics & Concepts