Finerenone and Cardiovascular Outcomes in Patients With Chronic Kidney Disease and Type 2 Diabetes

dc.contributor.authorFilippatos, Gerasimos
dc.contributor.authorAnker, Stefan D.
dc.contributor.authorAgarwal, Rajiv
dc.contributor.authorPitt, Bertram
dc.contributor.authorRuilope, Luis M.
dc.contributor.authorRossing, Peter
dc.contributor.authorKolkhof, Peter
dc.contributor.authorSchloemer, Patrick
dc.contributor.authorTornus, Ingo
dc.contributor.authorJoseph, Amer
dc.contributor.authorBakris, George L.
dc.contributor.departmentMedicine, School of Medicine
dc.date.accessioned2024-03-18T15:40:45Z
dc.date.available2024-03-18T15:40:45Z
dc.date.issued2021
dc.description.abstractBackground: The FIDELIO-DKD trial (Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease) evaluated the effect of the nonsteroidal, selective mineralocorticoid receptor antagonist finerenone on kidney and cardiovascular outcomes in patients with chronic kidney disease and type 2 diabetes with optimized renin-angiotensin system blockade. Compared with placebo, finerenone reduced the composite kidney and cardiovascular outcomes. We report the effect of finerenone on individual cardiovascular outcomes and in patients with and without history of atherosclerotic cardiovascular disease (CVD). Methods: This randomized, double-blind, placebo-controlled trial included patients with type 2 diabetes and urine albumin-to-creatinine ratio 30 to 5000 mg/g and an estimated glomerular filtration rate ≥25 to <75 mL per min per 1.73 m2, treated with optimized renin-angiotensin system blockade. Patients with a history of heart failure with reduced ejection fraction were excluded. Patients were randomized 1:1 to receive finerenone or placebo. The composite cardiovascular outcome included time to cardiovascular death, myocardial infarction, stroke, or hospitalization for heart failure. Prespecified cardiovascular analyses included analyses of the components of this composite and outcomes according to CVD history at baseline. Results: Between September 2015 and June 2018, 13 911 patients were screened and 5674 were randomized; 45.9% of patients had CVD at baseline. Over a median follow-up of 2.6 years (interquartile range, 2.0-3.4 years), finerenone reduced the risk of the composite cardiovascular outcome compared with placebo (hazard ratio, 0.86 [95% CI, 0.75-0.99]; P=0.034), with no significant interaction between patients with and without CVD (hazard ratio, 0.85 [95% CI, 0.71-1.01] in patients with a history of CVD; hazard ratio, 0.86 [95% CI, 0.68-1.08] in patients without a history of CVD; P value for interaction, 0.85). The incidence of treatment-emergent adverse events was similar between treatment arms, with a low incidence of hyperkalemia-related permanent treatment discontinuation (2.3% with finerenone versus 0.8% with placebo in patients with CVD and 2.2% with finerenone versus 1.0% with placebo in patients without CVD). Conclusions: Among patients with chronic kidney disease and type 2 diabetes, finerenone reduced incidence of the composite cardiovascular outcome, with no evidence of differences in treatment effect based on preexisting CVD status.
dc.eprint.versionFinal published version
dc.identifier.citationFilippatos G, Anker SD, Agarwal R, et al. Finerenone and Cardiovascular Outcomes in Patients With Chronic Kidney Disease and Type 2 Diabetes. Circulation. 2021;143(6):540-552. doi:10.1161/CIRCULATIONAHA.120.051898
dc.identifier.urihttps://hdl.handle.net/1805/39330
dc.language.isoen_US
dc.publisherWolters Kluwer
dc.relation.isversionof10.1161/CIRCULATIONAHA.120.051898
dc.relation.journalCirculation
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 Internationalen
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.sourcePMC
dc.subjectCardiovascular disease
dc.subjectChronic kidney disease
dc.subjectClinical trial
dc.subjectFinerenone
dc.subjectMineralocorticoid receptor
dc.subjectPrimary and secondary prevention
dc.subjecttype 2 diabetes
dc.titleFinerenone and Cardiovascular Outcomes in Patients With Chronic Kidney Disease and Type 2 Diabetes
dc.typeArticle
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