Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis
dc.contributor.author | Agarwal, Rajiv | |
dc.contributor.author | Filippatos, Gerasimos | |
dc.contributor.author | Pitt, Bertram | |
dc.contributor.author | Anker, Stefan D. | |
dc.contributor.author | Rossing, Peter | |
dc.contributor.author | Joseph, Amer | |
dc.contributor.author | Kolkhof, Peter | |
dc.contributor.author | Nowack, Christina | |
dc.contributor.author | Gebel, Martin | |
dc.contributor.author | Ruilope, Luis M. | |
dc.contributor.author | Bakris, George L. | |
dc.contributor.department | Medicine, School of Medicine | en_US |
dc.date.accessioned | 2023-05-02T16:25:13Z | |
dc.date.available | 2023-05-02T16:25:13Z | |
dc.date.issued | 2022 | |
dc.description.abstract | Aims: The complementary studies FIDELIO-DKD and FIGARO-DKD in patients with type 2 diabetes and chronic kidney disease (CKD) examined cardiovascular and kidney outcomes in different, overlapping stages of CKD. The purpose of the FIDELITY analysis was to perform an individual patient-level prespecified pooled efficacy and safety analysis across a broad spectrum of CKD to provide more robust estimates of safety and efficacy of finerenone compared with placebo. Methods and results: For this prespecified analysis, two phase III, multicentre, double-blind trials involving patients with CKD and type 2 diabetes, randomized 1:1 to finerenone or placebo, were combined. Main time-to-event efficacy outcomes were a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure, and a composite of kidney failure, a sustained ≥57% decrease in estimated glomerular filtration rate from baseline over ≥4 weeks, or renal death. Among 13 026 patients with a median follow-up of 3.0 years (interquartile range 2.3-3.8 years), the composite cardiovascular outcome occurred in 825 (12.7%) patients receiving finerenone and 939 (14.4%) receiving placebo [hazard ratio (HR), 0.86; 95% confidence interval (CI), 0.78-0.95; P = 0.0018]. The composite kidney outcome occurred in 360 (5.5%) patients receiving finerenone and 465 (7.1%) receiving placebo (HR, 0.77; 95% CI, 0.67-0.88; P = 0.0002). Overall safety outcomes were generally similar between treatment arms. Hyperkalaemia leading to permanent treatment discontinuation occurred more frequently in patients receiving finerenone (1.7%) than placebo (0.6%). Conclusion: Finerenone reduced the risk of clinically important cardiovascular and kidney outcomes vs. placebo across the spectrum of CKD in patients with type 2 diabetes. Key question: Does finerenone, a novel selective, nonsteroidal mineralocorticoid receptor antagonist, added to maximum tolerated renin-angiotensin system inhibition reduce cardiovascular disease and kidney disease progression over a broad range of chronic kidney disease in patients with type 2 diabetes? Key finding: In a prespecified, pooled individual-level analysis from two randomized trials, we found reductions both in cardiovascular events and kidney failure outcomes with finerenone. Because 40% of the patients had an estimated glomerular filtration rate of >60 mL/min/1.73m2 they were identified solely on the basis of albuminuria. Take home message: Finerenone reduces the risk of clinical cardiovascular outcomes and kidney disease progression in a broad range of patients with chronic kidney disease and type 2 diabetes. Screening for albuminuria to identify at-risk patients among patients with type 2 diabetes facilitates reduction of both cardiovascular and kidney disease burden. | en_US |
dc.eprint.version | Final published version | en_US |
dc.identifier.citation | Agarwal 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 [published correction appears in Eur Heart J. 2022 May 21;43(20):1989]. Eur Heart J. 2022;43(6):474-484. doi:10.1093/eurheartj/ehab777 | en_US |
dc.identifier.uri | https://hdl.handle.net/1805/32772 | |
dc.language.iso | en_US | en_US |
dc.publisher | Oxford University Press | en_US |
dc.relation.isversionof | 10.1093/eurheartj/ehab777 | en_US |
dc.relation.journal | European Heart Journal | en_US |
dc.rights | Attribution-NonCommercial 4.0 International | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc/4.0/ | * |
dc.source | PMC | en_US |
dc.subject | Cardiorenal outcomes | en_US |
dc.subject | Chronic kidney disease | en_US |
dc.subject | Finerenone | en_US |
dc.subject | Hospitalization for heart failure | en_US |
dc.subject | Hyperkalaemia | en_US |
dc.subject | Type 2 diabetes | en_US |
dc.title | Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis | en_US |
dc.type | Article | en_US |