Finerenone and effects on mortality in chronic kidney disease and type 2 diabetes: a FIDELITY analysis

作者：Gerasimos Filippatos, Stefan D. Anker, Phyllis August, Andrew J.S. Coats, James L. Januzzi, Boris Mankovsky, Peter Rossing, Luís M. Ruilope, Bertram Pitt, Pantelis Sarafidis, John R. Teerlink, Chris J. Kapelios, Martin Gebel, Meike Brinker, Amer Joseph, Andrea Lage, George L. Bakris, Rajiv Agarwal · 发表于：European Heart Journal - Cardiovascular Pharmacotherapy · 年份：2023 · DOI：10.1093/ehjcvp/pvad001 · 被引用次数：41 · 研究领域：Hormonal Regulation and Hypertension、Heart Failure Treatment and Management、Pulmonary Hypertension Research and Treatments

AIMS: Finerenone reduces the risk of cardiovascular events in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). We investigated the causes of mortality in the FIDELITY population. METHODS AND RESULTS: The FIDELITY prespecified pooled data analysis from FIDELIO-DKD and FIGARO-DKD excluded patients with heart failure and reduced ejection fraction. Outcomes included intention-to-treat and prespecified on-treatment analyses of the risk of all-cause and cardiovascular mortality. Of 13 026 patients [mean age, 64.8 years; mean estimated glomerular filtration rate (eGFR), 57.6 mL/min/1.73 m2], 99.8% were on renin-angiotensin system inhibitors. Finerenone reduced the incidence of all-cause and cardiovascular mortality vs. placebo (8.5% vs. 9.4% and 4.9% vs. 5.6%, respectively) and demonstrated significant on-treatment reductions [hazard ratio (HR), 0.82; 95% confidence interval (CI), 0.70-0.96; P = 0.014 and HR, 0.82; 95% CI, 0.67-0.99; P = 0.040, respectively]. Cardiovascular-related mortality was most common, and finerenone lowered the incidence of sudden cardiac death vs. placebo [1.3% (incidence rate 0.44/100 patient-years) vs. 1.8% (0.58/100 patient-years), respectively; HR, 0.75; 95% CI, 0.57-0.996; P = 0.046]. The effects of finerenone on mortality were similar across all Kidney Disease: Improving Global Outcomes risk groups. Event probability with finerenone at 4 years was consistent irrespective of baseline urine albumin-to-creatinine ratio, but seemingly ...