Finerenone and effects on mortality in chronic kidney disease and type 2 diabetes: a FIDELITY analysis
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Standard
Finerenone and effects on mortality in chronic kidney disease and type 2 diabetes : a FIDELITY analysis. / Filippatos, Gerasimos; Anker, Stefan D.; August, Phyllis; Coats, Andrew J.S.; Januzzi, James L.; Mankovsky, Boris; Rossing, Peter; Ruilope, Luis M.; Pitt, Bertram; Sarafidis, Pantelis; Teerlink, John R.; Kapelios, Chris J.; Gebel, Martin; Brinker, Meike; Joseph, Amer; Lage, Andrea; Bakris, George; Agarwal, Rajiv.
I: European heart journal. Cardiovascular pharmacotherapy, Bind 9, Nr. 2, 2023, s. 183-191.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Harvard
APA
Vancouver
Author
Bibtex
}
RIS
TY - JOUR
T1 - Finerenone and effects on mortality in chronic kidney disease and type 2 diabetes
T2 - a FIDELITY analysis
AU - Filippatos, Gerasimos
AU - Anker, Stefan D.
AU - August, Phyllis
AU - Coats, Andrew J.S.
AU - Januzzi, James L.
AU - Mankovsky, Boris
AU - Rossing, Peter
AU - Ruilope, Luis M.
AU - Pitt, Bertram
AU - Sarafidis, Pantelis
AU - Teerlink, John R.
AU - Kapelios, Chris J.
AU - Gebel, Martin
AU - Brinker, Meike
AU - Joseph, Amer
AU - Lage, Andrea
AU - Bakris, George
AU - Agarwal, Rajiv
N1 - Publisher Copyright: © The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.
PY - 2023
Y1 - 2023
N2 - 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 more pronounced in patients with higher baseline eGFR. CONCLUSION: In FIDELITY, finerenone significantly reduced the risk of all-cause and cardiovascular mortality vs. placebo in patients with T2D across a broad spectrum of CKD stages while on treatment, as well as sudden cardiac death in the intention-to-treat population. CLINICAL TRIALS REGISTRATION: FIDELIO-DKD and FIGARO-DKD are registered with ClinicalTrials.gov, numbers NCT02540993 and NCT02545049, respectively (funded by Bayer AG).
AB - 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 more pronounced in patients with higher baseline eGFR. CONCLUSION: In FIDELITY, finerenone significantly reduced the risk of all-cause and cardiovascular mortality vs. placebo in patients with T2D across a broad spectrum of CKD stages while on treatment, as well as sudden cardiac death in the intention-to-treat population. CLINICAL TRIALS REGISTRATION: FIDELIO-DKD and FIGARO-DKD are registered with ClinicalTrials.gov, numbers NCT02540993 and NCT02545049, respectively (funded by Bayer AG).
KW - All-cause mortality
KW - Cardiovascular mortality
KW - Chronic kidney disease
KW - Finerenone
KW - Non-steroidal MRA
KW - Type 2 diabetes
U2 - 10.1093/ehjcvp/pvad001
DO - 10.1093/ehjcvp/pvad001
M3 - Journal article
C2 - 36639130
AN - SCOPUS:85147318068
VL - 9
SP - 183
EP - 191
JO - European Heart Journal - Cardiovascular Pharmacotherapy
JF - European Heart Journal - Cardiovascular Pharmacotherapy
SN - 2055-6837
IS - 2
ER -
ID: 366827673