Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes by Sodium–Glucose Cotransporter 2 Inhibitor Treatment: The FIDELITY Analysis

Peter Rossing; Stefan D. Anker; Gerasimos Filippatos; Bertram Pitt; Luis M. Ruilope; Andreas L. Birkenfeld; Janet B. McGill; Sylvia E. Rosas; Amer Joseph; Martin Gebel; Luke Roberts; Markus F. Scheerer; George L. Bakris; Rajiv Agarwal

doi:10.2337/dc22-0294

Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes by Sodium–Glucose Cotransporter 2 Inhibitor Treatment: The FIDELITY Analysis

Peter Rossing^*, Stefan D. Anker, Gerasimos Filippatos, Bertram Pitt, Luis M. Ruilope, Andreas L. Birkenfeld, Janet B. McGill, Sylvia E. Rosas, Amer Joseph, Martin Gebel, Luke Roberts, Markus F. Scheerer, George L. Bakris, Rajiv Agarwal

^*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

161 Citationer (Scopus)

20 Downloads (Pure)

Abstract

OBJECTIVE Finerenone reduced the risk of kidney and cardiovascular events in people with chronic kidney disease (CKD) and type 2 diabetes in the FIDELIO-DKD and FIGARO-DKD phase 3 studies. Effects of finerenone on outcomes in patients taking sodium– glucose cotransporter 2 inhibitors (SGLT2is) were evaluated in a prespecified pooled analysis of these studies. RESEARCH DESIGN AND METHODS Patients with type 2 diabetes and urine albumin-to-creatinine ratio (UACR) ‡30 to #5,000 mg/g and estimated glomerular filtration rate (eGFR) ‡25 mL/min/ 1.73 m² were randomly assigned to finerenone or placebo; SGLT2is were permit-ted at any time. Outcomes included cardiovascular composite (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) and kidney composite (kidney failure, sustained ‡57% eGFR de-cline, or renal death) end points, changes in UACR and eGFR, and safety outcomes. RESULTS Among 13,026 patients, 877 (6.7%) received an SGLT2i at baseline and 1,113 (8.5%) initiated one during the trial. For the cardiovascular composite, the hazard ratios (HRs) were 0.87 (95% CI 0.79–0.96) without SGLT2i and 0.67 (95% CI 0.42–1.07) with SGLT2i. For the kidney composite, the HRs were 0.80 (95% CI 0.69–0.92) without SGLT2i and 0.42 (95% CI 0.16–1.08) with SGLT2i. Baseline SGLT2i use did not affect risk reduction for the cardiovascular or kidney compo-sites with finerenone (P_interaction = 0.46 and 0.29, respectively); neither did SGLT2i use concomitant with study treatment. CONCLUSIONS Benefits of finerenone compared with placebo on cardiorenal outcomes in patients with CKD and type 2 diabetes were observed irrespective of SGLT2i use.

Originalsprog	Engelsk
Tidsskrift	Diabetes Care
Vol/bind	45
Udgave nummer	12
Sider (fra-til)	2991-2998
Antal sider	8
ISSN	0149-5992
DOI	https://doi.org/10.2337/dc22-0294
Status	Udgivet - 2022

Bibliografisk note

Funding Information:
Medical writing assistance was provided by Kate Weatherall from Chameleon Communications International and was funded by Bayer AG.

Publisher Copyright:
© 2022 by the American Diabetes Association.

Adgang til dokumentet

10.2337/dc22-0294

FulltextForlagets udgivne version, 797 KB

OpenUrl tilgængelighed

Fuld tekst

Citationsformater

Rossing, P., Anker, S. D., Filippatos, G., Pitt, B., Ruilope, L. M., Birkenfeld, A. L., McGill, J. B., Rosas, S. E., Joseph, A., Gebel, M., Roberts, L., Scheerer, M. F., Bakris, G. L., & Agarwal, R. (2022). Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes by Sodium–Glucose Cotransporter 2 Inhibitor Treatment: The FIDELITY Analysis. Diabetes Care, 45(12), 2991-2998. https://doi.org/10.2337/dc22-0294

Rossing, P, Anker, SD, Filippatos, G, Pitt, B, Ruilope, LM, Birkenfeld, AL, McGill, JB, Rosas, SE, Joseph, A, Gebel, M, Roberts, L, Scheerer, MF, Bakris, GL & Agarwal, R 2022, 'Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes by Sodium–Glucose Cotransporter 2 Inhibitor Treatment: The FIDELITY Analysis', Diabetes Care, bind 45, nr. 12, s. 2991-2998. https://doi.org/10.2337/dc22-0294

@article{c6576527178f47a681572779f7348608,

title = "Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes by Sodium–Glucose Cotransporter 2 Inhibitor Treatment: The FIDELITY Analysis",

abstract = "OBJECTIVE Finerenone reduced the risk of kidney and cardiovascular events in people with chronic kidney disease (CKD) and type 2 diabetes in the FIDELIO-DKD and FIGARO-DKD phase 3 studies. Effects of finerenone on outcomes in patients taking sodium– glucose cotransporter 2 inhibitors (SGLT2is) were evaluated in a prespecified pooled analysis of these studies. RESEARCH DESIGN AND METHODS Patients with type 2 diabetes and urine albumin-to-creatinine ratio (UACR) ‡30 to #5,000 mg/g and estimated glomerular filtration rate (eGFR) ‡25 mL/min/ 1.73 m2 were randomly assigned to finerenone or placebo; SGLT2is were permit-ted at any time. Outcomes included cardiovascular composite (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) and kidney composite (kidney failure, sustained ‡57% eGFR de-cline, or renal death) end points, changes in UACR and eGFR, and safety outcomes. RESULTS Among 13,026 patients, 877 (6.7%) received an SGLT2i at baseline and 1,113 (8.5%) initiated one during the trial. For the cardiovascular composite, the hazard ratios (HRs) were 0.87 (95% CI 0.79–0.96) without SGLT2i and 0.67 (95% CI 0.42–1.07) with SGLT2i. For the kidney composite, the HRs were 0.80 (95% CI 0.69–0.92) without SGLT2i and 0.42 (95% CI 0.16–1.08) with SGLT2i. Baseline SGLT2i use did not affect risk reduction for the cardiovascular or kidney compo-sites with finerenone (Pinteraction = 0.46 and 0.29, respectively); neither did SGLT2i use concomitant with study treatment. CONCLUSIONS Benefits of finerenone compared with placebo on cardiorenal outcomes in patients with CKD and type 2 diabetes were observed irrespective of SGLT2i use.",

author = "Peter Rossing and Anker, {Stefan D.} and Gerasimos Filippatos and Bertram Pitt and Ruilope, {Luis M.} and Birkenfeld, {Andreas L.} and McGill, {Janet B.} and Rosas, {Sylvia E.} and Amer Joseph and Martin Gebel and Luke Roberts and Scheerer, {Markus F.} and Bakris, {George L.} and Rajiv Agarwal",

note = "Publisher Copyright: {\textcopyright} 2022 by the American Diabetes Association.",

year = "2022",

doi = "10.2337/dc22-0294",

language = "English",

volume = "45",

pages = "2991--2998",

journal = "Diabetes Care",

issn = "0149-5992",

publisher = "American Diabetes Association",

number = "12",

}

TY - JOUR

T1 - Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes by Sodium–Glucose Cotransporter 2 Inhibitor Treatment

T2 - The FIDELITY Analysis

AU - Rossing, Peter

AU - Anker, Stefan D.

AU - Filippatos, Gerasimos

AU - Pitt, Bertram

AU - Ruilope, Luis M.

AU - Birkenfeld, Andreas L.

AU - McGill, Janet B.

AU - Rosas, Sylvia E.

AU - Joseph, Amer

AU - Gebel, Martin

AU - Roberts, Luke

AU - Scheerer, Markus F.

AU - Bakris, George L.

AU - Agarwal, Rajiv

PY - 2022

Y1 - 2022

N2 - OBJECTIVE Finerenone reduced the risk of kidney and cardiovascular events in people with chronic kidney disease (CKD) and type 2 diabetes in the FIDELIO-DKD and FIGARO-DKD phase 3 studies. Effects of finerenone on outcomes in patients taking sodium– glucose cotransporter 2 inhibitors (SGLT2is) were evaluated in a prespecified pooled analysis of these studies. RESEARCH DESIGN AND METHODS Patients with type 2 diabetes and urine albumin-to-creatinine ratio (UACR) ‡30 to #5,000 mg/g and estimated glomerular filtration rate (eGFR) ‡25 mL/min/ 1.73 m2 were randomly assigned to finerenone or placebo; SGLT2is were permit-ted at any time. Outcomes included cardiovascular composite (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) and kidney composite (kidney failure, sustained ‡57% eGFR de-cline, or renal death) end points, changes in UACR and eGFR, and safety outcomes. RESULTS Among 13,026 patients, 877 (6.7%) received an SGLT2i at baseline and 1,113 (8.5%) initiated one during the trial. For the cardiovascular composite, the hazard ratios (HRs) were 0.87 (95% CI 0.79–0.96) without SGLT2i and 0.67 (95% CI 0.42–1.07) with SGLT2i. For the kidney composite, the HRs were 0.80 (95% CI 0.69–0.92) without SGLT2i and 0.42 (95% CI 0.16–1.08) with SGLT2i. Baseline SGLT2i use did not affect risk reduction for the cardiovascular or kidney compo-sites with finerenone (Pinteraction = 0.46 and 0.29, respectively); neither did SGLT2i use concomitant with study treatment. CONCLUSIONS Benefits of finerenone compared with placebo on cardiorenal outcomes in patients with CKD and type 2 diabetes were observed irrespective of SGLT2i use.

AB - OBJECTIVE Finerenone reduced the risk of kidney and cardiovascular events in people with chronic kidney disease (CKD) and type 2 diabetes in the FIDELIO-DKD and FIGARO-DKD phase 3 studies. Effects of finerenone on outcomes in patients taking sodium– glucose cotransporter 2 inhibitors (SGLT2is) were evaluated in a prespecified pooled analysis of these studies. RESEARCH DESIGN AND METHODS Patients with type 2 diabetes and urine albumin-to-creatinine ratio (UACR) ‡30 to #5,000 mg/g and estimated glomerular filtration rate (eGFR) ‡25 mL/min/ 1.73 m2 were randomly assigned to finerenone or placebo; SGLT2is were permit-ted at any time. Outcomes included cardiovascular composite (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) and kidney composite (kidney failure, sustained ‡57% eGFR de-cline, or renal death) end points, changes in UACR and eGFR, and safety outcomes. RESULTS Among 13,026 patients, 877 (6.7%) received an SGLT2i at baseline and 1,113 (8.5%) initiated one during the trial. For the cardiovascular composite, the hazard ratios (HRs) were 0.87 (95% CI 0.79–0.96) without SGLT2i and 0.67 (95% CI 0.42–1.07) with SGLT2i. For the kidney composite, the HRs were 0.80 (95% CI 0.69–0.92) without SGLT2i and 0.42 (95% CI 0.16–1.08) with SGLT2i. Baseline SGLT2i use did not affect risk reduction for the cardiovascular or kidney compo-sites with finerenone (Pinteraction = 0.46 and 0.29, respectively); neither did SGLT2i use concomitant with study treatment. CONCLUSIONS Benefits of finerenone compared with placebo on cardiorenal outcomes in patients with CKD and type 2 diabetes were observed irrespective of SGLT2i use.

U2 - 10.2337/dc22-0294

DO - 10.2337/dc22-0294

M3 - Journal article

C2 - 35972218

AN - SCOPUS:85137736615

SN - 0149-5992

VL - 45

SP - 2991

EP - 2998

JO - Diabetes Care

JF - Diabetes Care

IS - 12

ER -