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, Luís 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, on behalf of the FIDELIO-DKD and FIGARO-DKD Investigators, Diego Aizenberg, Inés Bartolacci, Diego Besada, Julio Bittar, Mariano Chahin, Alicia Elbert, Elizabeth Gelersztein, Alberto Liberman, Laura Maffei, Federico Pérez Manghi, Hugo Sanabria, Augusto Vallejos, Gloria Viñes, Alfredo Wassermann, Walter P. Abhayaratna, Shamasunder Acharya, Elif I. Ekinci, Darren Lee, Richard J. MacIsaac, Peak Mann Mah, Craig Nelson, David Packham, Alexia Pape, Simon D. Roger, Hugo Stephenson, Michael Suranyi, Gary Wittert, Elizabeth Vale, Peter G. Colman, David Colquhoun, Chris Ellis, Kim Joshua, Eugenia Pedagogos, Paul Regal, Duncan J. Topliss, James Vandeleur, Johan Verjans, Gary Wittert, Katie-Jane Wynne, Martin Clodi, Christoph Ebenbichler, Evelyn Fließer-Görzer, Ursula Hanusch, Michael Krebs, Karl Lhotta, Bernhard Ludvik, Gert Mayer, Peter Neudorfer, Bernhard Paulweber, Rudolf Prager, Wolfgang Preiß, Friedrich C. Prischl, G. Schernthaner, Harald Sourij, Martin Wiesholzer, Heinz Drexel, Rainer Oberbauer, Hans‐Robert Schönherr, Peter Doubel, W. Engelen, Pieter Gillard, Jean‐Michel Hougardy, Jean-Marie Krzesinski, Bart Maes, Marijn M. Speeckaert, Koen Stas, Luc Van Gaal, Hilde Vanbelleghem, Francis Duyck, André Scheen, Daniela Antunes, Roberto Botelho, Cláudia Brito, Luís Henrique Santos Canani, Maria Eugênia Fernandes Canziani, Maria Cerqueira, Rogério de Paula, Freddy G. Eliaschewitz, Carlos Eduardo Poli‐de‐Figueiredo, Adriana Costa e Forti, Miguel Nasser Hissa, Maurilo Leite, Emerson de Lima, Irene L. Noronha, Bruno Paolino
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 permitted 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 decline, 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 composites 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.