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

Diabetes Care, ISSN: 1935-5548, Vol: 45, Issue: 12, Page: 2991-2998
2022
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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 m 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 = 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.

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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; 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 Abhayaratna; Shamasunder Acharya; Elif Ekinci; Darren Lee; Richard MacIsaac; Peak Mann Mah; Craig Nelson; David Packham; Alexia Pape; Simon Roger; Hugo Stephenson; Michael Suranyi; Gary Wittert; Elizabeth Vale; Peter Colman; David Colquhoun; Chris Ellis; Kim Joshua; Eugenia Pedagogos; Paul Regal; Duncan Topliss; James Vandeleur; Johan Verjans; 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 Prischl; Gerit-Holger Schernthaner; Harald Sourij; Martin Wiesholzer; Heinz Drexel; Rainer Oberbauer; Hans-Robert Schönherr; Peter Doubel; Wendy Engelen; Pieter Gillard; Jean-Michel Hougardy; Jean-Marie Krzesinski; Bart Maes; Marijn Speeckaert; Koen Stas; Luc van Gaal; Hilde Vanbelleghem; Francis Duyck; André Scheen; Daniela Antunes; Roberto Botelho; Claudia Brito; Luis Canani; Maria Eugenia Canziani; Maria Cerqueira; Rogerio de Paula; Freddy Eliaschewitz; Carlos Eduardo Figueiredo; Adriana Forti; Miguel Hissa; Maurilo Leite Jr; Emerson Lima; Irene Noronha; Bruno Paolino; Nathalia Paschoalin; Raphael Paschoalin; Roberto Pecoits Filho; Marcio Pereira; Evandro Portes; Dalton Precoma; Rosangela Rea; Miguel Riella; Joao Eduardo Salles; Eduardo Vasconcellos; Sergio Vencio; Marcelo Bacci; Lilia Maia; Aline Villacorta; Emiliya Apostolova; Radostina Boshnyashka; Ghassan Farah; Dimitar Georgiev; Valentina Gushterova; Neli Klyuchkova; Mariya Lucheva; Petya Manova; Dotska Minkova; Boyan Nonchev; Mariyana Pichmanova; Zhulieta Prakova; Rangel Rangelov; Rosen Rashkov; Pavel Stanchev; Bilyana Stoyanovska-Elencheva; Zhivko Tagarev; Theodora Temelkova-Kurktschieva; Svetla Vasileva; Mariana Yoncheva-Mihaylova; Angel Marinchev; Mariya Miteva; Paul Barre; Brian Carlson; James Conway; Serge Cournoyer; Richard Dumas; Sameh Fikry; Richard Goluch; Pavel Hamet; Randolph Hart; Sam Henein; Joanne Liutkus; Francois Madore; Valdemar Martinho; Giuseppe Mazza; Philip McFarlane; Dennis O’Keefe; Sean Peterson; Daniel Schwartz; Daniel Shu; Andrew Steele; Guy Tellier; Karthik Tennankore; Sheldon Tobe; George Tsoukas; Richard Tytus; Louise Vitou; Michael Walsh; Stanley Weisnagel; Igor Wilderman; Jean-Francois Yale; Fadia El Boreky; Alan Kelly; Lawrence Leiter; Ivor Teitelbaum; Jorge Cobos; Juan Godoy; Fernando González; Sergio Lobos; Juan Carlos Palma; Juan Carlos Prieto Dominguez; Eliana Reyes; Carmen Romero; Victor Saavedra; Mario Vega; Marcelo Medina; Paola Varleta; Ruifang Bu; Hanqing Cai; Nan Chen; Qinkai Chen; Dejun Chen; Jinluo Cheng; Youping Dong; Junwu Dong; Tianjun Guan; Chuanming Hao; Wen Huang; Fangfang Jiang; Minxiang Lei; Ling Li; Zhonghe Li; Xuemei Li; Jingmei Li; Yan Li; 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Odugbesan; Jorge Paoli-Bruno; Samir Parikh; Rakesh Patel; Aldo Peixoto; Pablo Pergola; Alan Perlman; Karlton Pettis; Roberto Pisoni; Mirela Ponduchi; Jorge Posada; Sharma Prabhakar; Jai Radhakrishnan; Mahboob Rahman; Rupesh Raina; Anjay Rastogi; Efrain Reisin; Marc Rendell; David Robertson; Michael Rocco; Hugo Romeu; Sylvia Rosas; Jack Rosenfeld; Dennis Ross; Jeffrey Rothman; Lance Rudolph; Yusuf Ruhullah; Gary Ruoff; Jeffrey Ryu; Mandeep Sahani; Ramin Sam; Garfield Samuels; William Sanchez; Vladimir Santos; Scott Satko; Sanjeev Saxena; David Scott; Gilberto Seco; Melvin Seek; Harvey Serota; Tariq Shafi; Nauman Shahid; Michael Shanik; Santosh Sharma; Arjun Sinha; James Smelser; Mark Smith; Kyaw Soe; Richard Solomon; Eugene Soroka; Joseph Soufer; Bruce Spinowitz; Leslie Spry; Rosa Suarez; Bala Subramanian; Harold Szerlip; Aparna Tamirisa; Stephen Thomson; Tuan-Huy Tran; Richard Treger; Gretel Trullenque; Thomas Turk; Guillermo Umpierrez; Daniel Urbach; Martin Valdes; Shujauddin Valika; Damaris Vega; Peter Weissman; Adam Whaley-Connell; Jonathan Winston; Jonathan Wise; Alan Wynne; Steven Zeig; Emaad Abdel-Rahman; Edel Abreu; Alaa Awad; Nader Bahri; John Bertsch; David Bleich; Jonathan Bornfreund; Harjeet Brar; Susan Brian; Cynthia Brinson; Humberto Bruschetta; Jose Carpio; Steven Cohen; John Cosby; Soni Dhanireddy; Jorge Diaz; Fredrick Dunn; Sabitha Eppanapally; Joseph Fayad; Archana Goel; Kanakadurga Govindaraju; Stephen Halpern; Audrey Jones; William Kaye; Herbert Knight; Stanley Koch; Nandini Kohli; Guido Lastra; Sam Lerman; Jorge Loredo; Dragana Lovre; Mustafa Mandviwala; Earl Martin; Jill Meyer; John Murray; David Oliver; Suzanne Oparil; Jesus Penabad; Isabel Pereira; Larry Popeil; Gonzalo Quesada; Kodangudi Ramanathan; Luis Ramos-Gonez; Mandana Rastegar; Padmashri Rastogi; Juan Rondon; Prabir Roy-Chaudhury; David Smith; Don Williamson; Catherine Womack; Hala Yamout; Michael Yuryev; Phuong Chu; Lam Van Hoang; Tran Khanh; Nguyen Thi Phi Nga; Pham Nguyen Son; Lan Phuong Tran; Thuy Khuong Le; Boi Ngoc Nguyen; Thao Nguyen; Nguyen Minh Nui; Tran Quang Nam; Kim Chi Tran

American Diabetes Association

Medicine; Nursing

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