Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes by Sodium–Glucose Cotransporter 2 Inhibitor Treatment: The FIDELITY Analysis
Authors: Rossing Peter , Anker Stefan D. , Filippatos Gerasimos , Pitt Bertram , Ruilope Luis M. , Birkenfeld Andreas L. , McGill Janet B. , Rosas Sylvia E. , Joseph Amer , Gebel Martin , Roberts Luke , Scheerer Markus F. , Bakris George L. , Agarwal Rajiv ,   on behalf of the FIDELIO-DKD and FIGARO-DKD Investigators, Aizenberg Diego , Bartolacci Inés , Besada Diego , Bittar Julio , Chahin Mariano , Elbert Alicia , Gelersztein Elizabeth , Liberman Alberto , Maffei Laura , Pérez Manghi Federico , Sanabria Hugo , Vallejos Augusto , Viñes Gloria , Wassermann Alfredo , Abhayaratna Walter , Acharya Shamasunder , Ekinci Elif , Lee Darren , MacIsaac Richard , Mann Mah Peak , Nelson Craig , Packham David , Pape Alexia , Roger Simon , Stephenson Hugo , Suranyi Michael , Wittert Gary , Vale Elizabeth , Colman Peter , Colquhoun David , Ellis Chris , Joshua Kim , Pedagogos Eugenia , Regal Paul , Topliss Duncan , Vandeleur James , Verjans Johan , Wittert Gary , Wynne Katie-Jane , Clodi Martin , Ebenbichler Christoph , Fliesser-Görzer Evelyn , Hanusch Ursula , Krebs Michael , Lhotta Karl , Ludvik Bernhard , Mayer Gert , Neudorfer Peter , Paulweber Bernhard , Prager Rudolf , Preiß Wolfgang , Prischl Friedrich , Schernthaner Gerit-Holger , Sourij Harald , Wiesholzer Martin , Drexel Heinz , Oberbauer Rainer , Schönherr Hans-Robert , Doubel Peter , Engelen Wendy , Gillard Pieter , Hougardy Jean-Michel , Krzesinski Jean-Marie , Maes Bart , Speeckaert Marijn , Stas Koen , van Gaal Luc , Vanbelleghem Hilde , Duyck Francis , Scheen André , Antunes Daniela , Botelho Roberto , Brito Claudia , Canani Luis , Canziani Maria Eugenia , Cerqueira Maria , de Paula Rogerio , Eliaschewitz Freddy , Figueiredo Carlos Eduardo , Forti Adriana , Hissa Miguel , Leite Maurilo , Lima Emerson , Noronha Irene , Paolino Bruno , Paschoalin Nathalia , Paschoalin Raphael , Pecoits Filho Roberto , Pereira Marcio , Portes Evandro , Precoma Dalton , Rea Rosangela , Riella Miguel , Salles Joao Eduardo , Vasconcellos Eduardo , Vencio Sergio , Bacci Marcelo , Maia Lilia , Villacorta Aline , Apostolova Emiliya , Boshnyashka Radostina , Farah Ghassan , Georgiev Dimitar , Gushterova Valentina , Klyuchkova Neli , Lucheva Mariya , Manova Petya , Minkova Dotska , Nonchev Boyan , Pichmanova Mariyana , Prakova Zhulieta , Rangelov Rangel , Rashkov Rosen , Stanchev Pavel , Stoyanovska-Elencheva Bilyana , Tagarev Zhivko , Temelkova-Kurktschieva Theodora , Vasileva Svetla , Yoncheva-Mihaylova Mariana , Marinchev Angel , Miteva Mariya , Barre Paul , Carlson Brian , Conway James , Cournoyer Serge , Dumas Richard , Fikry Sameh , Goluch Richard , Hamet Pavel , Hart Randolph , Henein Sam , Liutkus Joanne , Madore Francois , Martinho Valdemar , Mazza Giuseppe , McFarlane Philip , O’Keefe Dennis , Peterson Sean , Schwartz Daniel , Shu Daniel , Steele Andrew , Tellier Guy , Tennankore Karthik , Tobe Sheldon , Tsoukas George , Tytus Richard , Vitou Louise , Walsh Michael , Weisnagel Stanley , Wilderman Igor , Yale Jean-Francois , El Boreky Fadia , Kelly Alan , Leiter Lawrence , Teitelbaum Ivor , Cobos Jorge , Godoy Juan , González Fernando , Lobos Sergio , Palma Juan Carlos , Prieto Dominguez Juan Carlos , Reyes Eliana , Romero Carmen , Saavedra Victor , Vega Mario , Medina Marcelo , Varleta Paola , Bu Ruifang , Cai Hanqing , Chen Nan , Chen Qinkai , Chen Dejun , Cheng Jinluo , Dong Youping , Dong Junwu , Guan Tianjun , Hao Chuanming , Huang Wen , Jiang Fangfang , Lei Minxiang , Li Ling , Li Zhonghe , Li Xuemei , Li Jingmei , Li Yan , Liang Xinling , Liang Bo , Liu Fang , Liu Yinghong , Liu Yuantao , Liu Zhihong , Long Gang , Lu Guoyuan , Lu Weiping , Lu Yibing , Luo Ping , Ma Jianhua , Mo Zhaohui , Niu Jianying , Peng Ai , Shen Jiansong , Shen Feixia , Shi Bingyin , Su Qing , Sun Zhuxing , Tang Shuifu , Tong Nanwei , Wang Hao , Wang Xinjun , Wang Guixia , Wang Jianqin , Wang Yangang , Wang Li , Wei Jiali , Wu Tianfeng , Wu Chaoqing , Xing Changying , Xiong Fei , Xu Xudong , Xu Ning , Yan Tiekun , Yang Jinkui , Yin Aiping , Zeng Longyi , Zhang Hao , Zhang Yanlin , Zhang Ying , Zhao Wenjing , Zhao Zhiquan , Zheng Hongguang , Zhong Ling , Zhu Dalong , Zhuang Yongze , Du Yuming , Fang Yi , Guo Weiying , Jiang Sheng , Kuang Jian , Li Dongmei , Li Hongmei , Li Yinan , Li Yuxiu , Liu Jian , Liu Yu , Miao Heng , Peng Wen , Wang Lihua , Xu Mingtong , Zhong Liyong , Zhu Jun , Arango Clara , Barrera Sandra , Beltrán López Nelly , Benitez Diego , Blanco Guillermo , Cadena Andrés , Coronel Julian , Cure Carlos , Durán Carlos , González Alexander , Guzmán Gustavo , Hernández Eric , Ibarra Jaime , Jaramillo Carlos , Jaramillo Nicolás , Kattah William , Molina Dora , Sánchez Gregorio , Terront Mónica , Trujillo Freddy , Urina Miguel , Vargas Ruben , Villegas Iván , Yupanqui Hernán , Arcos Edgar , Aroca Gustavo , Barreto Germán , Bermudez Andres , Botero Rodrigo , Cárdenas Tatiana , Figueroa Wilmer , Jaramillo Mónica , Liévano Manuel , López Mónica , Molina Dora , Rosero Ricardo , Trillos Pedro , Alferi Dino , Brada Michal , Brezina Jiri , Bucek Petr , Edelsberger Tomas , Gulakova Drahomira , Hasalova Zapletalova Jitka , Hola Olga , Hornova Lucie , Houdova Jana , Hrmova Helena , Karasek David , Kopecka Sarka , Kovar Richard , Krcova Eva , Kuchar Jiri , Kutejova Vlasta , Lubanda Hana , Matyasek Ivo , Mokrejsova Magdalena , Okenka Libor , Prazny Martin , Pumprla Jiri , Tomanek Pavel , Andersen Ulla , Andries Alin , Bech Jesper , Faber Jens , Gislason Gunnar , Hangaard Jørgen , Jaroslaw Pacyk Grzegorz , Juhl Claus , Krarup Thure , Lindhardt Morten , Madsbad Sten , Nielsen Joan , Pedersen-Bjergaard Ulrik , Poulsen Per , Rasmussen Ole , Rossing Peter , Schousboe Karoline , Gram Jeppe , Lauridsen Thomas , Pedersen Erling , Thorsteinsson Birger , Flöjt Päivi , Honkasalo Mikko , Honkasalo Mikko , Humaloja Kari , Kananen Kristiina , Kantola Ilkka , Koistinen Arvo , Korsoff Pirkko , Lahtela Jorma , Nieminen Sakari , Nieminen Tuomo , Sadeharju Karita , Strand Jorma , Sulosaari Sakari , Cariou Bertrand , Chantrel François , Clavel Sylvaine , Combe Christian , Fauvel Jean-Pierre , Gallouj Karim , Gouet Didier , Guerci Bruno , Guerrot Dominique , Hourmant Maryvonne , Klein Alexandre , Mariat Christophe , Marre Michel , Mesbah Rafik , Le Meur Yannick , Monier Arnaud , Moranne Olivier , Roussel Ronan , Serusclat Pierre , Vendrely Benoit , Verges Bruno , Zaoui Philippe , Axthelm Christoph , Bergmann Andreas , Birkenfeld Andreas L. , Braun Hermann , Busch Klaus , Contzen Christel , Degenhardt Stefan , Derwahl Karl , Giebel Thomas , Hagenow Andreas , Haller Hermann , Hasslacher Christoph , Horacek Thomas , Jungmair Wolfgang , Kloos Christof , Koch Thorsten , Krüger Thilo , Mühlfeld Anja , Müller Joachim , Pfützner Andreas , Pistrosch Frank , Rinke Andrea , Rose Ludger , Rump Lars , Schettler Volker , Schiefke Ingolf , Schlichthaar Heike , Schröppel Bernd , Schöll Norbert , Schubert Kristin , Schürholz Thomas , Sigal Helena , Stemler Lutz , Strack Georg , Täschner Heidrun , Toursarkissian Nicole , Tschöpe Diethelm , Ulmer Achim , van der Giet Markus , Wanner Christoph , Winkelmann Bernhard R. , Boletis Ioannis , Dimitriadis George , Hatziagelaki Erifili , Iatrou Christos , Ioannidis Ioannis , Kounadi Theodora , Makriniotou Ioanna , Papadopoulou Dorothea , Papagianni Aikaterini , Passadakis Ploumis , Piaditis George , Stefanidis Ioannis , Pang Ip Tai , Lee Paul , Luk On Yan Andrea , Ma Ronald , Chow Wing Sun , Wang Angela , Yeung Vincent , Bajcsi Dora , Danos Peter , Harcsa Eleonora , Kalina Akos , Kazup Szilvia , Keltai Katalin , Kirschner Robert , Kiss Julianna , Kovacs Laszlo , Lamboy Beata , Literati-Nagy Botond , Mileder Margit , Nagy Laszlo , Noori Ebrahim , Nyirati Gabor , Petro Gizella , Schneider Karoly , Simon Judit , Szocs Albert , Vasas Szilard , Wudi Krisztina , Zilahi Zsolt , Zsom Marianna , Eustace Joe , Holian John , Reddan Donal , O’Meara Yvonne , Abramof Ness Rosane , Adawi Faiad , Armaly Zaher , Atar Shaul , Bashkin 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, Popescu Alexandrina , Radulian Gabriela , Szilagyi Iosif , Turcu Liana , Vacaru Georgeta , Vlad Adrian , Filimon Adriana , Veresiu Ioan , Antsiferov Mikhail , Arkhipov Mikhail , Babkin Andrey , Barbarash Olga , Baranov Vitaliy , Chernyavskaya Elena , Demko Arkadiy , Dreval Alexander , Edin Anton , Ermakova Polina , Fadeev Valentin , Galyavich Albert , Gaysina Leyla , Gordeev Ivan , Ipatko Irina , Kalashnikova Marina , Khalimov Yuriy , Klimontov Vadim , Kobalava Zhanna , Kosmacheva Elena , Koziolova Natalya , Kvitkova Lyudmila , Levashov Sergey , Libis Roman , Marasaev Vyacheslav , Malykh Natalia , Martynenko Vladimir , Malyutina Sofya , Merai Imad , Mkrtumyan Ashot , Nechaeva Galina , Petunina Nina , Palyutin Shamil , Pimenov Leonid , Rechkova Elena , Rodionova Tatyana , Rymar Oksana , Sardinov Ruslan , Semenova Olga , Sherenkov Alexander , Solovev Oleg , Smolyarchuk Elena , Strongin Leonid , Ukhanova Olga , Verlan Nadezhda , Vorokhobina Natalya , Yakhontov Davyd , Yakushin Sergey , 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Oguz Aytekin , Ozdogan Oner , Sari Ibrahim , Temizhan Ahmet , Tigen Mustafa , Turk Ugur , Yilmaz Huseyin , Yilmaz Mehmet , Bondarets Iryna , Botsyurko Volodymyr , Chernikova Viktoriia , Donets Oleksandra , Fushtey Ivan , Grachova Mariia , Isayeva Anna , Kogut Dmytro , Komisarenko Julia , Kravchun Nonna , Malyar Kateryna , Mankovsky Borys , Martynyuk Liliya , Maslyanko Vitaliy , Myshanych Halyna , Pererva Larysa , Pertseva Nataliia , Serhiyenko Oleksandr , Smirnov Ivan , Sokolova Liubov , Stryzhak Vasyl , Vlasenko Maryna , Isayeva Ganna , Larin Oleksandr , AbouSaleh Ahmad , Barratt Jonathan , Dang Cuong , Kahal Hassan , Kirk Adam , Kilvert Anne , Kon Sui Phi , McCafferty Kieran , Patel Dipesh , Rice Sam , Vijayaraman Arutchelvam , Wong Yuk-ki , Gibson Martin , Wahba Mona , Zaidi Reza , Bilous Rudy , Johnson Andrew , Kalathil Dhanya , Kilvert Anne , Kyriakidou Christina , Mathew Amit , Mukhtar Rasha , Munsoor Imrozia , Poterajlo Anton , Swift Pauline , Acosta Idalia , Adams Atoya , Adler Sharon , Ajani Dilawar , Ali Slamat , Alicic Radica , Al-Karadsheh Amer , Alla Sreedhara , Andrawis D. Allison Nabil , Arif Ahmed , Awad Ahmed , Azizad Masoud , Bahrami Michael , Bansal Shweta , Barag Steven , Barakzoy Ahmad , Barney Mark , Barzilay Joshua , Bashir Khalid , Bautista Jose , Beddhu Srinivasan , Belo Diogo , Benjamin Sabrina , Berenji Ramin , Bhargava Anuj , Birriel Jose , Brietzke Stephen , Brosius Frank , Brusco Osvaldo , Burgner Anna , Busch Robert , Canadas Rafael , Caramori Maria , Cardona Jose , Case Christopher , Cruz Humberto , Dandillaya Ramprasad , Dawoud Dalia , Din Zia , Dixon Bradley , Doshi Ankur , Drakakis James , El Shahawy Mahfouz , El-Meanawy Ashraf , El-Shahawy Mohammed , Evans John , Fadda George , Farooq Umar , Fernando Roland , Fink Raymond , First Brian , Fitz-Patrick David , Flack John , Fluck Patrick , Fogelfeld Leon , Fonseca Vivian , Frias Juan , Galphin Claude , Garcia-Mayol Luis , Goldstein Gary , Gonzalez Edgar , Gonzalez-Abreu Francisco , Gore Ashwini , Grant David , Habwe Violet , Hamilton Maxine , Hammoud Jamal , Handelsman Stuart , Hartman Israel , Heigerick Glenn , Henry Andrew , Hernandez German , Hernandez-Cassis Carlos , Herrera Carlos , Hertel Joachim , Huang Wenyu , Iglesias Rogelio , Iranmanesh Ali , Jackson Timothy , Jain Mahendra , Jamerson Kenneth , Johnson Karen , Judd Eric , Kaplan Joshua , Kayali Zeid , Khan Bobby , Khan Muhammad , Kharait Sourabh , Kirkman M. Sue , Kopyt Nelson , Kotzker Wayne , Kovesdy Csaba , Kreit Camil , Krishna Arvind , Kronfli Saeed , Lee Keung , LeJeune Derek , Lemus Brenda , Leon-Forero Carlos , Linfert Douglas , Lora Henry , Lurie Alexander , Maddukuri Geetha , Magno Alexander , Maletz Louis , Mandayam Sreedhar , Markell Mariana , Mayfield Ronald , Mbogua Caroline , McMullen Dierdre , Meisner Carl , Minton Stephen , Mocherla Bharat , Mohandas Rajesh , Montero Manuel , Moustafa Moustafa , Nadkarni Salil , Nakhle Samer , Navarro Jesus , Neyra Nilda , Nica Romanita , Nicol Philip , Norwood Paul , Numrungroad Visal , O’Donovan Richard , Odugbesan A. , Paoli-Bruno Jorge , Parikh Samir , Patel Rakesh , Peixoto Aldo , Pergola Pablo , Perlman Alan , Pettis Karlton , Pisoni Roberto , Ponduchi Mirela , Posada Jorge , Prabhakar Sharma , Radhakrishnan Jai , Rahman Mahboob , Raina Rupesh , Rastogi Anjay , Reisin Efrain , Rendell Marc , Robertson David , Rocco Michael , Romeu Hugo , Rosas Sylvia , Rosenfeld Jack , Ross Dennis , Rothman Jeffrey , Rudolph Lance , Ruhullah Yusuf , Ruoff Gary , Ryu Jeffrey , Sahani Mandeep , Sam Ramin , Samuels Garfield , Sanchez William , Santos Vladimir , Satko Scott , Saxena Sanjeev , Scott David , Seco Gilberto , Seek Melvin , Serota Harvey , Shafi Tariq , Shahid Nauman , Shanik Michael , Sharma Santosh , Sinha Arjun , Smelser James , Smith Mark , Soe Kyaw , Solomon Richard , Soroka Eugene , Soufer Joseph , Spinowitz Bruce , Spry Leslie , Suarez Rosa , Subramanian Bala , Szerlip Harold , Tamirisa Aparna , Thomson Stephen , Tran Tuan-Huy , Treger Richard , Trullenque Gretel , Turk Thomas , Umpierrez Guillermo , Urbach Daniel , Valdes Martin , Valika Shujauddin , Vega Damaris , Weissman Peter , Whaley-Connell Adam , Winston Jonathan , Wise Jonathan , Wynne Alan , Zeig Steven , Abdel-Rahman Emaad , Abreu Edel , Awad Alaa , Bahri Nader , Bertsch John , Bleich David , Bornfreund Jonathan , Brar Harjeet , Brian Susan , Brinson Cynthia , Bruschetta Humberto , Carpio Jose , Cohen Steven , Cosby John , Dhanireddy Soni , Diaz Jorge , Dunn Fredrick , Eppanapally Sabitha , Fayad Joseph , Goel Archana , Govindaraju Kanakadurga , Halpern Stephen , Jones Audrey , Kaye William , Knight Herbert , Koch Stanley , Kohli Nandini , Lastra Guido , Lerman Sam , Loredo Jorge , Lovre Dragana , Mandviwala Mustafa , Martin Earl , Meyer Jill , Murray John , Oliver David , Oparil Suzanne , Penabad Jesus , Pereira Isabel , Popeil Larry , Quesada Gonzalo , Ramanathan Kodangudi , Ramos-Gonez Luis , Rastegar Mandana , Rastogi Padmashri , Rondon Juan , Roy-Chaudhury Prabir , Smith David , Williamson Don , Womack Catherine , Yamout Hala , Yuryev Michael , Chu Phuong , Hoang Lam Van , Khanh Tran , Nga Nguyen Thi Phi , Son Pham Nguyen , Tran Lan Phuong , Le Thuy Khuong , Nguyen Boi Ngoc , Nguyen Thao , Nui Nguyen Minh , Nam Tran Quang , Tran Kim Chi 
Published: August 2022

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.