Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes According to Baseline HbA1c and Insulin Use: An Analysis From the FIDELIO-DKD Study
Authors: Rossing Peter , Burgess Ellen , Agarwal Rajiv , Anker Stefan D. , Filippatos Gerasimos , Pitt Bertram , Ruilope Luis M. , Gillard Pieter , MacIsaac Richard J. , Wainstein Julio , Joseph Amer , Brinker Meike , Roessig Lothar , Scott Charlie , Bakris George L. ,   FIDELIO-DKD Investigators, Vallejos Augusto , MacIsaac Richard , Schernthaner Guntram , Gillard Pieter , Canziani Maria Eugenia F. , Temelkova-Kurktschiev Theodora , Burgess Ellen , Tobe Sheldon , González Fernando , Liu Zhi-Hong , Ángelo Andrés , Bonfanti Cadena , Francisco Jaramillo Carlos , Prazny Martin , Rossing Peter , Strand Jorma , Marre Michel , Schmieder Roland , Wanner Christoph , Sarafidis Pantelis A. , Chan Juliana , Rosivall László , Eustace Joseph , Grossman Ehud , Yagil Yoram , Remuzzi Giuseppe , Koya Daisuke , Wada Takashi , Madero Rovalo Magdalena , Gansevoort Ron , Kooy Adriaan , Finnes Trine , De Leon Froilan , Gumprecht Janusz , Teixeira e Costa Fernando , Dreval Alexander , Vathsala Anantharaman , Amod Aslam , Gon Kim Sin , Wan Lee Byung , Pascual Santos Julio , Tengmark Bengt-Olov , Burnier Michel , Lee Chien-Te , Yamwong Sukit , Sari Ramazan , McCafferty Kieran , Mankovsky Borys , Adler Sharon , Fried Linda , Toto Robert , Williams Mark , Quang Khanh Tran , Aizenberg Diego , Bartolacci Inés , Besada Diego , Bittar Julio , Chahin Mariano , Elbert Alicia , Gelersztein Elizabeth , Liberman Alberto , Maffei Laura , Pérez Manghi Federico , Sanabria Hugo , Viñes Gloria , Wassermann Alfredo , Abhayaratna Walter , Acharya Shamasunder , Ekinci Elif , Lee Darren , Mann Mah Peak , Nelson Craig , Packham David , Pape Alexia , Roger Simon , Stephenson Hugo , Suranyi Michael , Wittert Gary , Vale Elizabeth , 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 , Doubel Peter , Engelen Wendy , Hougardy Jean-Michel , Krzesinski Jean-Marie , Maes Bart , Speeckaert Marijn , Stas Koen , van Gaal Luc , Vanbelleghem Hilde , Antunes Daniela , Botelho Roberto , Brito Claudia , Canani Luis , Eugenia Canziani Maria , Cerqueira Maria , de Paula Rogerio , Eliaschewitz Freddy , Eduardo Figueiredo Carlos , Forti Adriana , Hissa Miguel , Leite Jr Maurilo , Lima Emerson , Noronha Irene , Paolino Bruno , Paschoalin Nathalia , Paschoalin Raphael , Pecoits Filho Roberto , Pereira Marcio , Portes Evandro , Precoma Dalton , Rea Rosangela , Riella Miguel , Eduardo Salles Joao , Vasconcellos Eduardo , Vencio Sergio , 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 , 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 , Tsoukas George , Tytus Richard , Vitou Louise , Walsh Michael , Weisnagel Stanley , Wilderman Igor , Yale Jean-Francois , Cobos Jorge , Godoy Juan , Lobos Sergio , Carlos Palma Juan , Carlos Prieto Juan , Reyes Eliana , Romero Carmen , Saavedra Victor , Vega Mario , 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 , 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, Kyu Oh Yun , Oh Dong-Jin , Park Junbeom , Joon Shin Seok , Sung Su-Ah , Myung Yu Jae , Agraz Irene , Javier Ampudia Francisco , Bouarich Hanane , Calero Francesca , Castro Cristina , Cigarrán Guldris Secundino , Cruzado Garrit Josep , de Álvaro Fernando , Galcerán Josep , González Albarrán Olga , Hernández Jaras Julio , Ibernón Meritxell , Martínez Deben Francisco , Dolores Martínez Esteban Ma , María Pascual Izuel José , Martins Judith , Mediavilla Juan , Michán Alfredo , Poch Esteban , Polaina Rusillo Manuel , Sánchez Juan Carlos , Santamaría Olmo Rafael , Julián José , de la Morena Segura , Soto Alfonso , Troya Maribel , Bruchfeld Annette , Curiac Dan , Eliasson Ken , Frank Malin , Guron Gregor , Hellberg Olof , Hellgren Margareta , Larnefeldt Hans , Lindholm Carl-Johan , Löndahl Magnus , Rein-Hedin Erik , Soveri Inga , Spaak Jonas , Ackermann Daniel , Bilz Stefan , Forster Christian , Kalbermatter Stefan , Kistler Andreas , Pechére-Bertschi Antoinette , Schultes Bernd , Chang Chiz-Tzung , Hung Cheng-Chieh , Jiang Ju-Ying , Lin Shuei-Liong , Tarng Der-Cherng , Tu Shih-Te , Wu Mai-Szu , Wu Ming-Ju , Deerochanawong Chaicharn , Kitiyakara Chagriya , Ophascharoensuk Vuddhidej , Pongchaiyakul Chatlert , Satirapoj Bancha , Eren Necmi , Gul Ibrahim , Gulel Okan , Kocyigit Ismail , Kumbasar Abdulbaki , Sahin Idris , Sayin Burak , Tavli Talat , Ustundag Sedat , Yenicerioglu Yavuz , Bondarets Iryna , Botsyurko Volodymyr , Chernikova Viktoriia , Donets Oleksandra , Fushtey Ivan , Grachova Mariia , Isayeva Anna , Kogut Dmytro , Komisarenko Julia , Kravchun Nonna , Malyar Kateryna , Martynyuk Liliya , Maslyanko Vitaliy , Myshanych Halyna , Pererva Larysa , Pertseva Nataliia , Serhiyenko Oleksandr , Smirnov Ivan , Sokolova Liubov , Stryzhak Vasyl , Vlasenko Maryna , AbouSaleh Ahmad , Barratt Jonathan , Dang Cuong , Kahal Hassan , Kirk Adam , Kilvert Anne , Phi Kon Sui , Patel Dipesh , Rice Sam , Vijayaraman Arutchelvam , Wong Yuk-ki , Gibson Martin , Wahba Mona , Zaidi 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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 , Chu Phuong , Van Hoang Lam , Khanh Tran , Thi Phi Nga Nguyen , Nguyen Son Pham , Phuong Tran Lan 
Published: January 2022

OBJECTIVE
Finerenone significantly improved cardiorenal outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) in the Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease trial. We explored whether baseline HbA1c level and insulin treatment influenced outcomes.

RESEARCH DESIGN AND METHODS
Patients with T2D, urine albumin-to-creatinine ratio (UACR) of 30–5,000 mg/g, estimated glomerular filtration rate (eGFR) of 25 to &lt;75 mL/min/1.73 m2, and treated with optimized renin–angiotensin system blockade were randomly assigned to receive finerenone or placebo. Efficacy outcomes included kidney (kidney failure, sustained decrease ≥40% in eGFR from baseline, or renal death) and cardiovascular (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) composite endpoints. Patients were analyzed by baseline insulin use and by baseline HbA1c &lt;7.5% (58 mmol/mol) or ≥7.5%.

RESULTS
Of 5,674 patients, 3,637 (64.1%) received insulin at baseline. Overall, 5,663 patients were included in the analysis for HbA1c; 2,794 (49.3%) had baseline HbA1c &lt;7.5% (58 mmol/mol). Finerenone significantly reduced risk of the kidney composite outcome independent of baseline HbA1c level and insulin use (Pinteraction = 0.41 and 0.56, respectively). Cardiovascular composite outcome incidence was reduced with finerenone irrespective of baseline HbA1c level and insulin use (Pinteraction = 0.70 and 0.33, respectively). Although baseline HbA1c level did not affect kidney event risk, cardiovascular risk increased with higher HbA1c level. UACR reduction was consistent across subgroups. Adverse events were similar between groups regardless of baseline HbA1c level and insulin use; few finerenone-treated patients discontinued treatment because of hyperkalemia.

CONCLUSIONS
Finerenone reduces kidney and cardiovascular outcome risk in patients with CKD and T2D, and risks appear consistent irrespective of HbA1c levels or insulin use.