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IRIS
Background: The efficacy and safety of sodium-glucose cotransporter 2 inhibitors such as sotagliflozin in preventing cardiovascular events in patients with diabetes with chronic kidney disease with or without albuminuria have not been well studied. Methods: We conducted a multicenter, double-blind trial in which patients with type 2 diabetes mellitus (glycated hemoglobin level, ≥7%), chronic kidney disease (estimated glomerular filtration rate, 25 to 60 ml per minute per 1.73 m2 of body-surface area), and risks for cardiovascular disease were randomly assigned in a 1:1 ratio to receive sotagliflozin or placebo. The primary end point was changed during the trial to the composite of the total number of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure. The trial ended early owing to loss of funding. Results: Of 19,188 patients screened, 10,584 were enrolled, with 5292 assigned to the sotagliflozin group and 5292 assigned to the placebo group, and followed for a median of 16 months. The rate of primary end-point events was 5.6 events per 100 patient-years in the sotagliflozin group and 7.5 events per 100 patient-years in the placebo group (hazard ratio, 0.74; 95% confidence interval [CI], 0.63 to 0.88; P<0.001). The rate of deaths from cardiovascular causes per 100 patient-years was 2.2 with sotagliflozin and 2.4 with placebo (hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P = 0.35). For the original coprimary end point of the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, the hazard ratio was 0.84 (95% CI, 0.72 to 0.99); for the original coprimary end point of the first occurrence of death from cardiovascular causes or hospitalization for heart failure, the hazard ratio was 0.77 (95% CI, 0.66 to 0.91). Diarrhea, genital mycotic infections, volume depletion, and diabetic ketoacidosis were more common with sotagliflozin than with placebo. Conclusions: In patients with diabetes and chronic kidney disease, with or without albuminuria, sotagliflozin resulted in a lower risk of the composite of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure than placebo but was associated with adverse events. (Funded by Sanofi and Lexicon Pharmaceuticals; SCORED ClinicalTrials.gov number, NCT03315143.).
Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease
Deepak L Bhatt;Christopher P Cannon;Lawrence A Leiter;Julia B Lewis;Darren K McGuire;MHScBertram Pitt;Matthew C Riddle;Gabriel Steg;Hertzel C Gerstein;Gary S Francis;John E Gerich;Johannes F E Mann;Weichung Joe Shih;James B Young;Clifford J Bailey;David Z I Cherney;Jamie P Dwyer;Silvio E Inzucchi;Mikhail N Kosiborod;Benjamin M Scirica;Renato D Lopes;Jennifer B Green;Karen P Alexander;Bryan C Batch;W Schuyler Jones;J Dedrick Jordan;Bradley J Kolls;David F Kong;Wanda C Lakey;Richard H Lee;Robin Mathews;Robert W McGarrah;Rajendra H Mehta;Chiara Melloni;John P Middleton;Thomas J Povsic;Patrick H Pun;Julia J Scialla;Shreyansh Shah;Luciano A Sposato;Thomas J Weber;Casey Norris;Jill Marcus;Nikieia Hayden;Dimitrios Stournaras;Sophie Wang;Linley Brown;Dominique Larrey;James Lewis;Joshua Beckman;Marc Bonaca;Nicholas Leeper;Phillip Banks;Eshetu Tesfaye;Kenneth Kassler-Taub;Chris Warner;Mark O'Neill;Rosemary Molinari Covance;Rafael Díaz;Mark Cooper;Chantal Mathieu;Freddy Goldberg Eliaschewitz;Tsvetalina Tankova;Jacob A Udell;Ramon Luis Corbalan Herreros;Lixin Jiang;Martin Haluzík;Ales Linhart;Steen Dalby Kristensen;Toomas Marandi;Ronan Roussel;Vakhtang Chumburidze;Jochen Seufert;Nikolaos Tentolouris;Milton Rivera;Béla Peter Merkely;Vijay Kumar Chopra;Doron Zahger;Enzo Bonora;Aivars Lejnieks;Birutė Žilaitienė;Tatjana Milenkovic;Armando García-Castillo;Marcel De Vries;Russell Scott;Hilde Risstad;Helard Andres Manrique Hurtado;Roger Martin Correa Flores;Zbigniew Gaciong;Pedro Filipe Lopes Silva Monteiro;Cristian Guja;Nadir M Akhmedzhanov;Neboiša Lalić;Emil Martinka;Jan Murin;Lesley Jean Burgess;MyungHo Jeong;José López-Sendón;Jonas Oldgren;Gottfried Rudofsky;Chern-En Chiang;Mehmet Özkan;Boris Mankovsky;Kausik K Ray;Steve Bain;Lilia Beatriz Schiavi;Ernesto Alfredo Duronto;Adrian Eduardo Hernandes Guana;Juan Carlos Medrano Allende;Sandra Marcela Del Valle Almagro;Guillermo Daniel Caime;Oscar Romano Montaña;Alberto Caccavo;Gabriela Carnero;Julio Andres Vallejos;Silvia Salome Saavedra;Maria Cecilia Cantero;Marcelo Trivi;Silvia Inés Orio;Gustavo Daniel Frechtel;Diego Aizenberg;Cesar Javier Zaidman;Patricia Mabel Castaño;Marcelo Alejandro Garrido;Gustavo Adolfo Paterlini;Matias Nicolas Lugo;Gustavo Gabriel Castiello;Virginia Sernia;Jose Osvaldo Fretes;Juan Andrés Oddino;Federico Carlos Perez Manghi;Matias Alberto Re;Archie Glenny;Maximiliano Sicer;Claire Morbey;James Rogers;Richard Walter Simpson;Richard MacIsaac;Robert Geoffrey Moses;Andrew James Hamilton;Patrick Anthony Carroll;Michael Gabriel Suranyi;Michael C D'Emden;Peter Colman;Stephen Stranks;Ferdinandus Johan de Looze;Michael Horowitz;Peak Mann Mah;Elif Ilhan Ekinci;Anne Therese Reutens;Timothy Mark Davis;Gregory Ronald Fulcher;Fabienne Liénart;Gerd Michel Marie Vanhaverbeke;Chris Vercammen;Samyah Shadid;Lilia Nigro Maia;Luiz Alberto Andreotti Turatti;Miguel Nasser Hissa;Jose Francisco Kerr Saraiva;Luiz Antonio Raio Granja;Paulo Roberto Ferreira Rossi;Maria Helena Vidotti;Cintia Cercato;Adriana Costa E Forti;Silvia Carreira Ribeiro;Marcio Antonio Pereira;Maria Eugenia Canziani;Hugo Roberto Kurtz Lisboa;Eduardo Freire Vasconcellos;Luis Henrique Santos Canani;Adrain Paulo Morales Kormann;Tiago Schuch;Rosangela Roginski Rea;Queulla Garret Santos;Luana Casari da Silva Lima;Luis Augusto Tavares Russo;Joao Batista Moraes Junior;Paulo Ernesto Leães;Alberto Gomes Taques Fonseca;Zahari Nikitov;Stefka Vladeva;Zdravko Asenov Kamenov;Anna-Maria Borissova-Ivanova;Emiliya Apostolova;Darina Zhekova Vasileva;Ivaylo N Lefterov;Velichka Ananieva Damyanova;Rositsa Ivanova Mihaylova-Shumkova;Yoana Savova Gerasimova Zheleva;Margarita Temelkova;Tsvetodara KunevaIvaylo P Ivanov;Antoaneta Zlateva-Nikolaeva;Thomas G Elliott;Harpreet Bajaj;René Therrien;Allan Jay Kelly;Sue Pedersen;Heather Anne Lochnan;Sam Henein;Roger Edmond Labonte;Tolulope O Olateju;Irene Hramiak;Joseph C Berlingieri;S John Weisnagel;Ying Tung Sia;James ChaJean-François Yale;Ronald Akhras;Jean-Claude Tardif;Ronald J Sigal;Guy Chouinard;Zubin Punthakee;Paul Poirier;Andrew William Steele;Thomas Peter Patrick Ransom;Luis Carlos Eugenio Noronha;Ronald Goldenberg;Imad John Nadra;Stephen S Cheung;Pierre Filteau;Bruce Alexander Sussex;Simon Kouz;Gonzalo Godoy;Patricia Gomez Gomez;Sergio Potthoff;Paola Varleta;Gladys Larenas;Margarita Vejar Jalaf;Gaston Dussaillant;Carlos Raffo;Juan Carlos Palma Carvajal;Victor Saavedra;Humberto Montecinos;Guillermo Araneda;Carmen Lia Solis;Eliana Reyes;Macarena Arias;Luis Morales;Juan Valderas;Juan Celis;Alfredo Dañin Vargas;German Cruz;Marcelo Medina;Luis Oviedo;Fernando Lanas;Monica Acevedo;Ping Qing;Linong Ji;Jinkui Yang;Weiping Lu;Ying Li;Jiyan Chen;Guoyue Yuan;Guohai Su;Hailong Lin;Xuelian Zhang;Guoyuan Lu;Xinjun Wang;Yan Liu;Minghui Zhao;Nanwei Tong;Zhaohui Mo;Wenxia Zong;Ji Hu;Dejun Chen;Zuyi Yuan;Zhuhua Yao;Jianchao Guo;Qingkai Chen;Huifang Tang;Ping Yang;Ying Liu;Jinguo Zhang;Juan Liu;Katerina Hejnicova;Jan Kanovsky;Vera Adamkova;Vilma Machova;Renata Golanova;Zdenek Jankovec;Lubor Golan;Jean Claude Mukonkole Lubanda;Jindrich Spinar;Rostislav Polasek;Michal Hudcovic;Katarina Halciakova;Petr Maule;Milan Kvapil;Martin Haluzik;Ondrej Cermak;Alica Vesela;Hans Perrild;Søren Gregersen;Morten Schou;Hans Eiskjær;Kenneth Egstrup;Jens Due Lomholdt;Jens Dahlgaard Hove;Peter Rossing;Maire Lubi;Anu Hedman;Didier Gouet;Alfred Penfornis;Michel Renè Pierre Galinier;Damien Logeart;Pierre Serusclat;Zaza Iominadze;Chumburidze Vakhtang;Tamaz Shaburishvili;Salome Glonti;Irakli Khintibidze;George Khabeishvili;Zurab Pagava;Karl Friedrich Appel;Winfried Keuthage;Thomas Schürholz;Katrin Arelin;Ekkehard Schmidt;Thomas Schaum;Moses Elisaf;Alexios Sotiropoulos;Alexandra Bargiota;Glykeria Tzatzagou;Rosa Elena Morales Siliezar;Omar Alonzo Villagran;Rómulo Rolando de León Mazariegos;Arnoldo Vinicio Granados Fuentes;Luis Alberto Ramirez;Flor de Maria Ranchos Monterroso;Ronaldo Arturo González Orellana;Victor Manuel Giordano Jerez;Béla Péter Merkely;Denes Pall;Ebrahim Noori;Albert Ferenc Szócs;Ferenc Lakatos;Géza Károly Lupkovics;Istvan Edes;Katalin Keltai;Gabriella Hódi;Robert Gabor Kiss;Tamás Szelestei;Zsuzsanna Papp;Zsolt Zilahi;András Csaba Nagy;János Tibor Kis;József Lippai;Rakesh Sahay;Jugal Bihari Gupta;Manjinder Singh Sandhu;Vijay K Chopra;Prasad Murigendrappa Renuka;Jubbin Jacob Jacob;Sridhar Papani;Ganapathi Bantwal;Abhijeet Bhaskar Joshi;Sunil Nilkanth Washimkar;Pankaj Vijaykumar Harkut;Dhiman Kahali;Prafulla Gopinath Kerkar;Bhagavathula Kutumba Srinivasa Sastry;Mohan Magdum;Nitin Kapoor;Manojkumar Bhavarila Chopada;Kiran Pal Singh;Harish Kumar;Anil Ranjeetmal Jain;Mukund Kumbla;Prabha Adhikari;Neeraj Manikath;Sandeep Garg;C B Keshavamurthy;Aparna Kodre;Prashant Prabhakar Udgire;Raj Kanwar Yadav;Vaishali Deshmukh;Mady Moriel;Ronen Beeri;Yaron Arbel;Shaul Atar;Idit Dobrecky Mery;Michael Shechter;Robert Zukermann;Itzhak Gabizon;Piermarco Piatti;Davide Lauro;Franco Luiga Cavalot;Agostino Gnasso;Graziano Di Cianni;Alberto Giacinto Ambrogio;Carlo Bruno Giorda;Giorgio Sesti;Paolo di Bartolo;Jun Kwon;Gooyeong Cho;Hae Young Lee;Seung Woo Park;MooHyun Kim;Jong Won Ha;Myung Ho Jeong;DuckWoo Park;Sun-Ae Yoon;SoonJib Yoo;Ārija Bušmane;Iveta Šime;Renáte Helda;Natalja Pontaga;Aldis Strelnieks;Valdis Pirags;Dace Teterovska;Žydrūnė Visockienė;Antanas Navickas;Lina Radzevičienė;Andrej Levinger;Audrone Velaviciene;Gediminas Urbonas;Audronė Augustėnienė;Birute Zilaitiene;Evalda Danytė;Stojko Bojovski;Tatjana Milenkovikj;Dushica Stefanovska;Mira Kostojchinoska;José Gerardo González González;Leobardo Sauque Reyna;Raul Alejandro Aguilar Orozco;Guillermo González Galvez;Juan Rosas Guzmàn;Juan Carlos Nuñez Fragoso;Vilda Katherine Handal Gamundi;Marco A Morales de Teresa;María Del Rosario Arechavaleta Granell;Gabriel Arturo Ramos López;Edmundo Alfredo Bayram Llamas;Marco Antonio Alcocer Gamba;Rodrigo Suárez Otero;Enrique López Rosas;Oscar Tarsicio Moreno Loza;Guillermo Antonio Llamas Esperón;Armando García Castillo;José Ángel Garza Ruiz;Enrique Ortiz Jiménez;Carlos Alejandro Stobschinski de Alba;Nacu Aureo Caracas Portilla;Emilia Susana Pelayo Orozco;Eduardo Salcido Vázquez;Luis Fernando Flota Cervera;Maricela Vidrio Velázquez;Hugo Antonio Laviada Molina;Klaas Hoogenberg;Manuel Castro Cabezas;Adriaan Kooy;Johannes Feenstra;John Michael Elliott;Rosemary Megan Hall;Michael Williams;John Dereck Antony Richmond;James Anthony Pemberton;Balaratnam Kingsley Nirmalaraj;Simon James Carson;Simon Christopher Young;Nine Madeleine Smuts;Helen Lunt;Ian Frank Richard Ternouth;Jocelyne Rachelle Benatar;Veronica Bernadette Crawford;Peter John Dunn;Jørn Ossum;Eli Heggen;Knut Risberg;Hans Olav Høivik;Angelica Maria Valdivia Portugal;Luis Alberto Camacho Cosavalente;César Manuel Delgado Butró;Miguel Angel Cotrina Orrego;Julio Roberto Durand Velásquez;Carlos Antero Chávez Ayala;Carlos Antonio Zea Nuñez;Rolando Jesus Vargas Gonzales;Rosa Esperanza Lisson Abanto;Luís Humberto Tercero Zapata Rincón;Carlos Enrique Guerreros 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Robles;Javier Elvira Gonzalez;Antonio Martinez Rubio;Antonio Reyes Domínguez;Emil Hagström;Henrik Wagner;Hans Larnefeldt;Georgios Mourtzinis;Magnus B Löndahl;Annette Bruchfeld;Stefan Berglund;Bengt-Olov Tengmark;Gottfried Günther Norbert Rudofsky;Birgit Constanze Bach-Kliegel;Bernd Schultes;Ting-Hsing Chao;I-Chang Hsieh;Ming-En Liu;Kuan-Cheng Chang;Chon-Seng Hong;Tsung-Hsien Lin;Gülhan Duman;Tevfik Demir;Yusuf Karavelioglu;Mehmet Ali Astarcioglu;Ismail Turkay Ozcan;Hasan Kudat;Osman Alper Onbasili;Murat Kazim Ersanlı;İsmail Koçyiğit;Necmi Eren;Ibrahim Sahin;Mustafa Araz;Nurhan Seyahi;Ramazan Sari;Serhiy Andreychyn;Oleksandr Karpenko;Halyna Myshanych;Yuriy Mostovoy;Liudmyla Sapozhnychenko;Nataliia Pentiuk;Mamuka Bazadze;Olena Kobrynska;Ivan Smirnov;Igor Vakaliuk;Valeriy Batushkin;Mykola Stanislavchuk;Oles Kutnii;Borys Mankovsky;Kateryna Maliar;Iurii Rudyk;Vadym Berenfus;Nataliia Sydor;Leonid Rudenko;Andriy Yagensky;Liubov Sokolova;Stephen C Bain;Gerry Rayman;Hamish Courtney;Adam 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Sahani;David J Schneider;David Scott;James R Shoemaker;Carl Wilson Sofley;Ralph David Wade;Ahmed M Awad;Osvaldo Alejandro Brusco;Harold Kennedy Cathcart;Jamal Hammoud;Timothy S Bailey;Derek Lewis;Michael J Lillestol;Salil Uday Nadkarni;John Chip H Reed 3rd;Lilia Rodriguez Ables;Mark Lowe Warren;Alan G Wynne;Peter E Bressler;Larry D Stonesifer;Mohamed Ali El-Shahawy;Luis F Soruco;Dilawar Ajani;Aron Schlau;Giselle Debs-Perez;Paul Carlton Norwood Jr;Paul S Denker;Dale Crawford Allison;Jose F Cardona;David Marc Gorson;Iftekhar Baig;Faizullah Syed;Mushtaq Ali Syed;Robert J Buynak;Donald Franklin Gardner;Atul K Singhal;Robert S Busch;Najmuddin K Karimjee;Thomas Lavern Pitts;Jose Guillermo Alvarez;Pierre R Blemur;Patrick J McCarthy;Franklin Joseph Zieve;Bhasker Rai Mehta;Raul Efrain Gaona Sr;Ana M Acosta;Gilda M De La Calle;Ivan Carreras;Gil Fernandez-Year;Miguel E Trevino;Gregorio A Cortes-Maisonet;Guillermo E Umpierrez;Elena I Barengolts;Ikeadi M Ndukwu;Vernon L Young;Daniel Lee Pomposini;James Sample Magee
2021-01-01
Abstract
Background: The efficacy and safety of sodium-glucose cotransporter 2 inhibitors such as sotagliflozin in preventing cardiovascular events in patients with diabetes with chronic kidney disease with or without albuminuria have not been well studied. Methods: We conducted a multicenter, double-blind trial in which patients with type 2 diabetes mellitus (glycated hemoglobin level, ≥7%), chronic kidney disease (estimated glomerular filtration rate, 25 to 60 ml per minute per 1.73 m2 of body-surface area), and risks for cardiovascular disease were randomly assigned in a 1:1 ratio to receive sotagliflozin or placebo. The primary end point was changed during the trial to the composite of the total number of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure. The trial ended early owing to loss of funding. Results: Of 19,188 patients screened, 10,584 were enrolled, with 5292 assigned to the sotagliflozin group and 5292 assigned to the placebo group, and followed for a median of 16 months. The rate of primary end-point events was 5.6 events per 100 patient-years in the sotagliflozin group and 7.5 events per 100 patient-years in the placebo group (hazard ratio, 0.74; 95% confidence interval [CI], 0.63 to 0.88; P<0.001). The rate of deaths from cardiovascular causes per 100 patient-years was 2.2 with sotagliflozin and 2.4 with placebo (hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P = 0.35). For the original coprimary end point of the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, the hazard ratio was 0.84 (95% CI, 0.72 to 0.99); for the original coprimary end point of the first occurrence of death from cardiovascular causes or hospitalization for heart failure, the hazard ratio was 0.77 (95% CI, 0.66 to 0.91). Diarrhea, genital mycotic infections, volume depletion, and diabetic ketoacidosis were more common with sotagliflozin than with placebo. Conclusions: In patients with diabetes and chronic kidney disease, with or without albuminuria, sotagliflozin resulted in a lower risk of the composite of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure than placebo but was associated with adverse events. (Funded by Sanofi and Lexicon Pharmaceuticals; SCORED ClinicalTrials.gov number, NCT03315143.).
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/20.500.12317/73693
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simulazione ASN
Il report seguente simula gli indicatori relativi alla propria produzione scientifica in relazione alle soglie ASN 2023-2025 del proprio SC/SSD. Si ricorda che il superamento dei valori soglia (almeno 2 su 3) è requisito necessario ma non sufficiente al conseguimento dell'abilitazione. La simulazione si basa sui dati IRIS e sugli indicatori bibliometrici alla data indicata e non tiene conto di eventuali periodi di congedo obbligatorio, che in sede di domanda ASN danno diritto a incrementi percentuali dei valori. La simulazione può differire dall'esito di un’eventuale domanda ASN sia per errori di catalogazione e/o dati mancanti in IRIS, sia per la variabilità dei dati bibliometrici nel tempo. Si consideri che Anvur calcola i valori degli indicatori all'ultima data utile per la presentazione delle domande.
La presente simulazione è stata realizzata sulla base delle specifiche raccolte sul tavolo ER del Focus Group IRIS coordinato dall’Università di Modena e Reggio Emilia e delle regole riportate nel DM 589/2018 e allegata Tabella A. Cineca, l’Università di Modena e Reggio Emilia e il Focus Group IRIS non si assumono alcuna responsabilità in merito all’uso che il diretto interessato o terzi faranno della simulazione. Si specifica inoltre che la simulazione contiene calcoli effettuati con dati e algoritmi di pubblico dominio e deve quindi essere considerata come un mero ausilio al calcolo svolgibile manualmente o con strumenti equivalenti.