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Effect of Linagliptin vs Placebo on Major Cardiovascular Events in Adults With Type 2 Diabetes and High Cardiovascular and Renal Risk The CARMELINA Randomized Clinical Trial
Authors :
Rosenstock J Perkovic V Johansen O Cooper M Kahn S Marx N Alexander J Pencina M Toto R Wanner C Zinman B Woerle H Baanstra D Pfarr E Schnaidt S Meinicke T George J von Eynatten M McGuire D Aizenberg D Fiorella A Edgardo N Belen C Alonso P Walter M Maia K Guillermo S Leandro B Constanza R Alejandra N Melina C Ariel I Rodrigo C Alvarez C Jorge M Gabriel C German S Bartolacci I Bolobanich G Tale T Meritano M Echeverria M Gerrini S Alvarez M Torrijos N Berli M Coggiola J Castaneda G Rode R Milessi R Roude A Bono J Caresani J Arias V Westberg J Allende G Liberman A Bordonava A Almagro S Gerbaudo C Schiavi L Budassi N Cecilia M Buncuga M Carlos S Osvaldo T Mercedes S Calella P Agustina V Aljandro M Alberto D Fiorella M Cantero M Cariganano M Anadon P Cartasegna L Gabriela M Fernanda A Alberto R Chacon C Jazmin F Colombo H Coni E Mattausch S Thomsenhall K della Torre M Morandini M Berra F Margarita H Commendatore V Tedesco J Bolzan P Cuneo C Narcisa G Caputi V Pablo S Sandra G Pacora F Tinari M Jure H Parody M Toranzo A Frechtel G Yohena S Lovecchio S Muller C Martin S Olivera C Breyaui M Bianchi G Garcia C Luciana V Florencia F Ruben G Gelersztein E Rey G Sanchez C Fornasari L Di Pierro L Giacomi G Miguel S Laura T Gonzalo C Ramon C Glenny J Koretzky M Porto A Tiberio O Ellenberg A Saurral R Igarzabal C Vilamajo O Matkovich J de Lapertosa S Villagra M Cuzziol G de la Cruz M Pinchetti R Mierez M Lopez C Gorosito V Gabito A Kleiban A Grosembacher L Adrian P Paula R Javier G Kraft F Andres F Krynski F Nicolas P Marcelo F Alfredo F de la Fuente R Natalia C Luquez H Recuero Y Becchetti N Ruiz M Costantino M Vazquez G Guzman C Pelatia P Maffei L Sassone S Yantorno M Prado G Khron B Maldonado N Gustavo L Veronica V Marino J Elizabeth A Alejandra C Oscar R Azize G Gallardo M Escudero M Vargas E Ramos H Lucero C Najenson M Crocci I Chiesa A Nardone L Dominguez S Zanini A Manghi F Grossman M Giudice G Romeo A Piskorz D Miguel C Susana D Noeli U Rosa S Martin V Soledad A Virginia M Lorena G Prado A Veronica L Eduardo H Adolfo P Florencia W Rista L Scolari C Rojas N Bertolio V Zarandon R Jair S Orlando C Sanabria H Ignacio D Viviana C Marina R Sarjanovich R Scaro G Huerta C Mana M Gutierrez M Dain A Gavicola R Sessa H Sacripanti J Felman R Vilarino P Sicer M Lagrutta M Sala J Casabella T Cecilia H Carlos B Vines G Javier R Vico M Lanchiotti P Martella C Torres L Villarino A Molina M Martinez J Farias C Bertola S Rojas M Guzman P Nisi J Martinez D Barrionuevo M Vita N Lopez A Vottero E Giuliano M Paron L Vogel D Mele P Imposti H Dominguez A Zaidman C Fernando G Beck M Beltrame P Chemello D Junior R Abreu A Fernandes V Saboia J Rodrigues L Carvalho M Gurgel M Gadelha D Ramos C Borba V Golbert M Pitthan M Golbert L Valentini R Canani L Gross J Valenti A Sartori C Dutra O Azevedo E Azevedo A Vaz R Vaz H da Costa F da Costa L Panarotto D Lain F Camazzola F Dellomea B Rech R Pizzato P Nunes C Jaeger C Silveira D Wagner L Machado L Rea R de Bem A Alves J Jonasson T Malucelli F Betti R Lerario A Lisboa H Bem J Tres G Tavares C Nardi A Pozzatto M Backes L Reolao J Scariot E Ziguer E Baldissera D Griz L Antunes D Victor F Freire K Barros A Costi B Sa M Carneiro A Felicio J Felicio K Penha P Ferreira J Melo F Alves A Souza A Costa L Pinheiro D Turatti L Augusto G Leanca C Santomauro A Forti A Sena R Marinho A Facanha C de Souza K de Souza A de Queiroz W Leite S Vieira S Gubert L Olsen A Piazzetta G Fuck A Ferreira M Fortes J Brandao T Alves F Radice E dos Santos J de Almeida R Franco D Saporito W Eliaschewitz F de Siqueira K Bona R Genestreti P de Castro D Visconti G Sampaio C Palhares F Konigsfeld H Alves E Feder C Leao B Saraiva J Rodovalho S Costa M Pires N Figueiredo E Werner G Garcia J de Paiva I Quirino B Botelho R da Silva R Navarro A Lourenco C Pereira A Arantes F Boner D Saad J Falchetto E Washizu E Mandil A Pimenta N Tofani F Fonseca T Teixeira L Maia L Lemos M Mouco O Nakazone M Weiand L Bohn J Hissa M Araripe F Carvalho F Cancado G Wang R Chacra A Fusaro A de Mendonca E Cercato C Halpern A Alves B Braile M Sestito R Mustafa E Ferreira V Sbardellini B de Almeida P Guimaraes F Piedade M Bienert I Braga J Daher R Hirakawa T Terra E Farias E Figueiredo M Lima L Moraes K Avelino I Flato U Plavnik F Portes E Moreira M Vendramini M Veloso R Padilha M Rodrigues A Adam R Santos S Sayeg N Guerrero D Madeira M Siqueira J Pinheiro R Villacorta A Mellazi A Braga T Kaiser S Paolino B Lefterov I Marinchev A Angelova S Klyuchkova N Lybomirova Z Kerekovski Y Kuneva T Penkova D Levterov G Videnova E Georgieva P Shinkov A Borissova A Vlahov J Dakovska-Dekova L Lucheva M Luchev P Temelkova M Borisova K Tsenov S Andreeva V Margaritov V Arasheva G Lozanov L Borisov R Gorcheva D Henein S Whatley S Boutros M Kalyniuk N Berlingieri J Nisker W Hoag G Hepburn D Harvey M Manjoo P Yale J Sherman M Tsoukas M Rehman W Mason M Santerre M De Kock J Barkhuizen F Rooke C Gill C Kooy J Burgoyne G de Kock J Degen G Hockman L Invik R Roberts P Ward K Alasaad H Susan A Davies V Gupta N Milhalidis J Grossman L Agawal N Yared Z Rwaheed Nouhad S Nahla A Khandwala H Warwick A Wadehra D Manan A Vecchiarelli J Aslam N Ferrao A St-Maurice F Collette R Davey B Nawaz S Coutu B Costi P Greiss I Mansour F Raymond J St-Phard W Nadra I Della Siega A Barahona L Klinke P Contractor H Fryer M Chandra N Conti B Telzer L Sorensen S Lounsbury N Martin E Mitchell L Pelzer E Nelson S Jones M Cox J Luco G Trhoughton T Labonte R Chouinard G Frechette A Rheaume M Cusson J Faucher J Dery V Kelly A Miranda B Al-Kayssi N Malette P Rheault P Fredette P Dumas R Palardy J Belanger A Boucher P Doyon B Charbonneau J Bailey G Odendaal M Stephan K Badenhorst J Knight D Thurgood A Johnston M Cooper-Rosen E Jagger R Green M Weisnagel S Gangloff A Bergeron J Pesant Y Chevalier P Woo V Hurd C Ruckert G Lira J Navarro G Venegas M Gonzalez P Montecinos H Vidal G Fernandez M Varas J Fernandez C Aguilar J Marin R Kindel C Yovaniniz P Gherman O Aravena M Carvajal J Macias E Corrado P Lazcano M Garrido B Charme G Carrasco J Vignolo P Saavedra S Gajardo V Saavedra C Santamaria D del Castillo B Balda I Zurvarra V Fu G Jiang D Huang H Wang M Song J Lu W Lin Y Lu Z Shi Y Zhong M Zhao X Chen D Zhang G He Y Shi P Chu K Gao Q Deng W Zhang J Zhang Y Chen H Liu E Xie Y Lin R Tan W Yuan Z Wang Y Ren J Yu H Luo M Ma W Shi W Xu H Xu M Liu G Dong Y Bai B Guo R Liu X Gao Y Li S Xu X Liu P Dong X Wang S Fu F Jiang Q Meng C Yin X Lu Y Cui Y Su G Miao W Wei F Zhao Q Li Z Gao X Lozno H Prada W Figueroa W Ordonez A Quintero E Vallejo G Contreras C Escobar J Alvaran J Ortiz L Marin M Montoya C Mendoza J Manjarres J Navarro B Martinez G Bonfanti A Perci X de la Hoz L Arroyo J Rendon C Lopez J Escobar N Franco J Lozano M Zapata C Ibarra L Barrero A Sarmiento A Lozada H Olitte M Florez L Munoz C Quintero G Correa G Ruiz S Dorado A Causa A Palma E Morales A Arteaga J Beltran J Granados M Rubio A Dada F Bueno W Rivera R Corredor K Romero V Accini F Palmera J Ruiz G Ortega M Sanchez A Lora Y Cano J Duque S Thiriez S Castano M Giraldo P Boljkovac Z Grcic I Balen M Zukanovic S Jeric M Dvorscak D Car S Knezevic A Herceg D Franov B Miskovic V Bakula M Hadak A Superba M Rubes J Gornik I Hamzic J Ballek L Sedlackova L Hejlova J Galatikova D Huskova A Zak P Flekac M Mraz M Potuznik P Palova S Novak P Okenka L Matuska J Rohac F Vondrak K Reichert P Shamasna A Skopek J Lejskova M Jiruska M Lang P Podoubsky R Svobodova J Cifkova R Jozifova M Krajcoviechova A Wolfhart P Sulc P Silhova E Cechakova M Machova V Balkova J Peterka M Votocek S Prosecky R Valis M Barton P Tomek J Pumprla J Axmannova M Vitaskova R Sincl F Horanska P Richter B Malicherova E Roderova E Jenickova P Winkelmann B Finger C Klausmann G Milek K Schwabe M Weiss N Mahlmann A Werth S Schmidt C Schoell I London M Steidl E Orban K Taeschner H Bonigut S Schiefke I Schwittay A Kornmann O Eich A Franke S Kis J Szobota E Danos P Beke E Grosz A Csecsei G Ferenczy J Filo A Ferencz I Mihaly E Baranyi T Revesz K Schlezak J Harcsa E Dombroczki Z Kocsis I Juhasz E Literati-Nagy B Kulcsar E Bezzeg K Kemeny V Peterfai E Buday B Keltai K Balo T Somogyi A Nagy G Oroszlan T Bagosi Z Bujtor Z Tabak A Ferencz V Domjan B Tanczer T Palinkas A Karolyi H Kovacs K Csaszar I Palhegyi E Engelhalter G Horthy R Vanko E Szabo G Sipos G Szigyarto M Sebo N Paragh G Zsiros N Szentimrei R Pal D Kobling T Szanto I Varadi Z Bajnok L Szujo S Nemes O Bajnok A Mezosi E Bodis B Marton Z Konyves L Farago M Kiss G Kiss O Nagy E Takacs R Nyitray S Abraham G Fehertemplomi K Deak L Dezso E Karneili E Deeb D Zloczower M Mahmid R Zolotov S Hochberg I Elias M Goldstein L Poletaev V Rock W Koren O Saliba W Wolf F Adawi F Nimer A Mosenzon O Raz I Potekhin M Cahn A Yulian T Zvulunov E Israel H Shpitz D Bar-Or I Chananashvili L Irena L Dessau H Halabe A Vishlitzky V Nabriski D Baraf L Itelman M Schiff E Willner N Fireman-Klein E Svistunov V Dotan Y Pavlichev O Saig L Bashkin A Kuyantseva E Gershkov S Nodelman M Arbel Y Bogomolny N Leshem-Rubinow E Rofe M Chorin E Havkuk O Wainstein J Feldman D Fujino Y Kitamura H Toriumi Y Ishiguro H Naganuma T Shu S Suzuki K Hirota Y Hayashi T Hozawa K Fukui T Abe Y Yamauchi K Maruyama M Matsumura S Kozuma R Nagai Y Kihara Y Maeda H Nakanishi K Iitsuka T Hatori M Shinozaki Y Akiyama D Kawabe M Takei M Sato A Kawai Y Kitajima K Ide M Sato N Morisaki H Nakashima K Takayanagi H Watanabe H Iwahashi N Tsujimoto M Hibuse K Hata T Ueno K Tatsuma H Wakida Y Ito T Mizuno R Fujita H Konishi N Kanehira T Watanabe R Miyaoka H Okada T Yamamoto M Okita S Murakami H Todo Y Umeoka F Hori K Shiraishi K Tada F Shimizu T Tamai J Sasaki C Okuzima Y Yasuda M Iwaita Y Tanaka K Rha S Na J Cho D Cho Y Hwang E Choi T Won K Kim H Kim S Oh D Lee J Choi H Chung H Park H Suh Y Kim Y Kim N Kim K An J Kim J Park K Kwak S Kim M Hwangbo Y Lee D Hong A Kim L Oh C Moon S Jung C Jin J Hyun B Yang Y Kong S Yoon K Yang H Hong T Oh J Park J Lee H Choi J Ahn J Han S Park W Jo S Suh S An W Park M Lee S Kim D Jin H Seo J Chung C Lim J Huh J Park I Yu S Sim N Khan S Albakari N Sivaraman J Manaf K Maharuddin I Nagendram S Ali N Abdul Latiff N Othman N Sarip S Chew E Mohamed S Aziz N Hui K Lin L Velaiutham S Khir A Lee L Manikam S Chooi K Chang M Ooi C Anthony J Seganathirajah M Ng O Ismail N Cheah C Ramanathan G Mui N Wen F Choo T Bin Ruhani A Jamaludin S Abidin S Nor F Abu Hassan M Hanari N Ahmad N Suan M Zainul N Ali S Sridhar G Han C Chin A Vin L Kadir K Zain A Hussain N Pusparajah P Lozano F Gomez A Zaccari E Vigil A Preciado C de Leon M Parra M Cervantes A Aguirre E Orozco E Gonzalez S Elizondo R Flores E Guerrero M Flores F Sanchez J Perez F Rodriguez J Martinez L Marquez D Gutierrez B Flores M Real M Campos P Garcia P Rios M Romero E Perez Z Tarabay C Munoz L Farias J Gonzalez J Palestino N Sanchez L Carrillo G Ordonez N Pech C Andrade M Euan J Ortegon M Garcia S Orozco J Vazquez H Herrera R Perez E Arango A Ibarra M Gonzales L Esperano J Quintana L Salazar I Ruiz L Barron C Ballesteros C Cervera L Hercilla E Gomez H Mesa J Herrera P Rodriguez M Ochoa R Mora E Charles C Silva R Mijangos J Diaz C Zavala C Baron P Bernal A Martinez F Tlapale M Ramirez E Basila A Munguia R Tello M Martinez M Mulder H van der Graaff P Nawaz A Keller I Schoofs M Smak-Gregoor P Al-Windy N Bulut S de Jong J Maas A Schaardenburgh P Imholz B Heijster J Hoogenberg K Smit C Kooy A Huvers F Landewe-Cleuren S Kars M van Moorsel D Wolffenbuttel B Lutgens H Schutte E Gansevoort R Idzerda N Westerink J Weijmans M Berg J van Kleef M Slob M Jaspers N Hovens M Monajemi H Kobielusz-Gembala I Zmuda W Adamczyk M Konieczny M Strzelecka-Sosik A Nowacka E Krzyzagorska E Sekulska M CzajkowskaKaczmarek E Kaczmarek B Opawska K Dabrowska M Kus W Wrzesien-Kus A Piotrowski G Hotlos L Ocicka-Kozakiewicz A Jurowiecki J Stasinska T Karczewicz-Janowska J Jaruga J ZytkiewiczJaruga D Krupinska E Pupek-Musialik D Bogdanski P Szulinska M Skrypnik D Skokowska E Bojarska-Los M Giermkowska-Samek M Pirog M Wojnowski L Jelinska A Gradzka M Danyluk A Lysek R Sliwinska T Podrazka-Szczepaniak A Barney M Tomczyk A Necki M Malicka J Dudzinska M KiszczakBochynska E Markiewicz A Galbas K Paciorkowski A Mazur S Mazur M Chmielowski A Swiatek A Sobocka B Wis J Jozefowska M Kaczmarek M Timler M Cieplucha Z Lazuka L Lazuka N Wittek A Spyra J Jasiel-Wojculewicz H Stefanski A Wierucki L Hanczuk A Misiura M Szmygel K Kolcowa O Orlowska-Kunikowska E Rutkowski M Ignaszewska-Wyrzykowska A Popenda G Maciejewska J Mostowy A WojteckaGrabka M Grazyna M Wieslaw K Barbara K Kramarczuk E Wojciech C Jaroslaw H Ewa B Karas P Agnieszka S Hanna C Justyna S Piotr K Wozniak I Mateusz W Katarzyna W Jacek F Andrzej J Cymerman K Gmytrasiewicz M Zambrzycki J Krysiak-Kowaluk H Klodawska K Klszczewski Z Zieleniewski J Opadczuk P Urbanska K Faran-Grabowska K Szczepanik T Siegel A Kleczek A Kincel K Nowak D Slowik-Gomulka L Watemborska-Matuszyk G Lampart J Strozik-Krecichwost A Dziewit T Broncel M Wojcik-Odyniec J Jakubczyk E Wierzbicka K Witowicz A Jedrych B Korczyk P Socik-Pojawa M Monteiro P Monteiro S Mendes P Soares F Mendes S Leite L Vicente J Santos M Ferreira A Alves P Rosario F Garrao A Duarte L Rogado C Duarte R Laginha T Matos P Raposo J Mariz J Teixeira J Capela C Leitao A Cardiga R Alface M Augusto S Basto L Cunha A Rei D Dantas J Verdasca I Andrade L Silva A Suarez M Dias V Silva J Pereira N Goncalves M Goncalves A Silveira A Sampaio A Dias A Diogo M Vilaca C Cif A Calin T Elena S Crisan C Adina S Ramona S Anghel V Simona C Turcu L Mihaela V Cosma D Cristina H Marius-Calin H Negrisanu G Andreea-Andrada M Maria-Mihaela V Camelia T Oana P Monia A Onaca A Mircea O Mot A Stolea V Elena N Barbonta D Cristian B Oana S Popescu A Madalina M Coman A Anca C Constantinescu S Mircea C Diaconu-Sotropa M Ene D Pintilei E Mihai G Delia R Toarba I Simona H Negru D Flaminzeanu F Iulian C Maria-Cristina C Doros R Cleo S Sorin B Demian L Mihai S Raul B Ioana A Nicolau A Cosmin P Isabela G Elena C Ileana T Valuyskikh E Miroshnichenko E Klementyeva N Zelman O Chumakova G Vigel A Leonova N Pergaeva Y Stefanovskaya O Pushkareva S Antoshkina L Zheleznova N Iveitsman Barbarash O Zvereva T Zhuravleva E Zavyrylina I Usoltceva E Savostyanova Y Kupriyanova T Krivoshapova K Kondyukova N Inozemceva A Argunova Y Tsyba L Belenky D Mariich O Terekhova A Tsygankova O Kuznetsova E Nagibovich G Ivchenko Y Dobronravov V Dobronravov A Bush M Trofimenko I Vishnevsky A Zikov V Kositsyn D Palzman Z Spiridonova T Rodina N Polozhentsev S Mamedova L Panov A Abesadze I Alugishvili M Ivashkin V Drapkina O Korneeva O Zyatenkova E Glinkina I Poluboyarinova I Gurova O Raykhman A Vertkin A Rodykova I Shamaeva K Petrovskaya T Uzueva E Milovanov Y Milovanova S Milovanova L Markina M Dobrosmyslov I Markov V Afanasiev S Babich E Belokopytova N Demyanov S Maximov A Maximov I Rebrova T Shtatolkina M Masin A Demko A Chuyko O Pronina A Charf G Akatova E Urlaeva I Nikolin O Khovaeva Y Ermachkova L Burdina E Shvalb P Suchkov I Pshennikov A Gryaznov S Rymar O Dolinskaya Y Bahareva Y Mustafina S Sherbakova L Ovsyannikova A Bolshakova O Polunicheva E Dora S Agafyina A Yashina A Vasilieva I Yakhontova P Selivanova S Kargapoltseva O Shilina N Bayramova G Sorokin I Astamirova K Kuchuk P Koniushenko D Malykh N Dvorkin M Krovelets T Konovalova K Seeber M van Niekerk F Siebert H Steenkamp W Wiid S Noeth M Siebert R Breedt J Bouwer J Kapp C Venter T Rayner B Trinder Y Rheeder P Delport E Mathijs S Soma P van Zyl D Strydom M Marais A Badat A Hansa S Fourie D Walton T Engelbrecht J Jansen J Roos J du Toit S Lehloenya K van Zyl L van Zyl F Naude M Mookadam M van der Merwe A Trokis J Lombard L Coetzee K Ismail S Bruning H Latiff G Yasmin O Pillay T Mohamed Z Dawood S Stapelberg A Abrahams P Jurgens J van Heerden P Swart E Botha C Meeding J Hemus A Oosthuysen W Visagie G Fourie N Hutton P van der Merwe N Chelin N Everton T Duki M Ghila N Joshi M Hira M Madueno F Martinez B Sebastian N Mercadal L Isbert S Gonzalez I Asencio J Figueras M Rivas M Garcia H Fusalba A Geat D Cambra G Sastre J Castro F Mas A Portillo C Serrano I Hernandez S Fajardo F Juan C Ferrer J Peralta F Padin C Mauricio D Madorell B San Miguel F Pedrol N Trescoli C Montanana C Gonzalo M Capellan J Estrella A Martinez C Montesinos I Loscos A Coronado J Perez J Castillo B Alonso C Quesada V Teruel J Perez S Lama M del Rio E Zlova T Ponomarenko K Karpenko O Bezuglova S Mitskevych L Kizim S Nevolina I Katerenchuk V Liudmyla B Ivan K Rudyk I Olena M Anna I Ganna B Topchii I Semenovykh P Yulia Y Mykhalchyshyn G Kirienko D Kobiliak N Bodnar Mykhalchyshyn Pertseva N Olena G Tomashkevych H Korpachev V Prybyla O Kovalchuk A Kushnarova N Zinych O Tseluyko V Andriy Z Olga R Mankovskyy B Zherdova N Lykhoshapko O Logoida P Godlevska O Olena V Olga C Gyrina O Alifer O Dozhuk K Pekhenko V Gorobets N Korneichuk A Makarenko E Martynyuk L Martynuyk O Stanislavchuk M Larysa P Natalia S Botsyurko V Kostitska I Dzeman O Ablitsov Y Ivaseiko S Konovart O Sandurska S Vendzilovych Y Samoylov O Iryna C Rozhkivska L Ulyanchenko I Kateryna V Orlenko V Ivaskina K Tronko M Tronko K Pashkovska N Stankova N Vynnychenko L Bolotnikova N Demokhova N Reshotko D Popova A Dr Bogdana Tetiana S Svitlana D Oksana R Vlasenko M Litvinova S Semenyuk I Fishchuk O Mostovoy Y Tkachenko T Ovcharuk M Rasputina L Vakaliuk I Tymochko N Drapchak I Petrovska L Lai W Yen H Voon W Lin T Cheng K Chiu C Chu C Hsu P Chiang C Li Y Kuo C Lin S Chao T Yu W Sung S Wang K Lu T Shih K Wu C Chiang F Hwang J Tsai C Juang J Jeng J Tang S Lai C Cheng C Hsieh I Hsieh M Chen C Lee C Pai P Ko P Wang T Chen T Wu H Chang S Chen K Hsieh L Chou C Jiang J Lee M Huang J Chen J Chiu K Tsai L Chen P Saxena M Collier D Vaidya B Harman S Ramell M Davies M Chatterjee S Meakin L Quinn M Bain S Mallipedhi A Min T Bashir J Blagden M Ali J McCrimmon R Brennan G Malcolm E McDonald D Pearson E Illsley G Darzy K Winocour P Hanif W Cockwell P Charlton M Thekkepat S Howat I Devers M Patrick J Wyatt N Smith C Singh B Nicholas J Gillani S Green F Bell E Boyle J MacKin S Livingstone R Arif A Syed M Hammoud J Sparks J Anderson M Tumey R Condit J Reddy M Abalos-Galito M Rebecca J Barker T Seaton B Campbell E Kompanik H Jayson L Huffman C Bialow M McDonnell G McCaffrey J Manis C DeLuca E Levins J Bartlett M Anorga K Franco M Gentry P Hodge D Pohil R Rschultz Leggett R Blair L Gisler J Niegos F Osburn M Parma K Schendel S Stines L Winnie M Wu P Canales J Yu J Cornett G Beavins J Hyde D Zapinski D Johnson T Levinson D Ahmed A Kenny B Kuehl A Bates C Jantzi C Ananthula P Shafer J Louthan J Bays A Stapleton A Staton P Strum D Taylor P Smith A Rapp R Bao S Randolph C MacGillivray B Schuster R Harden T Barnella C Dunnam T Whiles R Bolick C Brockmyre A Plucker S Marshall C Poteet C Morin D Tavel E Averill N McFann A Purcell D Dixon T Corey E Goss J Drescher R Irfan M Naeem M Egelhof R Mehta P Koehler T Walia J Fernandez J Bedel G Preet R Bhuchar S Ahmed F Onyema D Benchabbat A Kohanbash L Miller P Lalinde M Carrithers E Patterson R Raube-Miceli A Martinez A Harris B Levy R Siev E Berlin H DiMattia M Sugimoto D Dugas J Benson M Stegemoller R Schmoll M Kinnaman S O'Connor T Powel T Rudolph L Lewiecki M Best E Chavez J Garcia M Cohen R Colman D Ocampo M Heaney L Rappley G Quezada I Santos V Nikfarjam A Reyes M Rodriguez R Josephs L Hernandez R Flores P Espinoza L Mejia W Pedraza Z Castaneda R Laguerre J Cook R Patel R Werner H Blank R Small S Andersen J Holmes D Farmer M Wiener V Pharr W Bray B Beekman J Anderson A Andrawis N Gabra N Moche T Marty S Galvez O Reyes R Garcia R Lerma G Pliquin B Mayfield R Durham N Phillips R Baran A Kondo N Dempsey S Kufs W Laddis T Zimmer K Van Depol M Dweck L Kestler M Werner N Ashraf M Quick A Schallert G Sligh T Trueba P Batista J Martinez T Moya J Amarales V Santos E Torres P Diaz T Diaz J Hodish I Else T Buras E Moratis A Valika S Rahman A Malalis W Box E Box P Kerwood B Nagaeva J Metz C Hinnant J Griswell D Philbeck A Dukkipati R Shaarawy R Patak R Kaye W Steinsapir J Horowitz B Denenberg M Reynolds C Jenkinsdr M Adlakha A Hicklin H Peelman J Lerman S Lamkin S Smith S Gould G Cheung D Stephen Z Leigh T Norwood P Chelsea F Trejo R Neolms K Bache R Dinnerstein A Sachson R Aronoff S Mendez A Brooks S Jones L Dorfman S Schill J Leuck Miklius A Maw K Hahn J Gamarra L Buynak R Smith M Ames J Volom P Anderson R Desouza C Shivaswamy V Lefebvre G Schweppe L Berenguer R Nelson R Mas L Gonzalez N Palacio J Bartkowiak A Dilling J Jordan T Geishauser J Jordan R Arias E Griffin C Fisher M Bryant C Schnitz W Kipgen W Kasper J Lopez R Wright E Thomas J Weinstein D Emerick G Mendelson R Aqua K Lafaille J Seco G Garcia G Cubillas M de Souza J Schneider A Tjaden J Goswami G Schubart U Kishore P Bravo W Guerrero J Bertoli-Avella M Reyes C Dominguez M Ramos S Columbie A Ares-Romero P Hechavarria J Villaverde M Doyle N Sherrod T Krishnaswamy K Aamir S Giddaluri P Guevara S Kazmi P Thomas P Popeil L Albright D Pimentel S Mould E Cox M Alderson T Conrow J Sandberg J Raam S Suresh B Lafave J Lorenz T Johnston J Fereidouni S Mahadevan A West R Nelson A Scott K Ansari S Khan B Rastogi A Saumell F Gonzalez G Torres E Elias R Hart T Lozano J Gudavilla G Savin V Khan A Wiegmann T Goel A Gomes M Fernandez-Gonzalez M Gustavo F Ivan C Chiong R Llerena S Jimenez M Oram D George D Lewis J Kiefer J Dollman A Edje L Pastor F Kandath D Lorch D Graves A Powell R Hooker T Shah S Gomez N Miranda F Rosales J Bayona I Gomez Y Guedes R Rodriguez Y Wahlen J Jonathan W Spencer H Michael W Kumar U Govindariju K Ordonez S Aguirre H Sulur P Agarwal N Peters L Kaviani B Fomenko O Firek A Loreen W Ronald F Olha F Parrillo J Janovitz R Hutchinson R Delgado E Ashley A Robinson S Barbel-Johnson K Timothy L William C Al-Karadsheh A Hooper L Suarez J Perez D Guerrero V Tung D Loo C Sodolak K Michaelis C Jackson R Covington D Wise J Tran T Messina T Torres D Falcone J Barettella M Patel K Ribo A Mattews T Amendolare D McGeehan J Corder C Black C Hearne S Bounds C Cinderella J Etherton J Kiem S Treuth M Burke B Tivikaran V Howard S Miller C Neff H Giullian J Mcrae J Surratt D Phillips J Kretchmar J Valdes M Cruz J Navarro E Zewail A Tai-Chi-Kwo Stevens J Diane S Kim T Gregory L Neal S William S Sangrigoli R Gejer E Stoller S Jeffrey D Colar S Kenneth W Farris N Mooney S Jamal A Nitin B Syed R Andrew Y Christopher W Abid R Claudio G Mojtaba M Amna R Michael B Vincent T Cherlin R Ashton R Pudi K Julian W Stephen K Ronald A Frias J Kelly S Hsia S Clemens P Cara H Farley B Raible L Oliveros O Hafeez H Pecci P Bagga-Malhotra S Reza R Jamal M Mulgado M Guevara A Vela M Ochoa H Melliza T Pena G Awua-Larbi S Shafi M Alausa T Polster S Earl J McNeill R Farrington C Carr K Nabat M Matthew S Yvette E Handelsman Y Delkhah S Ismail Y Janna C Akhtar A Neiman A Blumenthal S Colleen V Schmidt D Ashraf E Bhargava A Khoo T Langel C Theuma P Wright D Fitzgerald K Hitchcock J Capasso-Gulve E Wolff E Umpierrez G Priyathama V Francisco P Dawn S Quraishi A Kahn B Ferro F Hertz B Phelps J Campbell A Downing J Pangtay D Pangatay S Villagran-Solis K Haseeb M Rettig K Kwan R Cox R Slimak V So A Schmedtje J Chang A Douglas Z McGarity W Jestel J Kanade P Julie J Asher R Canaan Y Perez A Alonso I Cutchin R Koser A Adeola Y Brito S Stocks J Frandsen B Weigelt M Stehouwer E Ince C Stephen P Shadi B Jeffrey C Thethi T Carpio G McDuffie R Moreau C Stell C Katalenich B McKendall-Lewis C Htun W Conroy K Lovre D Galagan R Olmeda C Sihota A Barton A Beasley R Nankivel P Aberle M Machin I Porras J Rodriguez D Albornoz A Haidar A Lopez-Santini R Rivero G Robins G Colyar L Hutchins C Sturm D Hart K Phillips T Montgomery C Albrecht W Fehlis K Overman D Box M Villarreal-Martinez D David-Svatek D Ajani D Shaikh Z Wheeler K Brown M Ghosh C Bandukwala I Kleber S Madden J Bishara M Perry K Paoli-Bruno J Abreu E Espiritu R Zmeili O Christensen T Grubb S Beloff S Caugh A van Dijk C Yalavarthy R DeGraauw J Fabian S Gillum D Corrigan G Singh H Jensen K DeMore S Montague T Zieve F Levy J Fredrickson S Tarkington P Chapla P Salacata A Walls U Iyer R Nguyen K Lettman J Appleman B Safavie F Scaliem L Eder F Maklad S Schlaen B Molstead J Hartwell J Hubish D Little R Rando K Kelly R Drury M Young P Wininger S Harman A Daza R Robbin S Sanchez M Rivera I Garcia-Estrada M Iglesias N Dobs A Andrade A Falkowski S Parrott T Koon A Wood T Burkett E Chavous K Gupta A Estes C Loud D Rhodes S Chen M Bromley L Palma R Kattan D Kirk U Tatu H Stamatin R Lupea S Frasie M Colfer H Kane L Teklinski A Gadowski G Levanovich P Saba F Confident L Hossain S Steinberg B Philippe B Choroenthkongtrakal S Boccalano F Anand R Syam V Manohar A Suresh P Madhusudhan P Patel P Cambier P Klonaris J Cheng W Fisher S Schelle M Reese L McLean S Poock J Hoens J Rosie A Welshons R Dean J Kuhlman P Luke R Lohrbauer L Cunningham M Buday P Lehmann M Chrzanowski K Fletcher A Hargrove J Harris F Debs-Perez G Maiquez A Cordoves L Georgescu M Tayoun H Munoz F Ortiz D Munoz G Hamzeh I Misra A Zhang L Forgosh L Loria K Roncari C Hommerding J Morris G Lebron C Blake K LaVenture K Lange C Levinson L Baungarten T Edevante S Shawley S Moyer H Elliott K Iachini K Rajan R Davis C Shattuck A Simon W Lakin G Secrist N Buth D Steere D Talbot K Singh N Mascolo R Sloan S Kmetzo J Brown J Carter L Lawrence M Arauz-Pacheco C Lender D Kozlow W Cavanaugh L Wilson J Gujja P Akhter F Khan M Mohammed A Satyavolu S Dev D Yalamanchili H Sumeyye C Fernandes H Chaleff F Jancko M Trenche S Kaplan W Wilcox S Goisse M Rua M Black J Chapman K Suh D Yan L Song D Chanara S Houchin V McKeinness A Sotolongo R Gutierrez K Miranda-Palma B Solano M Jain M Needell J Banerjee A Jarratt M Hantel S Lees K Welty F Freedman S Parhofer K Birkeland K McGill J Tijssen J Clemmensen P Pehrson S Grande P Januzzi J Wood M Petrie M Sairanen T Tatlisumak T Soinne L Kase C Turan T Mann J Agarwal R Fogarty D Navaneethan S Srinivas T Forsmark C Frossard J Gelrud A Mayerle J Lee R Heist R Sullivan R Buchbinder E Chodak G Edelman M Thompson V Coles A CARMELINA Investigators
Source :
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, r-IGTP. Repositorio Institucional de Producción Científica del Instituto de Investigación Germans Trias i Pujol, instname, r-FISABIO: Repositorio Institucional de Producción Científica, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO), r-FISABIO. Repositorio Institucional de Producción Científica
Publication Year :
2019
Publisher :
American Medical Association, 2019.
Abstract
IMPORTANCE Type 2 diabetes is associated with increased cardiovascular (CV) risk. Prior trials have demonstrated CV safety of 3 dipeptidyl peptidase 4 (DPP-4) inhibitors but have included limited numbers of patients with high CV risk and chronic kidney disease. OBJECTIVE To evaluate the effect of linagliptin, a selective DPP-4 inhibitor, on CV outcomes and kidney outcomes in patients with type 2 diabetes at high risk of CV and kidney events. DESIGN, SETTING, AND PARTICIPANTS Randomized, placebo-controlled, multicenter noninferiority trial conducted from August 2013 to August 2016 at 605 clinic sites in 27 countries among adults with type 2 diabetes, hemoglobin A(1c) of 6.5% to 10.0%, high CV risk (history of vascular disease and urine-albumin creatinine ratio [UACR] > 200mg/g), and high renal risk (reduced eGFR and micro-or macroalbuminuria). Participants with end-stage renal disease (ESRD) were excluded. Final follow-up occurred on January 18, 2018. INTERVENTIONS Patients were randomized to receive linagliptin, 5 mg once daily (n = 3494), or placebo once daily (n = 3485) added to usual care. Other glucose-lowering medications or insulin could be added based on clinical need and local clinical guidelines. MAIN OUTCOMES AND MEASURES Primary outcomewas time to first occurrence of the composite of CV death, nonfatalmyocardial infarction, or nonfatal stroke. Criteria for noninferiority of linagliptin vs placebo was defined by the upper limit of the 2-sided 95% CI for the hazard ratio (HR) of linagliptin relative to placebo being less than 1.3. Secondary outcome was time to first occurrence of adjudicated death due to renal failure, ESRD, or sustained 40% or higher decrease in eGFR from baseline. RESULTS Of 6991 enrollees, 6979 (mean age, 65.9 years; eGFR, 54.6 mL/min/1.73m2; 80.1% with UACR > 30mg/g) received at least 1 dose of study medication and 98.7% completed the study. During a median follow-up of 2.2 years, the primary outcome occurred in 434 of 3494 (12.4%) and 420 of 3485 (12.1%) in the linagliptin and placebo groups, respectively, (absolute incidence rate difference, 0.13 [95% CI,-0.63 to 0.90] per 100 person-years) (HR, 1.02; 95% CI, 0.89-1.17; P
Details
ISSN :
00987484
Database :
OpenAIRE
Journal :
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, r-IGTP. Repositorio Institucional de Producción Científica del Instituto de Investigación Germans Trias i Pujol, instname, r-FISABIO: Repositorio Institucional de Producción Científica, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO), r-FISABIO. Repositorio Institucional de Producción Científica
Accession number :
edsair.dedup.wf.001..251d043f2b614f28c7b01ad37a6976b4