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N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13.

Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes.

Collaborators (2302)

Bergenstal R, Buse J, Daniels G, Mann J, Marso SP, Moses AC, Nauck M, Nissen S, Pocock S, Poulter N, Steinberg W, Zinman B, Frandsen KB, Stockner M, Kristensen P, Ravn LS, Zychma M, Abell S, Davis T, D'Emden M, Ding SA, Gilfillan C, Greenaway T, Gunawan F, Ho J, Jackson R, Kalra B, Lau SL, Lin J, MacIsaac R, Makepeace A, Malabu U, Marjason J, McCallum R, McLean M, Moin N, Petersons C, Price S, Roberts A, Roberts D, Sangla K, Simpson R, Stranks S, Tan Y, Thynne T, Walters J, Ward G, Wen W, Zhang J, Brix J, Feder A, Höbaus C, Höllerl F, Höller V, Kotter T, Kratz E, Krzizek EC, Leb-Stoeger U, Mader J, Mras N, Novak E, Obendorf F, Peric S, Pesau G, Pieber T, Prager R, Ribitsch A, Schnack C, Schernthaner G, Schernthaner G, Wascher T, Batens AH, Benhalima K, De Block C, Ernest P, Fouckova A, Jandrain B, Lapauw B, Letiexhe M, Mathieu C, Neven S, Peiffer F, Ruige J, Scheen A, Taes Y, Van Boxelaer I, Vandistel G, Van Durme Y, Van Gaal L, Verhaegen A, Alencar E, Alencar R, Almeida AC, Alves B, Alves E, Alves G, Alves J, Araujo L, Arruda V, Augusto GA, Baggentoss R, Balestrassi L, Barbosa M, Barcelos I, Belem L, de Bem A, Betti RT, Bona R, Bosco A, Branda J, Bronstein M, Bueno T, Bulcão T, Caiado F, Camazzola F, Cambréa MF, Campos S, Campos S, Canani L, Carra MK, Caruso S, Carvalho N, Casillo A, Castro D, Cavalcanti T, Cavichioli V, Cercato C, Chacra A, Challela W, Charchar HS, Chaves C, Chrisman C, Chrisman C, Correia-Deur J, da Costa Junior A, Costa M, Costi B, Coutinho P, Coutinho W, Cunha MR, Daher Junior J, Davini E, Democh Junior D, Eliaschewitz F, Facin GE, Farias F, Felício J, Fernandes V, Filho C, Filho F, Filho M, Fontan D, Fontenele AP, Forti A, Franco D, Freire K, Fusaro A, Genestreti P, Gerchman F, Godi A, Gomes KF, Gonçalves P, Gonçalves R, Griz L, Gross J, Grossman M, Gurgel MH, Haddad AW, Halpern A, Hissa M, Inuy A, Jaime J, Jonasson T, Jorge JC, Malucelli FJ, Kohara S, Kramer C, Lacerda C, Ladeira S, Lana J, Lastebasse F, Leitão A, Leite S, Lerário AC, Lima D, Lima M, Lippi V, Lunardi M, Machado E, Maia F, Maia J, Maia KP, Mañas N, Marchisotti F, Marinho C, Martins C, de Medeiros FF, Melo A, Melo F, Mendonca E, Mendonça P, Menezes Filho R, Miguel M, Miléo K, Miyahara M, Montenegro AP, Moraes A, Moreira A, Mota JÍ, Mothe FS, Murro A, Nakatani V, Napoli TF, Neto BG, Neto OQ, Niclewicz E, Ohe LN, Oliveira F, Oliveira M, Panarotto D, Parente E, Parolin S, Pechmann L, da Penha PC, Perlamagna L, Perotta B, Pimentel L, Pinto M, Poço C, Ponte C, Prazeres P, Quintao E, Raduan R, Rassi DT, Rassi N, Rea R, Reck L, Montenegro R Jr, Ribeiro R, Rodovalho S, Rodrigues GS, Rollin G, Rossi S, Sabino C, Sales AP, Salles J, Sampaio CR, Santana L, Sato V, Santos Mda S, Santos NL, Santos R, Saraiva J, Sartori C, Sena R, Sevilha M, Sgarbi J, Silva D, Silva D, Silva LD, Silva ME, Siqueira K, Soares S, Sobreira W, Sousa B, Souza AC, Souza B, Tambascia M, Tarantino R, Tenor F, Tomarchio M, Triches C, Tristão LJ, Valenti A, Vasques E, Vencio S, Vianna A, Vidotto TM, Vieira S, Villar H, Visconti G, Volaco A, Wajchenberg B, Zanatta L, Zimmerman L, Abbott E, Abu-Bakare A, Advani A, Allison R, Bishara P, Bowering C, Cheng A, Chouinard S, Clayton D, Conway J, D'Amours M, de Tugwell B, DeYoung P, D'Ignazio G, Dube F, Ekoe JM, Fagan S, Garceau C, Gottesman I, Hanna A, Harris S, Hramiak IM, Hurd C, Imran S, Josse R, Joyce C, Kaiser S, Khan F, Kirouac I, Kovacs C, Labonte I, Langlois W, Leiter L, Levac MF, Liutkus J, McDonald C, Milosevic V, Nyomba BL, Paul T, Raby K, Ransom T, Reichert SM, Retnakaran R, Rabasa-Lhoret R, Raff E, Shaikholeslami R, Sigalas J, Yip CE, Weisnagel S, Woo V, Zinman B, Bao Y, Cai X, Chen J, Chen K, Chen M, Chen X, Chen Y, Ji L, Ji Y, Lei J, Li H, Liu P, Mu Y, Pan C, Ren M, Ren Y, Shi Y, Wang D, Wang F, Wang J, Wang Y, Yan L, Yang G, Yang J, Yu X, Yuan G, Xu M, Zhao X, Zheng J, Zhou L, Anderlová K, Brožová J, Haluzík M, Hanušová V, Kosák M, Křížová J, Mráz M, Owen K, Rušavý Z, Tomešová J, Trachta P, Žourek M, Andersen PH, Boesgaard T, Christensen S, Gram J, Gregersen S, Henriksen JE, Hermansen K, Jakobsen PE, Jensen J, Kristensen P, Krogsaa A, Larsen M, Lervang HH, Madsbad S, Mortensen L, Olesen T, Pietraszek A, Ridderstråle M, Safai N, Schioldan AG, Schmidt C, Snorgaard O, Stidsen J, Tarnow L, Cederberg H, Haapamäki H, Hukkanen J, Jauhiainen R, Kujari ML, Laakso M, Lahtela J, Laine M, Mäkelä J, Miilunpohja M, Savolainen M, Taurio J, Vänttinen M, Creton C, Cosma V, Dillinger J, Jacques JL, Guedj AM, Marre M, Moulla M, Petit C, Ratsianoharana V, Richter D, Rodier M, Roussel R, Travert F, Hinz A, Politz E, Esser M, Deuse U, Mittag D, Hagenow A, Jacob F, Jacob S, Jordan R, Gantke D, Venschott-Jordan U, Löhr C, Klausmann G, Eschenbrücher K, Karakas M, Jahrsdörfer B, Kunze MR, Wöhrle J, König W, Spielhagen H, Kilimnik A, Lüdemann HP, Lüdemann J, Mölle A, Mölle M, Müller J, Appelt S, Sauter A, Sauter J, Hartmann U, Löw A, Krötz F, Sohn HY, von Schacky C, Klauss V, Braun D, Segner A, Degtyareva E, Kreutzmann K, Paschmionka R, Hauck N, Sihal O, Busch AK, Maus O, Stübler P, Füllgraf-Horst S, Vietzke A, Müller C, Tosch-Sisting R, Lengsfeld B, Thaler J, Schaum T, Steindorf J, Steindorf S, König A, Reitschuster S, Schlott D, Clever HU, Witzel P, Kempe HP, Stemler L, Benis A, Benroubi M, Diakoumopoulou E, Kazakos K, Kypraios N, Liatis S, Pagkalos E, Siami E, Tentolouris N, Alur VC, Agrawal M, Ali M, Asirvatham A, Asirvatham E, Bandgar TR, Balaji M, Bardoloi N, Baruah M, Bekur R, Bhansali A, Bhatia S, Bhonsley S, Bhuyan S, Borah B, Bright N, Ambrish C, Chaudhury T, Choudhury S, Chellan G, Das M, Dharmalingam M, Dutta P, Erugu A, Vinutha FP, Gunasekaran P, Gupta RD, Iqbal A, Jagadish P, Jain S, Jain S, Jebasingh H, John A, John M, Kalra B, Kalra S, Kasaragod P, Kesavadev J, Kumar H, Kumar P, Lakshmanan V, Lila AR, Mathew T, Miyen H, Mohan T, Motha A, Murthy C, Shivashankara N, Nanaiah A, Ommen T, Pani K, Pandey K, Paramesh S, Paramesh V, Pillai B, Prabhu M, Kalki RC, Ramachandran S, Ramu M, Rao Y, Reddy S, Saikia P, Saravu K, Selvam K, Sethi B, Shankar A, Sharma A, Shah N, Shankar P, Shetty R, Shivane V, Srivalli S, Thaseen S, Thomas N, Sarada S, Shirisha A, Subramani M, Balaji V, Mohan V, Padmanaban V, Verma M, Vidyasagar S, Walinjkar V, Walia R, Davenport C, Forde H, Gadintshware G, Gan KJ, Hayes F, Khattak A, O'Connell J, O'Shea D, Smith D, Beilin V, Cahn A, Cohen O, Cukierman-Yaffe T, Daoud D, Darawsha M, Dicker D, Gavish A, Hochberg I, Ilany J, Inbal U, Itzhak B, Karasik A, Karnieli E, Khader N, Khamaisi M, Lender D, Lieberman GS, Mahamid R, Marcoviciu D, Michael L, Minuchin O, Mosenzon O, Narevichius F, Percik R, Potekhin M, Raz I, Sabbah M, Sawaed S, Schurr D, Segal E, Slezak L, Vollach I, Zaina A, Zloczower M, Zolotov S, Antenore A, Arnone M, Arturi F, Barbaro V, Barone M, Di Biagio R, Buscemi C, Buscemi S, Buzzetti R, Di Carlo A, Carlone A, Caruso V, Casadidio I, Cerrelli F, Ciavarella A, Cipolloni L, Colella A, Colotto M, Consoli A, Crippa VG, Cuccuru I, Cufone S, Desideri C, Fallarino M, Febo F, Filetti S, Foffi C, Formoso G, Frosio L, Di Fulvio P, Gambineri A, Ginestra F, Grimaldi MS, Lamanna C, Leto G, Lucotti P, Lugarà M, Lumera G, Magistro A, Mannucci E, Maranghi M, Martelli D, Mattina A, Monti LD, Parise M, Pedace E, Perticone F, Piatti P, Pompea Antonia Baldassarre M, Ragghianti B, Repaci A, Ribichini D, Da Ros S, Rossi M, Santilli M, Sesti G, Setola E, Shehaj E, Succurro E, Sussolano E, Tarquini G, Verga S, Vitale V, Alanis RR, Arechavaleta-Granell Mdel R, Beltran Jaramillo Tde J, Berrones DA, Briones IR, Briones RR, Castañeda ES, Chapa Grimaldo JB, Flores-Moreno CA, Felix SG, Flores JN, Franco GM, Garza Morán RA, González SO, González-Gálvez G, González González JG, Hernández Salazar E, Hernández PA, Hurtado SC, López-Velázco ML, Muñóz EG, Márquez RN, Moreno OV, Oliveros FJ, Ortiz JA, Pelayo-Orozco ES, Perez PS, Ramírez RV, Rios MA, Rodríguez JC, Rodríguez Rosales M, Robledo Durón I, Ruíz RA, Saldivar GG, Sánchez RR, Sánchez-Michel BL, Sandoval AY, Velasco Gutiérrez A, Verdín AE, Zavala MG, Abbink-Zandbergen EA, Ahdi M, Bugter A, van Dijk M, Eisma G, Erdtsieck R, Gerards M, Gerdes V, Haak H, Harbers V, Hoogenberg K, Huvers F, Janssen W, Kars M, Kooy A, Lafeber M, Landewé-Cleuren S, Lieverse A, Meesters E, Moerman S, van Moorsel D, Nijhuis J, Rutten G, Smit CJ, Tack C, Thevissen K, Thijssen DM, Willemsen A, Birkeland K, Cooper J, Gulseth H, Hjelmesæth J, Jørgensen P, Kilhovd BK, Kulseng B, Nicolaisen B, Skadberg Ø, Nordstrand N, Wium C, Antkowiak-Piatyszek K, Arciszewska M, Bajkowska-Fiedziukiewicz A, Bogdanski P, Czubek U, Cypryk K, Dabrowski J, Dabrowska M, Dziedzic S, Dziewit T, Faligowska M, Fedor-Plenkowska G, Franek E, Gajos G, Galicka-Latala D, Galuszka-Bilinska A, Gladysz I, Grycewicz J, Hachula G, Janas I, Jazwinska-Tarnawska E, Jedynasty K, Jozefowska M, Kaminska A, Katra B, Kitowska-Koterla J, Klupa T, Koblik T, Konduracka E, Konieczny J, Konieczny M, Kosinski M, Kulkowski G, Kunecki M, Kurmaniak M, Lesniewski R, Lominska T, Losa B, Majkowska D, Malecki M, Mirocka J, Misztal M, Mruk K, Musialik K, Olejniczak H, Opadczuk P, Peczynska J, Plinta M, Polaszewska-Muszynska M, Przech E, Pupek-Musialik D, Ruzga Z, Scibor Z, Sidorowicz-Bialynicka A, Siegel A, Stankiewicz A, Strzelecka-Sosik A, Swierszcz T, Szulinska M, Szymkowiak K, Trybul I, Witek P, Wozniak I, Zambrzycki J, Zarzycka-Lindner G, Zuradzka-Wajda D, Zurawska-Klis M, Ahn HY, Chin SO, Choi SH, Chon S, Han KA, Jang HC, Jeong KC, Kang SM, Kim JW, Kim HS, Kim SJ, Kim SW, Kim YS, Lee EY, Lim S, Min KW, Nam JY, Oh SJ, Park SY, Rhee SY, Shin JA, Son JI, Song YD, Woo JT, Yang HK, Yoo JS, Yoon JW, Yoon KH, Avram R, Braicu MD, Carlan L, Catrinoiu D, Ciomos D, Ciorba A, Ghise G, Girgavu S, Guja C, Mihai D, Mota M, Nicodim S, Nistor L, Pintilei DR, Pintilei E, Pletea N, Pop A, Rosu M, Savu O, Serban V, Sima A, Sitterli-Natea C, Suciu G, Szabo M, Szilagyi I, Timar B, Vlad A, Vladu IM, Alfaraj A, Dubova V, Dvoryashina I, Gaysina L, Gromova S, Gudkova K, Ivanova S, Ivashkina I, Kalashnikova M, Kazankova T, Khaykina E, Khaykina O, Kiseleva T, Komissarova E, Kononenko I, Koreneva V, Koshcheeva O, Koshel L, Kozachuk D, Kufelkina T, Kunitsyna M, Likhodey N, Lysenko T, Makarova O, Malceva A, Mikhailova S, Ogorodnikova E, Pavlikova I, Pekareva E, Postoeva A, Reshedko D, Reshedko G, Reshedko L, Rogaleva A, Rogova L, Rozanov D, Runov G, Samylina I, Semikina T, Sergeeva-Kondrachenko M, Shatskaya O, Shestakova M, Shimokhina O, Smetanina S, Startseva M, Strelkova A, Suplotova L, Suvorova L, Sych Y, Valeeva A, Valeeva F, Venjkova T, Vinokurova V, Voychik E, Yanovskaya E, Yanovskaya M, Yarkova N, Yarygina E, Yuzhakova N, Zakharova T, Zanozina O, Zenovko A, Zhuk S, Zhukova E, Aleksic S, Bulatovic A, Buric B, Cvijovic G, Jelic MA, Jojic B, Jotic A, Kendereski A, Lalic K, Lalic N, Lukic L, Macesic M, Marjanovic Petkovic M, Micic D, Milicic T, Popovic L, Prostran M, Rajkovic N, Seferovic J, Singh S, Stojanovic R, Stosic L, Vuksanovic M, Zamaklar M, Zivkovic TB, Zoric S, Aboo N, Albertse HW, Badat A, Basson M, Bawa E, Bester F, Blignaut S, Booysen S, Bosch FJ, Burgess L, Cassimjee S, Coetzee K, Du Bois J, Engelbrecht J, Finegan K, Gibson GJ, Hansa S, Hemus A, Immink IP, Jacovides A, Joshi P, Joshi S, Kapp C, Khoele-Machobane S, Knox HJ, Kok J, Komati S, Lai E, Lakha D, Lehloenyane K, Mahomed AG, Meeding R, Moodley R, Moosa N, Nel J, Nell HN, Van Niekerk FJ, Omar M, Pillay N, Pretorius M, Prozesky H, Ramduth S, Roos J, Sarvan M, Seeber M, Siebert M, Somasundram P, Stavrides A, Van Niekerk FJ, Venter N, Wadvalla S, Alcolea JO, de Arcaya Vicente AÁ, Arroyo MB, Bobillo ER, Buño MM, Carreira Arias JN, Camafort Babkowski M, Cepero García D, Comas LM, Coves Figueras MJ, de la Cuesta Mayor C, Feria-Carot MD, Fernández AM, Ferreiro Gómez M, García García C, García Delgado E, García SD, Gómez Gómez LA, González AS, Hernán García C, Herrero MÁ, Jodar Gimeno E, Juanals JQ, López Jiménez M, Masanes F, Mur ÁL, Navarro López M, Nicolau Ramis J, Palmer AG, Pascual AC, Pérez LG, Portillo CM, Prieto González S, Raya PM, Reyes García R, Ripoll Vera T, Rodríguez Castro C, Rodríguez Rodríguez I, Sacanella Meseguer E, Serrano Olmedo I, Soto AL, Toba Alonso F, Verdugo AA, Vidal Cortada J, Vigil Medina L, Ackefelt-Frick E, Alfredsson H, Beling E, Benedek P, Crisby M, Dorkhan M, Drescik T, Eeg-Olofsson K, Eliasson B, Eliasson K, Eriksson M, Fardelin P, Fredholm A, Frid A, Gerok-Andersson K, Hjelmaeus L, Hufnagl A, Jasinska E, Kowalska E, Lafolie P, Lindquist O, Lundvall M, Melander E, Nicander C, Moris L, Tengmark BO, Ridderstråle M, Saphir U, Skagerberg P, Steczkó-Nilsson C, Strandell B, Tomson Y, Chen JY, Chen YC, Chiang CY, Chou CW, Ho CW, Hsiao PJ, Hsieh MC, Hsu RS, Hsu SR, Huang CH, Huang YY, Hung WW, Lee MY, Lee YM, Lin CW, Lin CH, Lin KD, Lin SD, Lin SF, Liou MJ, Lu WT, Shin SJ, Sia HK, Su MH, Su SL, Sun JH, Tien KJ, Tsai DH, Tsai SS, Tu ST, Wang CC, Wang SY, Yang CY, Yen FC, Acikgoz A, Akalin S, Akin S, Akinci B, Akkurt A, Akturk M, Alkis N, Altun I, Altunbas HA, Altuntas Y, Araz M, Aribas S, Arslan E, Arslan G, Arslan M, Ataoglu EH, Ayan F, Aydin K, Aydogan BI, Ayvaz G, Bahadir MA, Balci MK, Basaran MN, Baskal N, Bugra MZ, Calan M, Cavdar U, Cetin F, Cinar N, Colbay M, Comlekci A, Dagdelen S, Damci T, Davutoglu V, Demir M, Demir T, Deyneli O, Dincer I, Dogan B, Doker KY, Engin I, Eraydin A, Erbas T, Erdogan MF, Ersoy C, Gedik A, Gokay F, Gul OO, Guler S, Gumus T, Gunes E, Gurler MY, Hatipoglu E, Ilkova H, Iyidir OT, Kabakci G, Karadag B, Karatemiz G, Karci AC, Kartal E, Kaya EB, Keskin C, Keskin EF, Kocabas G, Kocak F, Kol AK, Korkmaz H, Kucukler FK, Mesci BA, Oguz A, Orbay E, Oz H, Ozcan ND, Ozdem S, Ozisik S, Ozkan C, Ozsan M, Ozyazar M, Parlar H, Sargin H, Sargin M, Satman I, Saygili F, Selek A, Simsek Y, Sisman P, Solmaz K, Soydas C, Tatliagac S, Tamer I, Temizkan S, Tulunay C, Tuncel E, Turker F, Unluhizarci K, Unluturk U, Uygur MM, Vatansever B, Yazici D, Yavuz DG, Yener S, Yenigun M, 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Abstract

BACKGROUND:

The cardiovascular effect of liraglutide, a glucagon-like peptide 1 analogue, when added to standard care in patients with type 2 diabetes, remains unknown.

METHODS:

In this double-blind trial, we randomly assigned patients with type 2 diabetes and high cardiovascular risk to receive liraglutide or placebo. The primary composite outcome in the time-to-event analysis was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The primary hypothesis was that liraglutide would be noninferior to placebo with regard to the primary outcome, with a margin of 1.30 for the upper boundary of the 95% confidence interval of the hazard ratio. No adjustments for multiplicity were performed for the prespecified exploratory outcomes.

RESULTS:

A total of 9340 patients underwent randomization. The median follow-up was 3.8 years. The primary outcome occurred in significantly fewer patients in the liraglutide group (608 of 4668 patients [13.0%]) than in the placebo group (694 of 4672 [14.9%]) (hazard ratio, 0.87; 95% confidence interval [CI], 0.78 to 0.97; P<0.001 for noninferiority; P=0.01 for superiority). Fewer patients died from cardiovascular causes in the liraglutide group (219 patients [4.7%]) than in the placebo group (278 [6.0%]) (hazard ratio, 0.78; 95% CI, 0.66 to 0.93; P=0.007). The rate of death from any cause was lower in the liraglutide group (381 patients [8.2%]) than in the placebo group (447 [9.6%]) (hazard ratio, 0.85; 95% CI, 0.74 to 0.97; P=0.02). The rates of nonfatal myocardial infarction, nonfatal stroke, and hospitalization for heart failure were nonsignificantly lower in the liraglutide group than in the placebo group. The most common adverse events leading to the discontinuation of liraglutide were gastrointestinal events. The incidence of pancreatitis was nonsignificantly lower in the liraglutide group than in the placebo group.

CONCLUSIONS:

In the time-to-event analysis, the rate of the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke among patients with type 2 diabetes mellitus was lower with liraglutide than with placebo. (Funded by Novo Nordisk and the National Institutes of Health; LEADER ClinicalTrials.gov number, NCT01179048.).

PMID:
27295427
PMCID:
PMC4985288
DOI:
10.1056/NEJMoa1603827
[Indexed for MEDLINE]
Free PMC Article
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