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Lancet. 2019 Jul 13;394(10193):121-130. doi: 10.1016/S0140-6736(19)31149-3. Epub 2019 Jun 9.

Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial.

Collaborators (1421)

Abella M, Alebuena A, Almagro S, Amoroso E, Anadon P, Andreu E, Aristimuño G, Arzadun M, Barbieri M, Barcudi R, Bartolacci I, Bolobanich G, Bordonava A, Bustamante Labarta M, Bustos B, Caccavo A, Camino A, Cantero M, Carignano M, Cartasegna L, Cipullo M, Commendatore V, Conosciuto V, Costamagna O, Crespo C, Cuello J, Cuneo C, Cusimano S, Dean S, Dituro C, Dominguez A, Farah M, Fernandez A, Fernandez F, Ferrari A, Flammia P, Fuentealba J, Gallardo KB, Garcia C, Garcia Duran R, Garrido M, Gavicola R, Gerbaudo C, Gilli G, Giotto AP, Godoy Bolzán P, Gomez Vilamajo O, Guerlloy F, Guridi C, Gutierrez Garrido N, Hasbani E, Hermida S, Hominal M, Hrabar A, Ingaramo A, Izzicupo A, Krynski M, Lagrutta M, Lanchiotti P, Langhe M, Leonard V, Llanos J, Lopez Santi R, Lowenstein J, Luquez C, Mackinnon I, Mana M, Manzur S, Marino J, Martella C, Martinez R, Matias R, Matkovich J, Meritano M, Montaña O, Mulazzi M, Ochoa J, Paterlini G, Pelagagge M, Peralta Lopez ME, Prado A, Pruyas L, Racca M, Ricotti C, Rodriguez C, Romero Vidomlansky M, Ronderos R, Sadowski AL, Sala J, Sánchez A, Santoro A, Schiavi L, Sein M, Sernia V, Serra L, Sicer M, Smith T, Soso L, Sposetti G, Steinacher A, Stival J, Tedesco J, Tonin H, Tortolo M, Ulla M, Vallejos J, Vico M, Virgillito L, Visco V, Vogel D, Waisman F, Zaidman C, Zucchiatti N, Badshah I, Cohen N, Colman P, Colquhoun D, Davis T, Fourlanos S, Fulcher G, Hamlyn J, Haywood C, Hocking S, Huchinson M, Jeffries W, Kyl M, Lo C, Mah P, Makepeace A, Marope D, Nanayakkar N, Nankervis A, Palmer N, Palolus B, Pillai S, Price S, Price S, Proietto J, Reutens A, Rodrigo N, Sheikh A, Smith G, So M, Soldatos G, Stuckey B, Sumithran P, Teede H, Vora P, Williams L, Abib E, Adão Poço C, Alves ÉF, Andreatta Bernardi Barea J, Avezum Oliveira L, Castro DLDC, Correa da Cruz I, Costa M, Cruz I, Cunha S, Da Silva MAV, de Carvalho Camara Bona R, de Paula B, Eliaschewitz F, Fazolli G, Ferreira Filho CA, Fortes J, França C, Franco DR, Genestreti PR, Giorgeto F, Gonçalves RM, Grossman ME, Henrique Marcelino AC, Hernandes M, Horta A, Jaeger C, Kaneblai M, Kauffman Rutenberg C, Kerr Saraiva JF, Lemos MA, Maia L, Manenti ER, Marques M, Melissa Valerio C, Moreira R, Mothé F, Mouco OM, Moura P, Moura Jorge JC, Nakashima C, Nakazone M, Napoli T, Nunes C, Nunes Salles JE, Oliveira K, Oliveira M, Pantano GS, Petri F, Piazza L, Pires AC, Pizzato P, Prata S, Precoma D, Rech R, Reis G, Reis H, Resende E, Ribas Fortes J, Rodovalho S, Rossi Dos Santos F, Salles JE, Sampaio CR, Santos T, Santos Dos Santos V, Silva E Quadros T, Silveira D, Siqueira KN, Teireira M, Uehara M, Valerio C, Vianna H, Vidotti MH, Visconti GL, Zanella MT, Andreeva V, Borisov R, Botushanov N, Dimitrov G, Dimova K, Dragoychev T, Grigorova V, Gushterova V, Ivanov I, Kocelova T, Kurktschiev D, Miletieva M, Nenkova-Gugusheva N, Pancheva R, Pavlova M, Raev D, Spasova V, Stoikov A, Troev D, Yanev T, Yoncheva-Mihaylova M, Abitbol A, Ajala B, Alguwaihes A, Ardilouze JL, Aris-Jilwan N, Arnaout A, Aronson R, Aslam N, Babin S, Bailargeon JP, Bailey A, Bajaj H, Beauchesne C, Beca S, Belanger A, Bell A, Bellabarba D, Berard L, Berenbaum B, Bergeron V, Berlingieri J, Bernier F, Bishara P, Blank D, Blumer I, Brault S, Breton D, Carpentier A, Cha J, Chandra P, Chiasson JL, Conway JR, Couture G, Couture N, Dagenais G, Datta D, D'Ignazio G, Dumas R, Fay D, Frechette A, Frenette L, Fung D, Gagnon N, Galter M, Garon J, Gauthier JS, Geadah C, Gilbert J, Girard R, Goldenberg R, Grossman LD, Gupta N, Halle JP, Hivert MF, Houde G, Houlden R, Hramiak I, Jablonski T, Jain AJ, Khandwala H, Khosla M, Lachance C, Laflamme E, Langlois MF, Larivee L, Liutkus J, Lochnan H, Malik S, McDonald C, Mehta P, Mihailidis J, Milot A, Narula P, Nault P, Nayar A, Nisker W, Ouellet G, Palardy J, Patel M, Paul T, Pedersen S, Perron P, Pesant MH, Poirier P, Poulin MC, Punthakee Z, Rehman W, Ross S, Sagar P, Saliba N, Sandler S, Schiffrin A, Schlosser R, Seth-Sharma A, Sherman M, Sionit D, Sivakumar T, Soto J, St-Amour E, Steen O, Sussman J, Telner A, Tobe S, Twum-Barima DY, Van Zanten A, VanRossum N, Vecchiarelli J, Ward R, Wessengel J, Weisnagel S, Wilderman I, Woo V, Yakubovich N, Yale JF, Yared Z, Acevedo M, Aguirre ML, Aizman A, Barroso MS, Cobos L, Danin Vargas A, Descalzi B, Godoy G, Grumberg E, Lahsen R, Larenas G, Ortiz E, Paredes J, Potthoff S, Retamal E, Rojas L, Salgado M, Santibanez C, Solis C, Stokins B, Accini J, Acebedo J, Agudelo Baena LM, Alarcon S, Angel J, Arcos E, Aroca Martinez M, Atuesta L, Balaguera J, Ballestas D, Barrera SI, Barrios Reyes R, Bayona A, Bermudez A, Bernal DZ, Blanquicett M, Bravo V, Bueno W, Burbano Delgado A, Cadena A, Cadena A, Caicedo S, Celemin C, Consuegra R, Contreras Pimienta C, Corredor KJ, Cure C, De La Hoz Rueda LD, Delgado E, Diaz S, Diego M, Donado A, Encinales Sanabria W, Escobar J, Escorcia G, Forero L, Fuentes L, Garcia M, Garcia Lozada H, Garcia Ortiz L, Giraldo A, Gomez Gonzalez L, Granada J, Gutierrez C, Henao N, Hernandez E, Herrera Uejbe OM, Higuera Cobos JD, Ibarra Gómez J, Jaimes EH, Jaramillo M, Jaramillo N, Jaramillo Gomez C, Jaramillo Sanchez M, Jarava Durán I, Lopez Ceballos C, Madrid C, María Amastha E, Mercado J, Molina DI, Molina Soto J, Montoya C, Morales A, Muñoz C, Orozco LA, Osorio O, Palmera Sanchez JM, Peña A, Perez J, Perez Agudelo J, Pérez Amador G, Pertuz C, Posada I, Puerta C, Quintero A, Quiroz D, Rendon C, Reyes A, Reyes A, Ripoll D, Rivera C, Rocha M, Rodriguez JF, Rodriguez Villanueva KA, Rodriguez Zabala JE, Rojas S, Romero M, Rosero R, Rosillo Cardenas AR, Rueda L, Sanchez G, Sanchez T, Sotomayor Herazo A, Suarez M, Torres M, Trujillo F, Urina M, Van Strahlen L, Velandia C, Velasquez Guzman C, Velazquez E, Vidal Prada T, Yepez Alvaran JP, Zarate D, Andelova J, Benesova R, Buzova B, Cech V, Chodova I, Choura M, Dufka A, Gamova A, Gorgol J, Hala T, Havlova H, Hlavkova D, Horanska P, Ilcisin-Valova J, Jenickova P, Jerabek O, Kantorova I, Kolomaznikova K, Kopeckova I, Kopeckova M, Linhart K, Linhart T, Malecha J, Malicherova E, Neubauerova D, Oznerova M, Partys R, Pederzoliova E, Petrusova M, Prymkova V, Racicka E, Reissova I, Roderova E, Stanek L, Striova A, Svarcova D, Svoboda P, Szeghy Malicharova E, Urge J, Vesely L, Wasserburger B, Wasserburgerova H, Zahumensky E, Zamrazil V, Alawi H, Anastasiadis E, Axthelm E, Bieler T, Buhrig C, Degtyareva E, Dellanna F, Derwahl KM, Diessel S, Dogiami B, Dorn-Weitzel K, Ernst M, Faulmann G, Fetscher B, Forst T, Freyer-Lahres G, Funke K, Ganz X, Gleixner C, Hanefeld C, Heinrichs S, Helleberg S, Henkel E, Hetzel GR, Hoffmann C, Jacob F, Jacob S, John F, Jonczyk A, Kamke W, Klein C, Kleinhardt M, Kleophas W, Kosch C, Kreutzmann K, Kühn A, Lee-Barkey YH, Lier A, Maatouk S, Minnich J, Mitry M, Muessig I, Nicula D, Niemann M, Nothroff J, Ott P, Pfuetzner A, Pfützner A, Pistrosch F, Pohl W, Prochazkova Z, Retkowska M, Rosin H, Sachsenheimer D, Samer H, Sanuri M, Schaefer A, Schaper F, Schulze ED, Schulze M, Schumann M, Segiet T, Sowa V, Stahl HD, Steinfeldt F, Teige M, Trieb B, Tschoepe D, Uebel P, Warken B, Weigmann I, Weyland K, Wilhelm K, Balo T, Balsay M, Bende I, Bezzegh K, Birkus Z, Buday B, Csomai M, Deak L, Dezso E, Faludi P, Faluvegi M, Fazekas I, Feher A, Fejer C, Finta E, Fulcz A, Gaal Z, Gurzo M, Hati K, Herczeg G, Jozsef I, Juhasz M, Keltai K, Koranyi L, Kulcsar E, Kun K, Laczko A, Literáti-Nagy B, Mezo I, Mileder M, Moricz I, Nagy K, Nagybaczoni B, Nemeth C, Oze A, Pauer J, Peterfai E, Polocsanyi B, Poor F, Reiber I, Salamon C, Sebestyen J, Torok I, Tuu M, Varga A, Vass V, Ahn CM, Ahn C, ByungWon P, Chang HJ, Chang K, Choi EY, Choi HS, Chung JW, Hong BK, Hong YJ, Hyon MS, Jeong MH, Kang S, Kim BK, Kim JH, Kim JH, Kim KS, Kim KS, Kim MH, Kim PJ, Kim SK, Kim YS, Kim YK, Koh YS, Kwon HM, Lee BK, Lee BW, Lee JB, Lee MM, Lim YM, Min PK, Park JS, Park J, Park KH, Park S, Pyun WB, Rim SJ, Ryu DR, Seo HS, Seung KB, Shin DH, Sim DS, Yoon YW, Andersone I, Babicka K, Balcere I, Barons R, Capkovska I, Geldnere K, Grigane I, Jegere B, Lagzdina I, Mora L, Pastare S, Ritenberga R, Romanova J, Saknite I, Sidlovska N, Sokolova J, Steina S, Strizko I, Teterovska D, Vizina B, Barsiene L, Belozariene G, Daugintyte-Petrusiene L, Drungiliene N, Garsviene N, Grigiene A, Grizas V, Jociene V, Kalvaitiene D, Kaupiene J, Kavaliauskiene J, Kozloviene D, Lapteva I, Maneikiene B, Marcinkeviciene J, Markauskiene V, Meiluniene S, Norkus A, Norviliene R, Petrenko V, Radzeviciene R, Sakalyte G, Urbonas G, Urbutiene S, Vasiliauskas D, Velickiene D, Aguilar C, Alcocer M, Avalos-Ramirez JA, Banda-Elizondo R, Bricio-Ramirez R, Cardenas Mejia K, Cavazos F, Chapa J, Cienfuegos E, De la Peña A, de la Peña Topete G, De Los Rios Ibarra MO, Elias D, Flores-Moreno C, Garcia Hernandez P, Gonzalez LG, Guerra Moya RL, Guerra-Lopez A, Hernandez Baylon R, Herrera Colorado C, Herrera-Marmolejo M, Islas-Palacios N, Lopez E, Lopez F, Lopez Alvarado A, Luna Ceballos RI, Morales Villegas E, Moreno-Virgen G, Parra Perez RL, Pascoe Gonzalez S, Peralta-Cantu I, Previn R, Ramirez R, Ramirez R, Ramos Zavala MG, Rodriguez M, Salgado-Sedano R, Sanchez-Aguilar AC, Santa Rosa Franco E, Sauque-Reyna L, Suarez Otero R, Torres I, Velarde-Harnandez E, Villagordoa J, Villeda-Espinoza E, Vital-Lopez J, Zavala-Bello CJ, Baker J, Barrington-Ward E, Brownless T, Carroll R, Carson S, Choe M, Corin A, Corley B, Cutfield R, Dalaman N, Dixon P, Drury P, Dyson K, Florkowski C, Ford M, Frengley W, Helm C, Katzen C, Kerr J, Khanolkar M, Kim D, Koops R, Krebs J, Leikis R, Low K, Luckey A, Luke R, Macaulay S, Marks R, McNamara C, Millar-Coote D, Miller S, Mottershead N, Reid J, Robertson N, Rosen I, Rowe D, Schmiedel O, Scott R, Sebastian J, Sheahan D, Stiebel V, Ternouth I, Tofield C, Venter D, Williams M, Williams M, Wu F, Young S, Arciszewska M, Bochenek A, Borkowski P, Borowy P, Chrzanowski T, Czerwinski E, Dwojak M, Grodzicka A, Janiec I, Jaruga J, Jazwinska-Tarnawska EK, Jedynasty K, Juzwiak-Czapiewska D, Karczewicz-Janowska J, Konieczny J, Konieczny M, Korol M, Kozina M, Krzyzagorska E, Kucharczyk-Petryka E, Laz R, Majchrzak A, Mrozowska Z, Mularczyk M, Nowacka E, Peczynska J, Petryka R, Pietrzak R, Pisarczyk-Wiza D, Rozanska A, Ruzga Z, Rzeszotarska E, Sacha M, Sekulska M, Sidorowicz-Bialynicka A, Stasinska T, Strzelecka-Sosik A, Swierszcz T, Szymkowiak KM, Turowska O, Wisniewska K, Wiza M, Wozniak I, Zelazowska K, Ziolkowska-Gawron B, Zytkiewicz-Jaruga D, Albota A, Alexandru C, Avram R, Bala C, Barbonta D, Barbu R, Braicu D, Calutiu N, Catrinoiu D, Cerghizan A, Ciorba A, Craciun A, Doros R, Duma L, Dumitrache A, Ferariu I, Ferician Moza A, Ghergan A, Ghise G, Graur M, Gribovschi M, Mihai B, Mihalache L, Mihalcea M, Mindrescu N, Morosanu M, Morosoanu A, Mota M, Moza A, Nafornita V, Natea N, Nicodim S, Nita C, Onaca A, Onaca M, Pop C, Pop L, Popa A, Popescu A, Pruna L, Roman G, Rosu M, Sima A, Sipciu D, Sitterli-Natea CN, Szilagyi I, Tapurica M, Tase A, Tutescu AC, Vanghelie L, Verde I, Vlad A, Zarnescu M, Akhmetov R, Allenova I, Avdeeva I, Baturina O, Biserova I, Bokovin N, Bondar I, Burova N, Chufeneva G, Chumachek E, Demidova M, Demin A, Drobysheva V, Egorova I, Esenyan L, Gelig E, Gilyarevsky S, Golshmid M, Goncharov A, Gorbunova A, Gordeev I, Gorelysheva V, Goryunova T, Grebenshchikova I, Ilchenko R, Ivannikova M, Karabalieva S, Karpeeva J, Khaykina E, Kobalava Z, Kononenko I, Korolik O, Korshunova A, Kostenko V, Krasnopevtseva I, Krylova L, Kulkova P, Kuzmina I, Ledyaeva A, Levashov S, Lokhovinina N, Lvov V, Martirosyan N, Nedogoda S, Nilk R, Osmolovskaya Y, Panov A, Paramonova O, Pavlova E, Pekareva E, Petunina N, Ponamareva S, Reshedko G, Salasyuk A, Sepkhanyan M, Serebrov A, Shabelnikova O, Skvortsov A, Smirnova O, Spiridonova O, Strogova S, Taratukhin E, Tereschenko S, Trukhina L, Tsarkova O, Tsoma V, Tumarov F, Tyan N, Tyurina T, Villevalde S, Yankovaya E, Zarutskaya L, Zenkova E, Badat A, Bester F, Blignaut S, Blom D, Booysen S, Boyd W, Brice B, Brown S, Burgess L, Cawood R, Coetzee K, Conradie H, Cronje T, de Jong D, Ellis G, Emanuel S, Engelbrecht I, Foulkes S, Fourie D, Gibson G, Govender T, Hansa S, Hemus AC, Hendricks F, Heradien M, Holmgren C, Hoosain Z, Horak E, Howard J, Immink I, Janari E, Jivan D, Klusmann K, Labuschagne W, Lai YY, Latiff G, Lombaard J, Lottering H, Meeding R, Middlemost S, Mitha H, Mitha I, Mkhwanazi S, Moodley R, Murray A, Musungaie D, Osman Y, Peacey K, Pillay-Ramaya L, Pretorius C, Prozesky H, Sarvan M, Scholtz E, Sebesteny A, Skinner B, Skriker M, Smit M, Stapelberg AM, Swanepoel N, Urbach D, van Aswegen D, van Zyl F, Van Zyl L, Venter E, Wadvalla S, Wing J, Wolmarans K, Abreu C, Aguilà P, Aguilera E, Alonso N, Alvarez C, Cajas P, Castro JC, Codinachs R, Contreras J, Coves MJ, Fajardo C, Ferrer JC, Font N, Garcia M, Gil MA, Gomez F, Gomez LA, Gonzalbez J, Griera JL, Masmiquel L, Mauricio D, Narejos Perez S, Nicolau JA, Noheda Contreras O, Olivan J, Olivares J, Ortega E, Pellitero S, Pertusa S, Rius F, Rodriguez I, Sánchez-Juan C, Santos D, Soldevila B, Subias D, Terns M, Trescoli C, Vilaplana J, Villanueva A, Albo J, Antus K, Axelsson M, Bergström L, Binsell-Gerdin E, Boman K, Botond F, Dotevall A, Graipe A, Jarnet C, Kaminska J, Kempe A, Korhonen M, Linderfalk C, Liu B, Ljungstroem K, Ljungström K, Malmqvist L, Mellbin L, Mooe T, Nicol P, Norrby A, Ohlsson A, Rosengren A, Saaf J, Salmonsson S, Strandberg O, Svensson KA, Tengmark BO, Tsatsaris G, Ulvenstam A, Vasko P, Chang CT, Chang HM, Chen JF, Chen TP, Chung MM, Fu CP, Hsia TL, Hua SC, Kuo MC, Lee CL, Lee IT, Liang KW, Lin SY, Lu CH, Ma WY, Pei D, Shen FC, Su CC, Su SW, Tai TS, Tsai WN, Tsai YT, Tung SC, Wang JS, Yu HI, Al-Qaissi A, Arutchelvam V, Atkin S, Au S, Aye MM, Bain S, Bejnariu C, Bell P, Bhatnagar D, Bilous R, Black N, Brennan U, Brett B, Bujanova J, Chow E, Collier A, Combe A, Courtney C, Courtney H, Crothers J, Eavis P, Elliott J, Febbraro S, Finlayson J, Gandhi R, Gillings S, Hamling J, Harper R, Harris T, Hassan K, Heller S, Jane A, Javed Z, 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Abstract

BACKGROUND:

Three different glucagon-like peptide-1 (GLP-1) receptor agonists reduce cardiovascular outcomes in people with type 2 diabetes at high cardiovascular risk with high glycated haemoglobin A1c (HbA1c) concentrations. We assessed the effect of the GLP-1 receptor agonist dulaglutide on major adverse cardiovascular events when added to the existing antihyperglycaemic regimens of individuals with type 2 diabetes with and without previous cardiovascular disease and a wide range of glycaemic control.

METHODS:

This multicentre, randomised, double-blind, placebo-controlled trial was done at 371 sites in 24 countries. Men and women aged at least 50 years with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors were randomly assigned (1:1) to either weekly subcutaneous injection of dulaglutide (1·5 mg) or placebo. Randomisation was done by a computer-generated random code with stratification by site. All investigators and participants were masked to treatment assignment. Participants were followed up at least every 6 months for incident cardiovascular and other serious clinical outcomes. The primary outcome was the first occurrence of the composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes (including unknown causes), which was assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01394952.

FINDINGS:

Between Aug 18, 2011, and Aug 14, 2013, 9901 participants (mean age 66·2 years [SD 6·5], median HbA1c 7·2% [IQR 6·6-8·1], 4589 [46·3%] women) were enrolled and randomly assigned to receive dulaglutide (n=4949) or placebo (n=4952). During a median follow-up of 5·4 years (IQR 5·1-5·9), the primary composite outcome occurred in 594 (12·0%) participants at an incidence rate of 2·4 per 100 person-years in the dulaglutide group and in 663 (13·4%) participants at an incidence rate of 2·7 per 100 person-years in the placebo group (hazard ratio [HR] 0·88, 95% CI 0·79-0·99; p=0·026). All-cause mortality did not differ between groups (536 [10·8%] in the dulaglutide group vs 592 [12·0%] in the placebo group; HR 0·90, 95% CI 0·80-1·01; p=0·067). 2347 (47·4%) participants assigned to dulaglutide reported a gastrointestinal adverse event during follow-up compared with 1687 (34·1%) participants assigned to placebo (p<0·0001).

INTERPRETATION:

Dulaglutide could be considered for the management of glycaemic control in middle-aged and older people with type 2 diabetes with either previous cardiovascular disease or cardiovascular risk factors.

FUNDING:

Eli Lilly and Company.

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