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

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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.

authors

  • Gerstein, Hertzel Chaim
  • Colhoun, Helen M
  • Dagenais, Gilles R
  • Diaz, Rafael
  • Lakshmanan, Mark
  • Pais, Prem
  • Probstfield, Jeffrey
  • Riesmeyer, Jeffrey S
  • Riddle, Matthew C
  • Rydén, Lars
  • Xavier, Denis
  • Atisso, Charles Messan
  • Dyal, Leanne
  • Hall, Stephanie
  • Rao-Melacini, Purnima
  • Wong, Gloria
  • Avezum, Alvaro
  • Basile, Jan
  • Chung, Namsik
  • Conget, Ignacio
  • Cushman, William C
  • Franek, Edward
  • Hancu, Nicolae
  • Hanefeld, Markolf
  • Holt, Shaun
  • Jansky, Petr
  • Keltai, Matyas
  • Lanas, Fernando
  • Leiter, Lawrence A
  • Lopez-Jaramillo, Patricio
  • Cardona Munoz, Ernesto German
  • Pirags, Valdis
  • Pogosova, Nana
  • Raubenheimer, Peter J
  • Shaw, Jonathan E
  • Sheu, Wayne H-H
  • Temelkova-Kurktschiev, Theodora
  • Abella, Mercedes
  • Alebuena, Andrea
  • Almagro, Sandra
  • Amoroso, Eduardo
  • Anadon, Paula
  • Andreu, Elizabeth
  • Aristimuño, Guillermo
  • Arzadun, Maria
  • Barbieri, Maria
  • Barcudi, Raul
  • Bartolacci, Ines
  • Bolobanich, Gabriel
  • Bordonava, Anselmo
  • Bustamante Labarta, Miguel
  • Bustos, Betina
  • Caccavo, Alberto
  • Camino, Alejandra
  • Cantero, Maria
  • Carignano, Maria
  • Cartasegna, Luis
  • Cipullo, Marcela
  • Commendatore, Víctor
  • Conosciuto, Victoria
  • Costamagna, Osvaldo
  • Crespo, Claudia
  • Cuello, Jose
  • Cuneo, Carlos
  • Cusimano, Sandra
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  • Kaupiene, Jugeta
  • Kavaliauskiene, Jurate
  • Kozloviene, Dalia
  • Lapteva, Ilona
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  • Marcinkeviciene, Jolanta
  • Markauskiene, Vaidilija
  • Meiluniene, Salomeja
  • Norkus, Almantas
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  • Sakalyte, Gintare
  • Urbonas, Gediminas
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  • Cavazos, Francisco
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  • de la Peña Topete, Gilberto
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  • Elias, Daniel
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  • Garcia Hernandez, Pedro
  • Gonzalez, Luis Gerardo
  • Guerra Moya, Rosa Linda
  • Guerra-Lopez, Arturo
  • Hernandez Baylon, Raymundo
  • Herrera Colorado, Carolina
  • Herrera-Marmolejo, Marisol
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  • Lopez, Esteban
  • Lopez, Fernando
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  • Villagordoa, Juan
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  • Mularczyk, Michal
  • Nowacka, Elzbieta
  • Peczynska, Jadwiga
  • Petryka, Robert
  • Pietrzak, Radoslaw
  • Pisarczyk-Wiza, Dorota
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  • Ruzga, Zofia
  • Rzeszotarska, Emilia
  • Sacha, Malgorzata
  • Sekulska, Marzenna
  • Sidorowicz-Bialynicka, Anna
  • Stasinska, Teresa
  • Strzelecka-Sosik, Agnieszka
  • Swierszcz, Teresa
  • Szymkowiak, Katarzyna Miroslawa
  • Turowska, Olga
  • Wisniewska, Krystyna
  • Wiza, Maciej
  • Wozniak, Iwona
  • Zelazowska, Katarzyna
  • Ziolkowska-Gawron, Bernadetta
  • Zytkiewicz-Jaruga, Danuta
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  • Morosoanu, Andrea
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  • Pop, Lavinia
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  • Sima, Alexandra
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  • Sitterli-Natea, Carmen Narcisa
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  • Vanghelie, Luminita
  • Verde, Ioana
  • Vlad, Adrian
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  • Avdeeva, Irina
  • Baturina, Oksana
  • Biserova, Irina
  • Bokovin, Nikolay
  • Bondar, Irina
  • Burova, Natalia
  • Chufeneva, Galina
  • Chumachek, Elena
  • Demidova, Marina
  • Demin, Alexander
  • Drobysheva, Vera
  • Egorova, Irina
  • Esenyan, Lev
  • Gelig, Ekaterina
  • Gilyarevsky, Sergey
  • Golshmid, Maria
  • Goncharov, Arseniy
  • Gorbunova, Anastasia
  • Gordeev, Ivan
  • Gorelysheva, Vera
  • Goryunova, Tatiana
  • Grebenshchikova, Irina
  • Ilchenko, Roman
  • Ivannikova, Maria
  • Karabalieva, Saule
  • Karpeeva, Juliya
  • Khaykina, Elena
  • Kobalava, Zhanna
  • Kononenko, Irina
  • Korolik, Oxana
  • Korshunova, Anna
  • Kostenko, Victor
  • Krasnopevtseva, Irina
  • Krylova, Ludmila
  • Kulkova, Polina
  • Kuzmina, Irina
  • Ledyaeva, Alla
  • Levashov, Sergey
  • Lokhovinina, Natalia
  • Lvov, Vadim
  • Martirosyan, Narine
  • Nedogoda, Sergey
  • Nilk, Rostislav
  • Osmolovskaya, Yulia
  • Panov, Alexey
  • Paramonova, Olga
  • Pavlova, Ekaterina
  • Pekareva, Elena
  • Petunina, Nina
  • Ponamareva, Svetlana
  • Reshedko, Galina
  • Salasyuk, Alla
  • Sepkhanyan, Malvina
  • Serebrov, Alexandr
  • Shabelnikova, Olesya
  • Skvortsov, Andrey
  • Smirnova, Olga
  • Spiridonova, Oxana
  • Strogova, Svetlana
  • Taratukhin, Evgeny
  • Tereschenko, Sergey
  • Trukhina, Lubov
  • Tsarkova, Olga
  • Tsoma, Vera
  • Tumarov, Farid
  • Tyan, Natalya
  • Tyurina, Tatiana
  • Villevalde, Svetlana
  • Yankovaya, Elena
  • Zarutskaya, Ludmila
  • Zenkova, Elena
  • Badat, Aysha
  • Bester, Frederik
  • Blignaut, Suzanne
  • Blom, Dirk
  • Booysen, Susan
  • Boyd, Warren
  • Brice, Brigitte
  • Brown, Susan
  • Burgess, Lesley
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  • Coetzee, Kathleen
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  • Cronje, Tanja
  • de Jong, Douwe
  • Ellis, Graham
  • Emanuel, Shaunagh
  • Engelbrecht, Ingrid
  • Foulkes, Sharne
  • Fourie, Done
  • Gibson, Gilbert
  • Govender, Thirumani
  • Hansa, Sumayah
  • Hemus, Allana Colleen
  • Hendricks, Firzana
  • Heradien, Marshall
  • Holmgren, Chantelle
  • Hoosain, Zaheer
  • Horak, Emile
  • Howard, Johannes
  • Immink, Ignatius
  • Janari, E
  • Jivan, Daksha
  • Klusmann, Karl
  • Labuschagne, Weik
  • Lai, Yen-yu
  • Latiff, Gulam
  • Lombaard, J
  • Lottering, Hanlie
  • Meeding, Ronel
  • Middlemost, Shirley
  • Mitha, Haroon
  • Mitha, Ismail
  • Mkhwanazi, Sandile
  • Moodley, Rajendran
  • Murray, Almeri
  • Musungaie, Dany
  • Osman, Yasmin
  • Peacey, Kirsten
  • Pillay-Ramaya, Larisha
  • Pretorius, Catharina
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  • Sarvan, Mahomed
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  • Stapelberg, Anna-Marie
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  • Urbach, Dorothea
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  • van Zyl, Francois
  • Van Zyl, Louis
  • Venter, Esme
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  • Aguilera, Eva
  • Alonso, Nuria
  • Alvarez, Carmen
  • Cajas, Priscila
  • Castro, Jose Carlos
  • Codinachs, Roger
  • Contreras, Jose
  • Coves, Maria Jose
  • Fajardo, Carmen
  • Ferrer, Juan Carlos
  • Font, Neus
  • Garcia, Mar
  • Gil, Maria Apolonia
  • Gomez, Fernando
  • Gomez, Lluis Alberto
  • Gonzalbez, Jose
  • Griera, Jose Luis
  • Masmiquel, Luís
  • Mauricio, Didac
  • Narejos Perez, Silvia
  • Nicolau, Juana Ana
  • Noheda Contreras, Olga
  • Olivan, Josefina
  • Olivares, Josefina
  • Ortega, Emilio
  • Pellitero, Silvia
  • Pertusa, Salvador
  • Rius, Ferran
  • Rodriguez, Irene
  • Sánchez-Juan, Carlos
  • Santos, Dolores
  • Soldevila, Berta
  • Subias, David
  • Terns, Manel
  • Trescoli, Carlos
  • Vilaplana, Judith
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  • Albo, Jaan
  • Antus, Kjell
  • Axelsson, Mattias
  • Bergström, Lisa
  • Binsell-Gerdin, Emil
  • Boman, Kurt
  • Botond, Fabian
  • Dotevall, Annika
  • Graipe, Anna
  • Jarnet, C
  • Kaminska, Jessica
  • Kempe, Anders
  • Korhonen, Michael
  • Linderfalk, Carina
  • Liu, Bo
  • Ljungstroem, Karl
  • Ljungström, Karl
  • Malmqvist, Lennart
  • Mellbin, Linda
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  • Nicol, Peter
  • Norrby, Anders
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  • Rosengren, Annika
  • Saaf, Jan
  • Salmonsson, Staffan
  • Strandberg, Olof
  • Svensson, Karl-Axel
  • Tengmark, Bengt-Olov
  • Tsatsaris, Georgios
  • Ulvenstam, Anders
  • Vasko, Peter
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  • Chang, Hsin-Mei
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  • Chen, To-Pang
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  • Febbraro, Salvatore
  • Finlayson, Jim
  • Gandhi, Rajiv
  • Gillings, Sharon
  • Hamling, Jonathan
  • Harper, Roy
  • Harris, Tim
  • Hassan, Kahal
  • Heller, Simon
  • Jane, Alison
  • Javed, Zeeshan
  • Johnson, Tim
  • Jones, Stephen
  • Kennedy, Adele
  • Kerr, David
  • Kilgallon, Brian
  • Konya, Judith
  • Lindsay, John
  • Lomova-Williams, Lina
  • Looker, Helen
  • MacFarlane, David
  • Macrury, Sandra
  • Malik, Iqbal
  • McCrimmon, Rory
  • McKeith, Douglas
  • McKnight, John
  • Mishra, Biswa
  • Mukhtar, Racha
  • Mulligan, Ciara
  • O'Kane, Maurice
  • Olateju, Tolu
  • Orpen, Ian
  • Richardson, Tristan
  • Rooney, Desmond
  • Ross, Shorsha Bae
  • Sathyapalan, Thozhukat
  • Siddaramaiah, Naveen
  • Sit, Lee Euan
  • Stephens, Jeffrey
  • Turtle, Frances
  • Wakil, Ammar
  • Walkinshaw, Emma
  • Ali, Asem
  • Anderson, Robert
  • Arakaki, Richard
  • Aref, Omar
  • Ariani, Mehrdad Kevin
  • Arkin, David
  • Banarer, Salomon
  • Barchini, George
  • Bhan, Arti
  • Branch, Kelley
  • Brautigam, Donald
  • Brietzke, Stephen
  • Brinas, Maridez
  • Brito, Yudit
  • Carter, Casey
  • Casagni, Kimberely
  • Casula, Sabina
  • Chakko, Simon
  • Charatz, Seth
  • Childress, Dale
  • Chow, Lisa
  • Chustecka, Malgorzata
  • Clarke, Subha
  • Cohen, Lisa
  • Collins, Barry
  • Colon Vega, Gildred
  • Comulada-Rivera, Angel
  • Cortes-Maisonet, Gregorio
  • Davis, Matthew
  • de Souza, Jose
  • Desouza, Cyrus
  • Dinnan, Mary
  • Duffy-Hidalgo, Bobbi
  • Dunn, Barbara
  • Dunn, Julia
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  • Felicetta, James
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  • Fitz-Patrick, David
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  • Forker, Alan
  • Fowler, Wayne
  • Fredrickson, Sonja
  • Freedman, Zachary
  • Gainey Narron, Brooke
  • Gainey-Ferree, Kristin
  • Gardner, Michael
  • Gastelum, Christian
  • Giddings, Stephen
  • Gillespie, Eve
  • Gimness, Michael Paul
  • Goldstein, Gary
  • Gomes, Maria
  • Gomez, Nelson
  • Gorman, Timothy
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  • Graves, Arthur
  • Hacking, Scott
  • Hall, Charles
  • Hanson, Lenita
  • Harman, Sherman
  • Heber, David
  • Henry, Robert
  • Hiner, Janette
  • Hirsch, Irl
  • Hollander, Priscilla
  • Hooker, Thomas
  • Horowitz, Barry
  • Hoste, Laura
  • Huang, Loli
  • Huynh, Minh
  • Hyman, Dan
  • Idriss, Soha
  • Iranmanesh, Ali
  • Karounos, Dennis
  • Kashyap, Moti
  • Katz, Lois
  • Kaye, William
  • Khaiton, Yevgeniy
  • Khardori, Romesh
  • Kitchen, Timothy
  • Klein, Andrew
  • Knffem, Wendi
  • Kosiborod, Mikhail
  • Kreglinger, Nicola
  • Kruger, Davida
  • Kumar, Anubhav
  • Laboy, Ivan
  • Larrabee, Patricia
  • Larrick, Laura
  • Lawson, Donna
  • Ledet, Mike
  • Lenhard, James
  • Levy, James
  • Li, George
  • Li, Zhaoping
  • Lieb, David
  • Limcolioc, April
  • Lions-Patterson, Jane
  • Lorber, Daniel
  • Lorch, Daniel
  • Lorrello, Michael
  • Lu, Peter
  • Lucas, Kathryn Jean
  • Ma, Siu-Ling
  • MacAdams, Michael
  • Magee, Michelle
  • Magno, Alexander
  • Mahakala, Aparna Reddy
  • Marks, Jennifer
  • McCall, Anthony
  • McClanahan, William
  • McClary, Carole
  • Melendez, Lydia
  • Melish, John
  • Michaud, Deanna
  • Miller, Christopher
  • Miller, Neil
  • Mora, Pablo
  • Moten, Marriyam
  • Mudaliar, Sunder
  • Myrick, Gregory
  • Narayan, Puneet
  • Nassif, Mike
  • Neri, Karena
  • Newton, Tabitha
  • Niblack, Patricia
  • Nicol, Philip
  • Nyenwe, Ebenezer
  • Odugbesan, A Ola
  • Okorocha, Yolanda
  • Ortiz Carrasquillo, Ramón
  • Osei, Kwame
  • Palermo, Coromoto
  • Patel, Hiren
  • Patel, Krishna
  • Pau, Cindy
  • Perley, Michael
  • Plevin, Sanford
  • Plummer, Elena
  • Powell, Richard
  • Qintar, Mohammed
  • Rawls, Rex
  • Reyes-Castano, John
  • Reynolds, Lillian
  • Richards, Robert
  • Rosenstock, Julio
  • Rowe, Caroline
  • Saleh, Jahandar
  • Sam, Sony
  • Sanchez, Alfredo
  • Sander, Donald
  • Sanderson, Bruce
  • Savin, Virginia
  • Seaquist, Elizabeth
  • Shah, Jayendra
  • Shi, Serena
  • Shivaswamy, Vijay
  • Shlotzhauer, Tammi
  • Shore, David
  • Skukowski, Bobbie
  • Soe, Kyaw
  • Solheim, Vesna
  • Soufer, Joseph
  • Steinberg, Helmut
  • Steinsapir, Jaime
  • Tarkington, Phillip
  • Thayer, Debra
  • Thomson, Stephen
  • Thrasher, James
  • Tibaldi, Joseph
  • Tjaden, Jeff
  • Tores, Oberto
  • Trence, Dace
  • Trikudanathan, Subbulaxmi
  • Ullal, Jagdeesh
  • Uwaifo, Gabriel
  • Vo, Anthony
  • Vu, Kenny
  • Walia, Damandeep
  • Weiland, Karen
  • Whitehouse, Fred
  • Wiegmann, Thomas
  • Wyne, Kathleen
  • Wynne, Alan
  • Yuen, Kevin
  • Zaretzky, Joel
  • Zebrack, James
  • Zieve, Franklin
  • Zigrang, William

publication date

  • July 2019