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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial
The Lancet, Volume 394, No. 10193, Year 2019
Notification
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Description
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. © 2019 Elsevier Ltd
Authors & Co-Authors
Gerstein, Hertzel C.
Canada, Hamilton
Population Health Research Institute, Ontario
Colhoun, Helen M.
United Kingdom, Edinburgh
The University of Edinburgh
Dagenais, Gilles R.
Canada, Quebec
Université Laval
Díaz, Rafaël J.
Argentina, Rosario
Estudios Clínicos Latinoamérica, Argentina
Lakshmanan, Mark C.
United States, Indianapolis
Eli Lilly and Company
Pais, Prem S.
India, Bengaluru
St. John's Research Institute
Probstfield, Jeffrey L.
United States, Seattle
University of Washington
Riesmeyer, Jeffrey S.
United States, Indianapolis
Eli Lilly and Company
Riddle, Matthew C.
United States, Portland
Oregon Health & Science University
Ryde´n, Lårs E.
Sweden, Stockholm
Karolinska Institutet
Xavier, Denis
India, Bengaluru
St. John's Research Institute
Atisso, Charles Messan
United States, Indianapolis
Eli Lilly and Company
Dyal, Leanne
Canada, Hamilton
Population Health Research Institute, Ontario
Rao-Melacini, Purnima
Canada, Hamilton
Population Health Research Institute, Ontario
Wong, Gloria
Canada, Hamilton
Population Health Research Institute, Ontario
Avezum, Álvaro Jr
Brazil, Sao Paulo
Instituto Dante Pazzanese de Cardiologia
Basile, Jan Neil
United States, Charleston
Medical University of South Carolina
Chung, Namsik
South Korea, Seoul
Yonsei University Health System
Conget, Ignacio
Spain, Barcelona
Hospital Clinic Barcelona
Cushman, William C.
United States, Memphis
Memphis va Medical Center
Franek, Edward M.
Poland, Warszawa
Polish Academy of Sciences
Hâncu, Nicolae D.
Romania, Cluj Napoca
Universitatea de Medicina si Farmacie Iuliu Hatieganu Din Cluj-napoca
Hanefeld, Markolf G.
Germany, Dresden
Technische Universität Dresden
Holt, Shaun
New Zealand, Wellington
Victoria University of Wellington
Janský, Petr
Czech Republic, Prague
Fakultní Nemocnice V Motole
Keltai, Mátyás
Hungary, Budapest
Hungarian Institute of Cardiology
Leiter, Lawrence Alan
Canada, Toronto
Saint Michael's Hospital University of Toronto
López-Jaramillo, P.
Colombia, Bucaramanga
Universidad de Santander
Cardona-Muñoz, Ernesto Germán
Mexico, Guadalajara
Universidad de Guadalajara
Pirags, Valdis
Latvia, Riga
Latvijas Universitāte
Posogova, Nana
Russian Federation, Moscow
National Medical Research Center of Cardiology of the Ministry of Healthcare of the Russian Federation
Raubenheimer, Peter J.
South Africa, Cape Town
University of Cape Town
Shaw, Jonathan E.
Australia, Melbourne
Baker Heart and Diabetes Institute
Sheu, Wayne Huey Herng
Taiwan, Taichung
Veterans General Hospital-taichung Taiwan
Temelkova-Kurktschiev, Theodora S.
Bulgaria, Sofia
Robert Koch Medical Center
Abella, Mercedes
Unknown Affiliation
Alebuena, Andrea
Unknown Affiliation
Almagro, Sandra
Unknown Affiliation
Amoroso, Eduardo
Unknown Affiliation
Anadon, Paula
Unknown Affiliation
Andreu, Elizabeth
Unknown Affiliation
Aristimuño, Guillermo J.
Unknown Affiliation
Arzadun, Maria
Unknown Affiliation
Barbieri, Maria
Unknown Affiliation
Barcudi, Raúl J.
Unknown Affiliation
Bartolacci, Ines Palmira
Unknown Affiliation
Bolobanich, Gabriel
Unknown Affiliation
Bordonava, Anselmo Paulino
Unknown Affiliation
Bustamante-Labarta, Miguel H.
Unknown Affiliation
Bustos, Betina
Unknown Affiliation
Caccavo, Alberto
Unknown Affiliation
Camino, Alejandra Mabel
Unknown Affiliation
Cantero, Maria Cecilia
Unknown Affiliation
Carignano, Maria
Unknown Affiliation
Cartasegna, Luis Rodolfo
Unknown Affiliation
Cipullo, Marcela A.
Unknown Affiliation
Commendatore, Víctor Francisco
Unknown Affiliation
Conosciuto, Victoria
Unknown Affiliation
Costamagna, Osvaldo J.A.
Unknown Affiliation
Crespo, Claudia J.
Unknown Affiliation
Cuello, Jose L.
Unknown Affiliation
Cuneo, Carlos Alberto
Unknown Affiliation
Cusimano, Sandra
Unknown Affiliation
Dean, Sofia
Unknown Affiliation
Dituro, Claudio Fabián
Unknown Affiliation
Dominguez, Andrea
Unknown Affiliation
Farah, Miguel
Unknown Affiliation
Fernández, Alberto Alfredo
Unknown Affiliation
Fernández, Florencia
Unknown Affiliation
Ferrari, Adriana
Unknown Affiliation
Flammia, Patricia
Unknown Affiliation
Fuentealba, José Antonio
Unknown Affiliation
Gallardo, Karina Beatriz
Unknown Affiliation
García, Celso Fernando
Unknown Affiliation
Garcia-Duran, Ruben Omar
Unknown Affiliation
Garrido, Marcelo A.
Unknown Affiliation
Gavícola, Rodolfo
Unknown Affiliation
Gerbaudo, Claudio
Unknown Affiliation
Gilli, Graciela
Unknown Affiliation
Giotto, Ana Paula
Unknown Affiliation
Godoy Bolzán, Pedro
Unknown Affiliation
Gomez Vilamajó, Oscar Alberto
Unknown Affiliation
Guerlloy, Fernando P.
Unknown Affiliation
Guridi, Cristian
Unknown Affiliation
Gutierrez Garrido, Narcisa
Unknown Affiliation
Hasbani, Eduardo G.
Unknown Affiliation
Hermida, Sonia
Unknown Affiliation
Hominal, Miguel Angel
Unknown Affiliation
Hrabar, Adrián D.
Unknown Affiliation
Ingaramo, Adrián C.
Unknown Affiliation
Izzicupo, Alejandra
Unknown Affiliation
Krynski, Mario
Unknown Affiliation
Lagrutta, Mariana
Unknown Affiliation
Lanchiotti, Paulina Virginia
Unknown Affiliation
Langhe, Maria
Unknown Affiliation
Leonard, Veronica
Unknown Affiliation
Llanos, Javier R.
Unknown Affiliation
López Santi, Ricardo G.
Unknown Affiliation
MacKinnon, Ignacio J.
Unknown Affiliation
Martella, Carolina
Unknown Affiliation
Montaña, Oscar R.
Unknown Affiliation
Pelagagge, María Jose
Unknown Affiliation
Prado, Aldo
Unknown Affiliation
Ronderos, Ricardo Ernesto
Unknown Affiliation
Sala, Jorgelina M.
Unknown Affiliation
Schiavi, Lilia Beatriz
Unknown Affiliation
Vico, Marisa Liliana
Unknown Affiliation
Vogel, Daniel R.
Unknown Affiliation
Zaidman, Cesar Javier
Unknown Affiliation
Colman, P. G.
Unknown Affiliation
Colquhoun, David M.
Unknown Affiliation
Davis, Timothy M.E.
Unknown Affiliation
Fulcher, Greg R.
Unknown Affiliation
Smith, Greg W.
Unknown Affiliation
Stuckey, Bronwyn G.A.
Unknown Affiliation
Teede, Helena J.
Unknown Affiliation
Vora, Parind
Unknown Affiliation
Williams, Lyn Keoki
Unknown Affiliation
Franco, Denise Reis
Unknown Affiliation
Hernandes, Mauro Esteves
Unknown Affiliation
Maia, Lília Nigro
Unknown Affiliation
Manenti, Euler Roberto Fernandes
Unknown Affiliation
Précoma, Dalton Bertolim
Unknown Affiliation
Reis, Gilmar
Unknown Affiliation
Reis, Heleno
Unknown Affiliation
Rossi Dos Santos, Fabio
Unknown Affiliation
Ivanov, Ivaylo I.
Unknown Affiliation
Raev, Dimitar H.
Unknown Affiliation
Alguwaihes, Abdullah M.
Unknown Affiliation
Aronson, Ronnie S.
Unknown Affiliation
Bajaj, Harpreet Singh
Unknown Affiliation
Bell, Alan David
Unknown Affiliation
Carpentier, André C. C.
Unknown Affiliation
Chiasson, Jean Louis
Unknown Affiliation
Dagenais, Gilles R.
Unknown Affiliation
Goldenberg, Ronald M.
Unknown Affiliation
Hivert, Marie France
Unknown Affiliation
Houlden, Robyn L.
Unknown Affiliation
Milot, Alain
Unknown Affiliation
Pedersen, Sue D.
Unknown Affiliation
Poirier, Paul P.
Unknown Affiliation
Punthakee, Zubin
Unknown Affiliation
Ross, Stuart A.
Unknown Affiliation
Sherman, Mark H.
Unknown Affiliation
Tobe, Sheldon W.
Unknown Affiliation
Twum-Barima, David Yaw
Unknown Affiliation
Woo, Vincent C.
Unknown Affiliation
Yale, Jean François
Unknown Affiliation
Santibáñez, Claudio
Unknown Affiliation
Accini, José Luis
Unknown Affiliation
Cadena, Alberto
Unknown Affiliation
Cure, Carlos
Unknown Affiliation
Jaramillo, Mónica Lopez
Unknown Affiliation
Molina, Dora Ines
Unknown Affiliation
Reyes, Alvaro
Unknown Affiliation
Rivera, Carlos Jose Perez
Unknown Affiliation
Sánchez, Gregorio T.
Unknown Affiliation
Urina-Triana, Miguel
Unknown Affiliation
Hála, Tomáš
Unknown Affiliation
Kantorová, Ilona
Unknown Affiliation
Račická, Evá
Unknown Affiliation
Alawi, Hasan
Unknown Affiliation
Forst, Thomas
Unknown Affiliation
Jacob, Stephan
Unknown Affiliation
Pfútzner, Andreas
Unknown Affiliation
Schaefer, Axel
Unknown Affiliation
Schaper, Frank
Unknown Affiliation
Stahl, Hans Detlev
Unknown Affiliation
Keltai, Katalin
Unknown Affiliation
Ahn, Chul-min
Unknown Affiliation
Chang, Hyukjae
Unknown Affiliation
Jeong, Myungho
Unknown Affiliation
Kim, Byeong-keuk
Unknown Affiliation
Kim, Kee-sik
Unknown Affiliation
Kim, Moo-hyun
Unknown Affiliation
Lee, Byoung-kwon
Unknown Affiliation
Pyun, Wookbum
Unknown Affiliation
Seo, Hongseog Seong
Unknown Affiliation
Seung, Ki-bae
Unknown Affiliation
Šakalyte, Gintare
Unknown Affiliation
Veličkienė, Džilda
Unknown Affiliation
Rodríguez, Monica J.
Unknown Affiliation
Sauque-Reyna, Leobardo
Unknown Affiliation
Dixon, Paul
Unknown Affiliation
Drury, Paul Leslie
Unknown Affiliation
Florkowski, Christopher Michael
Unknown Affiliation
Krebs, Jeremy D.
Unknown Affiliation
Reid, Jim J.
Unknown Affiliation
Scott, R. S.
Unknown Affiliation
Czerwiński, Edward
Unknown Affiliation
Petryka, Robert
Unknown Affiliation
Sidorowicz-Białynicka, Anna
Unknown Affiliation
Moţa, Maria F.A.
Unknown Affiliation
Popa, Amorin Remus
Unknown Affiliation
Kobalava, Zhanna D.
Unknown Affiliation
Statistics
Citations: 1,505
Authors: 195
Affiliations: 30
Identifiers
Doi:
10.1016/S0140-6736(19)31149-3
ISSN:
01406736
Research Areas
Disability
Environmental
Noncommunicable Diseases
Study Design
Cross Sectional Study
Cohort Study
Participants Gender
Male
Female