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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo
American Heart Journal, Volume 169, No. 5, Year 2015
Notification
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Description
Background: Cardiovascular (CV) disease is the leading cause of morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Furthermore, patients with T2DM and acute coronary syndrome (ACS) have a particularly high risk of CV events. The glucagonlike peptide 1 receptor agonist, lixisenatide, improves glycemia, but its effects on CV events have not been thoroughly evaluated. Methods: ELIXA (www.clinicaltrials.gov no. NCT01147250) is a randomized, double-blind, placebo-controlled, parallelgroup, multicenter study of lixisenatide in patients with T2DM and a recent ACS event. The primary aim is to evaluate the effects of lixisenatide on CV morbidity and mortality in a population at high CV risk. The primary efficacy end point is a composite of time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. Data are systematically collected for safety outcomes, including hypoglycemia, pancreatitis, and malignancy. Results: Enrollment began in July 2010 and ended in August 2013; 6,068 patients from 49 countries were randomized. Of these, 69% are men and 75% are white; at baseline, the mean ± SD age was 60.3 ± 9.7 years, body mass index was 30.2 ± 5.7 kg/m2, and duration of T2DM was 9.3±8.2 years. The qualifying ACS wasamyocardial infarctionin83% and unstableangina in 17%. The study will continue until the positive adjudication of the protocol-specified number of primary CV events. Conclusion: ELIXA will be the first trial to report the safety and efficacy of a glucagon-like peptide 1 receptor agonist in people with T2DM and high CV event risk. © 2015 Elsevier Inc. All rights reserved.
Authors & Co-Authors
Aguilar, David A.
United States, Houston
Baylor College of Medicine
Riddle, Matthew C.
United States, Portland
Ohsu School of Medicine
Claggett, Brian Lee
United States, Boston
Brigham and Women's Hospital
Díaz, Rafaël J.
Argentina, Rosario
Etudios Cardiologica Latin America, Rosario
Dickstein, Kenneth
Norway, Stavanger
Stavanger Universitetssjukehus
Gerstein, Hertzel C.
Canada, Hamilton
Population Health Research Institute, Ontario
Johnston, Peter S.
France, Gentilly
Sanofi S.a.
Köber, Lars Valeur
Denmark, Copenhagen
Rigshospitalet
Lewis, Eldrin F.
United States, Boston
Brigham and Women's Hospital
Maggioni, Aldo Pietro
Italy, Florence
Associazione Nazionale Medici Cardiologi Ospedalieri
McMurray, John JV
United Kingdom, Glasgow
University of Glasgow
Ping, Lin
France, Gentilly
Sanofi S.a.
Probstfield, Jeffrey L.
United States, Seattle
Uw Medical Center – Montlake
Solomon, Scott David
United States, Boston
Brigham and Women's Hospital
Tardif, Jean Claude
Canada, Montreal
University of Montreal
Pfeffer, Marc Allan
United States, Boston
Brigham and Women's Hospital
Charytan, David M.
Unknown Affiliation
del Prato, Stefano
Unknown Affiliation
Petrie, John R.
Unknown Affiliation
Zuraw, Bruce L.
Unknown Affiliation
Scarpa, Aldo
Unknown Affiliation
Granger, Christopher B.
Unknown Affiliation
Rouleau, Jean-Lucien Lucien
Unknown Affiliation
DeMets, David L.
Unknown Affiliation
Chaturvedi, Nishi
Unknown Affiliation
Raccah, Denis
Unknown Affiliation
Bartolacci, Ines Palmira
Unknown Affiliation
Bordonava, Anselmo Paulino
Unknown Affiliation
Bustamante-Labarta, Miguel H.
Unknown Affiliation
Caccavo, Alberto
Unknown Affiliation
Cantero, Maria Cecilia
Unknown Affiliation
Commendatore, Víctor Francisco
Unknown Affiliation
Costamagna, Osvaldo J.A.
Unknown Affiliation
Cuello, Jose L.
Unknown Affiliation
Fernández, Alberto Alfredo
Unknown Affiliation
Garcia-Duran, Ruben Omar
Unknown Affiliation
Gomez Vilamajó, Oscar Alberto
Unknown Affiliation
Grinfeld, Diego D.
Unknown Affiliation
Hermida, Sonia
Unknown Affiliation
Lagrutta, Mariana
Unknown Affiliation
Luciardi, Héctor Lucas
Unknown Affiliation
MacKinnon, Ignacio J.
Unknown Affiliation
Maffei, Laura Elena
Unknown Affiliation
Montaña, Oscar R.
Unknown Affiliation
Novaretto, Leonardo P.
Unknown Affiliation
Orlandini, Andrés D.
Unknown Affiliation
Schiavi, Lilia Beatriz
Unknown Affiliation
Schygiel, Pablo Omar
Unknown Affiliation
Vico, Marisa Liliana
Unknown Affiliation
Amerena, John V.
Unknown Affiliation
van Gaal, William Joseph
Unknown Affiliation
Yeap, Bu Beng
Unknown Affiliation
Fasching, Peter Andreas
Unknown Affiliation
Pieber, Thomas Rudolf
Unknown Affiliation
Sudzhaeva, Svetlana G.
Unknown Affiliation
Mathieu, Chantal
Unknown Affiliation
Pouleur, Anne Catherine M.
Unknown Affiliation
Botelho, Roberto Vieira
Unknown Affiliation
Chacra, Antǒnio Roberto
Unknown Affiliation
Costa-E-Forti, Adriana E.
Unknown Affiliation
de Quadros, Alexandre Schaan
Unknown Affiliation
Reis, Gilmar
Unknown Affiliation
Rossi, Paulo R.F.
Unknown Affiliation
Raev, Dimitar H.
Unknown Affiliation
Tokmakova, Mariya Petkova
Unknown Affiliation
Bertrand, Olivier François
Unknown Affiliation
Warnica, James Wayne
Unknown Affiliation
Corbalàn, Ramõn L.
Unknown Affiliation
Lanas, Fernando T.
Unknown Affiliation
Saavedra, Víctor Villarroel
Unknown Affiliation
Chen, Li
Unknown Affiliation
Hu, Taohong
Unknown Affiliation
Lu, Juming
Unknown Affiliation
Ma, Changsheng
Unknown Affiliation
Peng, Yongde
Unknown Affiliation
Accini, José Luis
Unknown Affiliation
Cure, Carlos
Unknown Affiliation
Lopez, Patricio
Unknown Affiliation
Molina, Dora Ines
Unknown Affiliation
Sánchez-Vallejo, Gregorio
Unknown Affiliation
Torp-Pedersen, Christian Tobias
Unknown Affiliation
Assaad, Samir Naeim
Unknown Affiliation
Shelbaya, Salah Ahmed
Unknown Affiliation
Tuomilehto, Jaakko O.I.
Unknown Affiliation
Cariou, Bertrand
Unknown Affiliation
Ducloux, Roxane
Unknown Affiliation
Hadjadj, Samy
Unknown Affiliation
Chumburidze, Vakhtang
Unknown Affiliation
Arango, Juan Luis
Unknown Affiliation
Chopra, Vijay Kumar
Unknown Affiliation
Deshpande, Neeta Rohit
Unknown Affiliation
Gupta, Sandeep Kumar
Unknown Affiliation
Jha, Sujeet
Unknown Affiliation
Sahay, Rakesh Kumar
Unknown Affiliation
Singh, Kavita P.
Unknown Affiliation
Cohen, Ohad
Unknown Affiliation
Mosenzon, Ofri
Unknown Affiliation
Stern, Naftali
Unknown Affiliation
Consoli, Agostino
Unknown Affiliation
Mannucci, Edoardo
Unknown Affiliation
Orsi, Emanuela
Unknown Affiliation
Pozzilli, Paolo
Unknown Affiliation
Hirayama, Atsushi
Unknown Affiliation
Jang, Hakchul
Unknown Affiliation
Rha, Seungwoon
Unknown Affiliation
Kim, Chongjin
Unknown Affiliation
Park, Kyong-soo
Unknown Affiliation
Pirags, Valdis
Unknown Affiliation
Petrulioniene, Žaneta
Unknown Affiliation
Šakalyte, Gintare
Unknown Affiliation
Bayram, Edmundo
Unknown Affiliation
López, Gabriel Arturo Ramos
Unknown Affiliation
Cornel, Jan Hein
Unknown Affiliation
Nierop, Pieter R.
Unknown Affiliation
Correa Flores, Roger Martin
Unknown Affiliation
Zubiate, Carlos
Unknown Affiliation
Dans, Antonio L.L.
Unknown Affiliation
Panelo, Araceli A.
Unknown Affiliation
Bryniarski, Leszek
Unknown Affiliation
Czajkowska-Kaczmarek, Eugenia
Unknown Affiliation
Ponikowski, Piotr P.
Unknown Affiliation
Militaru, Constantin
Unknown Affiliation
Vinereanu, Dragoș
Unknown Affiliation
Barbarash, Olga Leonidovna
Unknown Affiliation
Karpov, Yu Aleksandrovich
Unknown Affiliation
Kobalava, Zhanna D.
Unknown Affiliation
Shogenov, Zaur S.
Unknown Affiliation
Vishnevsky, Alexander Yu
Unknown Affiliation
Lalić, Katarina S.
Unknown Affiliation
Lalić, Nebojša Malić
Unknown Affiliation
Pešić, Milica M.
Unknown Affiliation
Seferović, Petar M.
Unknown Affiliation
Stanković, Goran R.
Unknown Affiliation
Arnold, Susan
Unknown Affiliation
Burgess, Lesley Jean
Unknown Affiliation
Coetzee, Kathleen
Unknown Affiliation
Delport, Eluned F.
Unknown Affiliation
Ebrahim, Iftikhar Osman
Unknown Affiliation
Ellis, Graham Charlston
Unknown Affiliation
Ntsekhe, Mpiko
Unknown Affiliation
van Zyl, Louis T.
Unknown Affiliation
Gaztambide, Sonia
Unknown Affiliation
Marín, F. M.
Unknown Affiliation
Mauricio, Dídac P.
Unknown Affiliation
Jendle, Johan H.
Unknown Affiliation
Moccetti, Tiziano
Unknown Affiliation
Chiang, Chernen
Unknown Affiliation
Ueng, Kwo Chiang
Unknown Affiliation
Wang, Tzung-Dau Dau
Unknown Affiliation
Ben Abdallah, Néjib
Unknown Affiliation
Haouala, Habib
Unknown Affiliation
Slimane, Hédia
Unknown Affiliation
Zidi, Bourni
Unknown Affiliation
Dinççaǧ, Nevin
Unknown Affiliation
Oto, Ali
Unknown Affiliation
Y̌igit, Zerrin
Unknown Affiliation
Al-Mahmeed, Wael Abdulrahman R.
Unknown Affiliation
Kaddaha, Ghaida Mohamad
Unknown Affiliation
Andrews, Robert Charles
Unknown Affiliation
Bain, Stephen C.
Unknown Affiliation
Hammond, Peter J.
Unknown Affiliation
Jude, Edward B.
Unknown Affiliation
Malik, Rayaz Ahmed
Unknown Affiliation
Rayman, Gerry A.
Unknown Affiliation
Saravanan, Ponnusamy
Unknown Affiliation
Wilding, Prof John
Unknown Affiliation
Akinboboye, Ola O.
Unknown Affiliation
Alawad, Mohamad
Unknown Affiliation
French, William J.
Unknown Affiliation
Greenway, Frank Lyons
Unknown Affiliation
Hargrove, Joe L.
Unknown Affiliation
Harris, William S.
Unknown Affiliation
Kereiakes, Dean J.
Unknown Affiliation
Kosiborod, Mikhail N.
Unknown Affiliation
Madu, Ivy Joan
Unknown Affiliation
Mosley, Jonathan D.
Unknown Affiliation
Odio, Alberto
Unknown Affiliation
Erdmann, Jeanette Ali
Unknown Affiliation
Sachmechi, Issac
Unknown Affiliation
Umpierrez, Guillermo E.
Unknown Affiliation
Warner, Alberta L.
Unknown Affiliation
Wu, Wen Chih Hank
Unknown Affiliation
Statistics
Citations: 87
Authors: 182
Affiliations: 13
Identifiers
Doi:
10.1016/j.ahj.2015.02.002
ISSN:
00028703
Research Areas
Disability
Noncommunicable Diseases
Study Design
Cross Sectional Study
Participants Gender
Male