Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo

Rhonda Bentley-Lewis, David Aguilar, Matthew C. Riddle, Brian Claggett, Rafael Diaz, Kenneth Dickstein, Hertzel C. Gerstein, Peter Johnston, Lars V. Køber, Francesca Lawson, Eldrin F. Lewis, Aldo P. Maggioni, John J V McMurray, Lin Ping, Jeffrey L. Probstfield, Scott D. Solomon, Jean Claude Tardif, Yujun Wu, Marc A. Pfeffer, Ebrahim BarkoudahAbdel Brahimi, David Charytan, Peter Finn, Aiden Flynn, L. Howard Hartley, Galen Henderson, Jacob Joseph, Kayode Odutayo, Vinutha Rajesh, Ali Vazir, Larry Weinrauch, Stefano Del Prato, John Petrie, Allen Kaplan, Phil Lieberman, Bruce L. 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Frederiks, Wrm Hermans, Dirk Lok, Joan Meeder, Peter Nierop, John Cooper, Knut Tore Lappegård, Bjørn Gunnar Nedrebø, Eholo Castro, Baldomero Gonzalez Castillo, Elis Gonzalez, Ruben Nieto Ortega, Miguel Andrade, Jorge Calderon, Carlos Chavez, Roger Martin Correa Flores, Julio Farfan, Libia Lu, Edith Luque, Helard Manrique, Walter Mogrovejo, Marcos Pariona-Javier, Miguel Pinto, Yudy Roldan, Carlos Zubiate, Antonio Dans, Maria Honolina Gomez, Araceli Panelo, Nannette Rey, Dennis Jose Sulit, Rosa Allyn Sy, Miriam Timonera, Janusz Bednarski, Renata Bijata-Bronisz, Leszek Bryniarski, Benita Busz-Papiez, Eugenia Czajkowska-Kaczmarek, Anna Drzewiecka, Elzbieta Dulak, Maria Gorska, Maciej Hamankiewicz, Krzysztof Janik, Krzysztof Kincel, Marek Konieczny, Andrzej Lubinski, Magdalena Olszanecka-Glinianowicz, Piotr Ponikowski, Grazyna Pulka, Jerzy Rekosz, Dariusz Skudlarski, Katarzyna Szymkowiak, Przemyslaw Wilczewski, Nuno Bragança, João Duarte, Pedro Monteiro, Elisabete Rodrigues, Margarida Vinhas, Pop Moldovan Adina, Rodica Ioana Avram, Adriana Cif, Gabriela Creteanu, Dinu Dragomir, Ioana Emilia Ferariu, Adrian Corneliu Iancu, Octavian Istratoaie, Gabriel Ivanica, Radu Lichiardopol, Constantin Militaru, Bogdan Minescu, Adriana Onaca, Ella Pintilei, Cristian Podoleanu, Lavinia Pop, Bogdan Popa, Aurelian Emil Ranetti, Doina Rosu, Adrian Tase, Dan Nicolae Tesloianu, Dragos Vinereanu, Fail Ageev, Nadir Akhmedzhanov, Olga Barbarash, Vladimir Barbarich, Yury Belousov, Svetlana Berns, Igor Bokarev, Olga Bolshakova, Mikhail Boyarkin, Galina Chumakova, Platonov Dmitry, Sergey Fitilev, Albert Galyavich, Maria Glezer, Luidmila Ivanova, Victor Kalashnikov, Marina Kalashnikova, Yuri Karpov, Larisa Khaisheva, Yuri Khalimov, Zhanna Kobalava, Elena Kosmachova, Victor Kostenko, Natalya Koziolova, Elena Kulibaba, Victor Lesnov, Igor Libov, Nadezhda Lyamina, Valentin Markov, Valentin Moiseev, Olga Molchanova, Valentin Oleynikov, Olga Orlikova, Alexey Panov, Vladimir Rafalskiy, Tatiana Rodionova, Vasily Samitin, Vladimir Schokotov, Nataliya Shilkina, Zaur Shogenov, Sergey Shustov, Yuri Shvarts, Konstantin Sobolev, Raisa Stryuk, Ludmila Suplotova, Inna Viktorova, Alexander Vishnevsky, Natalia Vorokhobina, Vladimir Yakusevich, Sergey Yakushin, Vladimir Zadionchenko, Alsu Zalevskaya, Grigory Zalevsky, Anna Zateyshchikova, Marina Andjelic Jelic, Radivoj Kocic, Snezana Komnenovic, Katarina Lalic, Nebojsa Lalic, Dragan Micic, Petar Otasevic, Milica Pesic, Petar Seferovic, Goran Stankovic, Susan Arnold, Lesley Burgess, Kathleen Coetzee, Saleem Dawood, Eluned Delport, I. Ebrahim, Graham Ellis, Siddique Ismail, Dudley Kelbe, Visvakuren Naidoo, Mpiko Ntsekhe, Peter John Sebastian, Mirna Siebert, Louis Van Zyl, Tjaart Venter, Elena Lonso, Isabel Antorrena, Vicent Bodi, Marta Botella, Javier De La Fuente, Elias Delgado, Santiago Duran Garcia, Jose Elorza, Fidel Enciso, Sonia Gaztambide, Francisco Marin, Victoria Martin, Didac Mauricio, Alfonso Soto, Manuel Vida, Gunnar Boberg, Gun Jörneskog, Johan Jendle, Ulrik Mathiesen, Karl Axel Svensson, Ingemar Torstensson, Peter Vasko, Tiziano Moccetti, Chern En Chiang, Yu Wei Chiu, Tsuei Yuan Huang, Chieh Hsiang Lu, Dee Pei, Kou Gi Shyu, Kwo Chang Ueng, Tzung Dau Wang, Mohamed Abid, Nejib Ben Abdallah, Habib Haouala, Hedia Slimane, Borni Zidi, Neslihan Bascil Tutuncu, Ahmet Camsari, Tuncay Delibasi, Nevin Dinccag, Hakan Kultursay, Ali Oto, Mahmut Sahin, Fusun Saygili, Zerrin Yigit, Cafer Zorkun, Oleksandr Karpenko, Vadym Korpachev, Olena Koval, Vitaliy Maslyanko, Mykhaylo Perepelytsya, Tetyana Pertseva, Olena Petrosyan, Leonid Rudenko, Oleg Sychov, Volodymyr Synenko, Vira Tseluyko, Larisa Zhuravleva, Wael Al Mahmeed, Ghaida Mohamad Kaddaha, Robert Andrews, Stephen Bain, Ambar Basu, Deepak Bhatnagar, Alex Bickerton, Duncan Browne, Martin Gibson, Peter Hammond, Fahmy Hanna, Basil Issa, Alan Jaap, Franklin Joseph, Edward Jude, Chris Kelly, Atir Khan, Rayaz Malik, Babu Mukhopadhyay, M. O'Kane, Gerry Rayman, Anthony Robinson, Desmond Rooney, Chris Sainsbury, Ponnusamy Saravanan, Jayadave Shakher, Baldev Singh, Jeremy Turner, Donald Whitelaw, John Wilding, Philip Wiles, Babafemi Adenuga, Zia Ahmad, Olakunle Akinboboye, Laura Akright, Paul Alappat, Mohamad Alawad, Teresa Alfonso, Ramin Alimard, Opada Alzohaili, Mehrdad Ariani, Chander Arora, Nasrin Azad, Samir Azzam, Sabrina Benjamin, Bradley Block, Eliza Borzadek, Warren Breisblatt, Tamis Bright, Leroy Byrd, Choyen Chiou, Ronald Chochinov, Tom Christensen, Elena Christofides, Robert Cohen, Gamil Dawood, Jose De Souza, Michael Dempsey, Donald Eagerton, Cara East, Charles Elder, Ronald Fernando, Leon Fogelfeld, Jean Foucauld, William French, Mary Frohnauer, Mary Gaffney, Subroto Gangopadhyay, Harinder Gogia, Aidar Gosmanov, Craig Greenberg, Frank Greenway, Edward Hanna, Joe Hargrove, Anthony Harris, Bill Harris, Terence Hart, David Herrington, Mitzie Hewitt, David Howard, Kenneth Izuora, Preetham Jetty, Anoop Kapoor, Joseph F. Kasper, Shaun Kelehan, Richard Kelly, Dean Kereiakes, Ajit Khaira, Misal Khan, Salman Khan, Elie Korban, Mikhail Kosiborod, Jacques Laguerre, James Larocque, Kashif Latif, Frank Lester, Philip Levin, Steven Levine, Charles Li, Charles Lovell, Steven Lupovitch, Ivy Joan Madu, Vahid Mahabadi, Asif Mahmood, Stavros Maragos, Cary Mariash, Paul Martin, James Mathew, John Mathew, Michael May, Ronald Mayfield, Anthony McCall, Clayton Mcdaniel, Frank Mcgrew, Marcus Mckenzie, Ivan Mefford, Arvind Mehta, Ghiath Mikdadi, Magdy Mikhail, Travis Monchamp, Charles Moore, Michael Moran, Nidal Morrar, Jonathan Mosley, Mim Mulford, John Murray, Samer Nakhle, Mani Nallasivan, Alberto Odio, Charles Oh, Sarah Olelewe, Bryce Palchick, Yogesh Paliwal, Vasilios Papademetriou, Naresh Parikh, Sudhirkumar Patel, Lawrence Phillips, Thomas Pitts, Francisco Prieto, Rachel Puttnam, Arshed Quyyumi, Preet Randhawa, Marc Rendell, Francis Rhie, James Roberts, Jerome Robinson, Michael Robinson, John Rubino, Eugene Ryan, Steven Saathoff, Isaac Sachmechi, Ali Saifi, Abraham Salacata, Robyn Sanders, Jodi Sanson, Virginia Savin, Alex Schabauer, John Schmedtje, Alan Schwartz, Cranford Scott, Munni Selagamsetty, Michael Shannon, Sylvia Shaw, Dinesh Singal, Robert Sjoberg, Kenneth Smith, Carl Sofley, Anthony Sonn, Suzanne Sorof, Eugene Soroka, C. 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Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish
Pages (from-to)631-638.e7
JournalAmerican Heart Journal
Volume169
Issue number5
DOIs
Publication statusPublished - May 1 2015
Externally publishedYes

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All Science Journal Classification (ASJC) codes

  • Medicine(all)
  • Cardiology and Cardiovascular Medicine

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