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.

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

DEL PRATO, STEFANO;
2015

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.
Bentley Lewis, Rhonda; Aguilar, David; Riddle, Matthew C.; Claggett, Brian; Diaz, Rafael; Dickstein, Kenneth; Gerstein, Hertzel C.; Johnston, Peter; Køber, Lars V.; Lawson, Francesca; Lewis, Eldrin F.; Maggioni, Aldo P.; Mcmurray, John J. V.; Ping, Lin; Probstfield, Jeffrey L.; Solomon, Scott D.; Tardif, Jean Claude; Wu, Yujun; Pfeffer, Marc A.; Barkoudah, Ebrahim; Brahimi, Abdel; Charytan, David; Finn, Peter; Flynn, Aiden; Hartley, L. Howard; Henderson, Galen; Joseph, Jacob; Odutayo, Kayode; Rajesh, Vinutha; Vazir, Ali; Weinrauch, Larry; DEL PRATO, Stefano; Petrie, John; Kaplan, Allen; Lieberman, Phil; Zuraw, Bruce L.; O'Reilly, Eileen; Patel, Keyur; Allen, Peter; Scarpa, Aldo; Schattner, Mark; Granger, Christopher; Rouleau, Jean; Demets, David; Chaturvedi, Nishi; Raccah, Denis; Aizenberg, Diego; Alvarez, Carlos; Alvarisqueta, Andres; Baccaro, Claudia; Bartolacci, Ines; Bordonava, Anselmo; Bustamante Labarta, Miguel; Caccavo, Alberto; Calella, Pedro; Cantero, Maria; Codutti, Renzo; Commendatore, Victor; Costamagna, Osvaldo; Cuello, Jose; Fernandez, Alberto; Garcia Duran, Ruben; Gomez Vilamajo, Oscar; Gorban De Lapertosa, Silvia; Grinfeld, Diego; Hermida, Sonia; Lagrutta, Mariana; Leon De La Fuente, Ricardo; Licheri, Alberto; Luciardi, Hector; Mackinnon, Ignacio; Maffei, Laura; Marino, Javier; Montaña, Oscar; Novaretto, Leonardo; Orio, Silvia; Orlandini, Andres; Oviedo, Alejandra; Pérez Manghi, Federico; Patocchi, Cristian; Ramos, Hugo; Rolandi, Florencia; Saa Zarandon, Raquel; Saavedra, Silvia Salome; Schiavi, Lilia; Schygiel, Pablo; Trivi, Marcelo; Ulla, Maria; Urdiales, Pedro; Vallejos, Julio; Vico, Marisa; Waisman, Florencia; Amerena, John; Paul, Vincent; Sangla, Kunwarjit; Van Gaal, William; Yeap, Bu; Fasching, Peter; Pieber, Thomas; Danilova, Larisa; Mitkovskaya, Natalya; Sudzhaeva, Svetlana; Mathieu, Chantal; Pouleur, Anne Catherine; Botelho, Roberto Vieira; Cerqueira, Maria Jose; Chacra, Antonio; Dos Santos, Fabio; Feitosa, Gilson; Forti, Adriana; Golbert, Milton; Halpern, Alfredo; Hissa, Miguel; Lisboa, Hugo; Moraes, Joao; Nery, Max; Quadros, Alexandre; Raduan, Roberto; Reis, Gilmar; Ribeiro Filho, Fernando; Rollin, Guilherme; Rossi, Paulo; Santos, Elizabete; Sgarbi, Jose; Souza, Juliana; Souza, Maria Regina; Delchev, Alexy; Ivanov, Valentin; Klyuchkova, Neli; Kyoleyan, Michael; Levterov, Georgi; Lucheva, Mariya; Raev, Dimitar; Shumkova, Rositsa; Tokmakova, Mariya; Tzekova, Maria; Yordanov, Viktor; Bailey, Gordon; Bertrand, Olivier; Bhargava, Rakesh; Burton, Jeffrey; Campeau, Jean; Dumas, Richard; Filteau, Pierre; Syan, Gurcharan; Syan, Rajinder; Tsoukas, George; Warnica, James Wayne; Acuña, Silvia; Araneda, Guillermo; Bunster, Lia; Cobos, Leonardo; Corbalán, Ramón; Dussaillant, Gaston; Eggers, German; Florenzano, Fernando; Godoy, Gonzalo; Huidobro, Laura Andrea; Lahsen, Rodolfo; Lanas, Fernando; Larenas, Gladys; Manriquez, Leopoldo; Medina, Marcelo; Palma, Juan Carlos; Perez, Luis; Potthoff, Sergio; Raffo, Carlos; Reyes, Eliana; Saavedra, Victor; Sanhueza, Patricio; Sepulveda, Pablo; Solis, Carmen Lia; Soto, Nestor; Torres, Claudia; Westerberg, Bernhard; Yañez, Mario; Chen, Li; Dong, Yugang; Du, Jianling; Guo, Xiaohui; Han, Ping; Hu, Taohong; Jiang, Bin; Ke, Yuannan; Li, Zhanquan; Lu, Juming; Ma, Changsheng; Peng, Yongde; Shi, Yongquan; Su, Guohai; Tang, Baopeng; Xu, Biao; Yang, Jiefu; Yang, Jinkui; Yang, Yanmin; Accini, Jose Luis; Arteaga, Juan Manuel; Botero, Rodrigo; Castillo, Gilberto; Coronel, Julian; Cure, Carlos; Garcia, Henry; Garcia, Luis; Gomez, Claudia; Hernandez Triana, Eric; Hernandez, Hector; Lopez, Monica; Lopez, Patricio; Manzur, Fernando; Molina, Dora; Rodriguez, Jaime; Sanchez Vallejo, Gregorio; Yupanqui, Hernan; Bronnum Schou, Jens; Kaiser Nielsen, Peter; Nielsen, Henrik; Rønne, Henning; Rasmussen, Soeren; Rungby, Jørgen; Skagen, Knud; Thomsen, Kristian Korsgaard; Torp Pedersen, Christian; Duarte Vera, Yan; Marmol Alvear, Ricardo; Peñaherrera Patiño, Carlos; Assaad, Samir; Shelbaya, Salah; Ambos, Anu; Jakovlev, Ulle; Lubi, Maire; Märtsin, Kaja; Rosenthal, Svea; Vides, Hella; Alanko, Juha; Korsoff, Pirkko; Koski, Anna Mari; Lahtela, Jorma; Nelimarkka, Lassi; Tuomilehto, Jaakko; Cariou, Bertrand; Catargi, Bogdan; Ducloux, Roxane; Hadjadj, Samy; Kerlan, Veronique; Malecot, Jean Marc; Petit, Catherine; Rodier, Michel; Chumburidze, Vakhtang; Glonti, Salome; Lominadze, Zaza; Todua, Fridon; Contzen, Christel; Marck, Cornelia; Fischer, Hermann; Hagenow, Andreas; Himpel Bönninghoff, Agnes; Kihm, Lars; Killat, Holger; Kleinertz, Klaus; Kosch, Christine; Kreutzmann, Kristin; Lappo, Mariola; Mertes, Bernardo; Piechatzek, Richard; Prohaska, Martin; Rinke, Andrea; Schellenberg, Detlev; Toursarkissian, Nicole; Arango, Juan; Gonzalez, Ronaldo; Granados, Arnoldo; Herrera, Milton; Montenegro, Pablo; Munoz, Ricardo; Rodriguez, Edgar; Turcios, Erick; Villalobos, Renato; Wyss, Fernando; Hatterjee, Sanjay; Chopda, Manoj; Chopra, Vijay; Deshpande, Neeta; Dutta, R.; Dwivedi, Sudhanshu; Gandhi, Pramod; Gupta, Sandeep Kumar; Gupta, Jugal Bihari; Gupta, Sunil; Hiregouder, Narendra; Jha, Sujeet; Joshi, Abhijeet; Khan, Noor; Kumbla, Mukund; Magdum, Mohan; Murthy, Keshava; Prabhu, Mukhya; Sahay, Rakesh; Sethuraman, Selvamani; Shah, Navneet; Shamanna, Paramesh; Singh, K. Singh; Singh, Paminder; Somasekharan, Arun; Sreenivasamurthy, Lakshminarayanappa; Supe, Pravin; Adawi, Faiad; Atar, Shaul; Cohen, Ohad; Efrati, Shai; Karnieli, Eddy; Klainman, Eliezer; Minuchin, Oscar; Mosenzon, Ofri; Stern, Naftali; Turgeman, Yoav; Wainstein, Julio; Aimaretti, Gianluca; Berra, Cesare; Ciardullo, Anna Vittoria; Consoli, Agostino; Cucinotta, Domenico; Di Marco, Sandra; Giorda, Carlo; Giordano, Carla; Mannucci, Edoardo; Orsi, Emanuela; Piatti, Piermarco; Pontiroli, Antonio; Ponzani, Paola; Pozzilli, Paolo; Rivellese, Angela; Akahori, Hiroshi; Eki, Yutaka; Fujii, Kenshi; Hata, Yoshiki; Himeno, Hideo; Hirayama, Atsushi; Kishimoto, Ichiro; Kobayashi, Youichi; Miyaoka, Hiroaki; Niiya, Tetsuji; Nishi, Yutaro; Nozaki, Akira; Nunohiro, Tatsuya; Saito, Tomiyoshi; Satoh, Yasuhiro; Takahashi, Akihiko; Takahashi, Junichiro; Takase, Hiroyuki; Takase, Shinichi; Tsuboko, Yusuke; Tsujimoto, Mitsuru; Tsujino, Motoyoshi; Tsuzuki, Masahiro; Watanabe, Shuichi; Yamada, Takahisa; Chung, Wook Jin; Rim, Sejoong; Jang, Hakchul; Kim, Ung; Chung, Choon Hee; Shin, Sung Hee; Kim, Kyehun; Kim, Jaetaek; Rha, Seungwoon; Lee, Nae Hee; Kim, Chong Jin; Park, Kyong Soo; Amolina, Ildze; Ducena, Kristine; Helda, Renate; Konrade, Ilze; Pirags, Valdis; Sime, Iveta; Sokolova, Jelena; Kakariekiene, Vaida; Kavaliauskiene, Roma; Petrulioniene, Zaneta; Sakalyte, Gintare; Urboniene, Audrone; Zarankiene, Rima; Uribe, Marittza; Garcia Hernandez, Pedro; Garza, Jose; Vazquez Garcia, Abraham; Gonzalez, Jose Gerardo; Escalante, Miguel; Zavala, Alejandro; Bayram, Edmundo; Hernandez Muñuzuri, Jesus; Ramos, Null; Lopez, Gabriel Arturo; Lujan, Jesus; Garcia Soria, Martin; Velasco Sanchez, Raul; Rodriguez, Ignacio; Jimenez, Silvia; Galeana, Cielmar; Reyes, Eduardo; Lara, Susano; Garcia Castillo, Armando; Castro, Maria Guadalupe; Aguilar Orozco, Raul; Lopez Rosas, Enrique; Vidrio, Maricela; Llamas, Guillermo; Stobschinski De Alba, Carlos Alejandro; Carranza Madrigal, Jaime; Cardosa Torres, Francisco; Cornel, Jan Hein; Dekkers, Paulus; Frederiks, J.; Hermans, Wrm; Lok, Dirk; Meeder, Joan; Nierop, Peter; Cooper, John; Lappegård, Knut Tore; Nedrebø, Bjørn Gunnar; Castro, Eholo; Gonzalez Castillo, Baldomero; Gonzalez, Elis; Nieto Ortega, Ruben; Andrade, Miguel; Calderon, Jorge; Chavez, Carlos; Correa Flores, Roger Martin; Farfan, Julio; Lu, Libia; Luque, Edith; Manrique, Helard; Mogrovejo, Walter; Pariona Javier, Marcos; Pinto, Miguel; Roldan, Yudy; Zubiate, Carlos; Dans, Antonio; Gomez, Maria Honolina; Panelo, Araceli; Rey, Nannette; Sulit, Dennis Jose; Sy, Rosa Allyn; Timonera, Miriam; Bednarski, Janusz; Bijata Bronisz, Renata; Bryniarski, Leszek; Busz Papiez, Benita; Czajkowska Kaczmarek, Eugenia; Drzewiecka, Anna; Dulak, Elzbieta; Gorska, Maria; Hamankiewicz, Maciej; Janik, Krzysztof; Kincel, Krzysztof; Konieczny, Marek; Lubinski, Andrzej; Olszanecka Glinianowicz, Magdalena; Ponikowski, Piotr; Pulka, Grazyna; Rekosz, Jerzy; Skudlarski, Dariusz; Szymkowiak, Katarzyna; Wilczewski, Przemyslaw; Bragança, Nuno; Duarte, João; Monteiro, Pedro; Rodrigues, Elisabete; Vinhas, Margarida; Adina, Pop Moldovan; Avram, Rodica Ioana; Cif, Adriana; Creteanu, Gabriela; Dragomir, Dinu; Ferariu, Ioana Emilia; Iancu, Adrian Corneliu; Istratoaie, Octavian; Ivanica, Gabriel; Lichiardopol, Radu; Militaru, Constantin; Minescu, Bogdan; Onaca, Adriana; Pintilei, Ella; Podoleanu, Cristian; Pop, Lavinia; Popa, Bogdan; Ranetti, Aurelian Emil; Rosu, Doina; Tase, Adrian; Tesloianu, Dan Nicolae; Vinereanu, Dragos; Ageev, Fail; Akhmedzhanov, Nadir; Barbarash, Olga; Barbarich, Vladimir; Belousov, Yury; Berns, Svetlana; Bokarev, Igor; Bolshakova, Olga; Boyarkin, Mikhail; Chumakova, Galina; Dmitry, Platonov; Fitilev, Sergey; Galyavich, Albert; Glezer, Maria; Ivanova, Luidmila; Kalashnikov, Victor; Kalashnikova, Marina; Karpov, Yuri; Khaisheva, Larisa; Khalimov, Yuri; Kobalava, Zhanna; Kosmachova, Elena; Kostenko, Victor; Koziolova, Natalya; Kulibaba, Elena; Lesnov, Victor; Libov, Igor; Lyamina, Nadezhda; Markov, Valentin; Moiseev, Valentin; Molchanova, Olga; Oleynikov, Valentin; Orlikova, Olga; Panov, Alexey; Rafalskiy, Vladimir; Rodionova, Tatiana; Samitin, Vasily; Schokotov, Vladimir; Shilkina, Nataliya; Shogenov, Zaur; Shustov, Sergey; Shvarts, Yuri; Sobolev, Konstantin; Stryuk, Raisa; Suplotova, Ludmila; Viktorova, Inna; Vishnevsky, Alexander; Vorokhobina, Natalia; Yakusevich, Vladimir; Yakushin, Sergey; Zadionchenko, Vladimir; Zalevskaya, Alsu; Zalevsky, Grigory; Zateyshchikova, Anna; Andjelic Jelic, Marina; Kocic, Radivoj; Komnenovic, Snezana; Lalic, Katarina; Lalic, Nebojsa; Micic, Dragan; Otasevic, Petar; Pesic, Milica; Seferovic, Petar; Stankovic, Goran; Arnold, Susan; Burgess, Lesley; Coetzee, Kathleen; Dawood, Saleem; Delport, Eluned; Ebrahim, I.; Ellis, Graham; Ismail, Siddique; Kelbe, Dudley; Naidoo, Visvakuren; Ntsekhe, Mpiko; Sebastian, Peter John; Siebert, Mirna; Van Zyl, Louis; Venter, Tjaart; Lonso, Elena; Antorrena, Isabel; Bodi, Vicent; Botella, Marta; De La Fuente, Javier; Delgado, Elías; Duran Garcia, Santiago; Elorza, Jose; Enciso, Fidel; Gaztambide, Sonia; Marin, Francisco; Martin, Victoria; Mauricio, Didac; Soto, Alfonso; Vida, Manuel; Boberg, Gunnar; Jörneskog, Gun; Jendle, Johan; Mathiesen, Ulrik; Svensson, Karl Axel; Torstensson, Ingemar; Vasko, Peter; Moccetti, Tiziano; Chiang, Chern En; Chiu, Yu Wei; Huang, Tsuei Yuan; Lu, Chieh Hsiang; Pei, Dee; Shyu, Kou Gi; Ueng, Kwo Chang; Wang, Tzung Dau; Abid, Mohamed; Ben Abdallah, Nejib; Haouala, Habib; Slimane, Hedia; Zidi, Borni; Bascil Tutuncu, Neslihan; Camsari, Ahmet; Delibasi, Tuncay; Dinccag, Nevin; Kultursay, Hakan; Oto, Ali; Sahin, Mahmut; Saygili, Fusun; Yigit, Zerrin; Zorkun, Cafer; Karpenko, Oleksandr; Korpachev, Vadym; Koval, Olena; Maslyanko, Vitaliy; Perepelytsya, Mykhaylo; Pertseva, Tetyana; Petrosyan, Olena; Rudenko, Leonid; Sychov, Oleg; Synenko, Volodymyr; Tseluyko, Vira; Zhuravleva, Larisa; Al Mahmeed, Wael; Kaddaha, Ghaida Mohamad; Andrews, Robert; Bain, Stephen; Basu, Ambar; Bhatnagar, Deepak; Bickerton, Alex; Browne, Duncan; Gibson, Martin; Hammond, Peter; Hanna, Fahmy; Issa, Basil; Jaap, Alan; Joseph, Franklin; Jude, Edward; Kelly, Chris; Khan, Atir; Malik, Rayaz; Mukhopadhyay, Babu; O'Kane, M.; Rayman, Gerry; Robinson, Anthony; Rooney, Desmond; Sainsbury, Chris; Saravanan, Ponnusamy; Shakher, Jayadave; Singh, Baldev; Turner, Jeremy; Whitelaw, Donald; Wilding, John; Wiles, Philip; Adenuga, Babafemi; Ahmad, Zia; Akinboboye, Olakunle; Akright, Laura; Alappat, Paul; Alawad, Mohamad; Alfonso, Teresa; Alimard, Ramin; Alzohaili, Opada; Ariani, Mehrdad; Arora, Chander; Azad, Nasrin; Azzam, Samir; Benjamin, Sabrina; Block, Bradley; Borzadek, Eliza; Breisblatt, Warren; Bright, Tamis; Byrd, Leroy; Chiou, Choyen; Chochinov, Ronald; Christensen, Tom; Christofides, Elena; Cohen, Robert; Dawood, Gamil; De Souza, Jose; Dempsey, Michael; Eagerton, Donald; East, Cara; Elder, Charles; Fernando, Ronald; Fogelfeld, Leon; Foucauld, Jean; French, William; Frohnauer, Mary; Gaffney, Mary; Gangopadhyay, Subroto; Gogia, Harinder; Gosmanov, Aidar; Greenberg, Craig; Greenway, Frank; Hanna, Edward; Hargrove, Joe; Harris, Anthony; Harris, Bill; Hart, Terence; Herrington, David; Hewitt, Mitzie; Howard, David; Izuora, Kenneth; Jetty, Preetham; Kapoor, Anoop; Kasper, Joseph F.; Kelehan, Shaun; Kelly, Richard; Kereiakes, Dean; Khaira, Ajit; Khan, Misal; Khan, Salman; Korban, Elie; Kosiborod, Mikhail; Laguerre, Jacques; Larocque, James; Latif, Kashif; Lester, Frank; Levin, Philip; Levine, Steven; Li, Charles; Lovell, Charles; Lupovitch, Steven; Madu, Ivy Joan; Mahabadi, Vahid; Mahmood, Asif; Maragos, Stavros; Mariash, Cary; Martin, Paul; Mathew, James; Mathew, John; May, Michael; Mayfield, Ronald; Mccall, Anthony; Mcdaniel, Clayton; Mcgrew, Frank; Mckenzie, Marcus; Mefford, Ivan; Mehta, Arvind; Mikdadi, Ghiath; Mikhail, Magdy; Monchamp, Travis; Moore, Charles; Moran, Michael; Morrar, Nidal; Mosley, Jonathan; Mulford, Mim; Murray, John; Nakhle, Samer; Nallasivan, Mani; Odio, Alberto; Oh, Charles; Olelewe, Sarah; Palchick, Bryce; 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W.; Steinhoff, Jeffrey; Suresh, Damodhar; Tahir, Mohammad; Tanenberg, Robert; Thawani, Hemant; Thomson, Stephen; Thrasher, James; Trachtenbarg, David; Trotta, Michael; Tuan, Weiming; Twahirwa, Marcel; Umpierrez, Guillermo; Vaid, Brij; Vance, Carl; Wang, Thomas; Warner, Alberta; Watson, Henry; Weber, Sandra; Webster, Brian; Weindorff, Kathleen; Welch, Michelle; Welker, James; White, Anthony; White, Lindsey; Williams, Marcus; Wu, Wen Chih; Wynne, Alan; Yocono, Mark; Yuen, Kevin
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