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

Authors
Bentley-Lewis R.Aguilar D.Riddle M.C.Claggett B.Diaz R.Dickstein K.Gerstein H.C.Johnston P.Køber L.V.Lawson F.Lewis E.F.Maggioni A.P.McMurray J.J.V.Ping L.Probstfield J.L.Solomon S.D.Tardif J.-C.Wu Y.Pfeffer M.A.Barkoudah E.Brahimi A.Charytan D.Finn P.Flynn A.Hartley L.H.Henderson G.Joseph J.Odutayo K.Rajesh V.Vazir A.Weinrauch L.Del Prato S.Petrie J.Kaplan A.Lieberman P.Zuraw B.L.O'Reilly E.Patel K.Allen P.Scarpa A.Schattner M.Granger C.Rouleau J.DeMets D.Chaturvedi N.Raccah D.Aizenberg D.Alvarez C.Alvarisqueta A.Baccaro C.Bartolacci I.Bordonava A.Bustamante Labarta M.Caccavo A.Calella P.Cantero M.Codutti R.Commendatore V.Costamagna O.Cuello J.Fernandez A.Garcia Duran R.Gomez Vilamajo O.Gorban De Lapertosa S.Grinfeld D.Hermida S.Lagrutta M.Leon De La Fuente R.Licheri A.Luciardi H.Mackinnon I.Maffei L.Marino J.Montaña O.Novaretto L.Orio S.Orlandini A.Oviedo A.Pérez Manghi F.Patocchi C.Ramos H.Rolandi F.Saa Zarandon R.Saavedra S.S.Schiavi L.Schygiel P.Trivi M.Ulla M.Urdiales P.Vallejos J.Vico M.Waisman F.Amerena J.Paul V.Sangla K.Van Gaal W.Yeap B.Fasching P.Pieber T.Danilova L.Mitkovskaya N.Sudzhaeva S.Mathieu C.Pouleur A.-C.Botelho R.V.Cerqueira M.J.Chacra A.Dos Santos F.Feitosa G.Forti A.Golbert M.Halpern A.Hissa M.Lisboa H.Moraes J.Jr.Nery M.Quadros A.Raduan R.Reis G.Ribeiro Filho F.Rollin G.Rossi P.Santos E.Sgarbi J.Souza J.Souza M.R.Delchev A.Ivanov V.Klyuchkova N.Kyoleyan M.Levterov G.Lucheva M.Raev D.Shumkova R.Tokmakova M.Tzekova M.Yordanov V.Bailey G.Bertrand O.Bhargava R.Burton J.Campeau J.Dumas R.Filteau P.Syan G.Syan R.Tsoukas G.Warnica J.W.Acuña S.Araneda G.Bunster L.Cobos L.Corbalán R.Dussaillant G.Eggers G.Florenzano F.Godoy G.Huidobro L.A.Lahsen R.Lanas F.Larenas G.Manriquez L.Medina M.Palma J.C.Perez L.Potthoff S.Raffo C.Reyes E.Saavedra V.Sanhueza P.Sepulveda P.Solis C.L.Soto N.Torres C.Westerberg B.Yañez M.Chen L.Dong Y.Du J.Guo X.Han P.Hu T.Jiang B.Ke Y.Li Z.Lu J.Ma C.Peng Y.Shi Y.Su G.Tang B.Xu B.Yang J.Yang J.Yang Y.Accini J.L.Arteaga J.M.Botero R.Castillo G.Coronel J.Cure C.Garcia H.Garcia L.Gomez C.Hernandez Triana E.Hernandez H.Lopez M.Lopez P.Manzur F.Molina D.Rodriguez J.Sanchez Vallejo G.Yupanqui H.Bronnum-Schou J.Kaiser Nielsen P.Nielsen H.Rønne H.Rasmussen S.Rungby J.Skagen K.Thomsen K.K.Torp-Pedersen C.Duarte-Vera Y.Marmol Alvear R.Peñaherrera-Patiño C.Assaad S.Shelbaya S.Ambos A.Jakovlev U.Lubi M.Märtsin K.Rosenthal S.Vides H.Alanko J.Korsoff P.Koski A.-M.Lahtela J.Nelimarkka L.Tuomilehto J.Cariou B.Catargi B.Ducloux R.Hadjadj S.Kerlan V.Malecot J.-M.Petit C.Rodier M.Chumburidze V.Glonti S.Lominadze Z.Todua F.Contzen C.Marck C.Fischer H.Hagenow A.Himpel-Bönninghoff A.Kihm L.Killat H.Kleinertz K.Kosch C.Kreutzmann K.Lappo M.Mertes B.Piechatzek R.Prohaska M.Rinke A.Schellenberg D.Toursarkissian N.Arango J.Gonzalez R.Granados A.Herrera M.Montenegro P.Munoz R.Rodriguez E.Turcios E.Villalobos R.Wyss F.Hatterjee S.Chopda M.Chopra V.Deshpande N.Dutta R.Dwivedi S.Gandhi P.Gupta S.K.Gupta J.B.Gupta S.Hiregouder N.Jha S.Joshi A.Khan N.Kumbla M.Magdum M.Murthy K.Prabhu M.Sahay R.Sethuraman S.Shah N.Shamanna P.Singh K.S.Singh P.Somasekharan A.Sreenivasamurthy L.Supe P.Adawi F.Atar S.Cohen O.Efrati S.Karnieli E.Klainman E.Minuchin O.Mosenzon O.Stern N.Turgeman Y.Wainstein J.Aimaretti G.Berra C.Ciardullo A.V.Consoli A.Cucinotta D.Di Marco S.Giorda C.Giordano C.Mannucci E.Orsi E.Piatti P.Pontiroli A.Ponzani P.Pozzilli P.Rivellese A.Akahori H.Eki Y.Fujii K.Hata Y.Himeno H.Hirayama A.Kishimoto I.Kobayashi Y.Miyaoka H.Niiya T.Nishi Y.Nozaki A.Nunohiro T.Saito T.Satoh Y.Takahashi A.Takahashi J.Takase H.Takase S.Tsuboko Y.Tsujimoto M.Tsujino M.Tsuzuki M.Watanabe S.Yamada T.Chung W.J.Rim S.Jang H.Kim U.Chung C.H.Shin S.-H.Kim K.Kim J.Rha S.Lee N.H.Kim C.-J.Park K.S.Amolina I.Ducena K.Helda R.Konrade I.Pirags V.Sime I.Sokolova J.Kakariekiene V.Kavaliauskiene R.Petrulioniene Z.Sakalyte G.Urboniene A.Zarankiene R.Uribe M.Garcia-Hernandez P.Garza J.Vazquez-Garcia A.Gonzalez J.G.Escalante M.Zavala A.Bayram E.Hernandez-Muñuzuri J.RamosLopez G.A.Lujan J.Garcia-Soria M.Velasco-Sanchez R.Rodriguez I.Jimenez S.Galeana C.Reyes E.Lara S.Garcia-Castillo A.Castro M.G.Aguilar-Orozco R.Lopez Rosas E.Vidrio M.Llamas G.Stobschinski De Alba C.A.Carranza-Madrigal J.Cardosa-Torres F.Cornel J.H.Dekkers P.Frederiks J.Hermans W.Lok D.Meeder J.Nierop P.Cooper J.Lappegård K.T.Nedrebø B.G.Castro E.Gonzalez Castillo B.Gonzalez E.Nieto Ortega R.Andrade M.Calderon J.Chavez C.Correa Flores R.M.Farfan J.Lu L.Luque E.Manrique H.Mogrovejo W.Pariona-Javier M.Pinto M.Roldan Y.Zubiate C.Dans A.Gomez M.H.Panelo A.Rey N.Sulit D.J.Sy R.A.Timonera M.Bednarski J.Bijata-Bronisz R.Bryniarski L.Busz-Papiez B.Czajkowska-Kaczmarek E.Drzewiecka A.Dulak E.Gorska M.Hamankiewicz M.Janik K.Kincel K.Konieczny M.Lubinski A.Olszanecka-Glinianowicz M.Ponikowski P.Pulka G.Rekosz J.Skudlarski D.Szymkowiak K.Wilczewski P.Bragança N.Duarte J.Monteiro P.Rodrigues E.Vinhas M.Adina P.-M.Avram R.I.Cif A.Creteanu G.Dragomir D.Ferariu I.E.Iancu A.-C.Istratoaie O.Ivanica G.Lichiardopol R.Militaru C.Minescu B.Onaca A.Pintilei E.Podoleanu C.Pop L.Popa B.Ranetti A.E.Rosu D.Tase A.Tesloianu D.N.Vinereanu D.Ageev F.Akhmedzhanov N.Barbarash O.Barbarich V.Belousov Y.Berns S.Bokarev I.Bolshakova O.Boyarkin M.Chumakova G.Dmitry P.Fitilev S.Galyavich A.Glezer M.Ivanova L.Kalashnikov V.Kalashnikova M.Karpov Y.Khaisheva L.Khalimov Y.Kobalava Z.Kosmachova E.Kostenko V.Koziolova N.Kulibaba E.Lesnov V.Libov I.Lyamina N.Markov V.Moiseev V.Molchanova O.Oleynikov V.Orlikova O.Panov A.Rafalskiy V.Rodionova T.Samitin V.Schokotov V.Shilkina N.Shogenov Z.Shustov S.Shvarts Y.Sobolev K.Stryuk R.Suplotova L.Viktorova I.Vishnevsky A.Vorokhobina N.Yakusevich V.Yakushin S.Zadionchenko V.Zalevskaya A.Zalevsky G.Zateyshchikova A.Andjelic Jelic M.Kocic R.Komnenovic S.Lalic K.Lalic N.Micic D.Otasevic P.Pesic M.Seferovic P.Stankovic G.Arnold S.Burgess L.Coetzee K.Dawood S.Delport E.Ebrahim I.Ellis G.Ismail S.Kelbe D.Naidoo V.Ntsekhe M.Sebastian P.J.Siebert M.Van Zyl L.Venter T.Lonso E.Antorrena I.Bodi V.Botella M.De La Fuente J.Delgado E.Duran Garcia S.Elorza J.Enciso F.Gaztambide S.Marin F.Martin V.Mauricio D.Soto A.Vida M.Boberg G.Jörneskog G.Jendle J.Mathiesen U.Svensson K.-A.Torstensson I.Vasko P.Moccetti T.Chiang C.-E.Chiu Y.-W.Huang T.-Y.Lu C.-H.Pei D.Shyu K.-G.Ueng K.-C.Wang T.-D.Abid M.Ben Abdallah N.Haouala H.Slimane H.Zidi B.Bascil Tutuncu N.Camsari A.Delibasi T.Dinccag N.Kultursay H.Oto A.Sahin M.Saygili F.Yigit Z.Zorkun C.Karpenko O.Korpachev V.Koval O.Maslyanko V.Perepelytsya M.Pertseva T.Petrosyan O.Rudenko L.Sychov O.Synenko V.Tseluyko V.Zhuravleva L.Al Mahmeed W.Kaddaha G.M.Andrews R.Bain S.Basu A.Bhatnagar D.Bickerton A.Browne D.Gibson M.Hammond P.Hanna F.Issa B.Jaap A.Joseph F.Jude E.Kelly C.Khan A.Malik R.Mukhopadhyay B.O'Kane M.Rayman G.Robinson A.Rooney D.Sainsbury C.Saravanan P.Shakher J.Singh B.Turner J.Whitelaw D.Wilding J.Wiles P.Adenuga B.Ahmad Z.Akinboboye O.Akright L.Alappat P.Alawad M.Alfonso T.Alimard R.Alzohaili O.Ariani M.Arora C.Azad N.Azzam S.Benjamin S.Block B.Borzadek E.Breisblatt W.Bright T.Byrd L.Chiou C.Chochinov R.Christensen T.Christofides E.Cohen R.Dawood G.De Souza J.Dempsey M.Eagerton D.East C.Elder C.Fernando R.Fogelfeld L.Foucauld J.French W.Frohnauer M.Gaffney M.Gangopadhyay S.Gogia H.Gosmanov A.Greenberg C.Greenway F.Hanna E.Hargrove J.Harris A.Harris B.Hart T.Herrington D.Hewitt M.Howard D.Izuora K.Jetty P.Kapoor A.Kasper J.F.Kelehan S.Kelly R.Kereiakes D.Khaira A.Khan M.Khan S.Korban E.Kosiborod M.Laguerre J.Larocque J.Latif K.Lester F.Levin P.Levine S.Li C.Lovell C.Lupovitch S.Madu I.-J.Mahabadi V.Mahmood A.Maragos S.Mariash C.Martin P.Mathew J.Mathew J.May M.Mayfield R.McCall A.Mcdaniel C.Mcgrew F.Mckenzie M.Mefford I.Mehta A.Mikdadi G.Mikhail M.Monchamp T.Moore C.IIMoran M.Morrar N.Mosley J.Mulford M.Murray J.Nakhle S.Nallasivan M.Odio A.Oh C.Olelewe S.Palchick B.Paliwal Y.Papademetriou V.Parikh N.Patel S.Phillips L.Pitts T.Prieto F.Puttnam R.Quyyumi A.Randhawa P.Rendell M.Rhie F.Roberts J.Robinson J.Robinson M.Rubino J.Ryan E.Saathoff S.Sachmechi I.Saifi A.Salacata A.Sanders R.Sanson J.Savin V.Schabauer A.Schmedtje J.Schwartz A.Scott C.Selagamsetty M.Shannon M.Shaw S.Singal D.Sjoberg R.Smith K.Sofley C.Sonn A.Sorof S.Soroka E.Spellman C.W.Steinhoff J.Suresh D.Tahir M.Tanenberg R.Thawani H.Thomson S.Thrasher J.Trachtenbarg D.Trotta M.Tuan W.Twahirwa M.Umpierrez G.Vaid B.Vance C.Wang T.Warner A.Watson H.Weber S.Webster B.Weindorff K.Welch M.Welker J.White A.White L.Williams M.Wu W.-C.Wynne A.Yocono M.Yuen K.ELIXA Investigators
Issue Date
2015
Publisher
Mosby Inc.
Citation
American Heart Journal, v.169, no.5, pp 631 - 638.e7
Indexed
SCI
SCIE
SCOPUS
Journal Title
American Heart Journal
Volume
169
Number
5
Start Page
631
End Page
638.e7
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/30172
DOI
10.1016/j.ahj.2015.02.002
ISSN
0002-8703
1097-6744
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. © 2015 Elsevier Inc. All rights reserved.
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