6533b830fe1ef96bd1297cb8

RESEARCH PRODUCT

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 LewisDavid AguilarMatthew C. RiddleBrian ClaggettRafael DiazKenneth DicksteinHertzel C. GersteinPeter JohnstonLars V. KøberFrancesca LawsonEldrin F. LewisAldo P. MaggioniJohn J. V. McmurrayLin PingJeffrey L. ProbstfieldScott D. SolomonJean Claude TardifWu YujunMarc A. PfefferEbrahim BarkoudahAbdel BrahimiDavid CharytanPeter FinnAiden FlynnL. Howard HartleyGalen HendersonJacob JosephKayode OdutayoVinutha RajeshAli VazirLarry WeinrauchStefano Del PratoJohn PetrieAllen KaplanPhil LiebermanBruce ZurawEileen O'reillyKeyur PatelPeter AllenAldo ScarpaMark SchattnerChristopher GrangerJean RouleauDavid DemetsNishi ChaturvediDenis RaccahDiego AizenbergCarlos AlvarezAndres AlvarisquetaClaudia BaccaroInes BartolacciAnselmo BordonavaMiguel Bustamante LabartaAlberto CaccavoPedro CalellaMaria CanteroRenzo CoduttiVictor CommendatoreOsvaldo CostamagnaJose CuelloAlberto FernandezRuben Garcia DuranOscar Gomez VilamajoSilvia Gorban De LapertosaDiego GrinfeldSonia HermidaMariana LagruttaRicardo Leon De La FuenteAlberto LicheriHector LuciardiIgnacio MackinnonLaura MaffeiJavier MarinoOscar MontañaLeonardo NovarettoSilvia OrioAndres OrlandiniAlejandra OviedoFederico Pérez ManghiCristian PatocchiHugo RamosFlorencia RolandiRaquel Saa ZarandonSilvia Salome SaavedraLilia SchiaviPablo SchygielMarcelo TriviMaria UllaPedro UrdialesJulio VallejosMarisa VicoFlorencia WaismanJohn AmerenaVincent PaulKunwarjit SanglaWilliam Van GaalBu YeapPeter FaschingThomas R. PieberLarisa DanilovaNatalya P. MitkovskayaSvetlana SudzhaevaChantal MathieuAnne Catherine PouleurRoberto Vieira BotelhoMaria Jose CerqueiraAntonio ChacraFabio Dos SantosGilson FeitosaAdriana FortiMilton GolbertAlfredo HalpernMiguel HissaHugo LisboaJoao MoraesMax NeryAlexandre QuadrosRoberto RaduanGilmar ReisFernando Ribeiro FilhoGuilherme RollinPaulo RossiElizabete SantosJose SgarbiJuliana SouzaMaria Regina SouzaAlexy DelchevValentin IvanovNeli KlyuchkovaMichael KyoleyanGeorgi LevterovMariya LuchevaDimitar RaevRositsa ShumkovaMariya TokmakovaMaria TzekovaViktor YordanovGordon BaileyOlivier BertrandRakesh BhargavaJeffrey BurtonJean CampeauRichard DumasPierre FilteauGurcharan SyanRajinder SyanGeorge TsoukasJames Wayne WarnicaSilvia AcuñaGuillermo AranedaLia BunsterLeonardo CobosRamón CorbalánGaston DussaillantGerman EggersFernando FlorenzanoGonzalo GodoyLaura Andrea HuidobroRodolfo LahsenFernando T LanasGladys LarenasLeopoldo ManriquezMarcelo MedinaJuan Carlos PalmaLuis PerezSergio PotthoffCarlos RaffoEliana ReyesVictor SaavedraPatricio SanhuezaPablo SepulvedaCarmen Lia SolisNestor SotoClaudia TorresBernhard WesterbergMario YañezLi ChenYugang DongDu JianlingXiaohui GuoPing HanHu TaohongBin JiangKe YuannanLi ZhanquanLu JumingMa ChangshengYongde PengYongquan ShiSu GuohaiBaopeng TangXu BiaoJiefu YangJinkui YangYanmin YangJose Luis AcciniJuan Manuel ArteagaRodrigo BoteroGilberto CastilloJulian CoronelCarlos CureHenry GarciaLuis GarciaClaudia GomezEric Hernandez-trianaHector HernandezMonica LopezPatricio LopezFernando ManzurDora MolinaJaime RodriguezGregorio Sanchez VallejoHernan YupanquiJens Bronnum SchouPeter Kaiser NielsenHenrik NielsenHenning RønneSoeren RasmussenJørgen RungbyKnud SkagenKristian Korsgaard ThomsenChristian Torp PedersenYan Duarte VeraRicardo Marmol AlvearCarlos Peñaherrera PatiñoSamir AssaadSalah ShelbayaAnu AmbosUlle JakovlevMaire LubiKaja MärtsinSvea RosenthalHella VidesJuha AlankoPirkko KorsoffAnna Mari KoskiJorma LahtelaLassi NelimarkkaJaakko TuomilehtoBertrand CariouBogdan CatargiRoxane DuclouxSamy HadjadjVeronique KerlanJean Marc MalecotCatherine PetitMichel RodierVakhtang ChumburidzeSalome GlontiZaza LominadzeFridon ToduaChristel ContzenCornelia MarckHermann FischerAndreas HagenowAgnes Himpel BönninghoffLars KihmHolger KillatKlaus KleinertzChristine KoschKristin KreutzmannMariola LappoBernardo MertesRichard PiechatzekMartin ProhaskaAndrea RinkeDetlev SchellenbergNicole ToursarkissianJuan ArangoRonaldo GonzalezArnoldo GranadosMilton HerreraPablo MontenegroRicardo MunozEdgar RodriguezErick TurciosRenato VillalobosFernando WyssSanjay HatterjeeManoj ChopdaVijay ChopraNeeta DeshpandeR. DuttaSudhanshu DwivediPramod GandhiSandeep Kumar GuptaJugal Bihari GuptaSunil GuptaNarendra HiregouderSujeet JhaAbhijeet JoshiNoor KhanMukund KumblaMohan MagdumKeshava MurthyMukhya PrabhuRakesh SahaySelvamani SethuramanNavneet ShahParamesh ShamannaK. Singh SinghPaminder SinghArun SomasekharanLakshminarayanappa SreenivasamurthyPravin SupeFaiad AdawiShaul AtarOhad CohenShai EfratiEddy KarnieliEliezer KlainmanOscar MinuchinOfri MosenzonNaftali SternYoav TurgemanJulio WainsteinGianluca AimarettiCesare BerraAnna Vittoria CiardulloAgostino ConsoliDomenico CucinottaSandra Di MarcoCarlo GiordaCarla GiordanoEdoardo MannucciEmanuela OrsiPiermarco PiattiAntonio PontiroliPaola PonzaniPaolo PozzilliAngela RivelleseHiroshi AkahoriYutaka EkiKenshi FujiiYoshiki HataHideo HimenoAtsushi HirayamaIchiro KishimotoYouichi KobayashiHiroaki MiyaokaTetsuji NiiyaYutaro NishiAkira NozakiTatsuya NunohiroTomiyoshi SaitoYasuhiro SatohAkihiko TakahashiJunichiro TakahashiHiroyuki TakaseShinichi TakaseYusuke TsubokoMitsuru TsujimotoMotoyoshi TsujinoMasahiro TsuzukiShuichi WatanabeTakahisa YamadaWook Jin ChungSejoong RimHakchul JangUng KimChoon Hee ChungSung Hee ShinKyehun KimJaetaek KimSeungwoon RhaNae Hee LeeChong Jin KimKyong Soo ParkIldze AmolinaKristine DucenaRenate HeldaIlze KonradeValdis PiragsIveta SimeJelena SokolovaVaida KakariekieneRoma KavaliauskieneZaneta PetrulionieneGintare SakalyteAudrone UrbonieneRima ZarankieneMarittza UribePedro Garcia HernandezJose GarzaAbraham Vazquez GarciaJose Gerardo GonzalezMiguel EscalanteAlejandro ZavalaEdmundo BayramJesus Hernandez MuñuzuriNull RamosGabriel Arturo LopezJesus LujanMartin Garcia SoriaRaul Velasco SanchezIgnacio RodriguezSilvia JimenezCielmar GaleanaEduardo ReyesSusano LaraArmando Garcia CastilloMaria Guadalupe CastroRaul Aguilar OrozcoEnrique Lopez RosasMaricela VidrioGuillermo LlamasCarlos Alejandro Stobschinski De AlbaJaime Carranza MadrigalFrancisco Cardosa TorresJan Hein CornelPaulus DekkersJ. FrederiksWrm HermansDirk LokJoan MeederPeter NieropJohn CooperKnut Tore LappegårdBjørn Gunnar NedrebøEholo CastroBaldomero Gonzalez CastilloElis GonzalezRuben Nieto OrtegaMiguel AndradeJorge CalderonCarlos ChavezRoger Martin Correa FloresJulio FarfanLu LibiaEdith LuqueHelard ManriqueWalter MogrovejoMarcos Pariona JavierMiguel PintoYudy RoldanCarlos ZubiateAntonio DansMaria Honolina GomezAraceli PaneloNannette ReyDennis Jose SulitSy Rosa AllynMiriam TimoneraJanusz BednarskiRenata Bijata BroniszLeszek BryniarskiBenita Busz PapiezEugenia Czajkowska KaczmarekAnna DrzewieckaElzbieta DulakMaria GorskaMaciej HamankiewiczKrzysztof JanikKrzysztof KincelMarek KoniecznyAndrzej LubinskiMagdalena Olszanecka GlinianowiczPiotr PonikowskiGrazyna PulkaJerzy RekoszDariusz SkudlarskiKatarzyna SzymkowiakPrzemyslaw WilczewskiNuno BragançaJoão DuartePedro MonteiroElisabete RodriguesMargarida VinhasPop Moldovan AdinaRodica Ioana AvramAdriana CifGabriela CreteanuDinu DragomirIoana Emilia FerariuAdrian Corneliu IancuOctavian IstratoaieGabriel IvanicaRadu LichiardopolConstantin MilitaruBogdan MinescuAdriana OnacaElla PintileiCristian PodoleanuLavinia PopBogdan PopaAurelian Emil RanettiDoina RosuAdrian TaseDan Nicolae TesloianuDragos VinereanuFail AgeevNadir AkhmedzhanovOlga BarbarashVladimir BarbarichYury BelousovSvetlana BernsIgor BokarevOlga BolshakovaMikhail BoyarkinGalina ChumakovaPlatonov DmitrySergey FitilevAlbert GalyavichMaria GlezerLuidmila IvanovaVictor KalashnikovMarina KalashnikovaYuri KarpovLarisa KhaishevaYuri KhalimovZhanna KobalavaElena KosmachevaVictor KostenkoNatalya KoziolovaElena KulibabaVictor LesnovIgor LibovNadezhda LyaminaValentin MarkovValentin MoiseevOlga MolchanovaValentin OleynikovOlga OrlikovaAlexey PanovVladimir V RafalskyTatiana RodionovaVasily SamitinVladimir SchokotovNataliya ShilkinaZaur ShogenovSergey ShustovYuri ShvartsKonstantin SobolevRaisa StryukLudmila SuplotovaInna ViktorovaAlexander VishnevskyNatalia VorokhobinaVladimir YakusevichSergey YakushinVladimir ZadionchenkoAlsu ZalevskayaGrigory ZalevskyAnna ZateyshchikovaMarina Andjelic JelicRadivoj KocicSnezana KomnenovicKatarina LalicNebojsa LalicDragan MicicPetar OtasevicMilica PesicPetar SeferovicGoran StankovicSusan ArnoldLesley BurgessKathleen CoetzeeSaleem DawoodEluned DelportI. EbrahimGraham EllisSiddique IsmailDudley KelbeVisvakuren NaidooMpiko NtsekhePeter John SebastianMirna SiebertLouis Van ZylTjaart VenterElena LonsoIsabel AntorrenaVicent BodiMarta BotellaJavier De La FuenteElías DelgadoSantiago Duran GarciaJose ElorzaFidel EncisoSonia GaztambideFrancisco MarínVictoria MartinDidac MauricioAlfonso SotoManuel VidaGunnar BobergGun JörneskogJohan JendleUlrik MathiesenKarl Axel SvenssonIngemar TorstenssonPeter VaskoTiziano MoccettiChern En ChiangYu Wei ChiuTsuei Yuan HuangLu Chieh HsiangDee PeiKou Gi ShyuKwo Chang UengTzung-dau WangMohamed AbidNejib Ben AbdallahHabib HaoualaHedia SlimaneBorni ZidiNeslihan Bascil TutuncuAhmet CamsariTuncay DelibasiNevin DinccagHakan KultursayAli OtoMahmut SahinFusun SaygiliZerrin YigitCafer ZorkunOleksandr KarpenkoVadym KorpachevOlena KovalVitaliy MaslyankoMykhaylo PerepelytsyaTetyana PertsevaOlena PetrosyanLeonid RudenkoOleg SychovVolodymyr SynenkoVira TseluykoLarisa ZhuravlevaWael Al MahmeedGhaida Mohamad KaddahaRobert AndrewsStephen BainAmbar BasuDeepak BhatnagarAlex BickertonDuncan BrowneMartin GibsonPeter HammondFahmy HannaBasil IssaAlan JaapFranklin JosephEdward JudeChris KellyAtir KhanRayaz MalikBabu MukhopadhyayM. O'kaneGerry RaymanAnthony RobinsonDesmond RooneyChris SainsburyPonnusamy SaravananJayadave ShakherBaldev SinghJeremy TurnerDonald WhitelawJohn WildingPhilip WilesBabafemi AdenugaZia AhmadOlakunle AkinboboyeLaura AkrightPaul AlappatMohamad AlawadTeresa AlfonsoRamin AlimardOpada AlzohailiMehrdad ArianiChander AroraNasrin AzadSamir AzzamSabrina BenjaminBradley BlockEliza BorzadekWarren BreisblattTamis BrightLeroy ByrdChoyen ChiouRonald ChochinovTom ChristensenElena ChristofidesRobert CohenGamil DawoodJose De SouzaMichael DempseyDonald EagertonCara EastCharles ElderRonald FernandoLeon FogelfeldJean FoucauldWilliam FrenchMary FrohnauerMary GaffneySubroto GangopadhyayHarinder GogiaAidar GosmanovCraig GreenbergFrank GreenwayEdward HannaJoe HargroveAnthony HarrisBill HarrisTerence HartDavid HerringtonMitzie HewittDavid HowardKenneth IzuoraPreetham JettyAnoop KapoorJoseph F. KasperShaun KelehanRichard KellyDean KereiakesAjit KhairaMisal KhanSalman KhanElie KorbanMikhail KosiborodJacques LaguerreJames LarocqueKashif LatifFrank LesterPhilip LevinSteven LevineLi CharlesCharles LovellSteven LupovitchIvy Joan MaduVahid MahabadiAsif MahmoodStavros MaragosCary MariashPaul MartinJames MathewJohn MathewMichael MayRonald MayfieldAnthony MccallClayton McdanielFrank McgrewMarcus MckenzieIvan MeffordArvind MehtaGhiath MikdadiMagdy MikhailTravis MonchampCharles MooreMichael MoranNidal MorrarJonathan MosleyMim MulfordJohn MurraySamer NakhleMani NallasivanAlberto OdioOh CharlesSarah OleleweBryce PalchickYogesh PaliwalVasilios PapademetriouNaresh ParikhSudhirkumar PatelLawrence PhillipsThomas PittsFrancisco PrietoRachel PuttnamArshed QuyyumiPreet RandhawaMarc RendellFrancis RhieJames RobertsJerome RobinsonMichael RobinsonJohn RubinoEugene RyanSteven SaathoffIsaac SachmechiAli SaifiAbraham SalacataRobyn SandersJodi SansonVirginia SavinAlex SchabauerJohn SchmedtjeAlan SchwartzCranford ScottMunni SelagamsettyMichael ShannonSylvia ShawDinesh SingalRobert SjobergKenneth SmithCarl SofleyAnthony SonnSuzanne SorofEugene SorokaC. W. SpellmanJeffrey SteinhoffDamodhar SureshMohammad TahirRobert TanenbergHemant ThawaniStephen ThomsonJames ThrasherDavid TrachtenbargMichael TrottaWeiming TuanMarcel TwahirwaGuillermo UmpierrezBrij VaidCarl VanceThomas J. WangAlberta WarnerHenry WatsonSandra WeberBrian WebsterKathleen WeindorffMichelle WelchJames WelkerAnthony WhiteLindsey WhiteMarcus WilliamsWu Wen ChihAlan WynneMark YoconoKevin Yuen

subject

Malemedicine.medical_specialtyAcute coronary syndromePopulationLIXisenatide610 Medicine & healthHypoglycemiaPlacebop38 Mitogen-Activated Protein Kinases11171 Cardiocentro Ticino2705 Cardiology and Cardiovascular Medicinelaw.inventionSettore MED/13 - EndocrinologiaAcute Coronary Syndrome; Aged; Cardiovascular Diseases; Double-Blind Method; Female; Glucagon-Like Peptide 1; Humans; Male; Middle Aged; Peptides; Placebos; Protein Kinase Inhibitors; Research Design; p38 Mitogen-Activated Protein Kinases; Cardiology and Cardiovascular MedicinePlacebosLixisenatidechemistry.chemical_compoundRandomized controlled trialDouble-Blind MethodlawGlucagon-Like Peptide 1Internal medicineJournal ArticlemedicineHumansComparative StudyMyocardial infarctionAcute Coronary SyndromeeducationProtein Kinase InhibitorsAgededucation.field_of_studybusiness.industryUnstable anginaResearch Support Non-U.S. Gov'tta3121Middle Agedmedicine.diseaseSurgeryMulticenter StudychemistryCardiovascular DiseasesResearch DesignRandomized Controlled TrialCardiologyFemaleCardiology and Cardiovascular MedicinebusinessPeptides

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 glucagon-like 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, parallel-group, 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/m(2), and duration of T2DM was 9.3 ± 8.2 years. The qualifying ACS was a myocardial infarction in 83% and unstable angina 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.

yearjournalcountryeditionlanguage
2015-05-01
10.1016/j.ahj.2015.02.002http://hdl.handle.net/10447/227632