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N Engl J Med. 2015 Dec 3;373(23):2247-57. doi: 10.1056/NEJMoa1509225.

Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome.

Collaborators (784)

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, Patocchi C, Pérez Manghi F, Ramos H, Rolandi F, Saa Zarandon R, Saavedra SS, 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 AC, Botelho RV, Cerqueira MJ, Chacra A, De Moraes Junior J, Dos Santos F, Feitosa G, Filho F, Forti A, Golbert M, Halpern A, Hissa M, Lisboa H, Nery M, Quadros A, Raduan R, Reis G, Rollin G, Rossi P, Santos E, Sgarbi J, Souza J, Souza MR, 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, Tardif JC, Tsoukas G, Warnica JW, Acuña S, Araneda G, Bunster L, Cobos L, Corbalán R, Dussaillant G, Eggers G, Florenzano F, Godoy G, Huidobro LA, Lahsen R, Lanas F, Larenas G, Manriquez L, Medina M, Palma JC, Perez L, Potthoff S, Raffo C, Reyes E, Saavedra V, Sanhueza P, Sepulveda P, Solis CL, 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 JL, Arana C, Arteaga JM, Botero R, Castillo G, Coronel J, Cure C, De Salazar M, Garcia H, Garcia L, Gomez C, Hernandez Triana E, Hernandez H, Lopez M, Lopez P, Manzur F, Rodriguez J, Sanchez Vallejo G, Yupanqui H, Bronnum-Schou J, Kaiser Nielsen P, Nielsen H, Rønne H, Rasmussen S, Rungby J, Skagen K, Thomsen KK, 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 AM, Lahtela J, Nelimarkka L, Tuomilehto J, Cariou B, Catargi B, Ducloux R, Hadjadj S, Kerlan V, Malecot JM, 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 SK, Gupta JB, 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 KS, 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 AV, Consoli A, Cucinotta D, Del Prato S, 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 WJ, Rim S, Jang H, Kim U, Chung CH, Shin SH, Kim K, Kim J, Rha S, Lee NH, Kim CJ, Park KS, 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 JG, Escalante M, Zavala A, Bayram E, Hernandez-Muñuzuri J, Ramos, Lopez GA, Lujan J, Garcia-Soria M, Velasco-Sanchez R, Rodriguez I, Jimenez S, Galeana C, Reyes E, Lara S, Garcia-Castillo A, Castro MG, Aguilar-Orozco R, Lopez Rosas E, Vidrio M, Llamas G, Stobschinski De Alba CA, Carranza-Madrigal J, Cardosa-Torres F, Cornel JH, Dekkers P, Frederiks J, Hermans W, Lok D, Meeder J, Nierop P, Cooper J, Lappegård KT, Nedrebø BG, Castro E, Gonzalez Castillo B, Gonzalez E, Nieto Ortega R, Andrade M, Calderon J, Chavez C, Correa Flores RM, Farfan J, Lu L, Luque E, Manrique H, Mogrovejo W, Pariona-Javier M, Pinto M, Roldan Y, Zubiate C, Dans A, Gomez MH, Panelo A, Rey N, Sulit DJ, Sy RA, 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 PM, Avram RI, Cif A, Creteanu G, Dragomir D, Ferariu IE, Iancu AC, Istratoaie O, Ivanica G, Lichiardopol R, Militaru C, Minescu B, Onaca A, Pintilei E, Podoleanu C, Pop L, Popa B, Ranetti AE, Rosu D, Tase A, Tesloianu DN, 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 PJ, 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 KA, Torstensson I, Vasko P, Moccetti T, Chiang CE, Chiu YW, Huang TY, Lu CH, Pei D, Shyu KG, Ueng KC, Wang TD, 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 GM, 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 JF, 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 IJ, 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 2nd, Moran 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 CW, 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 WC, Wynne A, Yocono M, Yuen K.

Abstract

BACKGROUND:

Cardiovascular morbidity and mortality are higher among patients with type 2 diabetes, particularly those with concomitant cardiovascular diseases, than in most other populations. We assessed the effects of lixisenatide, a glucagon-like peptide 1-receptor agonist, on cardiovascular outcomes in patients with type 2 diabetes who had had a recent acute coronary event.

METHODS:

We randomly assigned patients with type 2 diabetes who had had a myocardial infarction or who had been hospitalized for unstable angina within the previous 180 days to receive lixisenatide or placebo in addition to locally determined standards of care. The trial was designed with adequate statistical power to assess whether lixisenatide was noninferior as well as superior to placebo, as defined by an upper boundary of the 95% confidence interval for the hazard ratio of less than 1.3 and 1.0, respectively, for the primary composite end point of cardiovascular death, myocardial infarction, stroke, or hospitalization for unstable angina.

RESULTS:

The 6068 patients who underwent randomization were followed for a median of 25 months. A primary end-point event occurred in 406 patients (13.4%) in the lixisenatide group and in 399 (13.2%) in the placebo group (hazard ratio, 1.02; 95% confidence interval [CI], 0.89 to 1.17), which showed the noninferiority of lixisenatide to placebo (P<0.001) but did not show superiority (P=0.81). There were no significant between-group differences in the rate of hospitalization for heart failure (hazard ratio in the lixisenatide group, 0.96; 95% CI, 0.75 to 1.23) or the rate of death (hazard ratio, 0.94; 95% CI, 0.78 to 1.13). Lixisenatide was not associated with a higher rate of serious adverse events or severe hypoglycemia, pancreatitis, pancreatic neoplasms, or allergic reactions than was placebo.

CONCLUSIONS:

In patients with type 2 diabetes and a recent acute coronary syndrome, the addition of lixisenatide to usual care did not significantly alter the rate of major cardiovascular events or other serious adverse events. (Funded by Sanofi; ELIXA ClinicalTrials.gov number, NCT01147250.).

PMID:
26630143
DOI:
10.1056/NEJMoa1509225
[Indexed for MEDLINE]
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