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Lancet Diabetes Endocrinol. 2019 Aug;7(8):618-628. doi: 10.1016/S2213-8587(19)30158-5. Epub 2019 Jul 1.

Effects of alirocumab on cardiovascular and metabolic outcomes after acute coronary syndrome in patients with or without diabetes: a prespecified analysis of the ODYSSEY OUTCOMES randomised controlled trial.

Collaborators (1679)

Schwartz GG, Steg PG, Bhatt DL, Bittner VA, Diaz R, Goodman SG, Harrington RA, Jukema JW, Szarek M, White HD, Zeiher AM, Tricoci P, Roe MT, Mahaffey KW, Edelberg JM, Hanotin C, Lecorps G, Moryusef A, Pordy R, Sasiela WJ, Tamby JF, Aylward PE, Drexel H, Sinnaeve P, Dilic M, Lopes RD, Gotcheva NN, Prieto JC, Yong H, López-Jaramillo P, Pećin I, Reiner Z, Ostadal P, Viigimaa M, Nieminen MS, Chumburidze V, Marx N, Danchin N, Liberopoulos E, Montenegro Valdovinos PC, Tse HF, Kiss RG, Xavier D, Zahger D, Valgimigli M, Kimura T, Kim HS, Kim SH, Erglis A, Laucevicius A, Kedev S, Yusoff K, Ramos López GA, Alings M, Halvorsen S, Correa Flores RM, Budaj A, Morais J, Dorobantu M, Karpov Y, Ristic AD, Chua T, Murin J, Fras Z, Dalby AJ, Tuñón J, de Silva HA, Hagström E, Landmesser U, Chiang CE, Sritara P, Guneri S, Parkhomenko A, Ray KK, Moriarty PM, Vogel R, Chaitman B, Kelsey SF, Olsson AG, Rouleau JL, Simoons ML, Alexander K, Meloni C, Rosenson R, Sijbrands EJG, Tricoci P, Alexander JH, Armaganijan L, Bagai A, Bahit MC, Brennan JM, Clifton S, DeVore AD, Deloatch S, Dickey S, Dombrowski K, Ducrocq G, Eapen Z, Endsley P, Eppinger A, Harrison RW, Hess CN, Hlatky MA, Jordan JD, Knowles JW, Kolls BJ, Kong DF, Leonardi S, Lillis L, Maron DJ, Marcus J, Mathews R, Mehta RH, Mentz RJ, Moreira HG, Patel CB, Bernardez-Pereira S, Perkins L, Povsic TJ, Puymirat E, Schuyler Jones W, Shah BR, Sherwood MW, Stringfellow K, Sujjavanich D, Toma M, Trotter C, Van Diepen S, Wilson MD, Yan AT, Schiavi LB, Garrido M, Alvarisqueta AF, Sassone SA, Bordonava AP, Alves De Lima AE, Schmidberg JM, Duronto EA, Caruso OC, Novaretto LP, Hominal MA, Montaña OR, Caccavo A, Gomez Vilamajo OA, Lorenzatti AJ, Cartasegna LR, Paterlini GA, Mackinnon IJ, Caime GD, Amuchastegui M, Salomone O, Codutti OR, Jure HO, Bono JO, Hrabar AD, Vallejos JA, Ahuad Guerrero RA, Novoa F, Patocchi CA, Zaidman CJ, Giuliano ME, Dran RD, Vico ML, Carnero GS, Guzman PN, Medrano Allende JC, Garcia Brasca DF, Bustamante Labarta MH, Nani S, Blumberg ED, Colombo HR, Liberman A, Fuentealba V, Luciardi HL, Waisman GD, Berli MA, Garcia Duran RO, Cestari HG, Luquez HA, Giordano JA, Saavedra SS, Zapata G, Costamagna O, Llois S, Waites JH, Collins N, Soward A, Hii CL, Shaw J, Arstall MA, Horowitz J, Ninio D, Rogers JF, Colquhoun D, Oqueli Flores RE, Roberts-Thomson P, Raffel O, Lehman SJ, Aroney C, Coverdale SG, Garrahy PJ, Starmer G, Sader M, Carroll PA, Dick R, Zweiker R, Hoppe U, Huber K, Berger R, Delle-Karth G, Frey B, Weidinger F, Faes D, Hermans K, Pirenne B, Leone A, Hoffer E, Vrolix MC, De Wolf L, Wollaert B, Castadot M, Dujardin K, Beauloye C, Vervoort G, Striekwold H, Convens C, Roosen J, Barbato E, Claeys M, Cools F, Terzic I, Barakovic F, Midzic Z, Pojskic B, Fazlibegovic E, Kulić M, Durak-Nalbantic A, Vulic D, Muslibegovic A, Goronja B, Reis G, Sousa L, Nicolau JC, Giorgeto FE, Silva RP, Nigro Maia L, Rech R, Rossi PR, Cerqueira MJA, Duda N, Kalil R, Kormann A, Abrantes JAM, Pimentel Filho P, Soggia AP, de Santos MO, Neuenschwander F, Bodanese LC, Michalaros YL, Eliaschewitz FG, Vidotti MH, Leaes PE, Botelho RV, Kaiser S, Manenti ERF, Precoma DB, Moura Jorge JC, de B Silva PG, Silveira JA, Saporito W, Marin-Neto JA, Feitosa GS, Ritt LEF, de Souza JA, Costa F, Souza WK, Reis HJ, Machado L, Ayoub JCA, Todorov GV, Nikolov FP, Velcheva ES, Tzekova ML, Benov HO, Petranov SL, Tumbev HS, Shehova-Yankova NS, Markov DT, Raev DH, Mollov MN, Kichukov KN, Ilieva-Pandeva KA, Ivanova R, Gospodinov M, Mincheva VM, Lazov PV, Dimov BI, Senaratne M, Stone J, Kornder J, Pearce S, Dion D, Savard D, Pesant Y, Pandey A, Robinson S, Gosselin G, Vizel S, Hoag G, Bourgeois R, Morisset A, Sabbah E, Sussex B, Kouz S, MacDonald P, Diaz A, Michaud N, Fell D, Leung R, Vuurmans T, Lai C, Nigro F, Davies R, Nogareda G, Vijayaraghavan R, Ducas J, Lepage S, Mehta S, Cha J, Dupuis R, Fong P, Lutchmedial S, Rodes-Cabau J, Fadlallah H, Cleveland D, Huynh T, Bata I, Hameed A, Pincetti C, Potthoff S, Prieto JC, Acevedo M, Aguirre A, Vejar M, Yañez M, Araneda G, Fernandez M, Perez L, Varleta P, Florenzano F, Huidobro L, Raffo CA, Olivares C, Nahuelpan L, Montecinos H, Chen J, Dong Y, Huang W, Wang J, Huang S, Yao Z, Li X, Cui L, Lin W, Sun Y, Wang J, Li J, Zhang X, Zhu H, Chen D, Huang L, Dong S, Su G, Xu B, Su X, Cheng X, Lin J, Zong W, Li H, Feng Y, Xu D, Yang X, Ke Y, Lin X, Zhang Z, Zheng Z, Luo Z, Chen Y, Ding C, Zhong Y, Zheng Y, Li X, Peng D, Zhao S, Li Y, Liu X, Wei M, Liu S, Yu Y, Qu B, Jiang W, Zhou Y, Zhao X, Yuan Z, Guo Y, Xu X, Shi X, Ge J, Fu G, Bai F, Fang W, Shou X, Yang X, Wang J, Xiang M, Sun Y, Lu Q, Zhang R, Zhu J, Xu Y, Fan Z, Li T, Wu C, Jaramillo N, Sanchez Vallejo G, Luna Botia DC, Botero Lopez R, Molina De Salazar DI, Cadena Bonfanti AJ, Cotes Aroca C, Diego Higuera J, Blanquicett M, Barrera Silva SI, Garcia Lozada HJ, Coronel Arroyo JA, Accini Mendoza JL, Fernandez Ruiz RL, Quintero Ossa AM, Manzur Jatin FG, Sotomayor Herazo A, Castellanos Parada J, Suarez Arambula R, Urina Triana MA, Fernandez Trujillo AM, Strozzi M, Car S, Jerić M, Miličić D, Benčić ML, Pintarić H, Prvulović Đ, Šikić J, Peršić V, Mileta D, Štambuk K, Babić Z, Tomulic V, Lukenda J, Mejic-Krstulovic S, Starcevic B, Spinar J, Horak D, Velicka Z, Stasek J, Alan D, Machova V, Linhart A, Novotny V, Kaucak V, Rokyta R, Naplava R, Coufal Z, Adamkova V, Podpera I, Zizka J, Motovska Z, Marusincova I, Svab P, Heinc P, Kuchar J, Povolny P, Matuska J, Poulsen SH, Raungaard B, Clemmensen P, Bang LE, May O, Bøttcher M, Hove JD, Frost L, Gislason G, Larsen J, Betton Johansen P, Hald F, Johansen P, Jeppesen J, Nielsen T, Kristensen KS, Walichiewicz PM, Lomholdt JD, Klausen IC, Nielsen PK, Davidsen F, Videbaek L, Soots M, Vahula V, Hedman A, Soopõld Ü, Märtsin K, Jurgenson T, Kristjan A, Helsinki JK, Vikman S, Huikuri H, Airaksinen J, Coste P, Ferrari E, Morel O, Montalescot G, Machecourt J, Barone-Rochette G, Mansourati J, Cottin Y, Leclercq F, Belhassane A, Delarche N, Boccara F, Paganelli F, Clerc J, Schiele F, Aboyans V, Probst V, Berland J, Lefèvre T, Citron B, Khintibidze I, Shaburishvili T, Pagava Z, Ghlonti R, Lominadze Z, Khabeishvili G, Hemetsberger R, Edward K, Rauch-Kröhnert U, Stratmann M, Appel KF, Schmidt E, Omran H, Stellbrink C, Dorsel T, Lianopoulos E, Vöhringer HF, Marx R, Zirlik A, Schellenberg D, Heitzer T, Laufs U, Werner C, Marx N, Gielen S, Nuding S, Winkelmann B, Behrens S, Sydow K, Karakas M, Simonis G, Muenzel T, Werner N, Leggewie S, Böcker D, Braun-Dullaeus R, Toursarkissian N, Jeserich M, Weißbrodt M, Schaeufele T, Weil J, Völler H, Waltenberger J, Natour M, Schmitt S, Müller-Wieland D, Steiner S, Heidenreich L, Offers E, Gremmler U, Killat H, Rieker W, Patsilinakos S, Kartalis A, Manolis A, Sionis D, Chachalis G, Skoumas I, Athyros V, Vardas P, Parthenakis F, Alexopoulos D, Hahalis G, Lekakis J, Hatzitolios A, Fausto Ovando SR, Arango Benecke JL, Rodriguez De Leon ER, Yan BP, Siu DC, Turi T, Merkely B, Ungi I, Lupkovics G, Nagy L, Katona A, Édes I, Müller G, Horvath I, Kapin T, Szigeti Z, Faluközy J, Kumbla M, Sandhu M, Annam S, Proddutur NR, Regella R, Premchand RK, Mahajan A, Pawar S, Abhyanakar AD, Kerkar P, Govinda RA, Oomman A, Sinha D, Patil SN, Kahali D, Sawhney J, Joshi AB, Chaudhary S, Harkut P, Guha S, Porwal S, Jujjuru S, Pothineni RB, Monteiro MR, Khan A, Iyengar SS, Grewal JS, Chopda M, Fulwani MC, Patange A, Sachin P, Chopra VK, Goyal NK, Shinde R, Manakshe GV, Patki N, Sethi S, Munusamy V, Karna S, Thanvi S, Adhyapak S, Patil C, Pandurangi U, Mathur R, Gupta J, Kalashetti S, Bhagwat A, Raghuraman B, Yerra SK, Bhansali P, Borse R, Rahul P, Das S, Kumar V, Abdullakutty J, Saathe S, Palimkar P, Sathe S, Atar S, Shechter M, Mosseri M, Arbel Y, Ehud C, Ofer H, Lotan C, Rosenschein U, Katz A, Henkin Y, Francis A, Klutstein M, Nikolsky E, Zukermann R, Turgeman Y, Halabi M, Marmor A, Kornowski R, Jonas M, Amir O, Hasin Y, Rozenman Y, Fuchs S, Zvi V, Hussein O, Gavish D, Vered Z, Caraco Y, Elias M, Tov N, Wolfovitz E, Lishner M, Elias N, Piovaccari G, De Pellegrin A, Garbelotto R, Guardigli G, Marco V, Licciardello G, Auguadro C, Scalise F, Cuccia C, Salvioni A, Musumeci G, Senni M, Calabrò P, Novo S, Faggiano P, Metra M, De Cesare NB, Berti S, Cavallini C, Puccioni E, Galvani M, Tespili M, Piatti P, Palvarini M, De Luca G, Violini R, De Leo A, Olivari Z, Perrone Filardi P, Ferratini M, Racca V, Dai K, Shimatani Y, Kamiya H, Ando K, Takeda Y, Morino Y, Hata Y, Kimura K, Kishi K, Michishita I, Uehara H, Higashikata T, Hirayama A, Hirooka K, Doi Y, Sakagami S, Taguchi S, Koike A, Fujinaga H, Koba S, Kozuma K, Kawasaki T, Ono Y, Shimizu M, Katsuda Y, Wada A, Shinke T, Kimura T, Ako J, Fujii K, Takahashi T, Sakamoto T, Nakao K, Furukawa Y, Sugino H, Tamura R, Mano T, Uematsu M, Utsu N, Ito K, Haraguchi T, Sato K, Ueda Y, Nishibe A, Fujimoto K, Masutani M, Yoon JH, Kim HL, Park HS, Chae IH, Kim MH, Jeong MH, Rha S, Kim C, Kim HS, Kim HY, Hong T, Tahk SJ, Kim Y, Busmane A, Pontaga N, Strelnieks A, Mintale I, Sime I, Petrulioniene Z, Kavaliauskiene R, Jurgaitiene R, Sakalyte G, Slapikas R, Norkiene S, Misonis N, Kibarskis A, Kubilius R, Bojovski S, Lozance N, Kjovkaroski A, Doncovska S, Ong TK, Kasim S, Maskon O, Kandasamy B, Liew HB, Wan Mohamed WMI, García Castillo A, Carrillo Calvillo J, Fajardo Campos P, Núñez Fragoso JC, Bayram Llamas EA, Alcocer Gamba MA, Carranza Madrigal J, González Salas LG, López Rosas E, González Díaz B, Salcido Vázquez E, Nacoud Ackar A, Llamas Esperón GA, Martínez Sánchez CR, Guerrero De Leon M, Suarez Otero R, Fanghänel Salmón G, Pérez Ríos JA, Garza Ruíz JA, Breedveld RW, Feenema-Aardema M, Borger-Van Der Burg A, Hoogslag PA, Suryapranata H, Oomen A, Van Haelst P, Wiersma JJ, Basart D, Van Der Wal RM, Zwart P, Monraats P, Van Kesteren H, Karalis I, Jukema J, Verdel GJ, Brueren BR, Troquay RP, Viergever EP, Al-Windy NY, Bartels GL, Cornel JH, Hermans WR, Herrman JP, Bos RJ, Groutars RG, Van Der Zwaan CC, Kaplan R, Lionarons R, Ronner E, Groenemeijer BE, Bronzwaer PN, Liem AA, Rensing BJ, Bokern MJ, Nijmeijer R, Hersbach FM, Willems FF, Gosselink AT, Rasoul S, Elliott J, Wilkins G, Fisher R, Scott D, Hart H, Stewart R, Harding S, Ternouth I, Fisher N, Wilson S, Aitken D, Anscombe R, Davidson L, Tomala T, Nygård O, Sparby JA, Andersen K, Gullestad L, Jortveit J, Munk PS, Singsaas EG, Hurtig U, Calderon Ticona JR, Durand Velasquez JR, Negron Miguel SA, Sanabria Perez ES, Carrion Chambilla JM, Chavez Ayala CA, Castillo Leon RP, Vargas Gonzales RJ, Hernandez Zuniga JD, Camacho Cosavalente LA, Bravo Mannucci JE, Heredia Landeo J, Llerena Navarro NC, Roldan Concha YM, Rodriguez Chavez VE, Anchante Hernandez HA, Zea Nunez CA, Mogrovejo Ramos W, Ferrolino A, Sy RAG, Tirador L, Sy RG, Matiga G, Coching RM, Bernan A, Rogelio G, Morales DD, Tan E, Sulit DJ, Wlodarczak A, Jaworska K, Skonieczny G, Pawlowicz L, Wojewoda P, Busz-Papiez B, Bednarski J, Goch A, Staneta P, Dulak E, Saminski K, Krasowski W, Sudnik W, Zurakowski A, Skorski M, Miklaszewicz B, Kubica J, Andrzej Lipko J, Kostarska-Srokosz E, Piepiorka M, Drzewiecka A, Stasiewski A, Blicharski T, Bystryk L, Szpajer M, Korol M, Czerski T, Mirek-Bryniarska E, Gniot J, Lubinski A, Gorny J, Franek E, Raczak G, Szwed H, Monteiro P, Mesquita Bastos J, Pereira HH, Martins D, Seixo F, Mendonça C, Botelho A, Caetano F, Minescu B, Istratoaie O, Tesloianu DN, Cristian G, Dumitrescu S, Podoleanu CG, Constantinescu MC, Bengus CM, Militaru C, Rosu D, Parepa IR, Matei AV, Alexandru TM, Malis M, Coman I, Stanescu-Cioranu R, Dimulescu D, Shvarts Y, Orlikova O, Kobalava Z, Barbarash OL, Markov V, Lyamina N, Gordienko A, Zrazhevsky K, Vishnevsky AY, Gurevich V, Stryuk R, Lomakin NV, Bokarev I, Khlevchuk T, Shalaev S, Khaisheva L, Chizhov P, Viktorova I, Osokina N, Shchekotov V, Akatova E, Chumakova G, Libov I, Voevoda MI, Tretyakova TV, Baranov E, Shustov S, Yakushin S, Gordeev I, Khasanov N, Reshetko O, Sotnikova T, Molchanova O, Nikolaev K, Gapon L, Baranova E, Shogenov Z, Kosmachova E, Karpov Y, Povzun A, Egorova L, Tyrenko VV, Ivanov IG, Ilya M, Kanorsky S, Simic D, Ivanovic N, Davidovic G, Tasic N, Asanin MR, Stojic S, Apostolovic SR, Ilic S, Putnikovic Tosic B, Stankovic A, Arandjelovic A, Radovanovic S, Todic B, Balinovac J, Dincic DV, Seferovic P, Karadzic A, Dodic S, Dimkovic S, Jakimov T, Poh KK, Ong HY, Tang I-Shing J, Micko K, Nociar J, Pella D, Fulop P, Hranai M, Palka J, Mazur J, Majercák I, Dzupina A, Fazekas F, Gonsorcik J, Bugan V, Selecky J, Kamensky G, Strbova J, Smik R, Dukat A, Žuran I, Poklukar J, Černič Šuligoj N, Cevc M, Cyster HP, Ranjith N, Corbett C, Bayat J, Makotoko EM, du Toit Theron H, Kapp IE, de V Basson MM, Lottering H, Van Aswegen D, Van Zyl LJ, Sebastian PJ, Pillay T, Saaiman JA, Commerford PJ, Cassimjee S, Riaz G, Ebrahim IO, Sarvan M, Mynhardt JH, Reuter H, Moodley R, Vida M, Cequier Fillat AR, Bodí Peris V, Fuentes Jimenez F, Marín F, Cruz Fernández JM, Hidalgo Urbano RJ, Gil-Extremera B, Toledo P, Worner Diz F, Garcia-Dorado D, Iñiguez A, Tuñón Fernández J, Gonzalez-Juanatey JR, Fernandez Portales J, Civeira Murillo F, Matas Pericas L, Zamorano JL, De Mora Martin M, Bruguera Cortada J, Alonso Martin JJ, Serrano Antolin JM, De Berrazueta Fernández JR, Vázquez de Prada JA, Díaz Fernández JF, García Lledó JA, Cosín Sales J, Botas Rodriguez J, Gusi Tragant G, Benedicto A, Gonzalez-Juanatey C, Camprubí Potau M, Plaza Perez I, De La Tassa CM, Loma-Osorio Rincon P, Balaguer Recena J, Escudier JM, Payeras AC, Alonso Orcajo N, Valdivielso P, Constantine G, Haniffa R, Tissera N, Amarasekera S, Ponnamperuma C, Fernando N, Fernando K, Jayawardena J, Wijeyasingam S, Ranasinghe G, Ekanayaka R, Mendis S, Senaratne V, Mayurathan G, Sirisena T, Rajapaksha A, Herath JI, Amarasena N, Berglund S, Rasmanis G, Vedin O, Witt N, Mourtzinis G, Nicol P, Hansen O, Romeo S, Agergaard Jensen S, Torstensson I, Ahremark U, Sundelin T, Moccetti T, Müller C, Mach F, Binde R, Tsai WC, Ueng KC, Lai WT, Liu ME, Hwang JJ, Yin WH, Hsieh IC, Hsieh MJ, Lin WH, Kuo JY, Huang TY, Fang CY, Kaewsuwanna P, Soonfuang W, Jintapakorn W, Sukonthasarn A, Wongpraparut N, Sastravaha K, Sansanayudh N, Kehasukcharoen W, Piyayotai D, Chotnoparatpat P, Camsari A, Kultursay H, Mutlu B, Ersanli M, Demirtas M, Kirma C, Ural E, Koldas L, Karpenko O, Prokhorov A, Vakaluyk I, Myshanych H, Reshotko D, Batushkin V, Rudenko L, Kovalskyi I, Kushnir M, Tseluyko V, Mostovoy Y, Stanislavchuk M, Kyiak Y, Karpenko Y, Malynovsky Y, Klantsa A, Kutniy O, Amosova E, Tashchuk V, Leshchuk O, Rishko M, Kopytsya M, Yagensky A, Vatutin M, Bagriy A, Barna OM, Ushakov O, Dzyak G, Goloborodko B, Rudenko A, Zheleznyy V, Trevelyan J, Zaman A, Lee K, Moriarty A, Aggarwal RK, Clifford P, Wong YK, Iqbal SM, Subkovas E, Braganza D, Sarkar D, Storey R, Griffiths H, McClure S, Muthusamy R, Smith S, Kurian J, Levy T, Barr C, Kadr H, Gerber R, Simaitis A, Soran H, Mathur A, Brodison A, Ayaz M, Cheema M, Oliver R, Thackray S, Mudawi T, Rahman G, Sultan A, Sharman D, Sprigings D, Butler R, Wilkinson P, Lip GY, Halcox J, Gallagher S, Ossei-Gerning N, Vardi G, Baldari D, Brabham D, Treasure Ii C, Dahl C, Palmer B, Wiseman A, Khan A, Puri S, Mohart AE, Ince C, Flores E, Wright S, Cheng SC, Rosenberg M, Rogers W Jr, Kosinski E, Forgosh L, Waltman J, Khan M, Shoukfeh M, Dagher G, Cambier P, Lieber I, Kumar P, East C, Krichmar P, Hasan M, White L, Knickelbine T, Haldis T, Gillespie E, Amidon T, Suh D, Arif I, Abdallah M, Akhter F, Carlson E, D'Urso M, El-Ahdab F, Nelson W, Moriarty K, Harris B, Cohen S, Carter L, Doty D, Sabatino K, Haddad T, Malik A, Rao S, Mulkay A, Jovin I, Klancke K, Malhotra V, Devarapalli SK, Koren M, Chandna H, Dodds Iii G, Goraya T, Bengston J, Janik M, Moran J, Sumner A, Kobayashi J, Davis W, Yazdani S, Pasquini J, Thakkar M, Vedere A, Leimbach W, Rider J, Fenton S, Singh N, Shah AV, Janosik D, Pepine C, Berman B, Gelormini J, Daniels C, Richard K, Keating F, Kondo NI, Shetty S, Levite H, Waider W, Takata T, Abu-Fadel M, Shah V, Aggarwal R, Izzo M, Kumar A, Hattler B, Do R, Link C, Bortnick A, Kinzfogl Iii G, Ghitis A, Larry J, Teufel E, Kuhlman P, Mclaurin B, Zhang W, Thew S, Abbas J, White M, Islam O, Subherwal S, Ranadive N, Vakili B, Gring C, Henderson D, Schuchard T, Farhat N, Kline G, Mahal S, Whitaker J, Speirs S, Andersen R, Daboul N, Horwitz P, Zahr F, Ponce G, Jafar Z, Mcgarvey J Jr, Panchal V, Voyce S, Blok T, Sheldon W, Azizad MM, Schmalfuss C, Picone M, Pederson R, Herzog W Jr, Friedman K, Lindsey J, Nowins R, Timothy E, Leonard P, Lepor N, El Shahawy M, Weintraub H, Irimpen A, Alonso A, May W, Christopher D, Galski T, Chu A, Mody F, Ramin E, Hodes Z, Rossi J, Rose G, Fairlamb J, Lambert C Jr, Raisinghani A, Abbate A, Vetrovec G, King M, Carey C, Gerber J, Younis L, Park HT, Vidovich M, Knutson T, Friedman D, Chaleff F, Loussararian A, Rozeman P, Kimmelstiel C, Kuvin J, Silver K, Foster M, Tonnessen G, Espinoza A, Amlani M, Wali A, Malozzi C, Jong GT, Massey C, Wattanakit K, O'Donnell PJ, 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Denham D, Macdonell A, Gibson P, Rahman A, Al Joundi T, Assi N, Conrad G, Kotha P, Love M, Giesler G, Rubenstein H, Gamil D, Akright L, Krawczyk J, Cobler J, Wells T, Welker J, Foster R, Gilmore R, Anderson J, Jacoby D, Harris B, Gardner G, Dandillaya R, Vora K, Kostis J, Hunter J, Laxson D, Ball E, Wells T, Vora K, Ball E, Welker J, Lopes R, Egydio F, Kawakami A, Oliveira J, Wozniak J, Matthews A, Ratky C, Valiris J, Berdan L, Hepditch A, Quintero K, Rorick T, Westbrook M, Pascual A, Rovito C, Bezault M, Drouet E, Simon T, White HD, Alsweiler C, Luyten A, Butters J, Griffith L, Shaw M, Grunberg L, Islam S, Brégeault MF, Bougon N, Faustino D, Fontecave S, Murphy J, Verrier M, Agnetti V, Andersen D, Badreddine E, Bekkouche M, Bouancheau C, Brigui I, Brocklehurst M, Cianciarulo J, Devaul D, Domokos S, Gache C, Gobillot C, Guillou S, Healy J, Heath M, Jaiwal G, Javierre C, Labeirie J, Monier M, Morales U, Mrabti A, Mthombeni B, Okan B, Smith L, Sheller J, Sopena S, Pellan V, Benbernou F, Bengrait N, Lamoureux M, Kralova K, Scemama M, Bejuit R, Coulange A, Berthou C, Repincay J, Lorenzato C, Etienne A, Gouet V, Lecorps G, Loizeau V, Normand M, Ourliac A, Rondel C, Adamo A, Beltran P, Barraud P, Dubois-Gache H, Halle B, Metwally L, Mourgues M, Sotty M, Vincendet M, Cotruta R, Chengyue Z, Fournie-Lloret D, Morrello C, Perthuis A, Picault P, Zobouyan I, Colhoun HM, Dempsey MA, McClanahan MA.

Erratum in

Abstract

BACKGROUND:

After acute coronary syndrome, diabetes conveys an excess risk of ischaemic cardiovascular events. A reduction in mean LDL cholesterol to 1·4-1·8 mmol/L with ezetimibe or statins reduces cardiovascular events in patients with an acute coronary syndrome and diabetes. However, the efficacy and safety of further reduction in LDL cholesterol with an inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9) after acute coronary syndrome is unknown. We aimed to explore this issue in a prespecified analysis of the ODYSSEY OUTCOMES trial of the PCSK9 inhibitor alirocumab, assessing its effects on cardiovascular outcomes by baseline glycaemic status, while also assessing its effects on glycaemic measures including risk of new-onset diabetes.

METHODS:

ODYSSEY OUTCOMES was a randomised, double-blind, placebo-controlled trial, done at 1315 sites in 57 countries, that compared alirocumab with placebo in patients who had been admitted to hospital with an acute coronary syndrome (myocardial infarction or unstable angina) 1-12 months before randomisation and who had raised concentrations of atherogenic lipoproteins despite use of high-intensity statins. Patients were randomly assigned (1:1) to receive alirocumab or placebo every 2 weeks; randomisation was stratified by country and was done centrally with an interactive voice-response or web-response system. Alirocumab was titrated to target LDL cholesterol concentrations of 0·65-1·30 mmol/L. In this prespecified analysis, we investigated the effect of alirocumab on cardiovascular events by glycaemic status at baseline (diabetes, prediabetes, or normoglycaemia)-defined on the basis of patient history, review of medical records, or baseline HbA1c or fasting serum glucose-and risk of new-onset diabetes among those without diabetes at baseline. The primary endpoint was a composite of death from coronary heart disease, non-fatal myocardial infarction, fatal or non-fatal ischaemic stroke, or unstable angina requiring hospital admission. ODYSSEY OUTCOMES is registered with ClinicalTrials.gov, number NCT01663402.

FINDINGS:

At study baseline, 5444 patients (28·8%) had diabetes, 8246 (43·6%) had prediabetes, and 5234 (27·7%) had normoglycaemia. There were no significant differences across glycaemic categories in median LDL cholesterol at baseline (2·20-2·28 mmol/L), after 4 months' treatment with alirocumab (0·80 mmol/L), or after 4 months' treatment with placebo (2·25-2·28 mmol/L). In the placebo group, the incidence of the primary endpoint over a median of 2·8 years was greater in patients with diabetes (16·4%) than in those with prediabetes (9·2%) or normoglycaemia (8·5%); hazard ratio (HR) for diabetes versus normoglycaemia 2·09 (95% CI 1·78-2·46, p<0·0001) and for diabetes versus prediabetes 1·90 (1·65-2·17, p<0·0001). Alirocumab resulted in similar relative reductions in the incidence of the primary endpoint in each glycaemic category, but a greater absolute reduction in the incidence of the primary endpoint in patients with diabetes (2·3%, 95% CI 0·4 to 4·2) than in those with prediabetes (1·2%, 0·0 to 2·4) or normoglycaemia (1·2%, -0·3 to 2·7; absolute risk reduction pinteraction=0·0019). Among patients without diabetes at baseline, 676 (10·1%) developed diabetes in the placebo group, compared with 648 (9·6%) in the alirocumab group; alirocumab did not increase the risk of new-onset diabetes (HR 1·00, 95% CI 0·89-1·11). HRs were 0·97 (95% CI 0·87-1·09) for patients with prediabetes and 1·30 (95% CI 0·93-1·81) for those with normoglycaemia (pinteraction=0·11).

INTERPRETATION:

After a recent acute coronary syndrome, alirocumab treatment targeting an LDL cholesterol concentration of 0·65-1·30 mmol/L produced about twice the absolute reduction in cardiovascular events among patients with diabetes as in those without diabetes. Alirocumab treatment did not increase the risk of new-onset diabetes.

FUNDING:

Sanofi and Regeneron Pharmaceuticals.

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