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N Engl J Med. 2018 Nov 29;379(22):2097-2107. doi: 10.1056/NEJMoa1801174. Epub 2018 Nov 7.

Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome.

Collaborators (1297)

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, Codutti OR, Jure HO, Bono JOE, 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 EDS, Colombo HR, Liberman A, Luciardi HL, Waisman GD, Berli MA, Garcia Duran RO, Cestari HG, Luquez HA, Giordano JA, Saavedra SS, Waites JH, Collins N, Soward A, Aylward PE, Hii CLS, Shaw J, Arstall MA, Horowitz J, Rogers JF, Colquhoun D, Oqueli Flores RE, Roberts-Thomson P, Raffel O, Lehman SJ, Coverdale SGM, Garrahy PJ, Starmer G, Sader M, Carroll PA, Zweiker R, Hoppe U, Drexel H, Huber K, Berger R, Weidinger F, Faes D, Hermans K, Pirenne B, Leone A, Hoffer E, Sinnaeve P, Vrolix MCM, 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, Dilic M, Durak-Nalbantic A, Vulic D, Muslibegovic A, Reis G, Sousa L, Nicolau JC, Giorgeto FE, Silva RP, Nigro Maia L, Rech R, Rossi PRF, Cerqueira MJAG, Duda N, Kalil R, Kormann A, Abrantes JAM, Pimentel Filho P, Soggia AP, de Santos MON, Neuenschwander F, Bodanese LC, Michalaros YL, Eliaschewitz FG, Vidotti MH, Leaes PE, Botelho RV, Kaiser S, Fernandes Manenti ERF, Precoma DB, Moura Jorge JC, de B Silva PGM, Silveira JA, Saporito W, Marin Neto JA, Feitosa GS, F Ritt LE, de Souza JA, Costa F, Souza WKSB, Reis HJL, Lopes RD, Saporito W, Machado L, Aidar Ayoub JC, 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, Gotcheva NN, Ivanova R, 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, 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, Chen J, Dong Y, Huang W, Wang J, Huang S, Yao Z, 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, Zheng Y, Li X, Peng D, Li Y, 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, Jaramillo N, Sanchez Vallejo G, Luna Botia DC, Botero Lopez R, Molina De Salazar DI, Cadena Bonfanti AJ, Diego Higuera J, Barrera Silva SI, Garcia Lozada HJ, Coronel Arroyo JA, Accini Mendoza JL, Fernandez Ruiz RL, Fernandez AM, Manzur Jatin FG, Sotomayor Herazo A, Castellanos Parada J, Urina Triana MA, Strozzi M, Car S, Miličić D, Benčić ML, Pintarić H, Prvulović Đ, Šikić J, Peršić V, Mileta D, Štambuk K, Babić Z, Spinar J, Horak D, 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, Ostadal P, Heinc P, Kuchar J, Povolny P, Poulsen SH, Raungaard B, Clemmensen P, Bang LE, May O, Bøttcher M, Hove JD, Frost L, Gislason G, Larsen J, Johansen PB, Hald F, Jeppesen J, Nielsen T, Kristensen KS, Walichiewicz PM, Lomholdt JD, Klausen IC, Nielsen PK, Davidsen F, Videbaek L, Viigimaa M, Soots M, Vahula V, Hedman A, Soopõld Ü, Märtsin K, Taskinen MR, Porthan K, Airaksinen JK, Juonala M, Kiviniemi T, Vikman S, Posio P, Taurio J, Huikuri H, Kaikkonen K, Coste P, Ferrari E, Danchin N, Morel O, Montalescot G, Barone-Rochette G, Mansourati J, Cottin Y, Steg PG, Leclercq F, Belhassane A, Delarche N, Boccara F, Paganelli F, Clerc J, Schiele F, Aboyans V, Probst V, Berland J, Lefèvre T, Chumburidze V, Khintibidze I, Shaburishvili T, Pagava Z, Ghlonti R, Lominadze Z, Khabeishvili G, Hemetsberger R, Rauch-Kröhnert U, Stratmann M, Appel KF, Schmidt E, Omran H, Stellbrink C, Dorsel T, Lianopoulos E, Marx R, Zirlik A, Schellenberg D, Heitzer T, Laufs U, Marx N, Gielen S, Winkelmann B, Behrens S, Sydow K, 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, Steiner S, Heidenreich L, Gremmler U, Killat H, Patsilinakos S, Kartalis A, Manolis A, Sionis D, Liberopoulos E, Skoumas I, Athyros V, Vardas P, Parthenakis F, Alexopoulos D, Hahalis G, Lekakis J, Xatzitolios A, Fausto Ovando SR, Montenegro Valdovinos PC, Arango Benecke JL, Rodriguez De Leon ER, Yan BPY, Siu DCW, Turi T, Merkely B, Kiss RG, Ungi I, Lupkovics G, Nagy L, Katona A, Édes I, Müller G, Horvath I, Kapin T, Faluközy J, Kumbla M, Sandhu M, Annam S, Proddutur NR, Premchand RK, Mahajan A, 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, Chopra VK, Goyal NK, Shinde R, Manakshe GV, Patki N, Sethi S, Munusamy V, Karna S, Adhyapak S, Pandurangi U, Mathur R, Kalashetti S, Bhagwat A, Raghuraman B, Yerra SK, Bhansali P, Borse R, Das S, Abdullakutty J, Saathe S, Palimkar P, Atar S, Shechter M, Mosseri M, Arbel Y, Lotan C, Rosenschein U, Katz A, Henkin Y, Francis A, Klutstein M, Nikolsky E, Turgeman Y, Halabi M, Kornowski R, Jonas M, Amir O, Rozenman Y, Fuchs S, Hussein O, Gavish D, Vered Z, Caraco Y, Elias M, Tov N, Piovaccari G, De Pellegrin A, Guardigli G, Licciardello G, Auguadro C, Cuccia C, Salvioni A, Musumeci G, Calabrò P, Novo S, Faggiano P, 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, Perrone Filardi P, Ferratini M, Dai K, Kamiya H, Ando K, Takeda Y, Morino Y, Hata Y, Kimura K, Kishi K, Michishita I, Uehara H, Higashikata T, Hirayama A, Hirooka K, 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, Furukawa Y, Sugino H, Mano T, Utsu N, Ito K, Haraguchi T, Ueda Y, Nishibe A, Fujimoto K, Yoon JH, Kim SH, Park HS, Chae IH, Kim MH, Jeong MH, Rha S, Kim C, Kim HS, Hong T, 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, Kedev S, Lozance N, Kjovkaroski A, Doncovska S, Ong TK, Kasim S, Maskon O, Kandasamy B, Yusoff K, Liew HB, Wan Mohamed WMI, García Castillo A, Ramos López GA, 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, Alings M, Breedveld RW, Hoogslag PAM, Suryapranata H, Oomen A, Wiersma JJ, Van Der Wal RMA, Hooft Van Huysduynen-Monraats PS, Karalis I, Verdel GJE, Brueren BRG, Troquay RPT, Viergever EP, Al-Windy NYY, Bartels GL, Cornel JH, Hermans WRM, Herrman JPR, Bos RJ, Groutars RGEJ, Van Der Zwaan CC, Kaplan R, Ronner E, Groenemeijer BE, Bronzwaer PNA, Liem AAH, Rensing BJWM, Bokern MJJA, Nijmeijer R, Hersbach FMRJ, Willems FF, Gosselink ATM, Elliott J, Wilkins G, Fisher R, Scott D, Hart H, Stewart R, Harding S, Ternouth I, Fisher N, Aitken D, Anscombe R, Tomala T, Nygård O, Sparby JA, Andersen K, Gullestad L, Jortveit J, Munk PS, Halvorsen S, Hurtig U, Correa Flores RM, 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, Llerena Navarro NC, Roldan Concha YM, Rodriguez Chavez VE, Anchante Hernandez HA, Zea Nunez CA, Ferrolino A, Sy RAG, Tirador L, Sy RG, Matiga G, Coching RM, Bernan A, Rogelio G, Morales DD, Tan E, Wlodarczak A, Jaworska K, Skonieczny G, Pawlowicz L, Wojewoda P, Busz-Papiez B, Bednarski J, Goch A, Staneta P, Dulak E, Budaj A, Saminski K, Krasowski W, Sudnik W, Zurakowski A, Skorski M, Lysek R, Miklaszewicz B, Kubica J, Lipko JA, Kostarska-Srokosz E, Piepiorka M, Drzewiecka A, Sciborski R, Stasiewski A, Blicharski T, Bystryk L, Szpajer M, Korol M, Czerski T, Mirek-Bryniarska E, Gniot J, Lubinski A, Gorny J, Franek E, Monteiro P, Mesquita Bastos J, Pereira HH, Martins D, Morais J, Seixo F, Mendonça C, Botelho A, Minescu B, Istratoaie O, Tesloianu DN, Dorobantu M, Cristian G, Podoleanu CGC, Constantinescu MCA, Bengus CM, Militaru C, Rosu D, Parepa IR, Matei AV, Alexandru TM, 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, Shalaev S, Khaisheva L, Chizhov P, Viktorova I, Osokina N, 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, Karpov Y, Povzun A, Egorova L, Tyrenko VV, Ivanov IG, Simic D, Ivanovic N, Davidovic G, Tasic N, Asanin MR, Stojic S, Apostolovic SR, Ilic S, Putnikovic B, Stankovic A, Arandjelovic A, Radovanovic S, Ristic AD, Balinovac J, Dincic DV, Seferovic P, Dodic S, Dimkovic S, Chua T, Poh KK, Ong HY, Micko K, Nociar J, Pella D, Fulop P, Hranai M, Palka J, Mazur J, Majercák I, Dzupina A, Fazekas F, Gonsorcik J, Bugan V, Murin J, Selecky J, Kamensky G, Strbova J, Smik R, Dukat A, Žuran I, Oklukar J, Šuligoj NČ, Cevc M, Lipar L, Cyster HP, Ranjith N, Corbett C, Bayat J, Makotoko EM, Kapp IE, Basson MMV, Lottering H, Van Zyl LJ, Sebastian PJ, Pillay T, Saaiman JA, Commerford PJ, Cassimjee S, Ebrahim IO, Sarvan M, Mynhardt JH, Dalby AJ, Reuter H, Moodley R, Vida M, Cequier Fillat AR, Bodí Peris V, Fuentes Jimenez F, Marín F, Cruz Fernández JM, Gil-Extremera B, Diz FW, 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, De Berrazueta Fernández JR, 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, Constantine G, Haniffa R, Tissera N, Amarasekera S, Fernando N, Jayawardena J, Santharaj W, Ekanayaka R, Mendis S, Senaratne V, Mayurathan G, Sirisena T, Rajapaksha A, Herath JI, Amarasena N, Berglund S, Rasmanis G, Hagström E, Witt N, Mourtzinis G, Nicol P, Hansen O, Romeo S, Jensen SA, Torstensson I, Ahremark U, Sundelin T, Moccetti T, Müller C, Mach F, Binder R, Chiang CE, Tsai WC, Ueng KC, Lai WT, Liu ME, Hwang JJ, Yin WH, Hsieh IC, Lin WH, Kuo JY, Huang TY, Fang CY, Kaewsuwanna P, Soonfuang W, Jintapakorn W, Sukonthasarn A, Sritara P, Wongpraparut N, Sastravaha K, Sansanayudh N, Kehasukcharoen W, Piyayotai D, Camsari A, Kultursay H, Guneri S, 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, Parkhomenko A, Rishko M, Kopytsya M, Yagensky A, Vatutin M, Bagriy A, Barna OM, Ushakov O, Dzyak G, Goloborodko B, Rudenko A, Trevelyan J, Zaman A, Lee K, Moriarty A, Aggarwal RK, Clifford P, Wong YK, Iqbal SMR, Subkovas E, Braganza D, Sarkar D, Storey R, Griffiths H, Mcclure S, Muthusamy R, Kurian J, Levy T, Barr C, Kadr H, Gerber R, Simaitis A, Soran H, Mathur A, Brodison A, Oliver R, Mudawi T, Reynolds T, Sharman D, Butler R, Wilkinson P, Lip GYH, Halcox J, Vardi G, Baldari D, Brabham D, Treasure C II, 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, Lieber I, Kumar P, East C, Krichmar P, White L, Knickelbine T, Haldis T, Gillespie E, Suh D, Arif I, Akhter F, Carlson E, D'Urso M, El-Ahdab F, Nelson W, Harris B, Cohen S, Carter L, Sabatino K, Haddad T, Malik A, Rao S, Mulkay A, Jovin I, Klancke K, Malhotra V, Devarapalli SK, Koren M, Chandna H, Dodds G III, Janik M, Moran J, Sumner A, Kobayashi J, Davis W, Yazdani S, Pasquini J, Thakkar M, Vedere A, Leimbach W, Rider J, Singh N, Shah AV, Moriarty PM, Janosik D, Pepine C, Berman B, Gelormini J, Daniels C, Keating F, Kondo NI, Shetty S, Waider W, Takata T, Abu-Fadel M, Shah V, Aggarwal R, Izzo M, Kumar A, Hattler B, Link C, Bortnick A, Kinzfogl G III, Ghitis A, Larry J, Teufel E, Kuhlman P, Mclaurin B, Zhang W, Thew S, Abbas J, White M, Ranadive N, Gring C, Henderson D, Schuchard T, Farhat N, Kline G, Mahal S, Whitaker J, Speirs S, Andersen R, Daboul N, Horwitz P, Jafar Z, Mcgarvey J Jr, Panchal V, Voyce S, Blok T, Sheldon W, Azizad MM, Schmalfuss C, Picone M, Herzog W Jr, Lindsey J, Nowins R, Lepor N, El Shahawy M, Weintraub H, Irimpen A, May W, Galski T, Chu A, Mody F, Hodes Z, Fairlamb J, Lambert C Jr, Raisinghani A, Abbate A, King M, Carey C, Gerber J, Younis L, Park HT, Vidovich M, Knutson T, Friedman D, Chaleff F, Loussararian A, Kimmelstiel C, Silver K, Foster M, Tonnessen G, Amlani M, Wali A, Malozzi C, Wattanakit K, O'Donnell PJ, Singal D, Jaffrani N, Banuru S, Fisher D, Xenakis M, Perlmutter N, Bhagwat R, Strader J Jr, Akyea-Djamson A, Labroo A, Lee K, Marais HJ, Claxton E Jr, Berk M, Rossi P, Joshi P, Khaira AS, Kumkumian G, Lupovitch S, Purow J, Welka S, Hoffman D, Fischer S, Soroka E, Eagerton D, Pancholy S, Ray M, Farrar M, Pollock S, French WJ, Diamantis S, Gimple L, Schwartz S, Pereira E, Spriggs D, Strain J, Vo A, Chane M, Hall J, Vijay N, Lotun K, Lester FM, Nahhas A, Pope T, Nager P, Vohra R, Bashir R, Ahmed H, Berlowitz M, Fishberg R, Barrucco R, Yang E, Radin M, Sporn D, Eisenberg S, Landzberg J, Mcgough M, Turk S, Schwartz M, Sundram PS, Jain D, Zainea M, Bayron C, Karlsberg R, Lui H, Keen W, Westerhausen D Jr, Khurana S, Agarwal H, Birchem J, Penny W Jr, Chang M, Gilbert JM, Chalavarya G, Eaton C, Schmedtje JF Jr, Christenson S, Denham D, Macdonell A, Gibson P, Rahman A, Al Joundi T, Conrad G, Kotha P, Love M, Giesler G, Rubenstein H, Akright L, Schifferdecker B, Krawczyk 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.

Abstract

BACKGROUND:

Patients who have had an acute coronary syndrome are at high risk for recurrent ischemic cardiovascular events. We sought to determine whether alirocumab, a human monoclonal antibody to proprotein convertase subtilisin-kexin type 9 (PCSK9), would improve cardiovascular outcomes after an acute coronary syndrome in patients receiving high-intensity statin therapy.

METHODS:

We conducted a multicenter, randomized, double-blind, placebo-controlled trial involving 18,924 patients who had an acute coronary syndrome 1 to 12 months earlier, had a low-density lipoprotein (LDL) cholesterol level of at least 70 mg per deciliter (1.8 mmol per liter), a non-high-density lipoprotein cholesterol level of at least 100 mg per deciliter (2.6 mmol per liter), or an apolipoprotein B level of at least 80 mg per deciliter, and were receiving statin therapy at a high-intensity dose or at the maximum tolerated dose. Patients were randomly assigned to receive alirocumab subcutaneously at a dose of 75 mg (9462 patients) or matching placebo (9462 patients) every 2 weeks. The dose of alirocumab was adjusted under blinded conditions to target an LDL cholesterol level of 25 to 50 mg per deciliter (0.6 to 1.3 mmol per liter). The primary end point was a composite of death from coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization.

RESULTS:

The median duration of follow-up was 2.8 years. A composite primary end-point event occurred in 903 patients (9.5%) in the alirocumab group and in 1052 patients (11.1%) in the placebo group (hazard ratio, 0.85; 95% confidence interval [CI], 0.78 to 0.93; P<0.001). A total of 334 patients (3.5%) in the alirocumab group and 392 patients (4.1%) in the placebo group died (hazard ratio, 0.85; 95% CI, 0.73 to 0.98). The absolute benefit of alirocumab with respect to the composite primary end point was greater among patients who had a baseline LDL cholesterol level of 100 mg or more per deciliter than among patients who had a lower baseline level. The incidence of adverse events was similar in the two groups, with the exception of local injection-site reactions (3.8% in the alirocumab group vs. 2.1% in the placebo group).

CONCLUSIONS:

Among patients who had a previous acute coronary syndrome and who were receiving high-intensity statin therapy, the risk of recurrent ischemic cardiovascular events was lower among those who received alirocumab than among those who received placebo. (Funded by Sanofi and Regeneron Pharmaceuticals; ODYSSEY OUTCOMES ClinicalTrials.gov number, NCT01663402 .).

Comment in

PMID:
30403574
DOI:
10.1056/NEJMoa1801174

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