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Safety of the PCSK9 inhibitor alirocumab: insights from 47 296 patient-years of observation

阿利罗库单抗 PCSK9 安慰剂 医学 Evolocumab公司 内科学 背景(考古学) 不利影响 糖尿病 胆固醇 内分泌学 脂蛋白 低密度脂蛋白受体 病理 古生物学 替代医学 载脂蛋白A1 生物
作者
Shaun G. Goodman,Philippe Gabríel Steg,Michael Szarek,Deepak L. Bhatt,Vera Bittner,Rafael Dı́az,Robert A. Harrington,J. Wouter Jukema,Harvey D. White,Andreas M. Zeiher,Garen Manvelian,Robert Pordy,Yann Poulouin,Wanda Stipek,Geneviève Garon,Gregory G. Schwartz,Gregory G. Schwartz,Philippe Gabríel Steg,Deepak L. Bhatt,Vera Bittner,Rafael Díaz,Shaun G. Goodman,Robert A. Harrington,J. Wouter Jukema,Michael Szarek,Harvey D. White,Andreas M. Zeiher,Pierluigi Tricoci,Matthew W. Sherwood,Kenneth W. Mahaffey,Jay M. Edelberg,Corinne Hanotin,Andreas M. Zeiher,Yukihiro Koretsune,Robert Pordy,William J. Sasiela,Jean‐François Tamby,Rafael Díaz,Philip E. Aylward,Corinne Hanotin,Peter Sinnaeve,Mirza Dilić,Renato D. Lópes,Nina Gotcheva,Shaun G. Goodman,William J. Sasiela,Jean‐François Tamby,Patricio López‐Jaramillo,Ivan Pećin,Željko Reiner,Petr Ostadal,Steen Hvitfeldt Poulsen,Margus Viigimaa,Markku S. Nieminen,Nicolas Danchin,Vakhtang Chumburidze,Nikolaus Marx,Evangelos Liberopoulos,Pablo Carlos Montenegro Valdovinos,Ivan Pećin,Róbert Gábor Kiss,Denis Xavier,Doron Zahger,Marco Valgimigli,Markku S. Nieminen,Hyo-Soo Kim,Yukihiro Koretsune,Andrejs Ērglis,Aleksandras Laucevičius,Pablo Carlos Montenegro Valdovinos,Khalid Yusoff,Róbert Gábor Kiss,Marco Alings,Harvey D. White,Doron Zahger,R. Correa,Rody G. Sy,Andrzej Budaj,João Morais,Maria Dorobanțu,Yuri Karpov,Arsen Ristić,Terrance Chua,J Murı́n,Zlatko Fras,Anthony Érico Guimarães,José Tuñón,H Asita de Silva,Rody G. Sy,Ulf Landmesser,Chern-En Chiang,Piyamitr Sritara,Sema Güneri,Alexander Parkhomenko,Kausik K. Ray,Patrick M. Moriarty,Bernard Chaitman,Sheryl F. Kelsey,Anders Olsson,Jean–Lucien Rouleau,Maarten L. Simoons,Karen P. Alexander,C Meloni,Robert S. Rosenson,Eric J.G. Sijbrands,Pierluigi Tricoci,John H. Alexander,Luciana Armaganijan,Akshay Bagai,M. Cecilia Bahit,James M. Brennan,Shaun Clifton,Adam D. DeVore,Shalonda Deloatch,Sheila Dickey,Keith Dombrowski,Grégory Ducrocq,C Meloni,Patricia Endsley,Arleen Eppinger,Robert W. Harrison,Connie Ng Hess,Mark A. Hlatky,J. Dedrick Jordan,Joshua W. Knowles,Brad J. Kolls,David F. Kong,Sergio Leonardi,Shalonda Deloatch,Renato D. Lópes,David J. Maron,Kenneth W. Mahaffey,Keith Dombrowski,Robin Mathews,Rajendra H. Mehta,Robert J. Mentz,Chetan B. Patel,Connie N. Hess,Lynn Perkins,Thomas J. Povsic,Etienne Puymirat,Matthew W. Sherwood,W. Schuyler Jones,Bimal R. Shah,Matthew W. Sherwood,Kenya Stringfellow,Darin Sujjavanich,David J. Maron,Charlene Trotter,Jill Marcus,Matthew D. Wilson,Andrew T. Yan,Lilia Schiavi,Marcelo Garrido,Andrés Alvarisqueta,Sonia Sassone,Anselmo Bordonava,Alberto Enrique Alves de Lima,Jorge M Schmidberg,Ernesto Duronto,Rodolfo Ahuad Guerrero,Leonardo P Novaretto,Miguel Angel Hominal,Oscar Montaña,Alberto Caccavo,Ricardo Dran,Alberto Lorenzatti,Luis Cartasegna,Pablo Guzman,Ignacio MacKinnon,Daniela Garcia Brasca,Marcos Amuchastegui,Oscar Salomone,Oscar R Codutti,Horacio O Jure,Alberto Enrique Alves de Lima,Adrián Hrabar,Julio Vallejos,Rodolfo A. Ahuad Guerrero,Federico Novoa,Cristian A Patocchi,Cesar Javier Zaidman,María Elena Giuliano,Ricardo Dario Dran,Silvia Saavedra,G. Carnero,Osvaldo Costamagna,Juan C Medrano Allende,Daniela F Garcia Brasca,Miguel H Bustamante Labarta,S Nani,Oscar R Codutti,Hugo Colombo,Alberto Liberman,Adrián Hrabar,Héctor Luciardi,Gabriel Waisman,David Colquhoun,Romulo Oqueli Flores,Philip Roberts-Thomson,H Luquez,Jorge Giordano,Constantine Aroney,Gerardo Zapata,Osvaldo Costamagna,Juan C Medrano Allende,J. Waites,Nicholas Collins,S Nani,Philip E. Aylward,Eduardo Ds Blumberg,Philip E. Aylward,Hugo Colombo,Margaret Arstall,John D. Horowitz,Héctor Luciardi,James Frederick Rogers,David Colquhoun,Romulo E Oqueli Flores,Philip Roberts-Thomson,H Luquez,Sam J. Lehman,Constantine Aroney,Steven G.M. Coverdale,P. Garrahy,G. Starmer,J. Waites,Patrick A. Carroll,Ronald Dick,Robert Zweiker,Uta Hoppe,Corinne Hanotin,Kurt Huber,Rudolf Berger,Georg Delle-Karth,Bernhard Frey,Daniel M. Ninio,James Frederick Rogers,B. Pirenne,Attilio Leone,E Hoffer,Peter Sinnaeve,Mathias C.M. Vrolix,Luc De Wolf,Bart Wollaert,Marc Castadot,Karl Dujardin,G. Starmer,Geert Vervoort,Harry Striekwold,R. Nässel Dick,Robert Zweiker,Emanuele Barbato,Marc J. Claeys,Frank Cools,Ibrahim Terzić,Fahir Baraković,Zlatko Midzic,Belma Pojskić,Kurt Hermans,Mirza Dilić,B. Pirenne,Mehmed Kulić,E Hoffer,Adis Muslibegovic,Boris Goronja,Gilmar Reis,Luciano Fernandes Sousa,José Carlos Nicolau,Jose Moura Jorge,Ricardo Pereira Silva,Lília Nigro Maia,Harry Striekwold,Paulo Rf Rossi,John Roosen,Norberto Duda,Marc J. Claeys,Adrian Kormann,Ibrahim Terzić,Fahir Baraković,Zlatko Midzic,Mayler O.N. de Santos,Emir Fazlibegović,Luiz Carlos Bodanese,Elena Velcheva,Freddy Goldberg Eliaschewitz,Maria Helena Vidotti,Paulo Leães,Roberto Botelho,Sérgio Kaiser,Euler Roberto Fernandes Manenti,Dalton Bertolim Précoma,José Carlos Moura Jorge,Pedro Silva,José Alexandre Silveira,Wladmir Faustino Saporito,José Antônio Marin‐Neto,Gílson Soares Feitosa,Luiz Eduardo Fonteles Ritt,Juliana Almeida-de-Souza,Fernando Costa,Jose Antonio M Abrantes,Helder José Lima Reis,Renato D. Lópes,Leandro Machado,José Carlos Aidar Ayoub,Fernando Carvalho Neuenschwander,Fedya Nikolov,Elena S Velcheva,Maria Tzekova,Haralambi Benov,Stanislav L Petranov,Haralin S Tumbev,Nina S Shehova-Yankova,Eric Sabbah,Dimitar Raev,Simon Kouz,Kostadin N Kichukov,Ariel Diaz,Nina Gotcheva,Wladmir Faustino Saporito,Maryana Gospodinov,Valentina Mincheva,Luiz Eduardo Fonteles Ritt,Bojidar Dimov,Manohara Senaratne,James Stone,Helder José Lima Reis,Danielle Dion,Daniel Savard,Yves Pesant,Fedya Nikolov,Simon D. Robinson,Carlos Peña,Haralambi Benov,Stanislav L Petranov,Ronald Bourgeois,Anne Morisset,Eric Sabbah,Dimitar Raev,Simon Kouz,Paul C. MacDonald,Ariel Diaz,Nina Gotcheva,Raya Ivanova,Tycho Vuurmans,Christopher C. Lai,Bojidar Dimov,Richard Davies,Gustavo Nogareda,Jan Kornder,Stephen Pearce,Danielle Dion,Daniel Savard,Yves Pesant,Robert E. Dupuis,Peter Fong,Sohrab Lutchmedial,Saul Vizel,Hussein Fadlallah,David Cleveland,Thao Huynh,Iqbal Bata,Bruce Sussex,Simon Kouz,Sergio Potthoff,Juan Carlos Prieto,Mónica Acevedo,Arnoldo Aguirre,Margarita Véjar,Tycho Vuurmans,Christopher C. Lai,Mauricio Fernandez,Luis Perez,Paola Varleta,Ram Vijayaraghavan,Laura Huidobro,C. A. Raffo,Claudia Olivares,James Cha,Robert E. Dupuis,Peter C.C. Fong,Sohrab Lutchmedial,Weijian Huang,Jianzhong Wang,David Cleveland,Zhuhua Yao,Iqbal Bata,Adnan Hameed,Wenhua Lin,Sergio Potthoff,Jingfeng Wang,Jianping Li,Xuelian Zhang,Margarita Véjar,Dandan Chen,Lan Huang,Shaohong Dong,Luis C. Velázquez Pérez,Paola Varleta,Xi Su,Xiaoshu Cheng,C. A. Raffo,Claudia Olivares,Huanming Li,Humberto Montecinos,Dingli Xu,Xinchun Yang,Yuannan Ke,Xuefeng Lin,Zheng Zhang,Zhuhua Yao,Zhurong Luo,Yundai Chen,Chunhua Ding,Yi Zhong,Yang Zheng,Xiaodong Li,Daoquan Peng,Shui‐Ping Zhao,Ying Li,Lan Huang,Meng Wei,Shaowen Liu,Yihua Yu,Baiming Qu,Weihong Jiang,Yujie Zhou,Xingsheng Zhao,Huanming Li,Ying Guo,Xiping Xu,Xubo Shi,Yuan-nan Ke,Guosheng Fu,Feng Bai,Weiyi Fang,Xiling Shou,Xiangjun Yang,Jian'An Wang,Meixiang Xiang,Yingxian Sun,Qinghua Lu,Ruiyan Zhang,Jianhua Zhu,Yizhou Xu,Zhongcai Fan,Tianchang Li,Chun Wu,Nicolas Jaramillo,Baiming Qu,Diana C Luna Botia,Rodrigo Botero Lopez,Dora I. Molina,Dean Mileta,Ying Guo,Juan Diego Higuera,Marco Blanquicett,Sandra I Barrera Silva,Stanka Mejic-Krstulovic,Julian A Coronel Arroyo,J.L. Mendoza,David Horak,Álvaro M. Quintero- Ossa,Josef Stasek,Aristides Sotomayor Herazo,Jeffrey Castellanos Parada,Qinghua Lu,Miguel A Urina Triana,Angelina Trujillo,Maja Strozzi,Siniša Car,Tianchang Li,Martina Lovrić Benčić,Hrvoje Pintarić,Đeiti Prvulović,Jozica Šikić,Viktor Peršić,Dean Mileta,Kresimir Štambuk,Zdravko Babić,Vjekoslav Tomulic,Josip Lukenda,Stanka Mejic-Krstulovic,Boris Starčević,Jindřich Špinar,David Horak,Zdenek Velicka,Josef Stasek,David Alan,Vilma Machova,Ales Linhart,Vojtěch Novotný,Vladimír Kaučák,Richard Rokyta,Robert Náplava,Zdeněk Coufal,Věra Adámková,Ivo Podpera,Jiri Zizka,Zuzana Moťovská,Jozica Šikić,Premysl Svab,Petr Ostadal,Dean Mileta,Jiri Kuchar,Zdravko Babić,Jiří Matuška,Steen Hvitfeldt Poulsen,Bent Raungaard,Peter Clemmensen,Lia E. Bang,Ole May,Morten Bøttcher,Jens D. Hove,David Alan,Gunnar Gislason,John Larsen,Peter Betton Johansen,Flemming Hald,Peter Johansen,Jørgen Jeppesen,Tonny Nielsen,Kjeld Kristensen,Ivo Podpera,Jens Lomholdt,Ib Christian Klausen,Peter Kaiser Nielsen,Přemysl Šváb,Lars Videbæk,Margus Viigimaa,Petr Heinc,Jiří Kuchař,Petr Povolny,Üllar Soopõld,Kaja Märtsin,Bent Raungaard,Arved Kristjan,Markku S. Nieminen,Heikki V. Huikuri,Pierre Coste,Émile Ferrari,Nicolas Danchin,Olivier Morel,Gilles Montalescot,Jacques Machecourt,Gilles Barone-Rochette,Jacques Mansourati,Flemming Hald,Philippe Gabríel Steg,Florence Leclercq,Abdelkader Belhassane,Nicolas Delarche,Kjeld Kristensen,Franck Paganelli,Jens Lomholdt,François Schiele,Victor Aboyans,Vincent Probst,Jacques Berland,Thierry Lefèvre,Bernard Citron,Vakhtang Chumburidze,Irakli Khintibidze,Anu Hedman,Üllar Soopõld,Ramaz Ghlonti,Nicole Toursarkissian,George Khabeishvili,Markku S. Nieminen,Heikki V. Huikuri,Ursula Rauch-Kröhnert,Émile Ferrari,Karl-Friedrich Appel,Ekkehard Schmidt,Heyder Omran,J Machecourt,Thomas Dorsel,Emmanouil Lianopoulos,Yves Cottin,R. Marx,Andreas Zirlik,Detlev Schellenberg,Thomas Heitzer,Ulrich Laufs,Christian Werner,Nikolaus Marx,Stephan Windecker,François Schiele,Bernhard Winkelmann,Steffen Behrens,Karsten Sydow,Mahir Karakas,Gregor Simonis,Thomas Münzel,Irakli Khintibidze,Stefan Stadler,Zurab Pagava,Ramaz Ghlonti,Nicole Toursarkissian,Michael Jeserich,Matthias Weißbrodt,Tim Schaeufele,Ursula Rauch-Kröhnert,Matthias Stratmann,Karl‐Friedrich Appel,Mohammed Natour,Susanne Schmitt,Dirk Müller‐Wieland,Stephan Steiner,Lothar Heidenreich,Elmar Offers,R. Marx,Holger Killat,Werner Rieker,Thomas Heitzer,Athanasios Kartalis,Athanassios Manolis,Dimitrios Sionis,Geargios Chachalis,Evangelos Liberopoulos,Ioannis Skoumas,Vasilios G. Athyros,Steffen Behrens,Karsten Sydow,Dimitrios Alexopoulos,George Hahalis,Mahir Karakas,Gregor Simonis,Abhijeet Joshi,Pablo Carlos Montenegro Valdovinos,Juan L Arango Benecke,Santanu Guha,Bryan P.Y. Yan,Deyond Y.W. Siu,Nicole Toursarkissian,Michael Jeserich,Róbert Gábor Kiss,Imre Ungi,Géza Lupkovics,Joachim Weil,András Katona,István Édes,Mohammed Natour,Susanne Schmitt,Tibor Kapin,Zsolt Szigeti,József Faluközy,Mukund Kumbla,Manjinder S. Sandhu,Sharath Anugula,Werner Rieker,S Patsilinakos,Rajendra K. Jain,Ajaykumar Mahajan,Dimitrios Sionis,Jugal Gupta,Prafulla Kerkar,Ajit Bhagwat,Abraham Oomman,Dhurjati Prasad Sinha,Prasant Bhansali,Dhiman Kahali,J.P.S. Sawhney,Abhijeet Joshi,Sanjeev Chaudhary,Pankaj Harkut,Santanu Guha,Sanjay Porwal,Srimannarayana Jujjuru,Ramesh Babu Pothineni,Shaul Atar,Aziz Khan,Shamanna S. Iyengar,Géza Lupkovics,L Nagy,Mahesh Fulwani,Dr Aparna Patange,Patil Sachin,Vijay Chopra,Naresh Goyal,Rituparna S. Shinde,József Faluközy,Mukund Kumbla,Sumeet Sethi,Sharath Anugula,Sunil Karnaand Sunil Thanvi,Srilakshmi Adhyapak,Chandrakant Patil,Ulhas M. Pandurangi,Rishabh Mathur,Jugal Gupta,Suhas Kalashetti,Ajit Bhagwat,Abraham Oomman,Shiv Kumar Yerra,Prasant Bhansali,Rohidas Borse,Patil Rahul,Abhijeet Joshi,Vinay Kumar,Pankaj Harkut,Shireesh Saathe,Priya Palimkar,J Srimannarayana,Shireesh Sathe,Shaul Atar,Michael Shechter,Morris Mosseri,Yaron Arbel,Manoj Chopda,Mahesh Fulwani,Chaim Lotan,Uri Rosenschein,Vijay Chopra,Yaakov Henkin,Rituparna S. Shinde,Marc Klutstein,Eugenia Nikolsky,Robert Zukermann,Yoav Turgeman,Majdi Halabi,Srilakshmi M. Adhyapak,Ran Kornowski,Michael Jonas,Rishabh Mathur,Yonathan Hasin,Yoseph Rozenman,Ajit Bhagwat,Bagirath Raghuraman,Osamah Hussein,Prasant Bhansali,Rohidas Borse,Yoseph Caraco,Mazen Elias,Naveh Tov,Efrat Wolfovitz,Michael Lishner,Priya Palimkar,Giancarlo Piovaccari,Annamaria De Pellegrin,Shaul Atar,Michael Shechter,Valgimigli Marco,Yaron Arbel,Ehud Chorin,Filippo Scalise,Claudio Cuccia,Uri Rosenschein,Giuseppe Musumeci,Yaakov Henkin,Adi Francis,Salvatore Novo,Eugenia Nikolsky,Marco Metra,Nicoletta B. de Cesare,Majdi Halabi,Alon Marmor,Enrico Puccioni,Marcello Galvani,Alfonso Ielasi,PierMarco Piatti,Yoseph Rozenman,Giuseppe De Luca,Roberto Violini,Alessandro De Leo,Zoran Olivari,Pasquale Perrone Filardi,Yoseph Caraco,Vittorio Racca,Naveh Tov,Yuji Shimatani,Michael Lishner,Nizar Elias,Yoshihiro Takeda,Yoshihiro Morino,Raffaella Garbelotto,Gabriele Guardigli,Koichi Kishi,Giovanni Licciardello,Hiroki Uehara,Filippo Scalise,Atsushi Hirayama,Keiji Hirooka,Yasuji Doi,Satoru Sakagami,Shuichi Taguchi,Akihiro Koike,Pompilio Faggiano,Shinji Koba,Nicoletta B. de Cesare,Tomohiro Kawasaki,Claudio Cavallini,Enrico Puccioni,Yousuke Katsuda,Atsuyuki Wada,Toshiro Shinke,Markku S. Nieminen,Michela Palvarini,Kenshi Fujii,Toshiyuki Takahashi,Alessandro De Leo,Zoran Olivari,Yutaka Furukawa,Hiroshi Sugino,Ritsu Tamura,Toshiaki Mano,Masaaki Uematsu,Hajime Kamiya,Kenji Ando,Takuya Haraguchi,Katsuhiko Sato,Yasunori Ueda,Akira Nishibe,Koichi Kishi,Ichiro Michishita,Akira Nishibe,Koichi Kishi,Junghan Yoon,Yukihiro Koretsune,Hack‐Lyoung Kim,Hun Sik Park,Keiji Hirooka,Moo Hyun Kim,Satoru Sakagami,Seung‐Woon Rha,Chongjin Kim,Hyo-Soo Kim,Haeyoung Kim,Taek-Jong Hong,Seung‐Jea Tahk,Young-Kwon Kim,Rodrigo Suarez Otero,Guillermo Fanghänel Salmón,Jesús Antonio Pérez Ríos,Iveta Mintāle,Shinke Toshiro,Ž. Petrulionienė,Roma Kavaliauskiene,Rūta Jurgaitienė,Gintarė Šakalytė,Rimvydas Slapikas,Sigutė Norkienė,Nerijus Misonis,Aleksandras Kibarskis,Ritsu Tamura,Stojko Bojovski,Pablo Carlos Montenegro Valdovinos,N Lozance,Noriaki Utsu,Snezana Doncovska,Takuya Haraguchi,Katsuhiko Sato,Oteh Maskon,Akira Nishibe,Khalid Yusoff,Houng Bang Liew,Motomaru Masutani,Akira Nishibe,Róbert Gábor Kiss,Kazuteru Fujimoto,Pedro Fajardo Campos,Juan Carlos Núñez Fragoso,Hack‐Lyoung Kim,Hun Sik Park,Jaime Carranza Madrigal,Luis Gerardo González Salas,Enrique López Rosas,Belinda González Díaz,Eduardo Salcido Vázquez,Hae Young Kim,Taek-Jong Hong,Carlos Rodolfo Martínez Sánchez,María Guerrero de Leon,Rodrigo Suarez Otero,Guillermo Fanghänel Salmón,Jesús Antonio Pérez Ríos,Iveta Mintāle,Marco Alings,Rob Breedveld,Ž. Petrulionienė,Roma Kavaliauskiene,Rūta Jurgaitienė,Gintarė Šakalytė,Antonius Oomen,Sigutė Norkienė,Nerijus Misonis,Jacobijne J. Wiersma,Raimondas Kubilius,Stojko Bojovski,Peter Zwart,N Lozance,Henricus van Kesteren,Ioannis Karalis,Tiong Kiam Ong,Gerardus J.E. Verdel,Bart R.G. Brueren,Balachandran Kandasamy,Eric P. Viergever,Nadea Y.Y. Al-Windy,G. L. Bartels,Jan H. Cornel,Walter R.M. Hermans,Pedro Fajardo Campos,Robert Bos,Edmundo Alfredo Bayram Llamas,Reynaldo Castillo Leon,Jaime Carranza Madrigal,Raymond Lionarons,Enrique Lopez Rosas,Björn E. Groenemeijer,Eduardo Salcido Vazquez,Alfredo Nacoud Ackar,Guillermo Antonio Llamas Esperón,Marcel J.J.A. Bokern,R. Nijmeijer,Ferry M R J Hersbach,Frank F. Willems,Jesus Antonio Perez Rios,Saman Rasoul,John Elliott,Gerard T. Wilkins,Raewyn Fisher,Douglas Scott,Pieter Hoogslag,Ralph Stewart,Scott Harding,Ian Ternouth,Nicholas G. Fisher,Samuel E. Wilson,Grzegorz Skonieczny,Russell Anscombe,Charles J. Davidson,Tadeusz Tomala,Ottar Nygård,Ioannis Karalis,Kjell Andersen,Lars Gullestad,Jarle Jortveit,Peter Scott Munk,Eric P. Viergever,Doron Zahger,Nadea Al-Windy,R. Correa,Beata Miklaszewicz,Julio R Durand Velasquez,Jan Andrzej Lipko,Enrique S Sanabria Perez,Jesus M Carrion Chambilla,Carlos Antero Chavez Ayala,Reynaldo P Castillo Leon,Arkadiusz Stasiewski,Jose D Hernandez Zuniga,Luis A Camacho Cosavalente,Jorge E Bravo Mannucci,Javier Heredia Landeo,Nassip C Llerena Navarro,Yudy M Roldan Concha,Víctor E Rodriguez Chavez,Henry Hernandez,Jerzy Gorny,Frank F. Willems,Arthur Ferrolino,Rosa Allyn Sy,Louie Tirador,Rody G. Sy,Generoso Matiga,Raewyn Fisher,Douglas Scott,Gregorio Rogelio,Dante D. Morales,Edgar Tan,I. Ternouth,Nicholas G. Fisher,Krystyna Jaworska,Grzegorz Skonieczny,Silviu Dumitrescu,Pawel Wojewoda,Tadeusz Tomala,Janusz Bednarski,Aleksander Goch,Pawel Staneta,Elzbieta Dulak,Andrzej Budaj,Krzysztof Saminski,Wlodzimierz Krasowski,Wanda Sudnik,Aleksander Żurakowski,Marcin Skorski,Roman Lysek,Beata Miklaszewicz,Jacek Kubica,Jan Andrzej Lipko,Edyta Kostarska-Srokosz,Marek Piepiorka,Anna Drzewiecka,Reynaldo P Castillo Leon,Arkadiusz Stasiewski,Jose D Hernandez Zuniga,Raisa Stryuk,Michał Szpajer,Marek Korol,Tomasz Czerski,Yudy M Roldan Concha,Jacek Gniot,Andrzej Lubiński,Jerzy Gorny,Edward Franek,Grzegorz Raczak,Rosa Allyn Sy,Pedro Monteiro,José Mesquita-Bastos,Hélder Pereira,Dinis Martins,João Morais,Filipe Seixo,Carlos Mendonça,Dante D. Morales,Francisca Caetano,Bogdan Minescu,Adrian Włodarczak,Dan Tesloianu,Maria Dorobanțu,G. 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Ball,Jay Anderson,Christelle Berthou,Kishor Vora,Christelle Lorenzato,James Welker,Valerie Gouet,Andreas M. Zeiher,Flávia Egydio,Anelise Kawakami,Janaina Oliveira,Christelle Rondel,Julianna Wozniak,Pascale Beltran,Pauline Barraud,Helene Dubois-Gache,Lisa G. Berdan,Lamia Metwally,Maxime Mourgues,Marc Sotty,Tyrus Rorick,Raluca Cotruta,Zhu Chengyue,Andrea Pascual,Christine Morrello,Aurelie Perthuis,Madeleine Bezault,Isabelle Zobouyan,Helen M. Colhoun,Michael Dempsey,Mark Mcclanahan
出处
期刊:European Heart Journal - Cardiovascular Pharmacotherapy [Oxford University Press]
卷期号:10 (4): 342-352
标识
DOI:10.1093/ehjcvp/pvae025
摘要

The ODYSSEY OUTCOMES trial, comprising over 47 000 patient-years of placebo-controlled observation, demonstrated important reductions in the risk of recurrent ischaemic cardiovascular events with the monoclonal antibody to proprotein convertase subtilisin/kexin type 9 alirocumab, as well as lower all-cause death. These benefits were observed in the context of substantial and persistent lowering of low-density lipoprotein cholesterol with alirocumab compared with that achieved with placebo. The safety profile of alirocumab was indistinguishable from matching placebo except for a ∼1.7% absolute increase in local injection site reactions. Further, the safety of alirocumab compared with placebo was evident in vulnerable groups identified before randomization, such as the elderly and those with diabetes mellitus, previous ischaemic stroke, or chronic kidney disease. The frequency of adverse events and laboratory-based abnormalities was generally similar to that in placebo-treated patients. Thus, alirocumab appears to be a safe and effective lipid-modifying treatment over a duration of at least 5 years.
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