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Shaun G. Goodman, P. Steg, M. Szarek, Deepak L. Bhatt, Vera A Bittner, Rafael Diaz, Robert A Harrington, J. Jukema, Harvey D. White, Andreas M. Zeiher, G. Manvelian, R. Pordy, Y. Poulouin, W. Stipek, Geneviève Garon, G. Schwartz, Gregory G Ph Gabriel Deepak L Vera A Rafael Shaun G Robert Schwartz Steg Bhatt Bittner Diaz Goodman Harringto, G. Schwartz, P. Steg, Deepak L. Bhatt, Vera A Bittner, Rafael Diaz, Shaun G. Goodman, Robert A Harrington, J. Jukema, M. Szarek, Harvey D. White, Andreas M. Zeiher, P. Tricoci, Matthew T. Roe, K. Mahaffey, Jay M. Edelberg, C. Hanotin, G. Lecorps, A. Moryusef, R. Pordy, W. Sasiela, J. Tamby, P. Aylward, Heinz Drexel, Peter Sinnaeve, M. Dilić, Renato D Lopes, Nina Gotcheva, J. Prieto, Huo Yong, Patricio López-Jaramillo, I. Pećin, Željko Reiner, Petr Ošťádal, S. H. Poulsen, M. Viigimaa, Markku S Nieminen, N. Danchin, Vakhtang Chumburidze, Nikolaus Marx, E. Liberopoulos, P. Valdovinos, Hung Fat Tse, R. G. Kiss, Denis Xavier, D. Zahger, M. Valgimigli, Takeshi Kimura, Hyo‐Soo Kim, Sang-Hyun Kim, A. Erglis, A. Laucevičius, S. Kedev, Khalid Yusoff, Gabriel Arturo Ramos López, M. Alings, Sigrun Halvorsen, Roger M Correa Flores, R. Sy, A. Budaj, João Morais, M. Dorobantu, Yuri Karpov, Arsen D Ristić, Terrance Chua, Jan Murin, Zlatko Fras, A. Dalby, José Tuñón, H. A. de Silva, Emil Hagström, Ulf Landmesser, Chern-En Chiang, P. Sritara, S. Guneri, Alexander Parkhomenko, Kausik K. Ray, P. M. Moriarty, Bernard Chaitman, Sheryl F. Kelsey, Anders G. Olsson, Jean-Lucien Rouleau, M. Simoons, Karen Alexander, Chiara Meloni, Robert S. Rosenson, Eric J G Sijbrands, John H. Alexander, Luciana Armaganijan, A. Bagai, M. Bahit, J. M. Brennan, Shaun Clifton, A. DeVore, Shalonda Deloatch, Sheila Dickey, Keith Dombrowski, Grégory Ducrocq, Zubin J. Eapen, P. Endsley, Arleen Eppinger, Robert W Harrison, Connie N. Hess, M. Hlatky, J. Dedrick Jordan, J. Knowles, Bradley J. Kolls, David F Kong, Sergio Leonardi, L. Lillis, David J. Maron, Jill Marcus, Robin Mathews, R. Mehta, R. J. Mentz, Chetan B Patel, Sabrina Bernardez Pereira, Lynn Perkins, T. Povsic, E. Puymirat, W. S. Jones, Bimal R. Shah, Matthew W Sherwood, Kenya Stringfellow, Darin Sujjavanich, Mustafa Toma, Charlene Trotter, Sean F P van Diepen, Matthew D Wilson, Andrew Tze-Kay Yan, Lilia Schiavi, Marcelo Garrido, A. Alvarisqueta, Sonia A Sassone, Anselmo P Bordonava, Alberto E Alves De Lima, Jorge M Schmidberg, Ernesto A Duronto, Orlando C Caruso, Leonardo P Novaretto, M. Hominal, Oscar R Montaña, A. Caccavo, O. Vilamajó, A. Lorenzatti, L. Cartasegna, G. Paterlini, Ignacio J Mackinnon, Guillermo D Caime, M. Amuchastegui, Oscar Salomone, Oscar R Codutti, H. Jure, Julio O E Bono, Adrian D Hrabar, Julio A Vallejos, R. A. A. Guerrero, Federico Novoa, Cristian A Patocchi, C. Zaidman, Maria E Giuliano, R. Dran, Marisa L. Vico, Gabriela S. Carnero, Pablo N Guzman, Juan C Medrano Allende, Daniela F Garcia Brasca, M. B. Labarta, Sebastian Nani, E. D. Blumberg, Hugo R Colombo, Alberto Liberman, V. Fuentealba, H. L. Luciardi, G. D. Waisman, M. Berli, R. Garcia Duran, Horacio G. Cestari, Hugo A Luquez, J. Giordano, Silvia S Saavedra, Gerardo Zapata, O. Costamagna, Susana C Llois, Jonathon H Waites, Nicholas Collins, A. Soward, Chris L S Hii, James Shaw, Margaret A. Arstall, John Horowitz, Daniel Ninio, James F Rogers, David Colquhoun, Romulo E Oqueli Flores, P. Roberts-Thomson, Owen Raffel, Sam J Lehman, Con Aroney, Steven G M Coverdale, P. Garrahy, Gregory Starmer, Mark Sader, Patrick A Carroll, R. Dick, R. Zweiker, Uta Hoppe, Kurt Huber, Rudolf Berger, G. Delle-Karth, Bernhard Frey, D. Faes, K. Hermans, B. Pirenne, A. Leone, Etienne Hoffer, Mathias C M Vrolix, L. De Wolf, B. Wollaert, Marc Castadot, K. Dujardin, Christophe Beauloye, G. Vervoort, H. Striekwold, C. Convens, John Roosen, Emanuele Barbato, Marc J. Claeys, F. Cools, I. Terzić, Fahir Baraković, Z. Midzić, B. Pojskić, E. Fazlibegović, A. Durak-Nalbantić, M. Kulić, D. Vulic, A. Muslibegovic, B. Goronja, Gilmar Reis, Luciano Sousa, Jose C. Nicolau, F. Giorgeto, Ricardo P Silva, L. N. Maia, Rafael Rech, Paulo R F Rossi, M. J. A. Cerqueira, Norberto Duda, Renato Kalil, A. Kormann, José Antonio M Abrantes, Pedro Pimentel Filho, A. Soggia, M. De Santos, F. Neuenschwander, L. C. Bodanese, Yorghos L Michalaros, F. G. Eliaschewitz, M. Vidotti, P. Leães, Roberto V Botelho, Sergio Kaiser, Euler Roberto F Fernandes Manenti, D. B. Précoma, Jose C Moura Jorge, Pedro Silva, Jose A Silveira, W. Saporito, Jose A Marin Neto, Gilson S Feitosa, L. Ritt, Juliana A de Souza, Fernando Costa, Weimar K S B Souza, Helder J L Reis, Leandro Machado, José Carlos Aidar Ayoub, Georgi V Todorov, Fedya Nikolov, Elena S Velcheva, Maria L Tzekova, H. Benov, Stanislav L Petranov, Haralin S Tumbev, Nina S Shehova-Yankova, Dimitar T Markov, D. Raev, Mihail N Mollov, K. Kichukov, Katya A Ilieva-Pandeva, Raya Ivanova, Maryana Gospodinov, V. Mincheva, Petar V Lazov, Bojidar I Dimov, M. Senaratne, James Stone, J. Kornder, Danielle Dion, D. Savard, Y. Pesant, Amrit Pandey, Simon Robinson, Gilbert Gosselin, S. Vizel, Gordon Hoag, R. Bourgeois, Anne Morisset, Eric Sabbah, B. Sussex, S. Kouz, Paul MacDonald, Ariel Diaz, Nicolas Michaud, David Fell, T. Vuurmans, Christopher Lai, Frank Nigro, Richard Davies, Gustavo Nogareda, Ram Vijayaraghavan, J. Ducas, Serge Lepage, Shamir R Mehta, James Cha, Robert Dupuis, Peter Fong, S. Lutchmedial, J. Rodés‐Cabau, Hussein Fadlallah, David Cleveland, T. Huynh, I. Bata, A. Hameed, Cristian Pincetti, S. Potthoff, J. Prieto, Monica Acevedo, Arnoldo Aguirre, Margarita Vejar, Mario Yañez, G. Araneda, Mauricio Fernandez, Luis Perez, P. Varleta, Fernando Florenzano, Laura Huidobro, Carlos A Raffo, Claudia Olivares, Leonardo Nahuelpan, H. Montecinos, Jiyan Chen, Yugang Dong, Weijian Huang, Jianzhong Wang, Shi'An Huang, Zhuhua Yao, Xiang Li, Lan Cui, Wenhua Lin, Yuemin Sun, Jingfeng Wang, Jianping Li, Xuelian Zhang, Hong Zhu, Dandan Chen, Lan Huang, Shaohong Dong, Guohai Su, Biao Xu, Xi Su, Xiaoshu Cheng, Jinxiu Lin, Wenxia Zong, Huanming Li, Yi Feng, Dingli Xu, Xinchun Yang, Yuannan Ke, Xuefeng Lin, Zheng Zhang, Zeqi Zheng, Zhurong Luo, Yundai Chen, Chunhua Ding, Yi Zhong, Yang Zheng, Xiaodong Li, Daoquan Peng, Shuiping Zhao, Ying Li, Xuebo Liu, Meng Wei, Shaowen Liu, Yihua Yu, Baiming Qu, Weihong Jiang, Yujie Zhou, Xingsheng Zhao, Zuyi Yuan, Ying Guo, Xiping Xu, Xubo Shi, Junbo Ge, 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, G. Vallejo, Diana C Luna Botia, Rodrigo Botero Lopez, Dora I Molina De Salazar, A. J. Cadena Bonfanti, Carlos Cotes Aroca, Juan Diego Higuera, Marco Blanquicett, Sandra I Barrera Silva, H. G. Lozada, Julian A Coronel Arroyo, J. L. Accini Mendoza, Ricardo L Fernandez Ruiz, Álvaro M. Quintero- Ossa, Fernando G Manzur Jatin, Arístides Sotomayor Herazo, Jeffrey Castellanos Parada, Rafael Suarez Arambula, Miguel A Urina Triana, Á. M. Fernández Trujillo, Maja Strozzi, Siniša Car, M. Jerić, M. L. Benčić, H. Pintarić, Đeiti Prvulović, J. Šikić, V. Peršić, D. Mileta, K. Štambuk, Z. Babić, Vjekoslav Tomulić, Josip Lukenda, Stanka Mejic-Krstulovic, Boris Starčević, J. Špinar, David Horak, Z. Velicka, Josef Stasek, David Alan, Vilma Machova, Aleš Linhart, Vojtech Novotny, Vladimír Kaučák, Richard Rokyta, R. Náplava, Z. Coufal, Vera Adamkova, I. Podpera, Jiri Zizka, Z. Motovska, Ivana Marušincová, Premysl Svab, Petr Heinc, J. Kuchar, P. Povolny, Jiri Matuska, S. H. Poulsen, Bent Raungaard, Peter M. Clemmensen, Lia E Bang, Ole May, Morten Bøttcher
3 20. 4. 2024.

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

Abstract 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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