1. Safety of the PCSK9 inhibitor alirocumab: insights from 47 296 patient-years of observation
- Author
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Goodman, Shaun G, Steg, Philippe Gabriel, Szarek, Michael, Bhatt, Deepak L, Bittner, Vera A, Diaz, Rafael, Harrington, Robert A, Jukema, J Wouter, White, Harvey D, Zeiher, Andreas M, Manvelian, Garen, Pordy, Robert, Poulouin, Yann, Stipek, Wanda, Garon, Genevieve, Schwartz, Gregory G, Steg, Ph Gabriel, Tricoci, Pierluigi, Roe, Matthew T, Mahaffey, Kenneth W, Edelberg, Jay M, Hanotin, Corinne, Lecorps, Guillaume, Moryusef, Angèle, Sasiela, William J, Tamby, Jean-François, Aylward, Philip E, Drexel, Heinz, Sinnaeve, Peter, Dilic, Mirza, Lopes, Renato D, Gotcheva, Nina N, Prieto, Juan-Carlos, Yong, Huo, López-Jaramillo, Patricio, Pećin, Ivan, Reiner, Zeljko, Ostadal, Petr, Poulsen, Steen Hvitfeldt, Viigimaa, Margus, Nieminen, Markku S, Danchin, Nicolas, Chumburidze, Vakhtang, Marx, Nikolaus, Liberopoulos, Evangelos, Valdovinos, Pablo Carlos Montenegro, Tse, Hung-Fat, Kiss, Robert Gabor, Xavier, Denis, Zahger, Doron, Valgimigli, Marco, Kimura, Takeshi, Kim, Hyo Soo, Kim, Sang-Hyun, Erglis, Andrejs, Laucevicius, Aleksandras, Kedev, Sasko, Yusoff, Khalid, López, Gabriel Arturo Ramos, Alings, Marco, Halvorsen, Sigrun, Flores, Roger M Correa, Sy, Rody G, Budaj, Andrzej, Morais, Joao, Dorobantu, Maria, Karpov, Yuri, Ristic, Arsen D, Chua, Terrance, Murin, Jan, Fras, Zlatko, Dalby, Anthony J, Tuñón, José, de Silva, H Asita, Hagström, Emil, Landmesser, Ulf, Chiang, Chern-En, Sritara, Piyamitr, Guneri, Sema, Parkhomenko, Alexander, Ray, Kausik K, Moriarty, Patrick M, Chaitman, Bernard, Kelsey, Sheryl F, Olsson, Anders G, and Rouleau, Jean-Lucien
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Clinical Trials and Supportive Activities ,Patient Safety ,Clinical Research ,6.1 Pharmaceuticals ,Good Health and Well Being ,Humans ,Antibodies ,Monoclonal ,Humanized ,Anticholesteremic Agents ,Biomarkers ,Cardiovascular Diseases ,Cholesterol ,LDL ,Dyslipidemias ,PCSK9 Inhibitors ,Proprotein Convertase 9 ,Randomized Controlled Trials as Topic ,Serine Proteinase Inhibitors ,Time Factors ,Treatment Outcome ,ODYSSEY OUTCOMES Investigators ,Alirocumab ,Cholesterol ,PCSK9 ,Safety ,Cardiorespiratory Medicine and Haematology ,Pharmacology and Pharmaceutical Sciences ,Cardiovascular medicine and haematology ,Pharmacology and pharmaceutical sciences - 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.
- Published
- 2024