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

Autor:	Goodman SG; Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.; St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada., Steg PG; Université Paris-Cité, Institut Universitaire de France, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, FACT (French Alliance for Cardiovascular Trials), and INSERM U1148, F-75018 Paris, France., Szarek M; CPC Clinical Research and Division of Cardiology, University of Colorado School of Medicine, Aurora, 80045 CO, USA.; State University of New York, Downstate Health Sciences University, Brooklyn, NY 11203, USA., Bhatt DL; Mount Sinai Heart, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA., Bittner VA; Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, AL 35233, USA., Diaz R; Estudios Cardiológicos Latinoamérica, Instituto Cardiovascular de Rosario, S2000 Rosario, Argentina., Harrington RA; Cornell University, New York, NY 10065, USA., Jukema JW; Department of Cardiology, Leiden University Medical Center, 2333 ZA Leiden, The Netherlands.; Netherlands Heart Institute, 3511 EP Utrecht, The Netherlands., White HD; Green Lane Cardiovascular Research Unit, Te Whatu Ora-Health New Zealand, Te Toka Tumai, and University of Auckland, Auckland 1030, New Zealand., Zeiher AM; Department of Medicine III, Goethe University, 60596 Frankfurt am Main, Germany., Manvelian G; Regeneron Pharmaceuticals Inc., Tarrytown, NY 10591, USA., Pordy R; Regeneron Pharmaceuticals Inc., Tarrytown, NY 10591, USA., Poulouin Y; IT&M Stats, Neuilly-sur-Seine 92200, France., Stipek W; Regeneron Pharmaceuticals Inc., Tarrytown, NY 10591, USA., Garon G; Sanofi, Toronto, ON M2R 3T4, Canada., Schwartz GG; University of Colorado School of Medicine, Aurora 80045, CO, USA.
Jazyk:	angličtina
Zdroj:	European heart journal. Cardiovascular pharmacotherapy [Eur Heart J Cardiovasc Pharmacother] 2024 Jul 16; Vol. 10 (4), pp. 342-352.
DOI:	10.1093/ehjcvp/pvae025
Abstrakt:	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. (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
Databáze:	MEDLINE
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