Safety of the PCSK9 inhibitor alirocumab: insights from 47 296 patient-years of observation.
Publication/Presentation Date
7-16-2024
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.
Volume
10
Issue
4
First Page
342
Last Page
352
ISSN
2055-6845
Published In/Presented At
Goodman, S. G., Steg, P. G., Szarek, M., Bhatt, D. L., Bittner, V. A., Diaz, R., Harrington, R. A., Jukema, J. W., White, H. D., Zeiher, A. M., Manvelian, G., Pordy, R., Poulouin, Y., Stipek, W., Garon, G., Schwartz, G. G., & ODYSSEY OUTCOMES Investigators (2024). Safety of the PCSK9 inhibitor alirocumab: insights from 47 296 patient-years of observation. European heart journal. Cardiovascular pharmacotherapy, 10(4), 342–352. https://doi.org/10.1093/ehjcvp/pvae025
Disciplines
Medicine and Health Sciences
PubMedID
38658193
Department(s)
Cardiology Division
Document Type
Article