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Safety of the PCSK9 inhibitor alirocumab: insights from 47 296 patient-years of observation.
- Source :
-
European heart journal. Cardiovascular pharmacotherapy [Eur Heart J Cardiovasc Pharmacother] 2024 Jul 16; Vol. 10 (4), pp. 342-352. - Publication Year :
- 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.<br /> (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Subjects :
- Humans
Anticholesteremic Agents adverse effects
Anticholesteremic Agents therapeutic use
Biomarkers blood
Cardiovascular Diseases prevention & control
Cardiovascular Diseases mortality
Cardiovascular Diseases diagnosis
Cardiovascular Diseases blood
Dyslipidemias drug therapy
Dyslipidemias blood
Dyslipidemias diagnosis
Proprotein Convertase 9 metabolism
Proprotein Convertase 9 immunology
Randomized Controlled Trials as Topic
Serine Proteinase Inhibitors adverse effects
Serine Proteinase Inhibitors therapeutic use
Time Factors
Treatment Outcome
Antibodies, Monoclonal, Humanized adverse effects
Antibodies, Monoclonal, Humanized therapeutic use
Cholesterol, LDL blood
PCSK9 Inhibitors
Subjects
Details
- Language :
- English
- ISSN :
- 2055-6845
- Volume :
- 10
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- European heart journal. Cardiovascular pharmacotherapy
- Publication Type :
- Academic Journal
- Accession number :
- 38658193
- Full Text :
- https://doi.org/10.1093/ehjcvp/pvae025