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

SUBMITTER: Goodman SG 

PROVIDER: S-EPMC11249957 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature