关键词:
adverse events
amyloid-associated imaging abnormalities
FAERS database
lecanemab
WHO-VigiAccess database
摘要:
Objective To provide reference for rational drug use through mining adverse drug event signals associated of lecanemab. Methods To collect adverse drug event reports of lecanemab from Q1 2023 to Q4 2024 in FAERS and WHO-VigiAccess databases. Data mining was performed using ROR and PRR methods in the proportional imbalance method. Results The FAERS database and WHO-VigiAccess database involved 25 and 23 SOC, respectively, mainly for various neurological diseases, systemic diseases, reactions at the drug administration site, and psychosis. In the FAERS database, the adverse drug event signals with the highest number of reported cases were related to headache, amyloid-associated imaging abnormality oedema/exudative type, amyloid-associated imaging abnormality microhaemorrhagic and haemoferritic type, chills, and fatigue, while in the WHO-VigiAccess database, they were headache, chills, fatigue, amyloid-associated imaging abnormality oedema/exudative type, and infusion-associated reactions. The top-ranked adverse drug event signals in both databases in terms of signal intensity were related to the preferred terms of amyloid-associated imaging abnormality, amyloid-associated imaging abnormality microhaemorrhagic and haemoferritic type, amyloid-associated imaging abnormality oedema/exudative type, central nervous system surface iron deposition disorders, and microhaemorrhages in the brain. The FAERS database showed that the occurrence of adverse drug event in most of the cases occurred within the first month of administration. Conclsion When using lencanumab, focus should be placed on elderly women and patients on long-term use of the drug, and be vigilant for rare adverse drug events such as infections, ischaemic stroke, etc. Clinical monitoring of the use of the drug should also be strengthened to reduce the impact of the adverse drug event on the patient’s prognosis as well as quality of life. © 2025 Tianjin Press of Chinese Herbal Medicines. All rights reserved.