A real-world analysis of Lomitapide-associated adverse events: Data from FAERS and CVAROD.

ABSTRACT: Lomitapide, a microsomal triglyceride transfer protein (MTP) inhibitor approved for the treatment of Homozygous Familial Hypercholesterolemia (HoFH), effectively lowers LDL cholesterol but raises safety concerns, particularly regarding hepatic and gastrointestinal adverse events (AEs). We conducted a pharmacovigilance disproportionality analysis using 2 major spontaneous reporting systems: the U.S. FDA Adverse Event Reporting System (FAERS, 2004-2024) and the Canada Vigilance Adverse Reaction Online Database (CVAROD, 2014-2025). All Lomitapide-related reports were extracted and analyzed using 4 statistical algorithms: reporting odds ratio (ROR), proportional reporting ratio, information component (IC), and Empirical Bayes Geometric Mean (EBGM). Signals were assessed at both the system orga

SUBMITTER: Liu X 

PROVIDER: S-EPMC12643635 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature