INTRODUCTION
DILI, liver abnormalities, hepatotoxicity, liver damage, cirrhosis, cholestasis, steatohepatitis, drug‐induced liver injury
HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA, HOFH, CIRRHOSIS, LIVER DAMAGE, LIVER FIBROSIS, CHOLESTASIS, HEPATIC STEATOSIS, HEPATIC STEATOSIS, STEATOHEPATITIS
Lomitapide is a microsomal triglyceride transfer protein (MTP) inhibitor indicated as an adjunctive therapy for low‐density lipoprotein cholesterol (LDL‐C) lowering in patients with homozygous familial hypercholesterolaemia (HoFH). Lomitapide reduces LDL‐C by a mean of 50.0%–76.6%Idiosyncratic hepatotoxicity is an unpredictable form of drug‐induced liver injury (DILI). It has varying delays to onset, occurs in the therapeutic dose range for the causative agent, and is characterised by high levels of liver transaminases and/or alkaline phosphatase and cholestasis.Hepatic steatosis is among the most common liver abnormalities,None of the types of long‐term liver damage outlined above have been observed during the clinical use of lomitapide in HoFH. However, as discussed, lomitapide has the potential to cause hepatic steatosis, and the question remains whether there is the development of steatohepatitis and subsequent liver fibrosis or cirrhosis over the long term. The current report includes previously unpublished hepatic safety data from several sources with the aim of gaining a better understanding of the long‐term hepatic safety of lomitapide.