Incidence, characteristics and risk factors for drug-induced liver injury in hospitalized patients: A matched case-control study

Aims: The diagnosis of drug-induced liver injury (DILI) is relatively complex and involves a wide variety of drugs. The purpose of this study was to use algorithms to quickly screen DILI patients, determine its incidence and identify risk factors.

Methods: The Adverse Drug Events Active Surveillance and Assessment System-2 was used to extract the data of patients hospitalized in 2019 according to the set standards and the Roussel Uclaf Causality Assessment Method was used to evaluate patients who met the standards. A retrospective case-control study was conducted according to suspected drugs, length of hospital stay and height- and weight-matched controls, and logistic regression was used to identify risk factors.

Results: Among the 156 570 hospitalized patients, 480 patients (499 cases) with DILI were confirmed and the incidence of DILI was 0.32%. Anti-infective agents, antineoplastic agents and nonsteroidal anti-inflammatory drugs were the major categories of drugs causing DILI, and the highest incidence of DILI was due to voriconazole. The latency period and hospital stay of patients with cholestasis were both relatively long. Patients with hyperlipidaemia (adjusted odds ratio [AOR] 1.884), cardiovascular disease (AOR 1.465), pre-existing liver disease (AOR 1.827) and surgical history (AOR 1.312) were at higher risk for DILI.

Conclusions: The incidence of DILI in hospitalized patients was uncommon (0.32%) and its pathogenic drugs were widely distributed. The incidence of DILI for many drugs has been seriously underestimated. It is recommended to focus on patients with hyperlipidaemia, cardiovascular disease, pre-existing liver disease and surgical history.