Paliperidone May Reduce Risk for Severe Hepatic Outcomes in Patients With Schizophrenia and Hepatitis

Fatty liver, conceptual illustration. Fatty liver is commonly associated with alcohol or metabolic syndrome (diabetes, hypertension and obesity), but can also be due to any one of many causes. Fatty liver disease is a reversible condition wherein large vacuoles of fat (pale yellow circles) accumulate in liver cells.
During the mean follow-up (3.57±1.62 years), severe hepatic outcomes occurred in 22 patients (5.47%), and of these, 2 people (1.49%) were receiving paliperidone.

Paliperidone treatment was associated with reduced risk for severe hepatic outcomes (SHOs) in patients with schizophrenia and viral hepatitis, according to study data published in Psychiatry Research.

Chun-Hung Chang, MD, of the department of psychiatry, China Medical University Hospital in Taichung, Taiwan, and colleagues conducted a nationwide population-based cohort study between 2007 and 2013 based on data from the Taiwan National Health Insurance Research Database. Data from patients who were newly diagnosed with schizophrenia and already receiving paliperidone were compared with data from those not receiving paliperidone. Patients were matched 1:2 with controls by age, sex, and index year of schizophrenia diagnosis, and individuals with pre-enrollment SHOs were excluded.

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The primary outcome was occurrence of SHOs, including liver failure, decomposition, transplantation, or cancer. Statistical analysis included Pearson tests, Student t-tests, Kaplan-Meier analyses, and Cox proportional hazards models.

The paliperidone cohort comprised 134 patients; the control cohort included 268 patients. In both groups, most participants were men (59.0%). During the mean follow-up (3.57±1.62 years), SHOs occurred in 22 patients (5.47%); 2 of these patients (1.49%) were receiving paliperidone.

Compared with controls, the paliperidone group experienced not only significantly lower incidence of SHOs, but also a significantly lower risk for SHOs (hazard ratio [HR], 0.194; P =.0135). In analyses adjusting for age, sex, outpatient visits, comorbidities, and antipsychotic medication use, the paliperidone group remained at significantly lower risk for SHOs compared with controls (adjusted HR, 0.155; 95% CI, 0.032-0.737; P =.019).

Notably, the paliperidone group also experienced slightly lower, nonsignificant risk for mortality compared with controls (HR, 0.759; 95% CI, 0.392-1.472; P =.437). The use of antipsychotic medications was also nonsignificantly associated with an increased risk for SHOs.

As study limitations, investigators noted that paliperidone dosage information could not be extracted. Additionally, severity of hepatitis at baseline was not ascertained. Further research is necessary to investigate the impact of paliperidone dosing and disease stage on the risk for SHOs.

“Early use of paliperidone treatment may benefit this category of patients by reducing the risk of liver failure, liver decompensation, and liver cancer,” investigators wrote.


Chang CH, Lane HY, Liu CY, Chen SJ, Lin CH. Paliperidone is associated with reduced risk of severe hepatic outcome in patients with schizophrenia and viral hepatitis: a nationwide population-based cohort study. Psychiatry Res. 2019;281:112597.