Heterogeneity in adverse events associated with lumateperone: a study on potential subgroup-specific differences
AI Summary
Females exhibited higher reporting frequency of nervous system disorders associated with lumateperone.
Tardive dyskinesia reports were more frequently associated with serious outcomes.
Bipolar disorder patients more often reported nervous system disorders, whereas schizophrenia patients more often reported psychiatric disorders; findings require future confirmatory studies.
Int J Neuropsychopharmacol. 2026 May 8:pyag022. doi: 10.1093/ijnp/pyag022. Online ahead of print.
ABSTRACT
BACKGROUND: Lumateperone, a novel atypical antipsychotic, has emerged as an illuminating hope for patients with schizophrenia and bipolar disorder. While prior studies have employed spontaneous reporting databases and identified over 100 novel adverse events associated with lumateperone, the differences in these adverse events across subgroups remain unclear.
OBJECTIVE: This study provides a comprehensive evaluation of the adverse event profile of lumateperone using the Food and Drug Administration Adverse Event Reporting System database, focusing on the potential differences in reporting adverse events across subgroups.
METHODS: Based on the results of clinical characteristics and signal detection, the potential differences in reporting lumateperone-associated adverse events across specific subgroups regarding report year, reporter type, sex, age, outcome, indication, and concomitant drug were analyzed using the ROR algorithm and Fisher’s exact test with Bonferroni correction. The observed differences were further validated using sensitivity analyses, stratified analyses, and comparative analyses.
RESULTS: This study identified 1762 reports and 5074 adverse events associated with lumateperone. Notably, females had a higher frequency of reporting nervous system disorders. Tardive dyskinesia was more frequently resulted in serious consequences. Moreover, bipolar disorder patients more frequently reported nervous system disorders, while schizophrenia patients more frequently reported psychiatric disorders.
CONCLUSIONS: This study underscores the need for future confirmatory studies into the potential sex, outcome and indication differences in adverse events associated with lumateperone. The findings should be considered preliminary and require further validation.
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