| アブストラクト | 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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| ジャーナル名 | The international journal of neuropsychopharmacology |
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| Pubmed追加日 | 2026/5/8 |
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| 投稿者 | Jiang, Cheng; Tang, Luhan; Li, Mingqian; Xia, Guoqin |
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| 組織名 | Zhejiang Academy of Traditional Chinese Medicine, Tongde Hospital of Zhejiang;Province, Hangzhou, Zhejiang 310012, China.;Zhejiang Provincial Key Laboratory of Disease-Syndrome Integrated Cancer;Prevention and Treatment, Tongde Hospital of Zhejiang Province Affiliated to;Zhejiang Chinese Medical University, Hangzhou, Zhejiang 310012, China.;Zhejiang Provincial Key Laboratory of Traditional Chinese Medicine for;Pharmacodynamic Material Basis Research of Chinese Medicine, Tongde Hospital of;Zhejiang Province, Hangzhou, Zhejiang 310012, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42102179/ |
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