| アブストラクト | BACKGROUND: Xanomeline-Trospium (Cobenfy(R)) improves cognitive function in schizophrenia, yet its post-marketing reporting patterns remain incompletely characterized. This hypothesis-generating pharmacovigilance study explores adverse event associations during its first year on market. OBJECTIVE: To characterize disproportionate reporting patterns and generate hypotheses for clinical monitoring strategies, acknowledging the inherent limitations of spontaneous reporting data. METHODS: Adverse event reports from Q4 2024-Q3 2025 were analyzed using disproportionality methods (ROR, PRR, BCPNN) and temporal distribution analysis. A dual-track approach incorporated both statistical signal detection (n >/= 3) and descriptive surveillance of rare serious events (n < 3). RESULTS: Of 1142 reports, urinary and neurological events exhibited the strongest statistical disproportionality: urinary retention (ROR=45.63, 95% CI: 35.97-57.87) and hypersalivation (ROR=64.39, 95% CI: 43.25-95.85). Psychiatric events were frequently reported but showed weaker specificity, likely reflecting disease confounding rather than drug-induced effects. Treatment non-adherence showed elevated reporting (ROR=7.58), potentially associated with psychiatric symptomatology. Time-to-onset analysis suggested acute-phase reporting concentration (median 2 days; 45.4% of non-day-0 events occurring within days 1-7). CONCLUSION: These findings suggest disproportionate reporting patterns for urinary, neurological, and psychiatric events associated with Xanomeline-Trospium. While these signals warrant further validation through prospective cohort studies, they offer complementary real-world context for clinical decision-making. Active monitoring during initial treatment weeks may be prudent, particularly among patients with renal impairment or concomitant anticholinergic use. |
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| ジャーナル名 | Psychiatry research |
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| Pubmed追加日 | 2026/4/16 |
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| 投稿者 | Song, Xiaoxue; Feng, Tianpu; Lin, Haiyan; Qian, Hong; Ji, Jing |
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| 組織名 | Jiangsu Key Laboratory of Marine Pharmaceutical Compound Screening, College of;Pharmacy, Jiangsu Ocean University, Lianyungang 222000, China.;Graduate Training Base of Jinzhou Medical University at Lianyungang First;People's Hospital, Lianyungang 222000, China.;College of Pharmacy, Taizhou University, Taizhou, 225300, China. Electronic;address: hongqian@stu.njmu.edu.cn.;address: jijing@jou.edu.cn. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41985280/ |
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