| アブストラクト | AIMS: Conventional pharmacovigilance identifies drug-event reporting signals but not heterogeneity among anti-HER2 cardiac dysfunction reports. We benchmarked this association using disproportionality analysis and assessed whether report-level clustering added information beyond cardiovascular co-reporting. METHODS: We analysed OpenVigil/FAERS data. A separate openFDA analysis estimated overall, individual-drug and drug-group reporting odds ratios (RORs) and proportional reporting ratios (PRRs). The clustering cohort comprised 589 unique reports, grouped by cardiovascular co-reporting and clustered using Gower distance-based partitioning around medoids. Severe outcome comprised death, hospitalization, life-threatening events or disability. Multivariable logistic regression and a nested likelihood-ratio test compared conventional and cluster-based models. RESULTS: Echocardiography-related cardiac dysfunction was disproportionately reported with anti-HER2 therapies overall (ROR 26.64, 95% CI 25.61-27.71; PRR 25.95, 95% CI 24.97-26.96) and across evaluated drugs and groupings. Among 589 reports, 383 (65.0%) had dysfunction only and 206 (35.0%) had cardiovascular co-reporting; severe outcomes occurred in 17.5% and 41.7%, respectively (adjusted OR 3.24, 95% CI 2.14-4.95). Five clusters were retained. The LV dysfunction with cardiovascular co-reporting cluster had the highest severe outcome proportion (52.0%) and higher adjusted odds than the ADC-associated EF-decline cluster (adjusted OR 4.18, 95% CI 1.55-11.68). Adding the cluster term improved model fit (chi(2) = 11.34; p = 0.023). CONCLUSIONS: Conventional analyses confirmed a strong anti-HER2 reporting signal and an association between cardiovascular co-reporting and severe outcomes. The retained clusters added complementary report-level resolution without constituting a validated clinical classification or prediction tool. |
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| ジャーナル名 | British journal of clinical pharmacology |
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| Pubmed追加日 | 2026/9/7 |
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| 投稿者 | Liu, Junjie; Chen, Yuhan; Jiang, Yuxuan; Liang, Weixuan; Wen, Zhuofeng; Liu, Meijun; Yang, Ziyang; Huang, Haopeng; Chen, Fei; Zhang, Yanling |
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| 組織名 | The Second School of Clinical Medicine, Guangzhou Medical University, Guangzhou,;China.;Department of Nutrition and Food Hygiene, Guangdong Provincial Key Laboratory of;Tropical Disease Research, School of Public Health, Southern Medical University,;Guangzhou, China.;The Clinical School of Integrated Traditional Chinese and Western Medicine,;Guangzhou Medical University, Guangzhou, China.;The First School of Clinical Medicine, Guangzhou Medical University, Guangzhou,;The Affiliated Qingyuan Hospital (Qingyuan People's Hospital), Guangzhou Medical;University, Qingyuan, China.;The Third School of Clinical Medicine, Guangzhou Medical University, Guangzhou,;Department of Ultrasound, The Second Affiliated Hospital of Guangzhou Medical;University, Guangzhou, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42705876/ |
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