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To mine the security alert signals of risk signals of adverse drug events (ADEs) associated with post-marketing use of avacopan based on the FDA Adverse Event Reporting System (FAERS) database. The findings are intended to provide a reference for clinical safety in medication practices.
The study collected ADE reports related to Apixaban from the FAERS database for the period of Q4 2021 to Q2 2024. Potential safety signals associated with Apixaban were identified using various methodologies, including reporting odds ratio (ROR), proportional reporting ratio (PRR), bayesian confidence propagation neural network (BCPNN), and multi-item gamma poisson shrinker (MGPS). Weber distribution test was used to determine the occurrence rule of ADE. The reporting odds ratio was used to estimate the relative risk of arvaracopam ADE in different genders.
A total of 6 519 ADE reports involving 2 730 patients with avacopan as the primary suspected drug were collected, and 75 avacopan ADE signals were mined involving 15 systems. ADE occurs mostly within 30 days after administration of avacopan. Consistent with the description in the package insert, ADEs of hepatobiliary system, infection and infection system were commonly observed. In addition, ADEs such as epistaxis, pulmonary hemorrhage, pharyngeal swelling and deep vein thrombosis were not included in the package insert. The analysis of gender differences in the risk signals associated with arvalacopam revealed that female patients were more susceptible to conditions such as jaundice, pulmonary vasculitis, esophageal candidiasis, cheilitis, Escherichia coli urinary tract infection, etc. In contrast, male patients were more likely to have dental hypersensitivity, pulmonary hemorrhage, elevated serum ferritin, and cardiac pacemaker implantation.
In the real-world application of avacopan, it is essential to focus on the ADE related to the hepatobiliary system, respiratory system, thoracic and mediastinal systems, as well as infectious conditions. Additionally, appropriate strategies should be implemented based on gender differences to mitigate the occurrence of ADEs.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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