Full
Outline
To identify and analyze post-marketing adverse drug event (ADE) signals associated with pralsetinib and selpercatinib, compare their respective adverse event profiles, and provide a more comprehensive evidence base to support clinical decision-making in drug selection.
ADE reports for pralsetinib and selpercatinib were extracted from the U.S. FDA Adverse Event Reporting System (FAERS) database from April 2020 to December 2024. Disproportionality analysis was conducted using the reporting odds ratio (ROR) method.
The analysis revealed significant differences in the adverse event profiles of the two drugs. For instance, in the affected system, although the system organ class (SOC) distribution for the top three adverse events was similar between the two drugs, pratinib was associated with a higher frequency of risk signals in gastrointestinal disorders, respiratory/thoracic/mediastinal disorders, and nervous system disorders. In contrast, cepratinib exhibited a greater incidence of adverse reactions related to hepatobiliary disorders, skin and subcutaneous tissue disorders, and other system-specific effects compared to pratinib. Notably, even within the same SOC, the specific adverse reactions differed between the two drugs. For instance, in regard to cardiovascular toxicity, pralsetinib was linked to elevated myocardial necrosis markers, whereas selpercatinib was more frequently associated with QT interval prolongation. These distinctions highlight the need for drug-specific monitoring in clinical practice.
While pralsetinib and selpercatinib share some overlapping adverse effects, their risk profiles exhibit distinct patterns. Individualized drug selection, guided by patient-specific factors and the unique toxicity profiles of each agent, is essential to optimize therapeutic outcomes.
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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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