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A real-world pharmacovigilance study of FDA adverse event reporting system events for Lutetium-177-PSMA-617.

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  • المؤلفون: Wu S;Wu S; Hu W; Hu W; Chen M; Chen M; Xiao X; Xiao X; Liu R; Liu R
  • المصدر:
    Scientific reports [Sci Rep] 2024 Oct 28; Vol. 14 (1), pp. 25712. Date of Electronic Publication: 2024 Oct 28.
  • نوع النشر :
    Journal Article
  • اللغة:
    English
  • معلومة اضافية
    • المصدر:
      Publisher: Nature Publishing Group Country of Publication: England NLM ID: 101563288 Publication Model: Electronic Cited Medium: Internet ISSN: 2045-2322 (Electronic) Linking ISSN: 20452322 NLM ISO Abbreviation: Sci Rep Subsets: MEDLINE
    • بيانات النشر:
      Original Publication: London : Nature Publishing Group, copyright 2011-
    • الموضوع:
    • نبذة مختصرة :
      Lutetium-177( 177 Lu)-PSMA-617 has been approved for the treatment of metastatic castration-resistant prostate cancer (mCRPC). Our main objective is to elucidate the association between 177 Lu-PSMA-617 and reported adverse events (AEs) in the FDA Adverse Event Reporting System (FAERS) database. Relevant information regarding 177 Lu-PSMA-617 usage and reports of AEs was extracted from the FAERS database. The Empirical Bayes Geometric Mean (EBGM), Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), and Bayesian Confidence Propagation Neural Network (BCPNN) with their 95% confidence intervals (CI) were calculated using four algorithms of disproportionality analysis. The pharmacovigilance signals deemed significant across the four algorithms were considered associated with drug use. We collected 6266 unique reports related to 177 Lu-PSMA-617 usage from the FAERS database. Compared to other drugs, 177 Lu-PSMA-617 usage was associated with a higher risk of anemia, platelet count decreased, and pancytopenia. In addition to hematologic AEs, consistent high signals were observed for AEs such as dry mouth, laboratory test abnormal, and general physical health deterioration. The analysis based on mCRPC treatment drugs showed that full blood count decreased, general physical health deterioration, and laboratory test abnormal continued to exhibit significant signals. Furthermore, the number of AEs reports for 177 Lu-PSMA-617 decreased over time, with most reports occurring within one month after drug administration. Our study compiled AEs associated with 177 Lu-PSMA-617 in real-world drug usage and highlighted its propensity for specific AEs in the context of mCRPC treatment. These findings will contribute to enhancing our clinical experience with this medication.
      (© 2024. The Author(s).)
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    • Grant Information:
      TJSJMYXYC-D2-026 Tianjin Municipal Health Commission
    • الرقم المعرف:
      0 (Pluvicto)
      5H0DOZ21UJ (Lutetium)
    • الموضوع:
      Date Created: 20241029 Date Completed: 20250204 Latest Revision: 20250204
    • الموضوع:
      20250204
    • الرقم المعرف:
      PMC11519899
    • الرقم المعرف:
      10.1038/s41598-024-77889-3
    • الرقم المعرف:
      39468291