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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Pharmacology of Anti-Cancer Drugs
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1527903
This article is part of the Research Topic Decoding the Epigenetic Landscape: Elucidating Cancer Pathology and Identifying Novel Therapeutic Targets View all 13 articles

DNA methylation inhibitors adverse reaction characteristic analysis: An Analysis Based on the European Spontaneous Adverse Event Reporting System

Provisionally accepted
Xia Zhang Xia Zhang 1Yuyu Liu Yuyu Liu 2Qingwang Hou Qingwang Hou 3Yongxin Guo Yongxin Guo 3Youfu He Youfu He 4*
  • 1 Department of Oncology, Guihang Guiyang Hospital, Guiyang, China
  • 2 School of Integrative Medicine, Nanjing University of Chinese Medicine, Nanjing, Jiangsu Province, China
  • 3 Department of Cardiology, Henan Provincial People’s Hospital, Zhengzhou, Henan Province, China
  • 4 Department of Cardiology, Guizhou Provincial People's Hospital, Guiyang, Guizhou Province, China

The final, formatted version of the article will be published soon.

    patients, severity and outcome of ADR, event year, geographical origin and the qualification of the reporting source. A comprehensive assessment was made for severe ADR cases. By means of the Reporting Odds Ratio (ROR) and 95% Confidence Interval (CI), a non-proportional analysis was made for MedDRA® SOC in DNA methylation inhibitors. Statistical analysis was executed with SPSS version 23.0, and p < 0.05 was regarded as statistically significant.The study reveals that reports related to AZACITIDINE increased from 2005 to 2023, with a slight decline in 2024, while those for DECITABINE have been on the rise since 2007. ICSRs were associated with a majority of males and individuals aged 65-85. Healthcare professionals frequently reported ICSRs related to DNA methylation inhibitors. A significant portion of these ICSRs were serious and completely resolved. The most common ADRs were identified, and certain ADRs had a higher reporting probability with AZACITIDINE (e.g., Febrile neutropenia, Anamia, etc.) and others with DECITABINE (e.g., Myelosuppression, Thrombocytopenia, etc.).The analysis regarding ADRs of DNA methylation inhibitors was consistent with the literature information disclosed. AZACITIDINE and DECITABINE each have ADRs with a high probability of being reported. Although the study has the advantage of using the database, it is limited by the spontaneous reporting system. Future improvements are needed to accurately evaluate the safety of the drugs.

    Keywords: DNA methylation inhibitors, adverse drug reactions, System organ class, Eudravigilance database, comparative observational study, Azacitidine, decitabine

    Received: 14 Nov 2024; Accepted: 26 Dec 2024.

    Copyright: © 2024 Zhang, Liu, Hou, Guo and He. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Youfu He, Department of Cardiology, Guizhou Provincial People's Hospital, Guiyang, Guizhou Province, China

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