| アブストラクト | OBJECTIVES: This pharmacovigilance analysis was conducted to assess the safety signals of FMS-related tyrosine kinase 3 (FLT3) inhibitors in a real-world setting using the United States Food and Drug Administration Adverse Event Reporting System (FAERS). DESIGN: We analyzed adverse event (AE) reports related to FLT3 inhibitors submitted to the FAERS database from the first quarter of 2015 to the fourth quarter of 2022. Disproportionality analysis was used to identify AEs of FLT3 inhibitors in the FAERS database. RESULTS: A total of 55,393 AE reports were identified, of which 5938, 44,013, and 5442 were attributed to midostaurin, sorafenib, and gilteritinib, respectively, as primary suspects. Compared to the full database, significant safety signals at the system organ class level were observed for midostaurin (blood and lymphatic system disorders and hepatobiliary disorders), sorafenib (skin and subcutaneous tissue disorders and hepatobiliary disorders), and gilteritinib (investigations, blood and lymphatic system disorders, infections and infestations, and hepatobiliary disorders). All the drugs studied were associated with hepatobiliary disorders. The most prominent AEs associated with midostaurin, sorafenib, and gilteritinib were cytopenia, palmar-plantar erythrodysesthesia syndrome, and increased blast cell count, respectively. Compared with chemotherapy, midostaurin and gilteritinib showed a higher risk of electrocardiogram QT prolongation, gastrointestinal hemorrhage, cerebral hemorrhage, and increased white blood cell count. Gilteritinib had the highest overall death percentage (30.28%), whereas sorafenib had the lowest (23.06%). CONCLUSION: Mining AE signals using the FAERS database provides a method for analyzing the safety of FLT3 inhibitors in post-marketing. We found several significant AE signals that corresponded to previous studies; however, some AE signals were not mentioned in the drug instructions. Our study could provide a direction for follow-up real-world studies to verify the results further. |
|---|
| ジャーナル名 | Therapeutic advances in drug safety |
|---|
| 投稿日 | 2024/10/9 |
|---|
| 投稿者 | Zhou, Jie; Zhang, Jinping; Wang, Qiaoyun; Peng, Miaoxin; Qian, Yun; Wu, Fang; Rao, Qi; DanZhen, Laji; Yang, Yonggong; Wang, Siliang; Liu, Mengying |
|---|
| 組織名 | Department of Pharmacy, Nanjing Drum Tower Hospital, School of Basic Medicine and;Clinical Pharmacy, China Pharmaceutical University, Nanjing, China.;Department of Pharmacy, Nanjing Drum Tower Hospital, Affiliated Hospital of;Medical School, Nanjing University, Nanjing, China.;Department of Hematology, Nanjing Drum Tower Hospital, Affiliated Hospital of;Department of Dermatologic Surgery, Institute of Dermatology, Chinese Academy of;Medical Science and Peking Union Medical College, Nanjing, China.;Medical School, Nanjing University, 321 Zhongshan Road, Nanjing 210008, China.;Clinical Pharmacy, China Pharmaceutical University, 321 Zhongshan Road, Nanjing;210008, China.;Medical School, 321 Zhongshan Road, Nanjing University, Nanjing, China. |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39381060/ |
|---|
