| アブストラクト | OBJECTIVE: To investigate the risk of developing diabetes and ketoacidosis in clinical patients with immune checkpoint inhibitors (ICIs). METHODS: We looked in the FDA Adverse Event Reporting System for reports of ICIs-associated diabetes mellitus (DM) and ketoacidosis between January 2004 and March 2022. We explored the signals using fourfold table-based proportional imbalance algorithms. Patient characteristics, country distribution, and outcomes of adverse reactions were described. Kruskal-Wallis test was used to compare the time of onset and prognosis of adverse reactions. RESULTS: A total of 2110 reports of ICIs-related DM were included in the study. The largest number of reports was from Japan (752, 35.64%), followed by the United States and France (624, 29.57%; 183, 8.67%). Seven drugs detected signals of DM and ketoacidosis according to 4 proportional imbalance algorithms: nivolumab, pembrolizumab, cemiplimab, dostarlimab, atezolizumab, avelumab, and durvalumab. Diabetes and ketoacidosis generally occurred early in the course of ICIs treatment, the median time to event onset was 144.5 (interquartile range 27-199) days. ICIs-related diabetes and ketoacidosis events resulted in 934 major medical events (44.3%), 524 hospitalizations (24.8%), 60 life-threatening events (2.8%), 42 deaths (2.0%), and 39 disability events (1.8%). CONCLUSION: The study reveals the risk and characteristics of diabetes and ketoacidosis associated with ICIs, which may provide evidence for postmarketing evaluation. Careful consideration should be given to the possibility of an increased risk of diabetes and ketoacidosis after using ICIs, and careful monitoring for diabetes and ketoacidosis is recommended. |
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| ジャーナル名 | Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists |
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| 投稿日 | 2024/6/15 |
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| 投稿者 | Han, Meifen; Jiang, Lin; Zhao, Bin; Liu, Xiaojun; Yang, Changqing; Chen, Wei |
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| 組織名 | Department of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of;Medical Science and Peking Union Medical College, Beijing, China; School of Basic;Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, China.;Medical Science and Peking Union Medical College, Beijing, China.;National Laboratory of Medical Molecular Biology, Institute of Basic Medical;Science, Chinese Academy of Medical Science and Peking Union Medical College,;Beijing, China.;School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University,;Nanjing, China.;Beijing Key Laboratory of the Innovative Development of Functional Staples and;the Nutritional Intervention for Chronic Disease, Department of Clinical;Nutrition, Peking Union Medical College Hospital, Beijing, China. Electronic;address: chenw@pumch.cn. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38876180/ |
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