| アブストラクト | BACKGROUND AND OBJECTIVE: Denosumab is widely used for osteoporosis and cancer treatment. However, hypocalcemia induced by denosumab is a frequent adverse event. The objective of this study is to comprehensively investigate the safety signals and the occurrence of hypocalcemia in real-world patient cases reported through the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). METHODS: Reports from January 1, 2017 to December 31, 2021 were extracted from the FAERS. Only cases of hypocalcemia suspected to denosumab were eligible in pharmacovigilance study. Denosumab-related hypocalcemia safety signal were identified to characterize their clinical features. A safety signal for hypocalcemia was evaluated using reporting odds ratios (ROR). RESULTS: Among the 102,413 cases related to denosumab, 1042 cases were reported with denosumab-related hypocalcemia. The affected patients were mainly elderly (median age 70 years) and male (n = 568, 63.5%). In available data, the median onset time of 23 (range 0-1601) days. Most patients required drug interruption (n = 226, 72.9%) and can achieve a recovered-resolved state (n = 318, 62.1%). For the whole database, denosumab exhibited a safety signal for hypocalcemia (ROR = 14.09, 95% Cl 13.18, 15.06). In the sensitivity analyses, denosumab also showed a safety signal for hypocalcemia in cancer (ROR = 21.28, 95% Cl 18.79, 24.11) and osteoporosis (ROR = 9.29, 95% Cl 6.80, 12.59). Compared with bisphosphonates, denosumab still has safety signal for hypocalcemia (ROR = 1.88, 95% Cl 1.67, 2.11). CONCLUSIONS: This pharmacovigilance database analysis indicates a high safety signal for hypocalcemia associated with denosumab, particularly in cancer patients. |
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| ジャーナル名 | Therapeutic innovation & regulatory science |
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| Pubmed追加日 | 2024/10/25 |
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| 投稿者 | Gao, Siyuan; Zheng, Guanhao; He, Zhichao; Chen, Lishi; Yan, Dengfeng; Lai, Zhisheng; Cai, Tingfeng; Hu, Shijie |
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| 組織名 | Guangdong Province Hospital for Occupational Disease Prevention and Treatment,;Guangzhou, China.;World Health Organization Collaborating Centre for Infectious Disease;Epidemiology and Control, School of Public Health, Li Ka Shing Faculty of;Medicine, The University of Hong Kong, Hong Kong Special Administrative Region,;China.;Department of Pharmacy, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,;Guangzhou, China. hushijie@163.com. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39453599/ |
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