Safety of deferasirox: A retrospective cohort study on the risks of gastrointestinal, liver and renal events

Weng Foung Huang, Hsin Chun Chou, Yi Wen Tsai, Fei Yuan Hsiao*


研究成果: Article同行評審

15 引文 斯高帕斯(Scopus)


Background: Deferasirox (DFX) is an effective and well-tolerated oral iron chelator elevating the adherence to iron chelating therapy among patients with iron overload. However, the US Food and Drug Administration issued a warning about the potential adverse events associated with DFX in 2010. Methods: To examine the risks of gastrointestinal (GI) bleeding, acute liver necrosis, and acute renal failure among DFX users compared with desferrioxamine (DFO) users in a real-world setting, first-time users of DFX or DFO between 2005 and 2008 in Taiwan's National Health Insurance database were observed in this population-based retrospective cohort study. The risks of different adverse events were individually analyzed by Cox proportional hazards models and adjusted by age, sex, concomitant medications, and prior medical conditions. Results: Deferasirox users had the highest incidence rates of GI bleeding (2.03 per 10000 patient-days), acute liver necrosis (0.26 per 10000 patient-days) and acute renal failure (1.45 per 10000 patient-days) compared with other iron chelator users. Compared with DFO users, DFX users were not associated with the risk of GI bleeding (adjusted HR 1.03, 95% CI 0.61-1.74, p=0.90) and the risk of acute liver necrosis (adjusted HR 2.13, 95% CI 0.49-9.33, p=0.32). The association between DFX use and acute renal failure was found to be statistically significant (HR 2.18, 95% CI 1.18-4.02, p=0.01; adjusted HR 2.41, 95% CI 1.27-4.58, p=0.01). Conclusion: In this study, we found statistically significant higher risk of acute renal failure and non-statistically significant higher risk of GI bleeding and acute liver necrosis associated with DFX use. More researches are warranted to evaluate the association between DFX use and potential adverse events.

頁(從 - 到)1176-1182
期刊Pharmacoepidemiology and Drug Safety
出版狀態Published - 1 11月 2014


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