| Summary: | 碩士 === 國立陽明大學 === 衛生福利研究所 === 100 === Background
Iron chelators (deferasirox or desferrioxamine) are essential to patients who need life-long blood transfusion (e.g. β-Thalassemia). However, in 2009 and 2010, the US Food and Drug Administration (FDA) had issued a warning on potential adverse events associated with deferasirox.
Objective
The objective was to compare the risk of acute renal failure, acute liver failure and gastrointestinal bleeding in patients using deferasirox with using desferrioxamine.
Methods
This retrospective cohort study used Taiwan National Health Insurance database. Our study subjects were first-time users of iron chelators, deferasirox or desferrioxamine, between 2005 and 2008. Risk of acute renal failure, acute liver necrosis and gastrointestinal bleeding during follow-up time were analyzed by Cox proportional hazards model, adjusted by age, sex, outcome-related history of medication, transfusion and health condition in the year before treatment initiation separately.
Results
There were 3,760 patients defined as first iron chelator users between 2005 and 2009.
In the outcome of acute renal failure, incidence of patients who received deferasirox alone was higher than those who received desferrioxamine alone or shifted from desferrioxamine to deferasirox (1.449, 0.515 and 0.256 per 10,000 patient-days, respectively). Before adjusting for patient demographics and baseline renal risk profile, deferasirox users had significantly higher risk than desferrioxamine users in all research population[HR 2.18 (1.18–4.02)] and the elderly over 60 years old[HR 2.47 (1.20–5.10)]. In the outcome of acute liver necrosis, incidence of deferasirox receivers was higher than desferrioxamine receivers (0.256 and 0.053) while no advers event happened in desferrioxamine-deferasirox shifters. In the outcome of gastrointestinal bleeding, deferasirox users had highest incidence rate of 0.074 per 10,000 patient-days while incidence rate of desferrioxamine users and desferrioxamine-deferasirox shift users were 2.027 and 1.505.
Conclusions
In this population-based analysis, patients using deferasirox were at higher incidence severe adverse events than those using desferrioxamine. Patients using deferasirox with renal-associated past history or drug using history have significantly higher hazard ratio than those using desferrioxamine, especially the elderly over age of 60s. Patients using deferasirox with gastrointestinal-associated past history or drug using history have significantly lower hazard ratio than those using desferrioxamine. After adjusting past history or drug using history, both are not significant. Though this study cannot prove higher risk in using deferasirox than using desferrioxamine, according to previous case reports and drug information, we suggest elder deferasirox users with renal, liver and gastrointestinal diseases sould be aware of adverse events.
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