Comparison of the Mean Serum Ferritin Levels in Thalassaemia Major Patients after Giving Deferasirox and Deferoxamine

Abstract

Objective: To compare the mean serum ferritin levels in thalassaemia major patients after giving  deferasirox and deferoxamine. This is a randomised control trial conducted at the Department of Paediatrics, Civil Hospital, Karachi from 29th January 2014 to 28th July 2014.

Methods: A total of 160 patients of either gender, with age between 1 to 14 years, who received blood transfusion at least once a month for one  year  and  had  serum  ferritin  >1000  mcg/L  were  included. Each enrolled patient was randomly allocated to group-A (deferoxamine) or group-B (deferasirox). Pre-    and post-treatment iron profile was done in both groups to assess the iron  status  in  the  body.  De- scriptive statistics were applied to calculate mean  and  standard  deviation  for  the  quantitative  vari-  ables.  Frequencies  and  percentages  were  calculated  for  the  qualitative  variables.  Independent  sample t-test was applied to compare mean change in serum ferritin  level  in  both  groups.  Effect  modifiers were controlled by  stratification.  Paired  t-test  was  also  applied  post  stratification  and  p-  value £ 0.05 was considered as significant.

Results:  Overall there were 96 male and 64 female patients. The overall mean age of study subjects was 7.54 ± 4.21 years. In the deferasirox group, mean age was 6.35 ± 4.11 years, mean weight wasv18.01 ± 6.74 kg, mean height was 102.04 ± 19.48 cm, and mean duration of transfusion was 7.48 ± 3.99  months/year.  In  the  deferoxamine  group,  mean  age  was  8.74  ±   3.97  years,  mean  weight  was 20.44 ± 6.77 kg, mean height was 102.19 ± 20.85 cm, and mean duration of transfusion was 8.14 ± 3.55 months/year. In the deferasirox group, before treatment mean serum ferritin level was 1385.73 ± 117.01 mcg/L. After treatment mean serum ferritin  level  was  reduced  to  1047.59  ±  117.08  mcg/L.  In the deferoxamine group, before treatment mean  serum  ferritin  level  was  1362.58  ± 134.42  mcg/L. Af- ter treatment mean serum ferritin level was reduced to 1124.36  ±  134.52  mcg/L.  Post-treatment  the serum ferritin level between two groups was significantly different with p<0.01. The mean difference in serum ferritin level in pre- and post-treatment among two groups was highly significant with p<0.01.

Conclusion: Deferasirox is an effective, safe and tolerable chelation therapy for the treatment of thalassaemia major with iron overload due to its ability to provide constant chelation  coverage  and  potential to improve compliance.