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