Digital archive of theses discussed at the University of Pisa


Thesis etd-06022016-210737

Thesis type
Tesi di specializzazione (4 anni)
Thesis title
Intravenous iron administration in iron deficiency anemia: a multicentre retrospective observational study comparing the effects of ferric carboxymaltose and sodium ferric gluconate
Course of study
relatore Dott. Mazzoni, Alessandro
  • iron deficiency anemia
Graduation session start date
BACKGROUND. Appropriate therapeutic management of iron deficiency anemia (IDA) is essential to prevent serious health risks and indiscriminate exposure to allogeneic blood transfusions. Iron therapy is administered intravenously in patients failing to respond to oral iron treatment or needing rapid iron repletion. Several parenteral iron carbohydrate complex formulations are now available, classified as stable, such as ferric carboxymaltose, or labile, such as sodium ferric gluconate, according to the release rate of iron, directly taken up by transferrin and other proteins. The first one preparations allow clinically well-tolerated administration of a single much higher dose of intravenous iron by more rapid infusion than the second one and various therapeutic areas can take advantages of their use, as appropriate therapy for IDA correction.

STUDY DESIGN AND METHODS. In this retrospective study, we considered 346 patients with IDA, eligible for the intravenous treatment. 222 patients (group A) received an average of three intravenous injections of ferric carboxymaltose (500 mg / visit), other 124 patients (group B) received an average of ten infusions of sodium ferric gluconate (62,5 mg / visit). Patients were assessed at first visit and at least after 2, 5 and 7 weeks from the beginning of the treatment. The primary endpoint was the difference in the mean Hb, ferritin and transferrin saturation values detected throughout the whole observation period between the two treatment groups. Drug-related adverse events and transfusion need were also evaluated.

RESULTS. Significantly lower baseline levels of Hb, ferritin and transferrin saturation (TSAT) were detected in group A, than in group B. Nevertheless, we found a faster and greater Hb, ferritin and TSAT increase with ferric carboxymaltose dosing regimen compared with sodium ferric gluconate. Throughout the whole observational period, group A showed a mean Hb level of 11,3 g/dL (95% CI 11,1 – 11,6), a mean ferritin level of 221,1 ng/mL (95% CI 184,4 – 257,7) and a mean TSAT of 20,7% (95% CI 18,9 – 22,5); group B showed a mean Hb level of 10,6 g/dL (95% CI 10,4 – 10,8), a mean ferritin level of 85,4 ng/mL (95% CI 50,9 – 119,9) and a mean TSAT of 14,1% (95% CI 11,8 – 16,4). After drug administration, statistical analysis showed a significant difference between the two groups in terms of mean Hb level (0,74 g/dL, 95% CI 0,42 – 1,06, p<0,0001), mean ferritin level (135,7 ng/mL, 95% CI 85,3 – 186,1, p<0,0001) and mean TSAT (6,6%, 95% CI 3,7 – 9,6, p<0,0001). The occurrence of intravenous iron-related adverse drug effects was very low and the difference among the two groups was not statistically significant (p=0,8). No serious adverse events were witnessed. Patients requiring transfusions after the beginning of the treatment decreased and were 1.4% in group A and 4.8% in group B (p=0,05). Even patients with baseline Hb ≤ 8 g/dL showed a greater increase in Hb concentration in group A compared to group B and a very low proportion of them needed transfusions.

CONCLUSION. The results of this study suggest that ferric carboxymaltose can be used safely and more effectively than sodium ferric gluconate to rapidly improve and maintain raised Hb concentration and TSAT values after drug withdrawal in patients with iron-restricted erythropoiesis, avoiding their exposure to the potential risks of untreated anemia, unnecessary transfusions or both.