Comparison of Efficacy and Safety of Intravenous Ferric Carboxymaltose Vs Iron Sucrose in the Treatment of Antepartum Iron Deficiency Anaemia – A Randomized Controlled Trial

Abstract

Background and objectives Ferric carboxymaltose has been recently introduced for the treatment of anaemia. The present study was planned to compare the efficacy, tolerability and safety of intravenous ferric carboxymaltose with intravenous iron sucrose in the treatment of iron deficiency anaemia among pregnant women. Methodology The present one year randomized control trial was done from January 2013 to July 2014 in the department of Obstetrics and Gynaecology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Belgaum. A total of 305 pregnant women were randomized into two groups comprising of 158 in group C (Received iron carboxymaltose transfusion) and 147 in Group S (Received iron sucrose transfusion). The outcome data was available among 153 in group C and 139 in group S. Results In the present study the commonest age group was 26 to 30 years in group C comprised of 40.52% compared to 21 to 25 years in group S with 38.85% of the women (p=0.312) and mean age of the study population in group C and S was comparable (25.33±3.53 vs 24.85±4.18 years; p=0.082) The socio demographic characteristics, obstetric history, vitals and pretreatment heamoglobin were comparable in both the groups (p>0.050). The post treatment haemoglobin levels in 54.9% of the women were found to be 11 or more in group C compared to 56.12% in group S (p=0.614) and mean post treatment haemoglobin levels were comparable in group C and group S (11.59±7.72 vs 11.02±0.75 gm%; p=0.358). Significantly higher number of women in group C had increase in haemoglobin levels between 2.0 to 2.5 gm% (56.86%) and the mean increase in haemoglobin levels post treatment was significantly high in group C (2.27 ± 0.39 gm%) (p<0.050). Also the mean percentage change in haemoglobin levels post treatment was significantly high in group C (26.54 ± 5.98 percent) (p=0.029). The side effects were comparable in group C and S (p=0.536) but significantly higher number of women had pyrexia in group C (8.5%) (p=0.041). Conclusion and interpretation Intravenous iron carboxymaltose is more effective in the treatment of iron deficiency anaemia among pregnant women compared to intravenous iron sucrose. Further it is well tolerated in pregnant women as side effects are comparable to that of iron sucrose except pyrexia