Comparison of efficacy and safety of two parenteral iron preparations in pregnant women

Abstract

Objective:To compare the efficacy and safety with a fixed dose of two parenteral iron preparations, iron sucrose complex and iron sorbitol citric acid as per the current practice.Materials and Methods:A prospective randomized open label study was conducted. In this study, 60 pregnant women with hemoglobin less than 8.5 g/dl received a fixed dose of either IV iron sucrose or IM iron sorbitol citric acid therapy. The efficacy of the therapy was assessed by laboratory parameters such as hemoglobin, hematocrit, MCV, MCH, and serum ferritin level after 14 and 28 days. To assess the safety, adverse drug reactions with both the therapies were recorded.Results:Hemoglobin concentration increased significantly (P < 0.001) with respect to time in both the groups. The rise in the hemoglobin level in third and fourth weeks was significantly higher in iron sucrose (0.92 g/dl) than iron sorbitol citric acid therapy (0.56 g/dl). There was no significant change in the rise of the serum ferritin level after both the therapies. Adverse events were common with iron sorbitol citric acid therapy. However, no serious adverse drug reactions were observed.Conclusions:No significant difference in the efficacy of both of the therapy. However, adverse events and dropout rates were much more common in the group of pregnant women who received iron sorbitol citric acid.

Study for Comparison of Iron Sucrose & Iron Sorbitol Citrate in Fixed Doses in Iron Deficiency Anemia during Pregnancy in a Tertiary Care Center

“…However rise was more in the intravenous group. Rise in our study, although achieved by fixed doses, was comparable to Dhanani et al 7 .…”

“…According to recent national guidelines, time tested intramuscular iron sorbitol citric acid complex is one of the first line drug for treating moderate IDA in pregnancy 6 . The major disadvantage faced by this preparation is pain and swelling at the injection site, rapid clearance requiring higher doses and need for multiple injections leading to poor compliance and high dropout rates 7 . A novel intravenous preparation, Iron sucrose promises to be more effective as it causes slow release of elemental iron from the complex, lesser renal excretion, faster replenishment of iron stores, high availability for erythropoiesis and hence rapid rise of hemoglobin (Hb) and safe due to its low allergic potential and organ toxicity 8 .…”

Safety and efficacy of intravenous iron polymaltose, iron sucrose and ferric carboxymaltose in pregnancy: A systematic review

“…While a small number of studies reported costs of treatment, 24,25,36,55,56 none of them included a formal cost-effectiveness analysis.…”

“…11,13,16,20,[22][23][24][25]27,31,32,34,36,38,40,44,49 Across all studies, the median reported prevalence of ADRs was similar among prospective (4.5%) 11,16,19,20,22,23,27,29,31,32,34,36,38,40,44,49,53,[55][56][57] and retrospective (5%) 13,52,54 studies. Eighteen studies administered a test dose, 15,23,[25][26][27][28][29][30][31]34,37,…”

“…The prevalence of moderate or severe adverse reactions requiring treatment or discontinuation of IV iron was slightly higher in observational studies (13/1352; 9.6 per 1000 women; n = 20 studies) 12,13,19,20,22,23,32,33,40,41,44- [11][12][13][14][15][16]19,20,[22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][44][45][46][47][49][50][51] or FCM (1/276; 3.6 per 1000).…”