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Ferric carboxymaltose: A revolution in the treatment of postpartum anemia in Indian women.

Rathod S, Samal SK, Mahapatra PC, Samal S - Int J Appl Basic Med Res (2015 Jan-Apr)

Bottom Line: Adverse effects to drug administration were also recorded.Adverse drug reactions were significantly less (P < 0.001) in FCM group when compared with other two groups.There was better overall satisfaction reported by the patients who received FCM treatment.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynaecology, SCB Medical College, Cuttack, Odisha, India.

ABSTRACT

Objectives: The objective of the present study is to compare the safety and efficacy of ferric carboxymaltose (FCM), intravenous (IV) iron sucrose and oral iron in the treatment of post = partum anemia (PPA).

Materials and methods: A total of 366 women admitted to SCB Medical College, Cuttack between September 2010 and August 2012 suffering from PPA hemoglobin (Hb) <10 g/dL were randomly assigned to receive either oral iron or IV FCM or iron sucrose. FCM, IV iron sucrose, and oral iron were given as per the protocol. Changes in hemoglobin (Hb) and serum ferritin levels at 2 and 6 weeks after treatment were measured and analyzed using ANOVA. Adverse effects to drug administration were also recorded.

Results: A statistically significant increase in Hb and serum ferritin level were observed in all three groups, but the increase in FCM group was significantly higher (P < 0.0001) than conventional iron sucrose and oral iron group. The mean increase in Hb after 2 weeks was 0.8, 2.4, and 3.2 g/dL and 2.1, 3.4, and 4.4 g/dL at 6 weeks in oral iron, iron sucrose and FCM groups, respectively. The mean increase in serum ferritin levels after 2 weeks was 2.5, 193.1, and 307.1 and 14.2, 64, and 106.7 ng/mL after 6 weeks in oral iron, iron sucrose and FCM groups, respectively. Adverse drug reactions were significantly less (P < 0.001) in FCM group when compared with other two groups.

Conclusion: Ferric carboxymaltose elevates Hb level and restores iron stores faster than IV iron sucrose and oral iron, without any severe adverse reactions. There was better overall satisfaction reported by the patients who received FCM treatment.

No MeSH data available.


Related in: MedlinePlus

Comparison of mean blood hemoglobin (g/dL) levels before and after therapy
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Figure 1: Comparison of mean blood hemoglobin (g/dL) levels before and after therapy

Mentions: A total of 532 postpartum women with (CDC recommended) risk factors were screened for postpartum iron deficiency anemia out of which 366 were found to be iron deficient. They were grouped according to the treatment they received viz., oral iron, iron sucrose or FCM. Double blinding was done to decide specific modality of treatment for a patient. A total of 300 women were analyzed (100 patients belonging to each group) after loss to follow-up; 30 in oral iron group, 22 in iron sucrose group and 14 in the FCM group. The demographic data like age, (body mass index), habitat, parity, presence of the antenatal anemia, mode of delivery and type of risk factors were comparable among the three groups (P > 0.05) [Table 1]. Delivery by caesarean section, instrumental vaginal delivery, postpartum hemorrhage (PPH), hypertensive disorders of pregnancy, placenta previa and multiple gestations were among the leading risk factors. Baseline Hb levels in the three groups was clinically insignificant. There was an overall increase in Hb and ferritin levels from baseline at 2 weeks and 6 weeks, which was significant between groups as well as within the group (P < 0.0001). The mean baseline Hb and ferritin was the lowest in the FCM group, but it showed the highest increase when compared to the other two groups [Figures 1 and 2]. The increase in Hb and serum ferritin levels in the FCM group was found statistically significant over both iron sucrose and oral iron group (P < 0.0001), whereas the increase with iron sucrose was found to be statistically significant over oral iron only (P < 0.0001) [Table 2]. Confidence interval (95%) was found in multiple comparisons of rise in Hb level and serum ferritin level in 3 groups above baseline [Tables 3 and 4]. Despite having the least mean baseline Hb, 66% of the patients in FCM group achieved a target Hb ≥ 12 g/dL (P < 0.0001) at 6 weeks whereas it was 12% and 27% in the oral iron and iron sucrose group, respectively [Table 5]. FCM proved better than oral iron and iron sucrose in achieving target Hb levels by the end of puerperium.


Ferric carboxymaltose: A revolution in the treatment of postpartum anemia in Indian women.

Rathod S, Samal SK, Mahapatra PC, Samal S - Int J Appl Basic Med Res (2015 Jan-Apr)

Comparison of mean blood hemoglobin (g/dL) levels before and after therapy
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4318097&req=5

Figure 1: Comparison of mean blood hemoglobin (g/dL) levels before and after therapy
Mentions: A total of 532 postpartum women with (CDC recommended) risk factors were screened for postpartum iron deficiency anemia out of which 366 were found to be iron deficient. They were grouped according to the treatment they received viz., oral iron, iron sucrose or FCM. Double blinding was done to decide specific modality of treatment for a patient. A total of 300 women were analyzed (100 patients belonging to each group) after loss to follow-up; 30 in oral iron group, 22 in iron sucrose group and 14 in the FCM group. The demographic data like age, (body mass index), habitat, parity, presence of the antenatal anemia, mode of delivery and type of risk factors were comparable among the three groups (P > 0.05) [Table 1]. Delivery by caesarean section, instrumental vaginal delivery, postpartum hemorrhage (PPH), hypertensive disorders of pregnancy, placenta previa and multiple gestations were among the leading risk factors. Baseline Hb levels in the three groups was clinically insignificant. There was an overall increase in Hb and ferritin levels from baseline at 2 weeks and 6 weeks, which was significant between groups as well as within the group (P < 0.0001). The mean baseline Hb and ferritin was the lowest in the FCM group, but it showed the highest increase when compared to the other two groups [Figures 1 and 2]. The increase in Hb and serum ferritin levels in the FCM group was found statistically significant over both iron sucrose and oral iron group (P < 0.0001), whereas the increase with iron sucrose was found to be statistically significant over oral iron only (P < 0.0001) [Table 2]. Confidence interval (95%) was found in multiple comparisons of rise in Hb level and serum ferritin level in 3 groups above baseline [Tables 3 and 4]. Despite having the least mean baseline Hb, 66% of the patients in FCM group achieved a target Hb ≥ 12 g/dL (P < 0.0001) at 6 weeks whereas it was 12% and 27% in the oral iron and iron sucrose group, respectively [Table 5]. FCM proved better than oral iron and iron sucrose in achieving target Hb levels by the end of puerperium.

Bottom Line: Adverse effects to drug administration were also recorded.Adverse drug reactions were significantly less (P < 0.001) in FCM group when compared with other two groups.There was better overall satisfaction reported by the patients who received FCM treatment.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynaecology, SCB Medical College, Cuttack, Odisha, India.

ABSTRACT

Objectives: The objective of the present study is to compare the safety and efficacy of ferric carboxymaltose (FCM), intravenous (IV) iron sucrose and oral iron in the treatment of post = partum anemia (PPA).

Materials and methods: A total of 366 women admitted to SCB Medical College, Cuttack between September 2010 and August 2012 suffering from PPA hemoglobin (Hb) <10 g/dL were randomly assigned to receive either oral iron or IV FCM or iron sucrose. FCM, IV iron sucrose, and oral iron were given as per the protocol. Changes in hemoglobin (Hb) and serum ferritin levels at 2 and 6 weeks after treatment were measured and analyzed using ANOVA. Adverse effects to drug administration were also recorded.

Results: A statistically significant increase in Hb and serum ferritin level were observed in all three groups, but the increase in FCM group was significantly higher (P < 0.0001) than conventional iron sucrose and oral iron group. The mean increase in Hb after 2 weeks was 0.8, 2.4, and 3.2 g/dL and 2.1, 3.4, and 4.4 g/dL at 6 weeks in oral iron, iron sucrose and FCM groups, respectively. The mean increase in serum ferritin levels after 2 weeks was 2.5, 193.1, and 307.1 and 14.2, 64, and 106.7 ng/mL after 6 weeks in oral iron, iron sucrose and FCM groups, respectively. Adverse drug reactions were significantly less (P < 0.001) in FCM group when compared with other two groups.

Conclusion: Ferric carboxymaltose elevates Hb level and restores iron stores faster than IV iron sucrose and oral iron, without any severe adverse reactions. There was better overall satisfaction reported by the patients who received FCM treatment.

No MeSH data available.


Related in: MedlinePlus