Efficacy and safety of ferric carboxymaltose versus ferrous sulfate for iron deficiency anemia during pregnancy: subgroup analysis of Korean women

Abstract

BackgroundWe performed a post-hoc subgroup analysis in Korean women who participated in the Phase III FER-ASAP (FERric carboxymaltose-Assessment of SAfety and efficacy in Pregnancy) study to compare the efficacy and safety of ferric carboxymaltose (FCM) with oral ferrous sulfate (FS).MethodsPregnant Korean women (gestational weeks 16–33) with iron-deficiency anemia (IDA) were randomized 1:1 to FCM (n = 46; 1000–1500 mg iron) or FS (n = 44; 200 mg iron/day) group for 12 weeks. The primary objective was to compare the mean hemoglobin (Hb) increase at week 3; secondary objectives included change in iron parameters, quality of life (QoL), and safety.ResultsBaseline characteristics of the Korean subgroup were consistent with those of non-Korean FER-ASAP population except for lower body-mass index and higher maternal age. Hb level increases were comparable between the two treatment groups in Korean women at week 3 (FCM 1.23 ± 0.89 g/dL vs FS 1.14 ± 1.72 g/dL). Iron parameters improved over time as secondary endpoints were significantly in favor of FCM. In terms of QoL, FCM treatment significantly improved the mental and physical components as well as vitality prior to delivery. Both treatments were well tolerated.ConclusionsFCM provided significantly greater improvements in iron parameters and QoL compared to FS in the Korean subgroup. FCM may be a preferable alternative to currently available treatments for IDA during pregnancy.

<p>Hypophosphatemia Associated with Intravenous Iron Therapies for Iron Deficiency Anemia: A Systematic Literature Review</p>

“…Within the literature reviewed, 13 of the 19 Level I and 4 of the 10 Level II studies did not report a definition of hypophosphatemia. 9,[23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38] Methodologies for serum phosphate measurement and clinical definition of hypophosphatemia varied within and across Level I and Level II studies. Of the 19 Level I studies, 15 did not explicitly report the methodology or timing of serum phosphate measurement.…”

“…Ten observational, retrospective, or post hoc studies were identified as a supplemental data source to RCT articles (Figure 4). 17,[35][36][37][38]42,[46][47][48][49] All ten studies investigated FCM; two also reported on iron sucrose treatment arms. 17,38 Level II studies reported hypophosphatemia rates ranging 0.0-82.0% with FCM and 0.0-22.0% with iron sucrose.…”

“…17,36,38,47 Seven of ten observational studies described hypophosphatemia as "asymptomatic" or "transient" due to spontaneous resolution after intervention cessation and no need for further interventions. [35][36][37][38][47][48][49] A retrospective review of patient medical records by Hardy et al (2015) reported that some FCM-treated patients experienced persistent fatigue despite anemia correction as a clinical consequence of hypophosphatemia. 17 Two other studies proposed further investigation of potential clinical consequences of hypophosphatemia such as bone disease development, osteomalacia and other long-term outcomes associated with repeat IVI treatments.…”

REGAIN STUDY: Retrospective Study to Assess the Effectiveness, Tolerability, and Safety of Ferric Carboxymaltose in the Management of Iron Deficiency Anemia in Pregnant Women

“…In a study that assessed efficacy and safety of IV FCM versus oral ferrous sulfate (FS), FCM achieved Hb increase of >2 g/dL in 7 days and >3 g/dL in 2 to 4 weeks [14]. Another study comparing the efficacy and safety of IV FCM versus oral FS in pregnant Korean women (gestational weeks: 16–33) with IDA showed that FCM provided significantly greater improvements in iron parameters and quality of life (QoL) than FS [15].…”

Iron infusion and newer intravenous iron formulations

“…[ 3 , 6 , 7 ] More than 20 randomized studies revealed that IV administration of iron offers better tolerability, efficacy, and effectiveness than oral iron therapy. [ 8 , 9 ] One randomized control trial reported that the cost of IV use does not exceed that of oral therapy, whereas IV use is more beneficial in terms of superior tolerance and effectiveness. [ 10 ] The adverse effects of iron infusion are major anaphylactic (rare), and less severe or minor reactions such as urticaria, dizziness, facial flushing, arthralgia, myalgia, dysgeusia etc.…”