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Efficacy and safety of emulsified microsomal ferric pyrophosphate vs. Ferrous Ascorbate in pregnancy with
Ameet Patki1, G S Jyothi2, Vidya Thobbi3
1Fertility Associates Clinic, 81, 4th Floor, Gupte House, Police Station, Swami Vivekananda Rd, near Khar, Ram Krishna Nagar, Khar West, Mumbai, 400054, Maharashtra, India.
Abstract:
This study evaluates the efficacy and safety of emulsified microsomal Ferric pyrophosphate (EMFP/SunActive™ Fe, 27 mg elemental iron) versus Ferrous Ascorbate (100 mg elemental iron) in second-trimester pregnant women with iron-deficiency anemia (IDA) for 4 weeks. Pregnant women aged 20-35 years with a singleton pregnancy, hemoglobin (Hb) 9-10.5 g/dL, and ferritin < 15 mcg/L were enrolled. The test group showed zero adverse effects vs. the control group, having 11.1% adverse events. The gastrointestinal(GI) adverse symptoms, including nausea, dark stools, and hyperacidity, were reported only in the Ferrous Ascorbate group, indicating superior tolerability and safety of EMFP tablets. Both groups showed similar improvements in Hb (Δ2.63 g/dL vs. Δ2.62 g/dL) and serum ferritin (61.09% vs. 61.92%). Reticulocyte hemoglobin (RET-He) increased by 20.5% in the test group and 16.2% in the control group, with no significant difference. Clinical symptoms such as dizziness, fatigue, and palpitations improved with greater magnitude in the test group. It was inferred that the test group receiving EMFP was as effective as the control group in improving efficacy endpoints at a significantly lower dose (1/3rd dose compared to ascorbate). EMFP showed better tolerability, safety and compliance, making it a promising option for managing IDA in pregnant women.
Insights
Emulsified microsomal Ferric pyrophosphate (EMFP) offers a safer, well-tolerated alternative for treating iron-deficiency anemia (IDA) in pregnant women, showing comparable efficacy to Ferrous Ascorbate with fewer side effects.
Area of Science:
- Obstetrics and Gynecology
- Hematology
- Nutritional Science
Background:
- Iron-deficiency anemia (IDA) is a prevalent complication during pregnancy, affecting maternal and fetal health.
- Traditional iron supplements like Ferrous Ascorbate can cause gastrointestinal (GI) side effects, impacting patient compliance.
- Novel iron formulations are needed to improve treatment outcomes and tolerability in pregnant populations.
Purpose of the Study:
- To compare the efficacy and safety of emulsified microsomal Ferric pyrophosphate (EMFP) against Ferrous Ascorbate in treating IDA in second-trimester pregnant women.
- To evaluate differences in adverse event profiles and clinical symptom improvement between the two iron formulations.
- To assess the effectiveness of EMFP at a significantly lower elemental iron dose.
Main Methods:
- A 4-week randomized controlled study involving pregnant women (20-35 years) with IDA (Hb 9-10.5 g/dL, ferritin <15 mcg/L).
- Participants received either EMFP (27 mg elemental iron) or Ferrous Ascorbate (100 mg elemental iron) daily.
- Efficacy endpoints included changes in hemoglobin, serum ferritin, and reticulocyte hemoglobin (RET-He); safety assessed via adverse event reporting.
Main Results:
- Both EMFP and Ferrous Ascorbate demonstrated similar significant improvements in hemoglobin and serum ferritin levels.
- EMFP showed a superior safety profile with zero adverse events compared to 11.1% in the Ferrous Ascorbate group, primarily GI-related symptoms.
- The EMFP group experienced greater improvement in clinical symptoms like dizziness and fatigue, despite receiving one-third the elemental iron dose.
Conclusions:
- EMFP is as effective as Ferrous Ascorbate in improving hematological parameters for IDA in pregnant women.
- EMFP exhibits significantly better tolerability and safety, with reduced GI adverse effects, enhancing patient compliance.
- EMFP presents a promising, lower-dose alternative for managing iron-deficiency anemia during pregnancy.
