Abstract

Real-World Efficacy and Tolerability of Heme Iron Polypeptide in Non-Pregnant and Pregnant Women with Iron Deficiency Anemia

Background: Iron deficiency anemia is a common condition affecting the quality of life, as well as maternal and fetal outcomes in non-pregnant and pregnant women respectively. Oral iron supplementation represents the most convenient and cost-effective form of therapy. Conventional non-heme iron oral supplements are known to be associated with poor gastrointestinal tolerability, and therefore reduced compliance and efficacy. Oral Heme iron supplementation represents a better tolerated and more bioavailable option for oral iron therapy. Though evidence of its efficacy and tolerability are available through some randomized clinical trials, real world data from its regular use in pregnant and non-pregnant patients is lacking. Methodology: 378 non-pregnant and pregnant women visiting 56 gynecology clinics across India with an in-clinic diagnosis of iron deficiency anemia based on baseline laboratory evaluation of hemoglobin (Hb), along with ferritin, MCV and hematocrit, were treated with daily tablets of heme iron polypeptide (HIP) for an average duration of 3 months. Laboratory parameters assessed at baseline were repeated at final follow up and the patients’ tolerability to therapy was also recorded. Results: In non-pregnant women, the average rise in Hb was 1.17, 2.06 and 3.28 (g/dl), in groups with baseline mild, moderate, and severe anemia, while in pregnant women, the average Hb rise was 2.70 and 3.53 (g/dl) in groups with baseline moderate and severe anemia. The rise in Hb was highly significant in both pregnant and non-pregnant women with baseline moderate and severe anemia. There was also a significant decline in the number of patients with moderate and severe anemia, as well as in percentage patients with low ferritin, MCV and hematocrit values. The tolerability of HIP was satisfactory with a treatment adverse event related discontinuation rate of less than 0.8%. Conclusion: This study suggests that oral HIP therapy can be an effective treatment option in pregnant and non-pregnant women with iron deficiency due to its better gastrointestinal tolerability and efficacy in improving hematological parameters.

• PDF