Comparison of Efficacy, Tolerability, and Cost of Iron Polymaltose Complex With Ferrous Sulphate in the Treatment of Iron Deficiency Anemia in Pregnant Women

Lekha Saha, MD, DM; Promila Pandhi, MD, DM; Sarala Gopalan, PhD, FRCOG; Samir Malhotra, MD, DM; Pradip kumar Saha, MD


January 02, 2007

In This Article


The World Health Organization (WHO) defines anemia in pregnancy as a hemoglobin (Hb) concentration of < 11 g/dL.[1] Iron deficiency anemia (IDA) is the most common type of anemia in pregnancy. The iron content of the body is normally kept constant by regulating the amount absorbed to balance the amount lost.

An increase in loss along with inadequate intake can lead to depletion of body iron stores, iron deficiency, and eventually to anemia. Iron requirements are increased during infancy, puberty, pregnancy, and during menstruation.[2] The WHO estimates that 58% of pregnant women in developing countries are anemic mainly because of iron deficiency.[3]

Anemia has a significant impact on the health of the fetus as well as that of the mother. It impairs the oxygen delivery through the placenta to the fetus and interferes with the normal intrauterine growth, leading to fetal loss and perinatal deaths.[2] Anemia is associated with increased preterm labor (28.2%), preeclampsia (31.2%), and maternal sepsis.[2,4] Severe anemia can lead to palpitations, tachycardia, breathlessness, and increased cardiac output leading to cardiac stress, which can cause decompensation and cardiac failure. Anemia is responsible for 40%-60% of maternal deaths in nonindustrialized countries.[2]

Almost all cases of iron deficiency anemia respond readily to treatment with iron supplementation.[5] However, patients do not always respond adequately to oral iron therapy because of noncompliance due to side effects.[6] Gastrointestinal disturbances characterized by colicky pain, nausea, vomiting, diarrhea, and gastric distress occur in about 6%-12% of patients taking iron preparations.[6] The most widely recommended oral iron is ferrous salts; however, the use of these salts is limited by low and variable absorption, chelation by food products, and free radical-mediated mucosal luminal damage.[7,8,9,10] Ferric compounds were introduced to avoid these problems. However, these compounds are generally less soluble at physiologic pH and precipitate intraluminally as hydroxide or phosphate and therefore have poor bioavailability.[11] A need for a ferric complex that could overcome these problems was realized.

Iron-polymaltose complex (IPC), a combination of ferric iron with maltol (a food additive), was developed as a molecule that is soluble at neutral pH and is not chelated by other substances.[12]

Despite the advantage of the IPC over ferrous salts, the efficacy of IPC has not been well established in pregnancy. Studies have shown that IPC is as effective as FS, or even more so.[13,14,15] But some studies contradict these results.[16,17] However, most of them do not involve pregnant anemic women.

Therefore, the present study was conducted to evaluate the efficacy, safety, and cost of iron polymaltose formulations with ferrous sulphate in pregnant women, and to determine the compliance rates associated with IPC use.


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