• Efficacy and safety of oral iron (III) polymaltose complex versus ferrous sulfate in pregnant women with iron-deficiency anemia: a multicenter, randomized, controlled study 
en To content Full text of article

Efficacy and safety of oral iron (III) polymaltose complex versus ferrous sulfate in pregnant women with iron-deficiency anemia: a multicenter, randomized, controlled study 


Efficacy and safety of oral iron (III) polymaltose complex versus ferrous sulfate in pregnant women with iron-deficiency anemia: a multicenter, randomized, controlled study 

Ortiz Ricardo, Eduardo Toblli Jorge, Romero Juan Diego, Monterrosa Beatriz, Frer Cristina, Macagno Eugenia, Breymann Christian 
Hospital Local del Norte, Bucaramanga, Colombia

Hospital Aleman, Buenos Aires, Argentina

Centro de Atencion Medica Inmediata Vista Hermosa, Bogota, Colombia

Universitats Spital Zurich, Klinik fur Geburtshilfe, Feto Maternal Research Group, Obstetric Research, Zurich, Switzerland

Original article published by Jornal of Maternal-Fetal and Neonatal Medicine. 2011. 1–6. Translation of the article published in the journal Reproduktivnaya endokrinologiya. — 2014, June. — №3 (17). — P. 118—125. 

Objective: To evaluate the efficacy and safety of iron (III) polymaltose complex (Maltofer) versus ferrous sulfate in iron-deficient pregnant women using recommended doses. 

Methods: An exploratory, open-label, randomized, controlled, multicenter study was undertaken in 80 pregnant women with iron-deficiency anemia (hemoglobin <10.5 g/dL, serum ferritin <15 ng/mL and mean corpuscular volume <80 fL). Patients were randomized 1:1 to oral iron (III) polymaltose complex or ferrous sulfate (each 100 mg iron twice daily) for 90 days. 

Results. The primary endpoint, change in hemoglobin from baseline to days 60 and 90, did not differ significantly between treatment groups. The mean change to day 90 was 2.16 (0.67) g/dL in the iron (III) polymaltose complex group and 1.93 (0.97) g/dL in the ferrous sulfate group. Mean serum ferritin at day 90 was 179 (38) ng/mL and 157 (34) ng/mL with iron (III) polymaltose complex and ferrous sulfate, respectively (p=0.014). Adverse events were significantly less frequent in the iron (III) polymaltose group, occurring in 12/41 (29.3%) patients, than in the ferrous sulfate group (22/39 [56.4%]) (p=0.015).

Conclusions: Oral iron (III) polymaltose complex offers at least equivalent efficacy and a superior safety profile compared to ferrous sulfate for the treatment of iron-deficiency anemia during pregnancy.

Key words: anemia, deficiency, ferrous, IPC, pregnancy, pregnant, iron, sulfate.


1. DeMaeyer Е, Adiels-Tegman М. 1985The prevalence of anaemia in the world. World Health Stat Q. 38: 302—316.

2. The prevalence of anaemia in women. A tabulation of available information. Geneva, World Health Organization. 1992. (WHO/MCH/MSM/92.2).

3. Zavaleta N, Berlanga R, Lonnerdal B, Brown KH. 1993. Prevalence and determinants of iron deficiency anaemia in a representative sample of pregnant women in Lima, Peru. Final report presented to the Pan American Health Organization. Washington DC: Pan American Health Organization.

4. Toblli JE, Brignoli R. 2007. Iron (III)-hydroxide polymaltose complex in iron deficiency anemia. Review and metaanalysis. Arzneimittelforschung. 57: 431—438.

5. Geisser P, Hohl H, Muller A. 1987. Clinical effectiveness of three different iron preparations in pregnant women. Schweiz Apoth Ztg. 125: 393—398.

6. Jacobs P, Fransman D, Coghlan P. 1993. Comparative bioavailability of ferric polymaltose and ferrous sulphate in iron-deficient blood donors. J Clin Apher. 8: 89—95.

7. Geisser P, Muller A. 1987. Pharmacokinetics of iron salts and ferric hydroxidecarbohydrate complexes. Arzneimittelforschung. 37: 100—104.

8. Dresow B, Petersen D, Fischer R, Nielsen P. 2008. Nontransferrin-bound iron in plasma following administration of oral iron drugs. Biometals. 21: 273—276.

9. Tuomainen TP, Nyyssoonen K, Porkkala-Sarataho E, Salonen R, Baumgartner JA, Geisser P, Salonen JT. 1999. Oral supplementation with ferrous sulfate but not with non-ionic iron polymaltose complex increases the susceptibility of plasma lipoproteins to oxidation. Nutr Res. 19: 1121—1132.

10. Macdougall IC. 1999. Strategies for iron supplementation: Oral versus intravenous. Kidney Int Suppl. 69: S61—S66.

11.Chandler G, Harchowal J, Macdougall IC. 2001. Intravenous iron sucrose: Establishing a safe dose. Am J Kidney Dis. 38: 988—991.

12. Jacobs P, Wood L, Bird AR. 2000. Erythrocytes: better tolerance of iron polymaltose complex compared with ferrous Sulphate in the treatment of Anaemia. Hematology. 5: 77—83.

13. Saha L, Pandhi P, Gopalan S, Malhotra S, Saha PK. 2007. Comparison of efficacy, tolerability, and cost of iron polymaltose complex with ferrous sulphate in the treatment of iron deficiency anemia in pregnant women. Med Gen Med. 9: 1.

14. Hajnaczky K, Demeter J, Szokely P, Udvardi E. 2002. Our experiences gained in the tolerability study of Maltofer® chewing tablet in the prevention and treatment of iron deficiency anemia in pregnancy. Magyar Noorvosok Lapja. 65: 1—5.

15. Khalafallah A, Dennis A, Bates J, Bates G, Robertson IK, Smith L, Ball MJ et al. 2010. A prospective randomized, controlled trial of intravenous versus oral iron for moderate iron deficiency anaemia of pregnancy. J Intern Med. 268: 286—295.

16. Maltofer® Prescribing Information. Vifor (International) Inc., St Gallen, Switzerland. Last updated September. 2004.

17. Geisser P. 2007. Safety and efficacy of iron (III)-hydroxide polymaltose complex. A review of over 25 years experience. Arzneimittelforschung. 57: 439—452.

18. Langstaff RJ, Geisser P, Heil WG, Bowdler MA. 1993. Treatment of iron-deficiency anemia: A lower incidence of adverse effects with Ferrum Hausmann than ferrous sulfate. Brit Journal of Clin Research. 4: 191—198.

19. Kaltwasser JP, Werner E, Niechzial M. 1987. Bioavailability and therapeutic efficacy of bivalent and trivalent iron preparations. Arzneimittelforschung. 37: 122—129.

20. Geisser P, Philipp E. 2009. True iron bioavailability, iron pharmacokinetics and clinically silent side effects. Nutrition, Immunity and Health. 1: 3—11.

21. Melamed N, Ben-Haroush A, Kaplan B, Yogev Y. 2007. Iron supplementation in pregnancy — does the preparation matter? Arch Gynecol Obstet. 276: 601—604.

22. Schmidt BJ, Morais MB, Fisberg M, Martins A, Machado NL. 1985. Therapeutic comparison between ferrous sulfate and trivalent iron, in form of polymaltosed ferric hydroxide complex, in treatment of iron deficiency. Folha Med. 90: 225—229.

23. Macgregor MW. 1963. Maternal anaemia as a factor in prematurity and perinatal mortality. Scottish Medical Journal. 8: 134.

24. Schorr TO, Hediger ML. 1994. Anemia and iron-deficiency anemia: Compilation of data on pregnancy outcome. Am J Clin Nutr. 59: 492S—501S.

25. Allen LH. 2000. Anaemia and iron deficiency: Effects on pregnancy outcome. Am J Clin Nutr. 71: 1280S—1284S.