Efficacy and safety of oral iron(iii) polymaltose complex versus ferrous sulfate in pregnant women with iron-deficiency anemia:a multicenter, randomized, controlled study
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.
Full Text:PDF (Русский)
DeMaeyer, E. Adiels-Tegman, M. «The prevalence of anaemia in the world.» World Health Stat Q, 38(1985):302-316.
«The prevalence of anaemia in women. A tabulation of available information.» Geneva, World Health Organization (1992) (WHO/MCH/MSM/92.2).
Zavaleta, N. Berlanga, R. Lonnerdal, B. Brown, K.H. «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 (1993).
Toblli, J.E. Brignoli, R. «Iron(III)-hydroxide polymaltose complex in iron deficiency anemia / review and metaanalysis.» Arzneimittelforschung, 57(2007):431-438.
Geisser, P. Hohl, H. Muller, A. «Clinical effectiveness of three different iron preparations in pregnant women.» Schweiz Apoth Ztg,125(1987):393-398.
Jacobs, P. Fransman, D. Coghlan, P. «Comparative bioavailability of ferric polymaltose and ferrous sulphate in irondeficient blood donors.» J Clin Apher, 8(1993):89-95.
Geisser, P. Muller, A. «Pharmacokinetics of iron salts and ferric hydroxide-carbohydrate complexes.» Arzneimittelforschung, 37(1987):100-104.
Dresow, B. Petersen, D. Fischer, R. Nielsen, P. «Nontransferrin-bound iron in plasma following administration of oral iron drugs.» Biometals, 21(2008):273-276.
Tuomainen, T.P. Nyyssoonen, K. Porkkala-Sarataho, E. Salonen, R. Baumgartner, J.A. Geisser, P. Salonen, J.T. «Oral supplementation with ferrous sulfate but not with non-ionic iron polymaltose complex increases the susceptibility of plasma lipoproteins to oxidation.» Nutr Res, 19(1999):1121-1132.
Macdougall IC. Strategies for iron supplementation: Oral versus intravenous. Kidney Int Suppl 1999;69:S61–S66.
Chandler, G. Harchowal, J. Macdougall, I.C. «Intravenous iron sucrose: Establishing a safe dose.» Am J Kidney Dis, 38(2001):988-991.
Jacobs, P. Wood, L. Bird, A.R. «Erythrocytes: better tolerance of iron polymaltose complex compared with ferrous Sulphate in the treatment of Anaemia.» Hematology, 5(2000):77-83.
Saha, L. Pandhi, P. Gopalan, S. Malhotra, S. Saha, P.K. «Comparison of efficacy, tolerability, and cost of iron polymaltose complex with ferrous sulphate in the treatment of iron deficiency anemia in pregnant women.» MedGenMed, 9(2007):1.
Hajnaczky, K. Demeter, J. Szokely, P. Udvardi, E. «Our experiences gained in the tolerability study of MaltoferR chewing tablet in the prevention and treatment of iron deficiency anemia in pregnancy.» Magyar Noorvosok Lapja, 65(2002):1-5.
Khalafallah, A. Dennis, A. Bates, J. Bates, G. Robertson, I.K. Smith, L. Ball, M.J. et al. «A prospective randomized, controlled trial of intravenous versus oral iron for moderate iron deficiency anaemia of pregnancy.» J Intern Med, 268(2010):286-295.
MaltoferR Prescribing Information. Vifor (International) Inc., St Gallen, Switzerland. Last updated September (2004).
Geisser, P. «Safety and efficacy of iron(III)-hydroxide polymaltose complex / a review of over 25 years experience.» Arzneimittelforschung, 57(2007):439-452.
Langstaff, R.J. Geisser, P. Heil, W.G. Bowdler, M.A. «Treatment of iron-deficiency anemia: A lower incidence of adverse effects with Ferrum Hausmann than ferrous sulfate.» Brit Journal of Clin Research, 4(1993):191-198.
Kaltwasser, J.P. Werner, E. Niechzial, M. «Bioavailability and therapeutic efficacy of bivalent and trivalent iron preparations.» Arzneimittelforschung, 37(1987):122-129.
Geisser, P. Philipp, E. «True iron bioavailability, iron pharmacokinetics and clinically silent side effects.» Nutrition, Immunity and Health, 1(2009):3-11.
Melamed, N. Ben-Haroush, A. Kaplan, B. Yogev, Y. «Iron supplementation in pregnancy – does the preparation matter?» Arch Gynecol Obstet, 276(2007):601-604.
Schmidt, B.J. Morais, M.B. Fisberg, M. Martins, A. Machado, N.L. «Therapeutic comparison between ferrous sulfate and trivalent iron, in form of polymaltosed ferric hydroxide complex, in treatment of iron deficiency.» Folha Med, 90(1985):225-229.
Macgregor, M.W. «Maternal anaemia as a factor in prematurity and perinatal mortality.» Scottish Medical Journal, 8(1963):134.
Schorr, T.O. Hediger, M.L. «Anemia and iron-deficiency anemia: Compilation of data on pregnancy outcome.» Am J Clin Nutr, 59(1994): 492S-501S.
Allen, L.H. «Anaemia and iron deficiency: Effects on pregnancy outcome.» Am J Clin Nutr, 71(2000):1280S-1284S.
GOST Style Citations
This work is licensed under a Creative Commons Attribution 4.0 International License.
ISSN 2411-1295 (Online), ISSN 2309-4117 (Print)