Ineffectiveness of oral iron hydroxide polymaltose in iron-deficiency ...

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Abstract. Two hundred and forty one patients with iron deficiency anemia (IDA) were identified in a single institution over a 24-year period; of these, 75 ...
Hematology, June 2007; 12(3): 255–256

Ineffectiveness of oral iron hydroxide polymaltose in iron-deficiency anemia ´ NDEZ1, ¨ ELLES1,2, ANGELES DI´AZ-HERNA GUILLERMO J. RUIZ-ARGU 1 3 CARLOS MANZANO , & GUILLERMO J. RUIZ-DELGADO 1

Centro de Hematologı´a y Medicina Interna de Puebla, Puebla, PUE, Mexico, 2Laboratorios Clı´nicos de Puebla, Puebla, PUE, Mexico, and 3Hospital Universitario de Nuevo Leo´n, Monterrey, NL, Mexico

(Received 21 September 2006; accepted 1 December 2006)

Abstract Two hundred and forty one patients with iron deficiency anemia (IDA) were identified in a single institution over a 24-year period; of these, 75 individuals were studied as the result of persistent IDA despite the administration of oral iron hydroxide polymatose (IP). The levels of hemoglobin when the patients were referred for study after being given oral IP had a median of 10.3 g/dl; after administration of oral iron fumarate during periods ranging from 1 to 14 months, the levels of hemoglobin rose to a median of 12.5 g/dl ( p . 0.01). Our data support previous observations made in other countries about the ineffectiveness of oral IP in the treatment of individuals with IDA and should alert the clinician to avoid unnecessary consultations and misdiagnosis.

Keywords: Iron deficiency anemia, iron hydroxide polymaltose, iron fumarate, hemoglobin

Introduction Iron deficiency anemia (IDA) is still the leading cause of nutritional anemia in Me´xico and other developing and developed countries [1]; it is the most common cause of anemia both in general medical practice and in the practice of clinical hematology and is considered to be the most common organic disorder in clinical medicine [1]. The therapeutic use of iron was mentioned in Greek mythology in the story of Iphiclus, who was cured of impotence by drinking iron rust dissolved in wine [2]. Iron is highly effective in treating IDA; this therapy is usually straightforward, simple and inexpensive; in general, the response is predictable and gratifying [3]. The standard preparation for oral use is ferrous sulfate: ferrous gluconate and ferrous fumarate are equally effective and have a similar incidence of side effects [1,3]. Oral iron hydroxide polymaltose (IP) preparations are ferric compounds, which have been both licensed and heavily promoted in some developing

countries to treat IDA. When compared with ferrous salts, oral ferric salts are absorbed less well and cause fewer gastrointestinal (GI) tract problems [4]. The better GI tolerability of IP has been widely used as an argument to promote its use in the treatment of IDA in some countries; however, its ineffectiveness in the treatment of IDA has also been clearly identified and published [4–7]. We analyze here the results of treating patients with IDA with oral ferrous sulfate after failing to respond to treatment with oral IP. Material and methods Patients with the diagnosis of iron deficiency anemia, studied at the Centro de Hematologı´a y Medicina Interna de Puebla between June 1983 and May 2006 were included in the study. Complete blood cell counts, serum iron levels, serum transferrin levels, serum ferritin levels and zinc-protoporphyrin in red blood cells were measured conventionally [1]. Individuals

Correspondence: G. J. Ruiz-Argu¨elles, Centro de Hematologı´a y Medicina Interna de Puebla, 8B Sur 3710, 72530 Puebla, PUE, Mexico. Tel: 52 222 243 8100. Fax: 52 222 243 8428. E-mail: [email protected] ISSN 1024-5332 print/ISSN 1607-8454 online q 2007 Informa UK Ltd. DOI: 10.1080/10245330701214160

256 G. J. Ruiz-Argu¨elles et al. Discussion

Hemoglobin (gr/dl)

16

12

8 0

2.1 Time in months

Figure 1. Mean and SD of the levels of hemoglobin of the 75 patients with persistent IDA despite the administration of oral IP and who given iron fumarate during a median of 2.1 months.

who had failed to resolve the anemia despite the administration of oral IP were analyzed separately and treated subsequently with oral iron fumarate (350 mg/day) together with pantoprazole (40 mg/day). Results Two hundred and forty one patients with IDA were identified in this period; of these, 75 individuals were referred to our clinic as the result of persistent iron deficiency despite the administration of oral IP. The levels of hemoglobin when the patients were referred for study after being given oral IP had a median of 10.3 g/dl (range 2.9 – 13.8). Patients had been given oral IP over periods ranging from 4 to 14 months, at doses between 178 and 356 mg of IP. After administration of oral iron fumarate during a median of 2.1 months (range 1 –14.6 months) to these 75 patients, the level of hemoglobin rose to a median of 12.5 g/dl (range 8.3 – 16.8) (Figure 1). In this group of individuals, there were 21 males and 54 females, the median age being 28 years (range 0.8 –68 years). The leading cause of iron deficiency was menorrhagia. In a subset of 22 individuals, the levels of hemoglobin before the administration of oral IP could be recorded; the median value of this variable was 8.8 g/dl (range 5 – 13.1); since the levels of hemoglobin had failed to increase despite the delivery of oral IP, they were referred to our clinic for further studies and subsequent treatment.

As a result of the heavy advertisement campaigns in Me´xico, both general practitioners and internists prescribe oral IP as the first choice in the treatment of IDA. In Me´xico, oral IP preparations are 15% more expensive than ferrous fumarate. Since a significant number of patients given oral IP fail to respond and show no increase in the hemoglobin levels, malabsorption is often considered with patients being referred for further evaluation of their iron metabolism. This was the case in 75 of the individuals reported here. By simply switching from the ferric compound (IP) to a ferrous one (iron fumarate or sulfate), coupled with a drug which improves the GI tolerance—such as a proton-pump inhibitor—the problem is solved in the majority of cases. IP has not been licensed in several countries and its ineffectiveness in the treatment of IDA has been clearly identified in other developing countries in which it has been licensed [4 – 7], such as Me´xico. Our data support previous observations made in other countries about the ineffectiveness of oral IP in the treatment of individuals with IDA and should alert the clinician to avoid unnecessary consultations and misdiagnosis.

References [1] Cano-Castellanos R. Anemia por deficiencia de hierro. In: RuizArgu¨elles GJ, editor. Fundamentos de Hematologı´a. 3rd ed. Me´xico City: Editorial Me´dica Panamericana; 2003. p 61–80. [2] Fraser JG. The golden bough: The magic art in the evolution of kings. New York: Mc Millan; 1935. p 158. [3] Lee GR. Iron deficiency and iron-deficiency anemia. In: Lee GR, Foerster J, Lukens J, Paraskeva F, Greer JP, Rodgers GM, editors. Wintrobe’s Clinical Hematology. 10th ed. Baltimore: Williams & Wilkins; 1999. p 979 –1010. [4] Mehta BC. Iron hydroxide polymaltose: Cause of persistent iron deficiency anemia at delivery. Indian J Med Sci 2001;55:616–620. [5] Nanivaderkar AS. Ineffectiveness of iron polymaltose in treatment of iron deficiency anemia. J Assoc Physicians India 2003;51:928–929. [6] Mehta BC. Iron hydroxide polymaltose: Iatrogenic cause of persistent iron deficiency anemia despite continuous oral iron therapy. J Assoc Physicians India 2002;50:279–280. [7] Arvas A, Gur E. Are ferric compounds useful in treatment of iron deficiency anemia? Turk J Pediatr 2002;42:352–353.