A comparative study of efficacy of single dose of intravenous ferric carboxymaltose over oral iron therapy in severe iron deficiency Anemia

 

 

Abstract              Background: Iron deficiency anemia (IDA) is a very common hematological complication with a global prevalence of 2% among adult men and 9–20% among adult women both pregnant and non-pregnant, depending on race and ethnicity. Objectives: to compare the efficacy of intravenous ferric carboxymaltose over oral iron therapy in adult males and non-pregnant females with severe iron deficiency anemia. Methodology: observational comparative study, carried out in a tertiary care hospital in western Maharashtra for a period of 6 months with a sample size of 100 patients. 50 cases each of anaemic patients treated with iv. Ferric Carboxymaltose and oral iron therapy. The iv. Ferric Carboxymaltose was given in two doses of 15 mg/kg (750mg) seven days apart, and oral iron tablets with 200 mg of elemental iron daily. The data was entered in Microsoft excel and was analysed using EpiInfo software. Results: There were 38 males and 62 females in the study, in which 20 males received oral therapy while 18 received IV. Ferric Carboxymaltose, amongst females, 30 received oral therapy while rest 32 received IV. Ferric Carboxymaltose therapy. The mean levels of Hb in males at the start of the treatment was 7.2 ± 0.8 g/dL, while in females it was 6.7 ± 1.3 g/dL. Interpretation: Salve M.P. at el which showed that target Hb levels were achieved significantly in even a single dose of IV. Ferric Carboxymaltose compared to oral iron. Conclusion: Intravenous Ferric Carboxymaltose is a very effective mode of treatment.

Keywords: Anemia, Iron deficiency, Ferric Carboxymaltose, oral iron.

 

INTRODUCTION

Iron deficiency anemia (IDA) is a very common hematological complication with a global prevalence of 2% among adult men and 9–20% among adult women both pregnant and non-pregnant, depending on race and ethnicity¹. IDA occurs in several medical conditions including inflammatory bowel disease (IBD) and chronic kidney disease (CKD), in association with cancer and its treatment, and in cases of acute blood loss resulting from gastrointestinal (GI) bleeding, trauma, infections, surgery, and obstetrics / gynecology and other surgical conditions². In developing countries like India the situation is even worse, according to National Iron Plus Initiative, Ministry of Health and Family Welfare India, the prevalence of anemia in India is as high as 43% making it a major public health problem of the country³. Oral iron (in addition to a thorough evaluation of the cause) is usually the initial treatment for anemia due to absolute iron deficiency, but a significant number of patients will not respond adequately, many have reported various side effects and low absorption due to various causes⁴. Iron deficiency anemia (IDA) is a common hematological complication with potentially serious clinical consequences that may require blood transfusions in severe cases. Intravenous iron therapy is a successful alternative to blood transfusion which also helpful in preventing the complications from blood transfusion and also in cases when blood is not easily available. Ferric carboxymaltose (FCM) is a stable, nondextran iron formulation administered intravenously in large single dose to treat IDA. This study has been carried out to compare the efficacy of intravenous ferric carboxymaltose over oral iron therapy in adult males and non-pregnant females with severe iron deficiency anemia.

 

METHODOLOGY

Study Design: Observational comparative study

Study Site: A tertiary care hospital and teaching institute in western Maharashtra.

Study Period: The study was done for a period of 6 months which was done between January 2018 and June 2018.

Sample size: According to Ministry of Health, India data, the prevalence of anaemia is estimated as 43% in developing countries like India [3]. So, p = 43 %

Using formula for sample size (n) calculation,

                              n = 4 x p x q

                                             e²

where, p = 43 % = 0.43 q = 1 - p = 0.57

Taking e, absolute error of 10%, e = 0.1

                              So, n = 4 x 0.43 x 0.57

                                              0.1 x 0.1

n = 98.04 ≈ 100

A total of 100 patients were included in the study.

Inclusion criteria:

1. Patients aged more than 18 years, both genders.
2. Patients diagnosed as iron deficiency anemia, with Hb < 8 g/L.
3. Patient willing to participate in the study by giving written informed consent.

Exclusion criterion:

1. Pregnant females
2. Patients with other causes of anemia.
3. Patients with Hb levels ≥ 8 g/L.

Source of Data and Data Collection:

The study took anaemic cases from medical wards and medicine OPD from the tertiary care hospital. The nature and purpose of the study was described to the subjects and informed consent was obtained from those willing to participate in the study. The study used a pre-tested semi structured proforma which was contained detailed information of the subjects which included personal history and examination details, lab investigations and treatment provided. 50 cases each of anaemic patients treated with iv. Ferric Carboxymaltose and oral iron therapy were selected for the study and the results were compared using Hb levels at the start of the treatment, at 14 days and at 30 days. The iv. Ferric Carboxymaltose was given in two doses of 15 mg/kg (750mg) seven days apart, and oral iron tablets with 200 mg of elemental iron daily.

The data was entered in Microsoft excel and was analysed using EpiInfo.

 

 

 

 

 

 

 

 

 

 

 

 

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