Comparison of efficacy, tolerability, and cost of iron polymaltose complex with ferrous sulphate in the treatment of iron deficiency anemia in pregnant women.
BACKGROUND
The efficacy of iron polymaltose complex (IPC) in the treatment of iron deficiency anemia (IDA) during pregnancy has not been well established, and the evidence is inconclusive.


OBJECTIVE
The aim of the study was to compare efficacy, safety, compliance, and cost-effectiveness of IPC with ferrous sulphate (FS) in pregnant patients.


METHODS
The randomized, double-blind, parallel-group study was conducted in the Department of Pharmacology in collaboration with the Department of Obstetrics and Gynaecology Postgraduate Institute of Medical Education and Research, Chandigarh, India.


METHODS
One hundred pregnant women aged 20-40 years at 14 to 27 weeks' gestation, with hemoglobin (Hb) < 9 g/dL, and serum ferritin < 12 mcg/L, were classified into 2 groups. One group received IPC (100 mg elemental iron), and the other group received FS (120 mg elemental iron) daily for 8 weeks. At Week 0 and Week 8, Hb, packed cell volume (PCV), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), serum iron, and serum ferritin were measured. Compliance with study medication was determined by pill counting at each visit. Cost minimization analysis was done to compare the costs of the 2 treatments.


METHODS
Data are expressed as mean -/+ SD. Paired and unpaired 't' test were used to analyze differences within groups and between groups. Chi-square (x2) test was used to analyze primary efficacy parameters and adverse drug reactions (ADR).


RESULTS
Statistically significant increases in Hb, PCV, MCV, MCH, MCHC, serum iron, and serum ferritin levels were seen at the end of 8 weeks of treatment in both groups. The overall adverse effects were more common in the FS group compared with the IPC group [41 (78%) vs 15 (31%), P < .001]. The compliance rate was significantly (P < .05) higher for the IPC (91%) group than for the FS (87%) group. The average total cost (direct + indirect) of treatment of anemia was comparable between the 2 groups.


CONCLUSIONS
The results of the present study suggest that IPC can be considered as a useful alternative formulation for the treatment of IDA during pregnancy for those patients who cannot tolerate other iron preparations (ferrous form); this is an important finding, as compliance is a significant concern during pregnancy.
Saha
Lekha
L
Department of Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh, India. lekhasaha@rediffmail.com
Pandhi
Promila
P
Gopalan
Sarala
S
Malhotra
Samir
S
Saha
Pradip Kumar
PK
D000328:Adult; D018798:Anemia, Iron-Deficiency / Q000188:drug therapy / Q000191:economics*; D003362:Cost-Benefit Analysis / Q000191:economics; D004311:Double-Blind Method; D005260:Female; D005290:Ferric Compounds / Q000191:economics* / Q000627:therapeutic use; D005296:Ferrous Compounds / Q000191:economics* / Q000627:therapeutic use; D006801:Humans; D011247:Pregnancy; D011250:Pregnancy Complications, Hematologic / Q000188:drug therapy / Q000191:economics*
D005290:Ferric Compounds; D005296:Ferrous Compounds; C020748:ferrous sulfate; C013276:teferrol