PMID- 17435611
OWN - NLM
STAT- MEDLINE
DCOM- 20070719
LR  - 20231103
IS  - 1531-0132 (Electronic)
IS  - 1531-0132 (Linking)
VI  - 9
IP  - 1
DP  - 2007 Jan 2
TI  - Comparison of efficacy, tolerability, and cost of iron polymaltose complex with 
      ferrous sulphate in the treatment of iron deficiency anemia in pregnant women.
PG  - 1
AB  - 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. AIMS: The aim of the study was to compare efficacy, 
      safety, compliance, and cost-effectiveness of IPC with ferrous sulphate (FS) in 
      pregnant patients. SETTINGS AND DESIGNS: 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. STATISTICAL ANALYSIS: 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. CONCLUSION: 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.
FAU - Saha, Lekha
AU  - Saha L
AD  - Department of Pharmacology, Postgraduate Institute of Medical Education and 
      Research, Chandigarh, India. lekhasaha@rediffmail.com
FAU - Pandhi, Promila
AU  - Pandhi P
FAU - Gopalan, Sarala
AU  - Gopalan S
FAU - Malhotra, Samir
AU  - Malhotra S
FAU - Saha, Pradip Kumar
AU  - Saha PK
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20070102
PL  - United States
TA  - MedGenMed
JT  - MedGenMed : Medscape general medicine
JID - 100894134
RN  - 0 (Ferric Compounds)
RN  - 0 (Ferrous Compounds)
RN  - 39R4TAN1VT (ferrous sulfate)
RN  - UM5219H89V (teferrol)
SB  - IM
MH  - Adult
MH  - Anemia, Iron-Deficiency/drug therapy/*economics
MH  - Cost-Benefit Analysis/economics
MH  - Double-Blind Method
MH  - Female
MH  - Ferric Compounds/*economics/therapeutic use
MH  - Ferrous Compounds/*economics/therapeutic use
MH  - Humans
MH  - Pregnancy
MH  - Pregnancy Complications, Hematologic/drug therapy/*economics
PMC - PMC1924983
EDAT- 2007/04/17 09:00
MHDA- 2007/07/20 09:00
PMCR- 2007/01/01
CRDT- 2007/04/17 09:00
PHST- 2007/04/17 09:00 [pubmed]
PHST- 2007/07/20 09:00 [medline]
PHST- 2007/04/17 09:00 [entrez]
PHST- 2007/01/01 00:00 [pmc-release]
AID - 548571 [pii]
PST - epublish
SO  - MedGenMed. 2007 Jan 2;9(1):1.