Clinical Study

Direct Comparison of the Safety and Efficacy of Ferric Carboxymaltose versus Iron Dextran in Patients with Iron Deficiency Anemia

Table 1

Baseline demographics and characteristics.

Demographic characteristicFCM ( )DEX ( ) value

Age (years)
 Mean (SD)46.2 (14.64)48.2 (17.10)
 Minimum, maximum20, 8618, 84
 ≤6572 (87.8%)63 (80.8%)
 66–755 (6.1%)9 (11.5%)
 76–855 (6.1%)6 (7.7%)
Gender
 Female73 (89.0%)69 (88.5%)
 Male9 (11.0%)9 (11.5%)
Race
 African American27 (32.9%)21 (26.9%)
 Asian4 (4.9%)3 (3.8%)
 Caucasian41 (50.0%)42 (53.8%)
 Hispanic7 (8.5%)11 (14.1%)
 Other3 (3.7%)1 (1.3%)
Iron intolerance
 No37 (45.1%)33 (42.3%)
 Yes45 (54.9%)45 (57.7%)
Weight (kg)
  Mean (SD)79.89 (22.960)82.18 (20.681)
Height (cm)
 Mean (SD)163.65 (7.965)163.80 (8.245)
Drug allergy
 No44 (53.7%)45 (57.7%)
 Yes38 (46.3%)33 (42.3%)
Baseline hemoglobin (g/dL)
  Mean (SD)9.63 (1.190)9.49 (1.260)
Hemoglobin category
 ≤8.0 g/dL9 (11.0%)9 (11.5%)
 8.1–9.5 g/dL23 (28.0%)20 (25.6%)
 ≥9.6 g/dL50 (61.0%)49 (62.8%)
Use of immunosuppressive therapy
 No79 (96.3%)77 (98.7%)
 Yes3 (3.7%)1 (1.3%)
Cardiovascular risk
 141 (50.0%)40 (51.3%)
 219 (23.2%)19 (24.4%)
 312 (14.6%)10 (12.8%)
 410 (12.2%)9 (11.5%)
Baseline TSAT (%)
 Mean (SD)10.05 (10.010)10.95 (11.257)
 <2072 (87.8%)63 (80.8%)
Baseline ferritin (ng/mL)
 Mean (SD)12.89 (21.848)23.12 (44.828)
 <10080 (97.6%)71 (91.0%)
Past response to iron therapy
 Poor/no17 (20.7%)18 (23.1%)
 Poor/yes65 (79.3%)60 (76.9%)
Etiology of IDA
 Heavy uterine bleeding32 (39.0%)27 (34.6%)
 Chronic kidney disease4 (4.9%)2 (2.6%)
 IBD/Gastrointestinal related31 (37.8%)
30 (38.5%)
 Other4 (4.9%)9 (11.5%)
 Postpartum2 (2.4%)1 (1.3%)
 Unknown9 (11.0%)9 (11.5%)

IBD: inflammatory bowel disease; IDA: iron deficiency anemia; SD: standard deviation.