Table 5.
Findings of other systematic reviews for all countries on effect of FCM for treatment of anemia.
| Study ID | Population | Intervention | Comparison | Hemoglobin | Serum Ferritin | Adverse Events | Additional comment |
|---|---|---|---|---|---|---|---|
| Govindappagari et al. (33) | Pregnant women with IDA Included 11 RCTs from LMICs, HICs |
IV Iron (Iron sucrose, FCM, iron dextran) | Oral Iron (Ferrous sulphate, ferrous fumarate, Iron polymaltose complex, ferrous ascorbate) | Achieved target Hb more often OR 2.66 (95% CI: 1.71–4.15; p < 0.001; I 2 = 47% Increased Hb level after 4 weeks WMD 0.84; 95% CI: 0.59–1.09; p < 0.001; I 2 = 89%) |
NR | Decreased adverse reactions, OR 0.35 (95% CI: 0.18–0.67; p = 0.001; I 2 = 74%) | IV iron is superior to oral iron for treatment of IDA in pregnancy Women receiving IV iron more often achieve desired Hb targets, faster and with fewer side effects |
| Pollock et al. (34) | Patients with IDA | Iron isomaltose (IIM) 5 RCTs of IIM (4 versus oral iron and 1 versus ISC) |
FCM 14 RCTs of FCM (11 versus oral iron and 3 versus ISC) |
IIM: Significantly larger increase from BL Hb: MD = +0.249 g/dL with IIM relative to FCM | NR | Hypersensitivity Hypophosphatemia | This SR identified no completed RCTs of IIM versus FCM Higher increase from baseline Hb in IIM than FCM |
| Qassim et al. (35) | Pregnant women with IDA Included 21 RCTs & 26 observational studies from LMICs & HICs |
IV iron
|
Regardless of comparator | All IV iron preparations led to significant improvements in Hb, with a median increase of 2.18 g/dL at 3 to 4 weeks and 3.43 g/dL by delivery Increase in Hb with high dose: 2.5 (2.0–3.96) g/dL Increase in Hb with low dose: 2.0 (6.2–50.3) g/dL |
All IV iron preparations led to significant improvements in Ferritin by a median of 27 μg/L over first 4 weeks | Median prevalence of ADR for: IPM: 2.2 (0–4.5) % FCM: 5.0 (0–20% ISC: 6.7 (0–19.5) % |
No single preparation of IV iron appeared to be superior |
| Rognoni et al. (36) | >18 years with IDA Included 21 RCTs from LMICs, HICs |
FCM | Other iron formulations (ferric gluconate, oral iron) and placebo | 1. FCM vs. ferric gluconate (g/dL)(Change score): MD = 0.6; 95% CI 0.2–0.9 2. FCM vs. oral iron: (Change score): MD = 0.8; 95% CI 0.6–0.9 3. FCM vs. Placebo: (Change score): MD = 2.1; 95% CI 1.2–3.0 |
FCM verses ferric gluconate(μg/l) (Change score): MD = 1.5; 95% CI 131.4 to 122.8 FCM vs. Oral iron (μg/l)(Change score): MD = 172.8; 95% CI 66.7–234.4 ISC verses FCM (μg/l) (Change score): MD = 21.4; 95% CI 160.7 to 118.4 |
FCM was well tolerated and associated with a minimal risk of AEs | All currently available IV iron preparations appear to be safe and effective FCM is better with quicker correction of Hb and serum ferritin levels in patients with IDA |
| Rogozińska et al. (37) | Pregnant women with IDA Included RCTs from LICs, LMICs and HICs |
Iron preparations, with at least 60 mg of elemental iron (ISC and FCM) | Another iron or non-iron preparation (Oral ferrous sulfate) | IS verses oral iron: Change-score: MD = 0.71; 95% CI 0.262–1.17 g/dL; 7 trials FCM verses oral iron: Change-score: MD = 0.85; 95% CI 0.051–1.65 g/dL; 1 trial 53 trials (9,145 women), 30 (15 interventions; 3,243 women) |
IS: MD 49·66; 95% CI 13·63–85·69 μg/L; 4 trials 15 (9 interventions; 1,396 women) |
Less common AE in IS and FCM: local pain, skin irritation, rare occasions, allergic reactions Common AE in oral iron: GI effects (nausea, vomiting, and altered bowel movements) |
Good evidence of benefit for ISC and some evidence for FCM |
| Shin et al. (38) | Obstetric and gynaecologic patients with IDA Included 9 RCTs with 910 patients (FCM: n = 456; ISC: n = 454) from LMICs and HIC |
FCM | ISC | Higher Hb in FCM vs. ISC: MD = 0.67; 95% CI 0.25–1.08 g/dL; p = 0.002, I2 = 92% | Higher in FCM vs. ISC: MD = 24.41; 95% CI, 12.06–36.76; p = 0.0001; I2 = 75% | Lower incidence of AE in FCM than ISC: RR, 0.53; 95% CI 0.35–0.80; p = 0.003; I2 = 0% | FCM group showed better efficacy in increasing Hb and ferritin levels and a favorable safety profile with fewer adverse events compared with IS group |
OR, Odds Ratio; ISC, Iron sucrose complex; BL, Baseline; MD, Mean Difference; Iron polymaltose (IPM); LMICs, Low Middle-Income Countries; HICs, High-Income Countries; RR, Risk Ratio.