Iron Supplementation, Response in Iron-Deficiency Anemia: Analysis of Five Trials.
Study Goal
The researchers aimed to determine whether hemoglobin response at day 14 of oral iron therapy could predict the need to transition patients to intravenous iron for iron-deficiency anemia.
Results Summary
Most subjects (72.8%) responded to oral iron with ≥1.0-g/dL hemoglobin increases by day 14, with postpartum anemia patients showing the highest response rates. A ≥1.0-g/dL increase at day 14 accurately predicted satisfactory hemoglobin response by day 42/56, suggesting early non-responders should switch to IV iron.
Population
Subjects with iron-deficiency anemia, including postpartum anemia, heavy uterine bleeding, gastrointestinal-related causes, and other causes.
Effective Dosage
Not specified
Duration
Up to 56 days
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
oral iron-replacement therapy | neutral | Hemoglobin response at day 14 | patients with iron-deficiency anemia | - | may be useful in assessing whether and when to transition patients | #1 |
oral iron-replacement therapy | increase | The proportion of subjects with hemoglobin increases ≥1.0, ≥2.0, and ≥3.0 g/dL | subjects with postpartum anemia | ≥1.0, ≥2.0, and ≥3.0 g/dL | was greatest among | #2 |
oral iron-replacement therapy | increase | The proportion of subjects with hemoglobin increases ≥1.0, ≥2.0, and ≥3.0 g/dL | subjects with heavy uterine bleeding or gastrointestinal-related causes of anemia | ≥1.0, ≥2.0, and ≥3.0 g/dL | was intermediate among | #3 |
oral iron-replacement therapy | increase | The proportion of subjects with hemoglobin increases ≥1.0, ≥2.0, and ≥3.0 g/dL | subjects with other causes of anemia | ≥1.0, ≥2.0, and ≥3.0 g/dL | was lowest among | #4 |
oral iron-replacement therapy | increase | The proportion of subjects with hemoglobin increases ≥1.0, ≥2.0, and ≥3.0 g/dL | responders | ≥1.0, ≥2.0, and ≥3.0 g/dL | was significantly greater among | #5 |
oral iron-replacement therapy | increase | A ≥1.0-g/dL increase in hemoglobin on day 14 | subjects with iron-deficiency anemia | ≥1.0-g/dL | most accurately predicted satisfactory overall hemoglobin response | #6 |
Iron-replacement therapy | increase | quality of life | - | - | improved | #7 |
Iron-replacement therapy | decrease | fatigue | - | - | reduced | #8 |
oral iron | increase | Hemoglobin responses <1.0 g/dL at day 14 | subjects with iron-deficiency anemia | <1.0 g/dL | identify subjects who should be transitioned to IV iron supplementation | #9 |
BACKGROUND: Oral iron-replacement therapy is the mainstay of treatment for iron-deficiency anemia, but it is often poorly tolerated or ineffective. Hemoglobin response at day 14 of oral iron may be useful in assessing whether and when to transition patients from oral to intravenous (IV) iron. METHODS: Pooled data from 5 randomized trials were analyzed to compare oral and IV iron-replacement therapy for iron-deficiency anemia. Treatment criteria and assignment to oral versus IV iron were defined per protocol; this analysis included only subjects receiving oral iron. Responders were subjects with ≥1.0-g/dL increases in hemoglobin at day 14, and nonresponders were those with smaller increases. Demographic and clinical characteristics were evaluated for association with hemoglobin response at multiple timepoints. RESULTS: Most subjects (72.8%) were classified as responders. The proportion of subjects with hemoglobin increases ≥1.0, ≥2.0, and ≥3.0 g/dL was greatest among those with postpartum anemia, intermediate among those with heavy uterine bleeding or gastrointestinal-related causes of anemia, and lowest among those with other causes; this proportion was also significantly greater among responders than nonresponders. A ≥1.0-g/dL increase in hemoglobin on day 14 most accurately predicted satisfactory overall hemoglobin response to oral iron on day 42/56 (sensitivity 90.1%; specificity 79.3%; positive and negative predictive values of 92.9% and 72.7%, respectively). Iron-replacement therapy improved quality of life and reduced fatigue. CONCLUSION: Hemoglobin responses <1.0 g/dL at day 14 of oral iron identify subjects with iron-deficiency anemia who should be transitioned to IV iron supplementation.