Efficacy and Tolerability of Intravenous Ferric Carboxymaltose in Patients with Iron Deficiency at a Hospital Outpatient Clinic: A Retrospective Cohort Study of Real-World Clinical Practice

Ferric carboxymaltose (FCM) is an intravenous iron formulation to correct iron deficiency. Although its use has been extensively studied in clinical trials, real-world evidence regarding FCM treatment is scarce. Our aim was to evaluate the efficacy and tolerability of FCM treatment in patients with iron deficiency, with or without anemia, at a hospital outpatient clinic. Data was collected retrospectively from medical records. During this 2-year study, 459 patients were included. Mean age was 58.6 +/- 17.5 years and most patients received cumulative FCM doses of 501-1000mg (63.2%). Six weeks after administration of FCM, efficacy endpoints hemoglobin increase >2 g/dL, hemoglobin increase >3 g/dL, and transferrin saturation > 20% were attained by 41%, 20%, and 63% of patients, respectively. Patients who received higher FCM doses showed significant reduced odds of not achieving hemoglobin increase >= 2 g/dL (501-1000mg, adjusted odds ratio [OR]: 0.34, 95% confidence interval [CI] 0.18-0.62; 1001-3000mg, OR: 0.19, 95% CI 0.07-0.49), compared to 500mg doses. Treatment-emergent adverse events were documented in < 4% of patients. In conclusion, FCM treatment was effective and well-tolerated by outpatients with iron deficiency at a hospital clinic, and its dosage should be adjusted to improve iron deficiency management in clinical practice.