Abstract
Background: Physicians are reluctant to recommend high dose intravenous (IV) iron infusion for iron deficient (ID) patients due to concerns of adverse events (AEs) including anaphylaxis. This retrospective analysis evaluates efficacy and AEs with LMW iron dextran (ID) total dose infusion (TDI) in patients with iron deficiency.
Methods: We retrospectively evaluated the Electronic Medical Records of 468 consecutive patients with iron deficient anemia (IDA) who received IV LMW ID between 01/2008 and 07/2011 in an ambulatory infusion center. Diagnostic parameters for IDA included hemoglobin [Hgb] <11 g/dL, transferrin saturation [TSAT] 19%, ferritin <100 ng/mL. The majority had documented intolerance of or inadequate response to oral iron. All received TDI of LMW ID (1130 ± 217 mg) over 1 hour after a test dose of 25 mg. Pre-medication was not used. Patients were closely monitored for AEs during and immediately after infusions. Laboratory data for baseline and repeat hematological parameters within 8 weeks following infusions were analyzed. End points were safety and efficacy. Safety data was available for all 468 patients. Follow-up data at 8 weeks was available on 315.
Results: There were 103 males and 365 female patients. Most common diagnoses were GI bleed, chemotherapy, menorrhagia and chronic kidney disease. At baseline, mean Hgb was 9.8 g/dL, ferritin 92.08ng/mL, and TSAT 12.37%. At 8 weeks the mean hemoglobin increased to 10.97 g/dL (p =0.0001), Ferritin 279.63 ng/mL (p =0.0001), and TSAT 21.85% (p=0.0001). All tolerated the infusion well. There were no incidents of fever, chills, wheezing, hypotension, stridor, periorbital edema, anaphylaxis or death. One complained of chest tightness, but completed the infusion after several minutes and the administration of diphenhydramine and steroids. One developed a rash. Fatigue and myalgia were reported in 17.31% and 8.33% of patients respectively.
Conclusions: This study demonstrates TDI of LMW ID can be given safely and conveniently over 1 hour in an outpatient setting without premedication to ID patients. Easily manageable minor reactions did not affect the therapeutic plan. No allergic or anaphylactic reactions were observed. This study demonstrated TDI of LMW ID improved hemoglobin levels more than 1 g/dL within 8 weeks. Consistent with the preponderance of published evidence TDI of LMW ID should be considered an important therapeutic option for iron replacement in patients with IDA.
No relevant conflicts of interest to declare.
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