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Comparative Rates of Adverse Events with 2-Hour versus 4-Hour Infusion of Total Dose Intravenous Iron Polymaltose

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DOI: 10.4236/ijcm.2014.54025    2,681 Downloads   3,718 Views   Citations

ABSTRACT

Background and aim of the study: Patients with iron deficiency (ID) who are unable to tolerate or show sub-optimal response to oral iron therapy are candidates for parenteral iron therapy. This study evaluated the patient safety and tolerance of iron polymaltose given either as a 2-hour infusion or as a 4-hour infusion. Methods: A total of 243 patients with ID were randomized alternatively to receive iron polymaltose infusion either as a 2-hour infusion or as a 4-hour infusion. All patients received pre-medication with certizine hydrochloride 10 mg PO one-hour before infusion and hydrocortisone 50 mg IVI immediately before infusion. Infusion related adverse events/side-effects during the infusion and over the next seven days were documented and graded as mild, moderate or severe. Results: The age of the patients ranged from 17 years to 92 years (mean 55.5 yr); M:F = 1:3.5. One hundred and twenty-two patients were in the 2-hour arm (M:F = 1:5; mean age 52.9 yr) and 121 were in the 4-hour arm (M:F = 1:2.6; mean age 58.1 yr). Iron infusion therapy was generally well tolerated by patients in both arms. Adverse events/side effects were documented in 14 patients in each arm (22 events in the 2-hour arm and 20 in the 4-hour arm) and included aches and pains, cannula-site pain/swelling, nausea, abdominal cramps, rash, vagal response, metallic taste, hot flushes and headaches. In most patients, these events were mild and none had any severe events. Conclusion: The incidence of adverse events with 2-hour infusion of iron polymaltose is similar to that observed with 4-hour infusion of iron polymaltose.

Conflicts of Interest

The authors declare no conflicts of interest.

Cite this paper

A. Manoharan, W. Alexander, R. Ramakrishna, J. Legge and J. Uebel, "Comparative Rates of Adverse Events with 2-Hour versus 4-Hour Infusion of Total Dose Intravenous Iron Polymaltose," International Journal of Clinical Medicine, Vol. 5 No. 4, 2014, pp. 145-148. doi: 10.4236/ijcm.2014.54025.

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