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.
Cite this paper
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