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A post-hoc analysis of data from 4 prospective, active-controlled clinical trials evaluating the safety and efficacy of ferric carboxymaltose (FCM) showed that for patients with iron deficiency anemia (IDA) resulting from gastrointestinal (GI) disorders, FCM was an effective treatment with a safety profile comparable to that of other intravenous (IV) iron therapies. The findings were published in the journal Digestive Diseases and Sciences.
Within these 4 studies, a total of 191 patients were identified for inclusion (having IDA secondary to GI disorders). Changes from baseline in hemoglobin, ferritin, and transferrin saturation (TSAT) were considered efficacy measures; what effect baseline hemoglobin level had on these changes was also assessed. Safety was determined by the incidence and type of treatment-emergent adverse events reported in each treatment group.
Results showed that patients treated with FCM had greater hemoglobin responses compared with those treated with oral iron, and similar responses to those administered iron sucrose or other IV iron therapies (change in hemoglobin from baseline to maximum value: oral iron: 0.8g/dL; FCM: 2.2g/dL; any IV iron: 2.0g/dL; iron sucrose: 1.9g/dL). Compared with those receiving other iron treatments, patients receiving FCM had significantly greater peak absolute ferritin values and greater increases in TSAT values. The analysis also showed that the more severe the anemia was at baseline, the greater the response was to treatment in regards to hemoglobin changes; this effect was not seen, however, in patients treated with oral iron therapy.
With regard to safety, treatment-emergent adverse events were lower for FCM (11.9%) compared with other IV iron groups (26.2%) or iron sucrose (25%). No serious adverse events were considered treatment-related in the FCM arm, however 2 were considered related in the iron sucrose group (renal infarct and hypotension).
Based on the findings, the authors concluded that “high-dose FCM was shown to be effective and well tolerated in the treatment of IDA in the GI setting”, adding that “FCM may be an appropriate alternative to more established parenteral iron therapies, allowing higher doses with each infusion and therefore fewer infusions to achieve repletion of iron stores and rapid [hemoglobin] responses.”
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