Acute isovolemic anemia occurs when blood loss is replaced with fluid.
It is often observed after surgery and negatively influences short-term and long-term outcomes.
Dr Young-Woo Kim and colleagues evaluated the efficacy and safety of ferric carboxymaltose to treat acute isovolemic anemia following gastrectomy.
The FAIRY trial was a patient-blinded, randomized, phase 3, placebo-controlled, 12-week study conducted between 2013, and 2015, in 7 centers across the Republic of Korea.
Patients with a serum hemoglobin level of 7 g/dL to less than 10 g/dL at 5 to 7 days following radical gastrectomy were included.
Patients were randomized to receive a 1-time or 2-time injection of 500 mg or 1000 mg of ferric carboxymaltose according to body weight or normal saline group.
The team's primary end point was the number of hemoglobin responders, defined as a hemoglobin increase of 2 g/dL or more from baseline, a hemoglobin level of 11 g/dL or more, or both at week 12.
|The absolute difference was 38% between the groups|
|Journal of the American Medical Association|
The researchers' secondary end points included changes in hemoglobin, ferritin, and transferrin saturation levels over time, percentage of patients requiring alternative anemia management, and quality of life at weeks 3 and 12.
Among 454 patients who were randomized, 96% completed the trial.
At week 12, the number of hemoglobin responders was significantly greater for ferric carboxymaltose vs placebo.
The research team found that the absolute difference was 38% between the groups.
Compared with the placebo group, patients in the ferric carboxymaltose group experienced significantly greater improvements in serum ferritin level, and transferrin saturation level.
However, the researchers observed no significant differences in quality of life.
The research team noted that patients in the ferric carboxymaltose group required less alternative anemia management than patients in the placebo group.
The total rate of adverse events was higher in the ferric carboxymaltose group than the placebo group, but no severe adverse events were reported in either group.
Dr Kim's team concludes, "Among adults with isovolemic anemia following radical gastrectomy, the use of ferric carboxymaltose compared with placebo was more likely to result in improved hemoglobin response at 12 weeks."