Effect of intravenous ferric carboxymaltose on hemoglobin response among patients with acute isovolemic anemia following gastrectomy the FAIRY randomized clinical trial

IMPORTANCE 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. OBJECTIVE To evaluate the efficacy and safety of ferric carboxymaltose to treat acute isovolemic anemia following gastrectomy. DESIGN, SETTING, AND PARTICIPANTS The FAIRY trialwas a patient-blinded, randomized, phase 3, placebo-controlled, 12-week study conducted between February 4, 2013, and December 15, 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 gastrectomywere included. INTERVENTIONS Patients were randomized to receive a 1-time or 2-time injection of 500mg or 1000mg of ferric carboxymaltose according to body weight (ferric carboxymaltose group, 228 patients) or normal saline (placebo group, 226 patients). MAINOUTCOMESANDMEASURES Theprimaryendpointwasthenumberofhemoglobinresponders, defined as a hemoglobin increase of 2 g/dL or more from baseline, a hemoglobin level of 11 g/dL or more, or both atweek 12. Secondary end points included changes in hemoglobin, ferritin, and transferrin saturation levels over time, percentage of patients requiring alternative anemia management (oral iron, transfusion, or both), and quality of life atweeks 3 and 12. RESULTS Among 454 patientswhowere randomized (mean age, 61.1 years;women, 54.8%; mean baseline hemoglobin level, 9.1 g/dL), 96.3%completed the trial.Atweek 12, the number of hemoglobin responderswas significantly greater for ferric carboxymaltose vs placebo. Compared with the placebo group, patients in the ferric carboxymaltose group experienced significantly greater improvements in serum ferritin level and transferrin saturation level; but therewere no significant differences in quality of life. Patients in the ferric carboxymaltose group required less alternative anemia management than patients in the placebo group. The total rate of adverse eventswas higher in the ferric carboxymaltose group than the placebo group, but no severe adverse eventswere reported in either group. (Table presented) CONCLUSION AND RELEVANCE 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.