Ferric carboxymaltose improves post-gastrectomy acute isovolemic anemia

Last Updated: 2017-05-24

By Megan Brooks

NEW YORK (Reuters Health) - Ferric carboxymaltose is an effective treatment for isovolemic anemia following radical gastrectomy, according to results of a phase 3 randomized clinical trial conducted at seven centers in the Republic of Korea.

“The benefits of this short and easily administered therapy were immediate and sustained as measured through increased hemoglobin and iron levels over time and a decreased need for alternative treatments for anemia,” the researchers report in JAMA online May 23.

“Clinicians should now consider intravenous ferric carboxymaltose in the immediate postoperative period to effectively treat moderate anemia with otherwise stable vital signs,” Dr. Young-Woo Kim from the Graduate School of Cancer Science and Policy in Goyang, South Korea, told Reuters Health by email.

“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. Kim and colleagues note in their paper.

The FAIRY trial enrolled 454 patients (mean age 61, 55% women) with a serum hemoglobin level of 7 to <10 g/dL five to seven days after radical gastrectomy. The mean baseline hemoglobin level was 9.1 g/dL.

Patients were randomly allocated to receive ferric carboxymaltose (1000 mg for a body weight of 50 kg or more, or 500 mg for a body weight of <50 kg) or normal saline. Patients with a serum ferritin level <15 ng/mL and a hemoglobin level <10 g/dL received an additional dose of 500 mg of ferric carboxymaltose or 100 mL of normal saline at week 3.

The 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.

At week 12, the number of hemoglobin responders was significantly greater in the ferric carboxymaltose arm than the placebo arm (92.2% vs 54.0%, P=0.001).

Patients who received ferric carboxymaltose also had significantly greater improvements in serum ferritin level (233.3 vs 53.4 ng/mL, P=0.001) and transferrin saturation level (35.0% vs 19.3%, P=0.001). They also required less alternative anemia management (P=0.006).

Ferric carboxymaltose was well tolerated overall, the researchers say, although the total rate of adverse events was higher in the ferric carboxymaltose arm than in the placebo arm (6.8% vs 0.4%). Adverse events related to ferric carboxymaltose included injection site reaction in five patients (2.3%) and urticaria in five patients (2.3%). There were no severe adverse events reported in either group.

There were no significant between-group differences in quality of life. “QOL measurements over time showed ferric carboxymaltose-related improvements in fatigue and dyspnea but did not meet the predefined clinically relevant QOL improvement criterion,” the authors note. “This may be because the patients were enrolled into this study immediately after receiving a major surgery, and there may be confounding factors influencing QOL that could not be distinguished by the questionnaires.”

Dr. Kim told Reuters Health the FAIRY trial findings call for a change in current clinical practice.

“Acute postoperative anemia has been neglected or inappropriately treated with transfusion of red blood cells. Today, there is a global movement underway to change current clinical practice in transfusion medicine, and these findings work to support that transition,” Dr. Kim said.

“A shift away from liberal transfusion policies towards Patient Blood Management (PBM) is taking place, and now that the previously default procedure to treat patients with anemia is generally off the table, there is a clinical need to find and validate new treatments to take its place. Intravenous ferric carboxymaltose has been found to rapidly normalize patients' serum hemoglobin levels and assist in recovery from major surgery without transfusion,” Dr. Kim commented.

The FAIRY trial was investigator-initiated and funded by JW Pharmaceutical and Vifor Pharma, makers of ferric carboxymaltose. The authors report no conflicts of interest.

SOURCE: http://bit.ly/2qjPd57

JAMA 2017.