Ferric Carboxymaltose for Anemic Perioperative Populations: A Systematic Literature Review of Randomized Controlled Trials

Abstract

Importance: Perioperative anemia is a common comorbid condition associated with increased risk of morbidity and mortality in patients undergoing elective surgical procedures.

Objective: We conducted a systematic literature review (SLR) to determine the efficacy and safety of the use of intravenous ferric carboxymaltose (FCM) for the treatment of perioperative anemia in preoperative, intraoperative, and postoperative elective surgical care.

Evidence review: Studies meeting inclusion criteria for the SLR reported on treatment efficacy in an adult study population randomly allocated to FCM for the treatment of perioperative anemia during the perioperative period. After screening, 10 of 181 identified studies from searches in MEDLINE and EMBASE databases were identified for inclusion in this review.

Findings: Preoperative treatment was reported in six studies, intraoperative treatment in one study, postoperative treatment in two studies, and both pre- and postoperative treatment in one study. Together, 1975 patients were studied, of whom 943 were randomized to FCM, of whom 914 received FCM treatment. The 10 studies reported elective surgical populations for colorectal, gastric, orthopedic, abdominal, urologic, plastic, neck, gynecologic, and otolaryngologic procedures. Given the clinical and methodological heterogeneity of the studies, the analyses were limited to qualitative assessments without meta-analyses. All 10 studies reported statistically greater changes in hemoglobin concentration, serum ferritin, and/or transferrin saturation with FCM treatment compared with comparators (placebo, oral iron, standard care, or a combination of these). Two studies reported statistically significant differences in transfusion rate and 2 studies reported significant differences in length of hospital stay between FCM and its comparator(s).

Conclusions and relevance: This SLR adds to existing data that administration of FCM in preoperative and postoperative settings improves hematologic parameters. Several studies in the review supported the beneficial effects of FCM in reducing transfusion rate and length of stay. Larger, well-designed, longer-term studies may be needed to further establish the efficacy and safety of FCM in elective surgery patients with perioperative anemia.

Keywords: elective surgery; hemoglobin; intravenous iron; iron-deficiency anemia; patient blood management.

Conflict of interest statement

John Jeffrey Jones was a postdoctoral fellow employed by St. John’s University (Jamaica, NY, USA) through a grant funded by American Regent, Inc. John Jeffrey Jones is currently employed by AVROBIO, Inc.; AVROBIO, Inc. was not involved in the content of this research or manuscript preparation. Linda M. Mundy, Nicole Blackman, and Michelle Shwarz are employees of American Regent, Inc., a wholly owned subsidiary of Daiichi Sankyo.

© 2021 Jones et al.

Figures

Figure 1

Preferred Reporting Items for Systematic Reviews and Meta-Analyses flowchart of the study selection process. Note: Adapted from Page MJ, Moher D, Bossuyt PM, et al. PRISMA 2020 explanation and elaboration: updated guidance and exemplars for reporting systematic reviews. BMJ. 2021;372:n160.

Figure 2

Risk of bias summary: authors’ judgment about risk of bias for each item for each of the 6 included studies. The symbol “+” indicates low risk of bias, “?” indicates unclear risk of bias, and “–” indicates high risk of bias.

Figure 3

Risk of bias: authors’ judgment about risk of bias presented as percentages across all 6 included studies.