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:

• intravenous iron
• hemoglobin
• elective surgery
• patient blood management
• iron-deficiency anemia

Abbreviations

ABT, allogeneic blood transfusion; AE, adverse event; ASA, American Society of Anesthesiologists; ENT, ear, nose, and throat; EORTC-QLQ-C30, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30; EPO, erythropoietin; EQ-5D, EuroQol 5-dimension quality of life scale; FCM, ferric carboxymaltose; GRADE, Grading of Recommendations Assessment, Development, and Evaluation; Hb, hemoglobin; IDA, iron-deficiency anemia; IV, intravenous; NHMRC, National Health and Medical Research Council; NICE, National Institute for Health and Care Excellence; NS, not significant; PBM, perioperative blood management; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses; QLQ-ST022, Quality of Life Questionnaire-Gastric Cancer Module; QOL, quality of life; RBC, red blood cell; SC, subcutaneous; SD, standard deviation; SLR, systematic literature review; TSAT, transferrin saturation.

Acknowledgments

We would like to thank Jaclyn Vialet, BS, MLS, Director of the Health Education Resource Center at St. John’s University College of Pharmacy and Health Sciences for her peer review and assessment of the electronic search strategies.

Author Contributions

JJJ, LMM, NB, MS: Main contribution to the study concepts and study design as well as supervision and revision of the manuscript.

JJJ, MS, LMM: Main contribution to the data acquisition, analysis, and interpretation.

JJJ and LMM: Main contribution to manuscript preparation.

NB: Main contribution to statistical support.

All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval of the version to be published; and agree to be accountable for all aspects of the work.

Disclosure

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.

Additional information

Funding

Editorial support for the preparation of this article was provided by Peloton Advantage, LLC (Parsippany, NJ, USA), an OPEN Health company, funded by American Regent, Inc. (Shirley, NY, USA), a wholly owned subsidiary of Daiichi Sankyo.