Christian Breymann*, Nils Milman, Anna Mezzacasa, Roubert Bernard and Joachim Dudenhausen, on behalf of the FER-ASAP investigators
*Corresponding author: Christian Breymann, MD, Clinic of Obstetrics, Obstetric Research and Feto-Maternal Haematology Unit, University HospitalZürich, Frauenklinikstrasse 10, CH-8091 Zürich, Switzerland Nils Milman: Departments of Clinical Biochemistry and Obstetrics, Næstved Hospital, University of Copenhagen, Næstved, Denmark Anna Mezzacasa: Global Medical Affairs Director Women’s Health, Patient Blood Management and Life Cycle Management, Vifor Pharma, Glattbrugg, Switzerland
Roubert Bernard: Vifor Pharma, Glattbrugg, Switzerland Joachim Dudenhausen: Department of Obstetrics, Charité –Universitätsmedizin Berlin, Berlin, Germany
Abstract
Objective
To compare the efficacy and safety of intra-venous ferric carboxymaltose (FCM) with first-line oral ferrous sulfate (FS) in pregnant women with iron defi-ciency anemia (IDA).
Materials and methods
Pregnant women (n = 252; gesta-tional weeks 16–33) with IDA were randomized 1:1 to FCM (1000–1500 mg iron) or FS (200 mg iron/day) for 12 weeks. The primary objective was to compare efficacy; secondary objectives included safety and quality of life.
Results
Hemoglobin (Hb) levels improved at compara-ble rates across both treatments; however, significantly more women achieved anemia correction with FCM vs. FS [Hb 11.0 g/dL; 84% vs. 70%; odds ratio (OR): 2.06, 95% confidence interval (CI): 1.07, 3.97; P = 0.031] and within a shorter time frame (median 3.4 vs. 4.3 weeks). FCM treat-ment significantly improved vitality (P = 0.025) and social functioning (P = 0.049) prior to delivery. Treatment-related adverse events were experienced by 14 (FCM; 11%) and 19 (FS; 15%) women, with markedly higher rates of gastroin-testinal disorders reported with FS (16 women) than with FCM (3 women). Newborn characteristics were similar across treatments.
Conclusions
During late-stage pregnancy, FCM may be a more appropriate option than first-line oral iron for rapid and effective anemia correction, with additional benefits for vitality and social functioning.
(Reference link : www.degruyter.com/downloadpdf/j/jpme.2017.45.issue-4/jpm-2016-0050/jpm-2016-0050.pdf )
Volume 49, December 2009, TRANSFUSION 2719
Large dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial.
David B. VanWyck, Antoinette Mangione, John Morrison, Phillip Earl Hadley, Judi A. Jehle, and Lawrence Tim Goodnough for the Ferric Carboxymaltose Study Group
From DaVita, Inc., Tucson, Arizona; American Regent/Luitpold Pharmaceuticals, Norristown, Pennsylvania; the University of Mississippi Medical Center, Jackson, Mississippi; the Medical Network for Education and Research, Decatur, Georgia; The Obstetric Group, Montgomery, Alabama; and the Stanford University School of Medicine, Stanford, California.
Abstract
Background
The objective was to evaluate efficacy and safety of rapid, large dose intravenous (IV) administration of ferric carboxymaltose compared to oral iron in correcting iron deficiency anemia due to heavy uterine bleeding.
Study design and Methods
In a randomized, controlled trial, 477 women with anemia, iron deficiency, and heavy uterine bleeding were assigned to receive either IV ferric carboxymaltose (#1000 mg over 15 min, repeated weekly to achieve a total calculated replace-ment dose) or 325 mg of ferrous sulfate (65 mg elemental iron) prescribed orally thrice daily for 6 weeks.
Results
Compared to those assigned to ferrous sulfate, more patients assigned to ferric carboxymaltose responded with a hemoglobin (Hb) increase of 2.0 g/dL or more (82% vs. 62%, 95% confidence interval for treatment difference 12.2-28.3, p<0.001), more achieved a 3.0 g/dL or more increase (53% vs. 36%, p<0.001), and more achieved correction (Hb≥12 g/ dL) of anemia (73% vs. 50%, p<0.001). Patients treated with ferric carboxymaltose compared to those prescribed ferrous sulfate reported greater gains in vitality and physical function and experienced greater improvement in symptoms of fatigue (p<0.05). There were no serious adverse drug events.
Conclusion
In patients with iron deficiency anemia due to heavy uterine bleeding, rapid IV administration of large doses of a new iron agent, ferric car-boxymaltose, is more effective than oral iron therapy in correcting anemia, replenishing iron stores, and improving quality of life.
(Reference link: http://onlinelibrary.wiley.com/doi/10.1111/j.1537-2995.2009.02327.x/epdf )
Am J Obstet Gynecol, 2008
Ferric carboxymaltose injection in the treatment of postpartum iron deficiency anemia: a randomized controlled clinical trial
Melvin H. Seid, MD, FACOG, CPI; Richard J. Derman, MD, FACOG; Jeffrey B. Baker, MD, FACOG; Warren Banach, MD, FACOG; Cynthia Goldberg, MD, FACOG; Ralph Rogers, MD, FACOG
From Lyndhurst Gynecologic Associates, Winston-Salem, NC (Dr Seid); University of Missouri–Kansas City, Kansas City, MO (Dr Derman); Rosemark WomenCare Specialists, Idaho Falls, ID (Dr Baker); Choice Research, LLC/Enterprise Women’s Center, LLC, Enterprise, AL (Dr Banach); Visions Clinical Research–Tucson, Tucson, AZ (Dr Goldberg); and Women’s Clinical Research, Newburgh, IN (Dr Rogers).
Abstract
Objective
The objective of the study was to evaluate the efficacy, safety, and tolerability of intravenous ferric carboxymaltose, compared with oral ferrous sulfate in women with postpartum anemia.
Study design
In a multicenter, randomized, controlled study, 291 women less than 10 days after delivery with hemoglobin 10 g/dL or less were randomized to receive ferric carboxymaltose (n 5 143) 1000 mg or less intravenously over 15 minutes or less, repeated weekly to a calculated replacement dose (maximum 2500 mg) or ferrous sulfate (n 5 148) 325 mg orally thrice daily for 6 weeks.
Results
Ferric carboxymaltose-treated subjects were significantly more likely to: (1) achieve a hemoglobin greater than 12 g/dL in a shorter time period with a sustained hemoglobin greater than 12 g/dL at day 42, (2) achieve hemoglobin rise 3 g/dL or greater more quickly, and (3) attain higher serum transferrin saturation and ferritin levels. Drug-related adverse events occurred less frequently with ferric carboxymaltose.
Conclusion
Intravenous ferric carboxymaltose was safe and well tolerated with an efficacy superior to oral ferrous sulfate in the treat-ment of postpartum iron deficiency anemia.
(Reference link: www.ajog.org/article/S0002-9378(08)00880-6/pdf )
