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Effect of Intravenous Ferric Carboxymaltose on Hemoglobin Response Among Patients With Acute Isovolemic Anemia Following Gastrectomy: The FAIRY Randomized Clinical Trial.
JAMA. 2017 May 23; 317(20):2097-2104.JAMA

Abstract

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 trial was 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 gastrectomy were included.

INTERVENTIONS

Patients were randomized to receive a 1-time or 2-time injection of 500 mg or 1000 mg of ferric carboxymaltose according to body weight (ferric carboxymaltose group, 228 patients) or normal saline (placebo group, 226 patients).

MAIN OUTCOMES AND MEASURES

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. 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 at weeks 3 and 12.

RESULTS

Among 454 patients who were randomized (mean age, 61.1 years; women, 54.8%; mean baseline hemoglobin level, 9.1 g/dL), 96.3% completed the trial. At week 12, the number of hemoglobin responders was significantly greater for ferric carboxymaltose vs placebo (92.2% [200 patients] for the ferric carboxymaltose group vs 54.0% [115 patients] for the placebo group; absolute difference, 38.2% [95% CI, 33.6%-42.8%]; P = .001). Compared with the placebo group, patients in the ferric carboxymaltose group experienced significantly greater improvements in serum ferritin level (week 12: 233.3 ng/mL for the ferric carboxymaltose group vs 53.4 ng/mL for the placebo group; absolute difference, 179.9 ng/mL [95% CI, 150.2-209.5]; P = .001) and transferrin saturation level (week 12: 35.0% for the ferric carboxymaltose group vs 19.3% for the placebo group; absolute difference, 15.7% [95% CI, 13.1%-18.3%]; P = .001); but there were no significant differences in quality of life. Patients in the ferric carboxymaltose group required less alternative anemia management than patients in the placebo group (1.4% for the ferric carboxymaltose group vs 6.9% for the placebo group; absolute difference, 5.5% [95% CI, 3.3%-7.6%]; P = .006). The total rate of adverse events was higher in the ferric carboxymaltose group (15 patients [6.8%], including injection site reactions [5 patients] and urticaria [5 patients]) than the placebo group (1 patient [0.4%]), but no severe adverse events were reported in either group.

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.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT01725789.

Authors+Show Affiliations

Department of Cancer Control and Population Health, Graduate School of Cancer Science and Policy, National Cancer Center, Goyang, Republic of Korea2Center for Gastric Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea.Center for Gastric Cancer, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.Department of Gastroenterologic Surgery, Chonnam National University Hwasun Hospital, Hwasun County, Republic of Korea.Department of Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea.Center for Gastric Cancer, Gastric Cancer Center, Kyungpook National University Medical Center, Daegu, Republic of Korea.Center for Gastric Cancer, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.Department of Gastrointestinal Surgery, Yonsei University Health System, Seoul, Republic of Korea.Cancer Registration and Biostatistics Branch, Center for Clinical Trials, National Cancer Center, Goyang, Republic of Korea.Center for Gastric Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea.Center for Gastric Cancer, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.Department of Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea.Center for Gastric Cancer, Gastric Cancer Center, Kyungpook National University Medical Center, Daegu, Republic of Korea.Department of Gastroenterologic Surgery, Chonnam National University Hwasun Hospital, Hwasun County, Republic of Korea.Center for Gastric Cancer, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.Center for Gastric Cancer, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.Center for Gastric Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea.Center for Gastric Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea.Center for Gastric Cancer, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.Center for Gastric Cancer, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.Department of Gastroenterologic Surgery, Chonnam National University Hwasun Hospital, Hwasun County, Republic of Korea.Department of Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea.Center for Gastric Cancer, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.Center for Gastric Cancer, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.Department of Gastroenterologic Surgery, Chonnam National University Hwasun Hospital, Hwasun County, Republic of Korea.Center for Gastric Cancer, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.Department of Gastrointestinal Surgery, Yonsei University Health System, Seoul, Republic of Korea.Center for Gastric Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea.Center for Gastric Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea.Cancer Registration and Biostatistics Branch, Center for Clinical Trials, National Cancer Center, Goyang, Republic of Korea.No affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

28535237

Citation

Kim, Young-Woo, et al. "Effect of Intravenous Ferric Carboxymaltose On Hemoglobin Response Among Patients With Acute Isovolemic Anemia Following Gastrectomy: the FAIRY Randomized Clinical Trial." JAMA, vol. 317, no. 20, 2017, pp. 2097-2104.
Kim YW, Bae JM, Park YK, et al. Effect of Intravenous Ferric Carboxymaltose on Hemoglobin Response Among Patients With Acute Isovolemic Anemia Following Gastrectomy: The FAIRY Randomized Clinical Trial. JAMA. 2017;317(20):2097-2104.
Kim, Y. W., Bae, J. M., Park, Y. K., Yang, H. K., Yu, W., Yook, J. H., Noh, S. H., Han, M., Ryu, K. W., Sohn, T. S., Lee, H. J., Kwon, O. K., Ryu, S. Y., Lee, J. H., Kim, S., Yoon, H. M., Eom, B. W., Choi, M. G., Kim, B. S., ... Nam, B. H. (2017). Effect of Intravenous Ferric Carboxymaltose on Hemoglobin Response Among Patients With Acute Isovolemic Anemia Following Gastrectomy: The FAIRY Randomized Clinical Trial. JAMA, 317(20), 2097-2104. https://doi.org/10.1001/jama.2017.5703
Kim YW, et al. Effect of Intravenous Ferric Carboxymaltose On Hemoglobin Response Among Patients With Acute Isovolemic Anemia Following Gastrectomy: the FAIRY Randomized Clinical Trial. JAMA. 2017 May 23;317(20):2097-2104. PubMed PMID: 28535237.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of Intravenous Ferric Carboxymaltose on Hemoglobin Response Among Patients With Acute Isovolemic Anemia Following Gastrectomy: The FAIRY Randomized Clinical Trial. AU - Kim,Young-Woo, AU - Bae,Jae-Moon, AU - Park,Young-Kyu, AU - Yang,Han-Kwang, AU - Yu,Wansik, AU - Yook,Jeong Hwan, AU - Noh,Sung Hoon, AU - Han,Mira, AU - Ryu,Keun Won, AU - Sohn,Tae Sung, AU - Lee,Hyuk-Joon, AU - Kwon,Oh Kyoung, AU - Ryu,Seung Yeob, AU - Lee,Jun-Ho, AU - Kim,Sung, AU - Yoon,Hong Man, AU - Eom,Bang Wool, AU - Choi,Min-Gew, AU - Kim,Beom Su, AU - Jeong,Oh, AU - Suh,Yun-Suhk, AU - Yoo,Moon-Won, AU - Lee,In Seob, AU - Jung,Mi Ran, AU - An,Ji Yeong, AU - Kim,Hyoung-Il, AU - Kim,Youngsook, AU - Yang,Hannah, AU - Nam,Byung-Ho, AU - ,, PY - 2017/5/24/entrez PY - 2017/5/24/pubmed PY - 2017/7/14/medline SP - 2097 EP - 2104 JF - JAMA JO - JAMA VL - 317 IS - 20 N2 - 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 trial was 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 gastrectomy were included. INTERVENTIONS: Patients were randomized to receive a 1-time or 2-time injection of 500 mg or 1000 mg of ferric carboxymaltose according to body weight (ferric carboxymaltose group, 228 patients) or normal saline (placebo group, 226 patients). MAIN OUTCOMES AND MEASURES: 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. 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 at weeks 3 and 12. RESULTS: Among 454 patients who were randomized (mean age, 61.1 years; women, 54.8%; mean baseline hemoglobin level, 9.1 g/dL), 96.3% completed the trial. At week 12, the number of hemoglobin responders was significantly greater for ferric carboxymaltose vs placebo (92.2% [200 patients] for the ferric carboxymaltose group vs 54.0% [115 patients] for the placebo group; absolute difference, 38.2% [95% CI, 33.6%-42.8%]; P = .001). Compared with the placebo group, patients in the ferric carboxymaltose group experienced significantly greater improvements in serum ferritin level (week 12: 233.3 ng/mL for the ferric carboxymaltose group vs 53.4 ng/mL for the placebo group; absolute difference, 179.9 ng/mL [95% CI, 150.2-209.5]; P = .001) and transferrin saturation level (week 12: 35.0% for the ferric carboxymaltose group vs 19.3% for the placebo group; absolute difference, 15.7% [95% CI, 13.1%-18.3%]; P = .001); but there were no significant differences in quality of life. Patients in the ferric carboxymaltose group required less alternative anemia management than patients in the placebo group (1.4% for the ferric carboxymaltose group vs 6.9% for the placebo group; absolute difference, 5.5% [95% CI, 3.3%-7.6%]; P = .006). The total rate of adverse events was higher in the ferric carboxymaltose group (15 patients [6.8%], including injection site reactions [5 patients] and urticaria [5 patients]) than the placebo group (1 patient [0.4%]), but no severe adverse events were reported in either group. 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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01725789. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/28535237/Effect_of_Intravenous_Ferric_Carboxymaltose_on_Hemoglobin_Response_Among_Patients_With_Acute_Isovolemic_Anemia_Following_Gastrectomy:_The_FAIRY_Randomized_Clinical_Trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.5703 DB - PRIME DP - Unbound Medicine ER -