Hypophosphatemia after high-dose iron repletion with ferric carboxymaltose and ferric derisomaltose-the randomized controlled HOMe aFers study.
FGF23
Ferric carboxymaltose
Ferric derisomaltose
Hypophosphatemia
Iron deficiency anemia
Journal
BMC medicine
ISSN: 1741-7015
Titre abrégé: BMC Med
Pays: England
ID NLM: 101190723
Informations de publication
Date de publication:
13 07 2020
13 07 2020
Historique:
received:
22
02
2020
accepted:
19
05
2020
entrez:
14
7
2020
pubmed:
14
7
2020
medline:
16
12
2020
Statut:
epublish
Résumé
In patients with iron deficiency anemia, ferric carboxymaltose (FCM) and ferric derisomaltose (FDI) allow high-dose iron repletion. While FCM is reported to induce hypophosphatemia, the frequency of hypophosphatemia after an equivalent dosage of FDI had not been assessed prospectively. In the prospective, single-center, double-blind HOMe aFers study, 26 women with iron deficiency anemia (hemoglobin < 12 g/dL plus either plasma ferritin ≤ 100 ng/mL or a plasma ferritin ≤ 300 ng/mL and transferrin saturation (TSAT) ≤ 30%) were randomized to a single intravenous infusion of 20 mg/kg body weight (up to a maximum of 1000 mg) FCM or FDI. The primary endpoint was the incidence of hypophosphatemia (plasma phosphorus levels < 2.0 mg/dL at day 1, day 7 ± 2, and/or day 35 ± 2 after the infusion). In order to investigate potential skeletal and cardiovascular implications, we assessed changes in other components of mineral and bone metabolism, left ventricular function, and arrhythmias. Hypophosphatemia occurred more frequently in women treated with FCM (9 out of 12 [75%]) than in those treated with FDI (1 out of 13 [8%]; p = 0.001). Within 24 h after iron supplementation, women in the FCM group had significant higher plasma intact FGF23 (p < 0.001) and lower plasma 1.25-dihydroxyvitamin D (p < 0.001). As an indicator of urinary phosphorus losses, urinary fractional phosphorus excretion was higher in the FCM group (p = 0.021 at day 7 ± 2 after iron supplementation). We did not observe differences in skeletal and cardiovascular markers, potentially because of the limited number of participants. While both FCM and FDI provide efficient iron repletion in participants with iron deficiency anemia, FCM induced hypophosphatemia more often than FDI. Clinical Trials.gov NCT02905539. Registered on 8 September 2016. 2015-004808-36 (EudraCT Number) U1111-1176-4563 (WHO Universal Trial Number) DRKS00010766 (Deutsches Register Klinischer Studien).
Sections du résumé
BACKGROUND
In patients with iron deficiency anemia, ferric carboxymaltose (FCM) and ferric derisomaltose (FDI) allow high-dose iron repletion. While FCM is reported to induce hypophosphatemia, the frequency of hypophosphatemia after an equivalent dosage of FDI had not been assessed prospectively.
METHODS
In the prospective, single-center, double-blind HOMe aFers study, 26 women with iron deficiency anemia (hemoglobin < 12 g/dL plus either plasma ferritin ≤ 100 ng/mL or a plasma ferritin ≤ 300 ng/mL and transferrin saturation (TSAT) ≤ 30%) were randomized to a single intravenous infusion of 20 mg/kg body weight (up to a maximum of 1000 mg) FCM or FDI. The primary endpoint was the incidence of hypophosphatemia (plasma phosphorus levels < 2.0 mg/dL at day 1, day 7 ± 2, and/or day 35 ± 2 after the infusion). In order to investigate potential skeletal and cardiovascular implications, we assessed changes in other components of mineral and bone metabolism, left ventricular function, and arrhythmias.
RESULTS
Hypophosphatemia occurred more frequently in women treated with FCM (9 out of 12 [75%]) than in those treated with FDI (1 out of 13 [8%]; p = 0.001). Within 24 h after iron supplementation, women in the FCM group had significant higher plasma intact FGF23 (p < 0.001) and lower plasma 1.25-dihydroxyvitamin D (p < 0.001). As an indicator of urinary phosphorus losses, urinary fractional phosphorus excretion was higher in the FCM group (p = 0.021 at day 7 ± 2 after iron supplementation). We did not observe differences in skeletal and cardiovascular markers, potentially because of the limited number of participants.
CONCLUSIONS
While both FCM and FDI provide efficient iron repletion in participants with iron deficiency anemia, FCM induced hypophosphatemia more often than FDI.
TRIAL REGISTRATION
Clinical Trials.gov NCT02905539. Registered on 8 September 2016. 2015-004808-36 (EudraCT Number) U1111-1176-4563 (WHO Universal Trial Number) DRKS00010766 (Deutsches Register Klinischer Studien).
Identifiants
pubmed: 32654663
doi: 10.1186/s12916-020-01643-5
pii: 10.1186/s12916-020-01643-5
pmc: PMC7359262
doi:
Substances chimiques
FGF23 protein, human
0
Ferric Compounds
0
ferric carboxymaltose
6897GXD6OE
Maltose
69-79-4
Fibroblast Growth Factor-23
7Q7P4S7RRE
Iron
E1UOL152H7
Banques de données
ClinicalTrials.gov
['NCT02905539']
DRKS
['DRKS00010766']
EudraCT
['2015-004808-36']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
178Références
JAMA. 1989 Aug 18;262(7):925-30
pubmed: 2754793
JCI Insight. 2018 Dec 6;3(23):
pubmed: 30518682
J Bone Miner Res. 2013 Aug;28(8):1793-803
pubmed: 23505057
Int Clin Psychopharmacol. 1996 Jun;11 Suppl 3:89-95
pubmed: 8923116
Am J Med. 2008 Nov;121(11):943-8
pubmed: 18954837
Curr Opin Nephrol Hypertens. 2017 Jul;26(4):266-275
pubmed: 28399017
Transfusion. 2009 Dec;49(12):2719-28
pubmed: 19682342
J Clin Endocrinol Metab. 2011 Nov;96(11):3541-9
pubmed: 21880793
Nat Clin Pract Nephrol. 2006 Mar;2(3):136-48
pubmed: 16932412
Eur J Obstet Gynecol Reprod Biol. 2018 May;224:41-44
pubmed: 29529476
Public Health Nutr. 2009 Apr;12(4):444-54
pubmed: 18498676
Proc Natl Acad Sci U S A. 2011 Nov 15;108(46):E1146-55
pubmed: 22006328
J Am Soc Echocardiogr. 2005 Dec;18(12):1440-63
pubmed: 16376782
Eur J Haematol. 2002 Jun;68(6):341-4
pubmed: 12225391
JAMA. 2020 Feb 4;323(5):432-443
pubmed: 32016310
J Psychosom Res. 1995 Apr;39(3):315-25
pubmed: 7636775