PMID- 34162484
OWN - NLM
STAT- MEDLINE
DCOM- 20210913
LR  - 20210913
IS  - 1879-1913 (Electronic)
IS  - 0002-9149 (Linking)
VI  - 152
DP  - 2021 Aug 1
TI  - Safety and Efficacy of Intravenous Ferric Derisomaltose Compared to Iron Sucrose 
      for Iron Deficiency Anemia in Patients with Chronic Kidney Disease With and 
      Without Heart Failure.
PG  - 138-145
LID - S0002-9149(21)00422-7 [pii]
LID - 10.1016/j.amjcard.2021.04.042 [doi]
AB  - Ferric derisomaltose (FDI) is an intravenous (IV) high-dose iron formulation 
      approved in the US for the treatment of iron deficiency anemia in adults who are 
      intolerant of/have had an unsatisfactory response to oral iron, or who have 
      non-dialysis-dependent chronic kidney disease (NDD-CKD). FERWON-NEPHRO was a 
      randomized, open-label, multicenter clinical trial evaluating the safety and 
      efficacy of a single infusion of FDI 1,000 mg versus up to 5 doses of iron 
      sucrose (IS) 200 mg (recommended cumulative dose, 1,000 mg) over 8 weeks in 
      patients with NDD-CKD and iron deficiency anemia. Of 1,525 patients included in 
      the safety analysis, 244 (16%) had a history of heart failure (HF). Overall, the 
      rate of serious or severe hypersensitivity reactions was low and did not differ 
      between treatment groups. Cardiovascular adverse events (AEs) were reported for 
      9.4% of patients who had HF and 4.2% who did not. Time to first cardiovascular AE 
      was longer following administration of FDI compared with IS (hazard ratio: 0.59 
      [95% CI: 0.37, 0.92]; p=0.0185), a difference that was similar in patients with 
      or without HF (p=0.908 for interaction). Patients achieved a faster hematological 
      response (assessed by changes in hemoglobin and ferritin concentrations, and 
      increase in transferrin saturation) with FDI versus IS. In conclusion, in 
      patients with NDD-CKD, a single infusion of FDI was safe, well tolerated, and was 
      associated with fewer cardiovascular AEs and a faster hematological response, 
      compared to multiple doses of IS. These effects were similar for patients with 
      and without HF.
CI  - Copyright (c) 2021 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Ambrosy, Andrew P
AU  - Ambrosy AP
AD  - Department of Cardiology, Kaiser Permanente San Francisco Medical Center, San 
      Francisco, California; Division of Research, Kaiser Permanente Northern 
      California, Oakland, California. Electronic address: andrew.p.ambrosy@kp.org.
FAU - von Haehling, Stephan
AU  - von Haehling S
AD  - Department of Cardiology and Pneumology, University of Gottingen Medical Center, 
      Gottingen, Germany; German Center for Cardiovascular Research (DZHK), Partner 
      Site Gottingen, Gottingen, Germany.
FAU - Kalra, Paul R
AU  - Kalra PR
AD  - Department of Cardiology, Portsmouth Hospitals University NHS Trust, Portsmouth, 
      United Kingdom.
FAU - Court, Emma
AU  - Court E
AD  - Cambridge - a Prime Global Agency, Cambridge, United Kingdom.
FAU - Bhandari, Sunil
AU  - Bhandari S
AD  - Department of Renal Medicine, Hull University Teaching Hospitals NHS Trust, 
      Kingston upon Hull, United Kingdom.
FAU - McDonagh, Theresa
AU  - McDonagh T
AD  - Department of Cardiology, King's College Hospital NHS Foundation Trust, London, 
      United Kingdom.
FAU - Cleland, John G F
AU  - Cleland JGF
AD  - Robertson Centre for Biostatistics & Clinical Trials Unit, University of Glasgow, 
      United Kingdom; National Heart & Lung Institute, Imperial College, London, United 
      Kingdom.
LA  - eng
GR  - K23 HL150159/HL/NHLBI NIH HHS/United States
GR  - RE/18/6/34217/BHF_/British Heart Foundation/United Kingdom
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20210620
PL  - United States
TA  - Am J Cardiol
JT  - The American journal of cardiology
JID - 0207277
RN  - 0 (Disaccharides)
RN  - 0 (Ferric Compounds)
RN  - 0 (Hematinics)
RN  - 0 (Hemoglobins)
RN  - 0 (Transferrin)
RN  - 9007-73-2 (Ferritins)
RN  - AHU547PI9H (ferric derisomaltose)
RN  - FZ7NYF5N8L (Ferric Oxide, Saccharated)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Anemia, Iron-Deficiency/blood/complications/*drug therapy
MH  - Case-Control Studies
MH  - Disaccharides/*therapeutic use
MH  - Female
MH  - Ferric Compounds/therapeutic use
MH  - Ferric Oxide, Saccharated/*therapeutic use
MH  - Ferritins/blood
MH  - Heart Failure/*blood/complications
MH  - Hematinics/*therapeutic use
MH  - Hemoglobins/metabolism
MH  - Humans
MH  - Infusions, Intravenous
MH  - Male
MH  - Middle Aged
MH  - Proportional Hazards Models
MH  - Renal Insufficiency, Chronic/*blood/complications
MH  - Severity of Illness Index
MH  - Transferrin/metabolism
MH  - Treatment Outcome
EDAT- 2021/06/25 06:00
MHDA- 2021/09/14 06:00
CRDT- 2021/06/24 05:38
PHST- 2021/02/05 00:00 [received]
PHST- 2021/04/13 00:00 [revised]
PHST- 2021/04/16 00:00 [accepted]
PHST- 2021/06/25 06:00 [pubmed]
PHST- 2021/09/14 06:00 [medline]
PHST- 2021/06/24 05:38 [entrez]
AID - S0002-9149(21)00422-7 [pii]
AID - 10.1016/j.amjcard.2021.04.042 [doi]
PST - ppublish
SO  - Am J Cardiol. 2021 Aug 1;152:138-145. doi: 10.1016/j.amjcard.2021.04.042. Epub 
      2021 Jun 20.