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

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. Department of Cardiology and Pneumology, University of Göttingen Medical Center, Göttingen, Germany; German Center for Cardiovascular Research (DZHK), Partner Site Göttingen, Göttingen, Germany. Department of Cardiology, Portsmouth Hospitals University NHS Trust, Portsmouth, United Kingdom. Cambridge - a Prime Global Agency, Cambridge, United Kingdom. Department of Renal Medicine, Hull University Teaching Hospitals NHS Trust, Kingston upon Hull, United Kingdom. Department of Cardiology, King's College Hospital NHS Foundation Trust, London, United Kingdom. Robertson Centre for Biostatistics & Clinical Trials Unit, University of Glasgow, United Kingdom; National Heart & Lung Institute, Imperial College, London, United Kingdom.

The American journal of cardiology. 2021
Abstract
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.
Study details
Language : eng
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