Abstract | BACKGROUND: METHODS: A total of 2584 participants were randomized to two doses of FCM 750 mg in one week, or iron sucrose 200 mg administered in up to five infusions in 14 days. The primary efficacy endpoint was the mean change to highest hemoglobin from baseline to Day 56. The primary composite safety endpoint included all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, unstable angina, congestive heart failure, arrhythmias and hyper- and hypotensive events. RESULTS: The mean hemoglobin increase was 1.13 g/dL in the FCM group and 0.92 g/dL in the iron sucrose group (95% CI, 0.13-0.28). Similar results were observed across all subgroups, except Stage 2 CKD. More subjects in the FCM group achieved a hemoglobin increase of ≥ 1.0 g/dL between baseline and Day 56 (48.6 versus 41.0%; 95% CI, 3.6-11.6%). There was no significant difference between FCM and iron sucrose recipients with respect to the primary composite safety endpoint, including the major adverse cardiac events of death, myocardial infarction, or stroke. A significant difference in the number of protocol-defined, predominantly transient hypertensive episodes was observed in the FCM group. CONCLUSIONS:
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Authors | Jane E Onken, David B Bregman, Robert A Harrington, David Morris, John Buerkert, Douglas Hamerski, Hussain Iftikhar, Roberto Mangoo-Karim, Edouard R Martin, Carlos O Martinez, George Edward Newman, Wajeh Y Qunibi, Dennis L Ross, Bhupinder Singh, Mark T Smith, Angelia Butcher, Todd A Koch, Lawrence T Goodnough |
Journal | Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association
(Nephrol Dial Transplant)
Vol. 29
Issue 4
Pg. 833-42
(Apr 2014)
ISSN: 1460-2385 [Electronic] England |
PMID | 23963731
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Ferric Compounds
- Hematinics
- Hemoglobins
- ferric carboxymaltose
- Maltose
- Iron
- Ferric Oxide, Saccharated
- Glucaric Acid
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Topics |
- Aged
- Anemia, Iron-Deficiency
(blood, etiology, therapy)
- Dose-Response Relationship, Drug
- Drug Therapy, Combination
- Female
- Ferric Compounds
(administration & dosage)
- Ferric Oxide, Saccharated
- Glomerular Filtration Rate
(physiology)
- Glucaric Acid
(administration & dosage)
- Hematinics
(administration & dosage)
- Hemoglobins
(metabolism)
- Humans
- Infusions, Intravenous
- Iron
(blood)
- Male
- Maltose
(administration & dosage, analogs & derivatives)
- Middle Aged
- Renal Dialysis
- Renal Insufficiency, Chronic
(blood, complications, physiopathology)
- Treatment Outcome
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