Document Detail


Efficacy and safety of iron sucrose for iron deficiency in patients with dialysis-associated anemia: North American clinical trial.
MedLine Citation:
PMID:  11157370     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Iron sucrose has been used to provide intravenous (IV) iron therapy to patients outside the United States for more than 50 years. In a multicenter North American clinical trial, we determined the efficacy and safety of iron sucrose therapy in patients with dialysis-associated anemia, evidence of iron deficiency, and below-target hemoglobin (Hgb) levels despite epoetin therapy. Evidence of iron deficiency included a transferrin saturation (Tsat) less than 20% and ferritin level less than 300 ng/mL, and below-target Hgb levels included values less than 11.0 g/dL. We administered iron sucrose in 10 doses, each administered undiluted as 100 mg IV push over 5 minutes, without a prior test dose. We assessed efficacy by determining the subsequent change in Hgb, Tsat, and ferritin values. We assessed safety by recording blood pressure and adverse events after iron sucrose injection and comparing results with those for the same patients during an observation control period. Results showed a significant increase in Hgb level that was first evident after three doses of iron sucrose and persisted at least 5 weeks after the 10th dose. Tsat and ferritin levels also increased significantly and remained elevated. In 77 enrolled patients, including those with previous iron dextran sensitivity, other drug allergies, or concurrent angiotensin-converting enzyme inhibitor use, we saw no serious adverse drug reactions and no change in intradialytic blood pressure associated with iron sucrose administration. We conclude that iron sucrose injection administered as 1,000 mg in 10 divided doses by IV push without a prior test dose is safe and effective for the treatment of iron deficiency in patients with dialysis-associated anemia.
Authors:
C Charytan; N Levin; M Al-Saloum; T Hafeez; S Gagnon; D B Van Wyck
Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  American journal of kidney diseases : the official journal of the National Kidney Foundation     Volume:  37     ISSN:  1523-6838     ISO Abbreviation:  Am. J. Kidney Dis.     Publication Date:  2001 Feb 
Date Detail:
Created Date:  2001-02-22     Completed Date:  2001-05-10     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8110075     Medline TA:  Am J Kidney Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  300-7     Citation Subset:  IM    
Affiliation:
Cornell University Medical College, Renal Division, New York Hospital Medical Center of Queens, New York, USA.
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MeSH Terms
Descriptor/Qualifier:
Aged
Anemia, Iron-Deficiency / drug therapy*,  etiology
Epoetin Alfa / therapeutic use
Erythrocyte Indices
Ferric Compounds / administration & dosage,  therapeutic use*
Hemoglobins / analysis
Humans
Injections, Intravenous
Iron / blood
Kidney Failure, Chronic / blood,  therapy
Middle Aged
Prospective Studies
Renal Dialysis / adverse effects*
Chemical
Reg. No./Substance:
0/Ferric Compounds; 0/Hemoglobins; 113427-24-0/Epoetin Alfa; 7439-89-6/Iron; 8047-67-4/ferric oxide, saccharated

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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