Document Detail


Ferric carboxymaltose in patients with heart failure and iron deficiency.
MedLine Citation:
PMID:  19920054     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Iron deficiency may impair aerobic performance. This study aimed to determine whether treatment with intravenous iron (ferric carboxymaltose) would improve symptoms in patients who had heart failure, reduced left ventricular ejection fraction, and iron deficiency, either with or without anemia. METHODS: We enrolled 459 patients with chronic heart failure of New York Heart Association (NYHA) functional class II or III, a left ventricular ejection fraction of 40% or less (for patients with NYHA class II) or 45% or less (for NYHA class III), iron deficiency (ferritin level <100 microg per liter or between 100 and 299 microg per liter, if the transferrin saturation was <20%), and a hemoglobin level of 95 to 135 g per liter. Patients were randomly assigned, in a 2:1 ratio, to receive 200 mg of intravenous iron (ferric carboxymaltose) or saline (placebo). The primary end points were the self-reported Patient Global Assessment and NYHA functional class, both at week 24. Secondary end points included the distance walked in 6 minutes and the health-related quality of life. RESULTS: Among the patients receiving ferric carboxymaltose, 50% reported being much or moderately improved, as compared with 28% of patients receiving placebo, according to the Patient Global Assessment (odds ratio for improvement, 2.51; 95% confidence interval [CI], 1.75 to 3.61). Among the patients assigned to ferric carboxymaltose, 47% had an NYHA functional class I or II at week 24, as compared with 30% of patients assigned to placebo (odds ratio for improvement by one class, 2.40; 95% CI, 1.55 to 3.71). Results were similar in patients with anemia and those without anemia. Significant improvements were seen with ferric carboxymaltose in the distance on the 6-minute walk test and quality-of-life assessments. The rates of death, adverse events, and serious adverse events were similar in the two study groups. CONCLUSIONS: Treatment with intravenous ferric carboxymaltose in patients with chronic heart failure and iron deficiency, with or without anemia, improves symptoms, functional capacity, and quality of life; the side-effect profile is acceptable. (ClinicalTrials.gov number, NCT00520780).
Authors:
Stefan D Anker; Josep Comin Colet; Gerasimos Filippatos; Ronnie Willenheimer; Kenneth Dickstein; Helmut Drexler; Thomas F L?scher; Boris Bart; Waldemar Banasiak; Joanna Niegowska; Bridget-Anne Kirwan; Claudio Mori; Barbara von Eisenhart Rothe; Stuart J Pocock; Philip A Poole-Wilson; Piotr Ponikowski;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2009-11-17
Journal Detail:
Title:  The New England journal of medicine     Volume:  361     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2009 Dec 
Date Detail:
Created Date:  2009-12-18     Completed Date:  2010-01-05     Revised Date:  2010-04-20    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2436-48     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2009 Massachusetts Medical Society
Affiliation:
Department of Cardiology, Campus Virchow-Klinikum, Charit? Universit?tsmedizin, Berlin.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00520780
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MeSH Terms
Descriptor/Qualifier:
Aged
Anemia, Iron-Deficiency / complications,  drug therapy*
Chronic Disease
Female
Ferric Compounds / adverse effects,  therapeutic use*
Ferritins / blood
Follow-Up Studies
Heart Failure / blood,  complications,  drug therapy*,  physiopathology
Hematinics / adverse effects,  therapeutic use*
Humans
Iron / deficiency*
Male
Maltose / adverse effects,  analogs & derivatives*,  therapeutic use
Quality of Life
Stroke Volume / drug effects
Ventricular Dysfunction, Left / etiology
Chemical
Reg. No./Substance:
0/Ferric Compounds; 0/Hematinics; 0/ferric carboxymaltose; 69-79-4/Maltose; 7439-89-6/Iron; 9007-73-2/Ferritins
Investigator
Investigator/Affiliation:
S D Anker / ; P Ponikowski / ; K Dickstein / ; G S Filippatos / ; T F L?scher / ; R Willenheimer / ; J Comin Colet / ; H Drexler / ; P A Poole-Wilson / ; R P W?thrich / ; J Lubsen / ; J H Altamirano / ; Alberto C Taquini / ; S V Rodriguez / ; J Spinar / ; J Povoln? / ; J Belohl?vek / ; Z Pal?ch / ; J Hor?k / ; S Anker / ; D Wolf / ; M Natour / ; M Durak / ; A Manolis / ; J Nanas / ; D T Kremastinos / ; D Alexopoulos / ; M Volterrani / ; G Vescovo / ; K Dickstein / ; M Mysliwiec / ; K Dluskiego / ; M Ogorek / ; M Kopernika / ; P Staneta / ; J Niegowska / ; M D?uzniewski / ; P Ponikowski / ; L Polonski / ; M Radoi / ; C E Macarie / ; C C Iliescu / ; G A Dan / ; P I Kikeli / ; E S Pasechnik / ; A A Eremenko / ; A A Gorbachenkov / ; A E Bragina / ; A Y Ivleva / ; B Y Bart / ; G P Arutyunov / ; R A Khokhlov / ; S N Tereschenko / ; V A Lusov / ; V N Ardashev / ; V Y Mareev / ; Z D Kobalava / ; O P Alexeeva / ; V E Oleynikov / ; N A Koziolova / ; D V Duplyakov / ; A A Petrov / ; D U Butko / ; M Y Sitnikova / ; O A Berkovich / ; S A Boldueva / ; S R Minkin / ; V A Kostenko / ; Y G Shvarts / ; Y B Karpov / ; S V Nedogoda / ; J Bruguera / ; J Gonz?lez Costell? / ; M Mart?nez Sell?s / ; J Quiles Granado / ; O A Koval / ; G A Ignatenko / ; I G Kraiz / ; O V Prohorov / ; V I Tseluyko / ; O M Parkhomenko / ; K M Amosova / ; L V Rudenko / ; O M Gyrina / ; V Y Lishnevska / ; S S Pavlyk / ; I P Kovalsky / ; G S Popik / ; Z Y Telyatnikova / ; I V Chopey / ; V A Vizir /
Comments/Corrections
Comment In:
Ann Intern Med. 2010 Apr 20;152(8):JC4-5   [PMID:  20404374 ]
N Engl J Med. 2009 Dec 17;361(25):2475-7   [PMID:  19920053 ]

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


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