Document Detail


Effect of darbepoetin alfa on exercise tolerance in anemic patients with symptomatic chronic heart failure: a randomized, double-blind, placebo-controlled trial.
MedLine Citation:
PMID:  17306703     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: This study sought to investigate whether darbepoetin alfa, an erythropoiesis-stimulating protein (ESP), improves exercise capacity in patients with symptomatic chronic heart failure (CHF) and anemia. BACKGROUND: Anemia is common in patients with CHF. METHODS: In a multicenter, randomized, double-blind, placebo-controlled study, CHF patients with anemia (hemoglobin > or =9.0 to < or =12.0 g/dl) received subcutaneous placebo (n = 22) or darbepoetin alfa (n = 19) at a starting dose of 0.75 microg/kg every 2 weeks for 26 weeks. The primary end point was change in exercise tolerance from baseline to week 27 as measured by peak oxygen uptake (ml/min/kg body weight). Other end points included changes in absolute peak VO2 (ml/min), exercise duration, and health-related quality of life. RESULTS: Differences (95% confidence interval) in mean changes from baseline to week 27 between treatment groups were 1.5 g/dl (0.5 to 2.4) for hemoglobin concentration (p = 0.005), 0.5 ml/kg/min (-0.7 to 1.7) for peak VO2 (p = 0.40), 45 ml/min (-35 to 127) for absolute peak VO2 (p = 0.27), and 108 s (-11 to 228) for exercise duration (p = 0.075). Patients receiving darbepoetin alfa compared with placebo had an improvement in self-reported Patient's Global Assessment of Change (79% vs. 41%, p = 0.01) but no significant differences in the Kansas City Cardiomyopathy and Minnesota Living with Heart Failure Questionnaire scores. Darbepoetin alfa was well tolerated. CONCLUSIONS: In patients with symptomatic CHF and anemia, darbepoetin alfa increased and maintained hemoglobin concentrations and improved health-related quality of life. A trend toward increased exercise time but not peak VO2 was observed. (Impact of Darbepoetin Alfa on Exercise Tolerance and Left Ventricular Structure in Subjects With Symptomatic Congestive Heart Failure (CHF) and Anemia; http://clinicaltrials.gov/ct/show/NCT00117234?order = 1; NCT00117234).
Authors:
Piotr Ponikowski; Stefan D Anker; Joanna Szachniewicz; Darlington Okonko; Mark Ledwidge; Robert Zymlinski; Enda Ryan; Scott M Wasserman; Nigel Baker; Dylan Rosser; Stuart D Rosen; Philip A Poole-Wilson; Waldemar Banasiak; Andrew J S Coats; Ken McDonald
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2007-02-05
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  49     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2007 Feb 
Date Detail:
Created Date:  2007-02-19     Completed Date:  2007-03-12     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  753-62     Citation Subset:  AIM; IM    
Affiliation:
Cardiac Department, Military Hospital, Wroclaw, Poland.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00117234
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MeSH Terms
Descriptor/Qualifier:
Activities of Daily Living
Aged
Anemia / etiology*,  physiopathology*,  therapy
Body Weight
Double-Blind Method
Erythropoietin / analogs & derivatives*,  therapeutic use
Exercise Test / drug effects
Exercise Tolerance / drug effects*
Female
Heart Failure / complications*
Hematinics / therapeutic use*
Hemoglobins / drug effects
Hospitalization
Humans
Injections, Subcutaneous
Male
Natriuretic Peptide, Brain / blood
Oxygen Consumption / drug effects
Quality of Life
Treatment Outcome
Chemical
Reg. No./Substance:
0/Hematinics; 0/Hemoglobins; 11096-26-7/Erythropoietin; 114471-18-0/Natriuretic Peptide, Brain; 209810-58-2/darbepoetin alfa
Comments/Corrections
Comment In:
J Am Coll Cardiol. 2007 Feb 20;49(7):763-4   [PMID:  17306704 ]

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