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J Am Coll Cardiol, 2007; 49:753-762, doi:10.1016/j.jacc.2006.11.024 (Published online 6 February 2007).
© 2007 by the American College of Cardiology Foundation
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Effect of Darbepoetin Alfa on Exercise Tolerance in Anemic Patients With Symptomatic Chronic Heart Failure

A Randomized, Double-Blind, Placebo-Controlled Trial

Piotr Ponikowski, MD, PhD*,3,6, Stefan D. Anker, MD, PhD{dagger},{ddagger},1,3,4,6, Joanna Szachniewicz, MD*, Darlington Okonko, BSc, MRCP{dagger},2, Mark Ledwidge, PhD§, Robert Zymlinski, MD*, Enda Ryan, MRCP§, Scott M. Wasserman, MD||, Nigel Baker, MSc||,5, Dylan Rosser, BSc||,5, Stuart D. Rosen, MD{dagger}, Philip A. Poole-Wilson, MD{dagger}, Waldemar Banasiak, MD, PhD*, Andrew J.S. Coats, DM,3,4 and Ken McDonald, MD§,3,*

* Cardiac Department, Military Hospital, Wroclaw, Poland
{dagger} Clinical Cardiology, National Heart and Lung Institute, Imperial College London, London, England
{ddagger} Division of Applied Cachexia Research, Department of Cardiology, Charité Campus Virchow-Klinikum, Berlin, Germany
§ Department of Cardiology, St. Vincent’s University Hospital, Elm Park, Dublin, Ireland
|| Amgen Limited, 240 Cambridge Science Park, Cambridge, England
Faculty of Medicine, University of Sydney, Sydney, Australia.


Figure 1
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Figure 1 Summary of Study Design and Procedures

Hb = hemoglobin; HRQOL = health-related quality of life; NYHA = New York Heart Association.

 

Figure 2
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Figure 2 Change From Baseline in Measures of Exercise Tolerance and Duration Over Time

(A) Mean change in peak VO 2 over time, p = 0.248 for darbepoetin alfa versus placebo. (B) Mean change in total VO 2 over time, p = 0.134 for darbepoetin alfa versus placebo. (C) Mean change in exercise duration over time, p = 0.074 for darbepoetin alfa versus placebo. Data are mean ± SE.

 

Figure 3
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Figure 3 Individual Changes From Baseline to Week 27 in Hemoglobin Concentration Relative to the Change From Baseline in Exercise Duration

Multiple values may occur in the same location. Placebo: change in VO 2 = 16.5 x change in Hb – 74.8; darbepoetin alfa: change in VO 2 = 158 x change in Hb – 310. Solid line = placebo; dashed line = darbepoetin alfa.

 

Figure 4
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Figure 4 Development of Hemoglobin Concentrations Over Time in Patients Receiving Placebo or Darbepoetin Alfa (Intent-To-Treat Analysis Set)

Data are mean ± SE.

 

Figure 5
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Figure 5 Improvement in PGA at Week 13 and Week 27

PGA = Patient’s Global Assessment of Change.

 




 
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