Author + information
- Received June 14, 2006
- Revision received August 30, 2006
- Accepted September 11, 2006
- Published online February 20, 2007.
- Piotr Ponikowski, MD, PhD⁎,3,6,
- Stefan D. Anker, MD, PhD†,‡,1,3,4,6,
- Joanna Szachniewicz, MD⁎,
- Darlington Okonko, BSc, MRCP†,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†,
- Philip A. Poole-Wilson, MD†,
- Waldemar Banasiak, MD, PhD⁎,
- Andrew J.S. Coats, DM¶,3,4 and
- Ken McDonald, MD§,3,⁎ ()
- ↵⁎Reprint requests and correspondence:
Dr. Ken McDonald, St. Vincent’s University Hospital, Elm Park, Dublin 4, Ireland.
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 ≥9.0 to ≤12.0 g/dl) received subcutaneous placebo (n = 22) or darbepoetin alfa (n = 19) at a starting dose of 0.75 μg/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 Vo2was 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).
↵1 Dr. Anker is supported by a Vandervell Fellowship (London, England) and by a grant from the Charité Medical School, Berlin, Germany.
↵2 Dr. Okonko is supported by a fellowship from the British Heart Foundation, London, England. The Department of Clinical Cardiology, Imperial College London, is supported by the British Heart Foundation, London, England.
↵3 Drs. Ponikowski, Anker, Coats, and McDonald have received honoraria for consulting from Amgen, Inc. and from Hoffmann-La Roche, Ltd.
↵4 Drs. Anker and Coats have received research grants from Amgen, Inc.
↵5 Drs. Baker and Rosser are employees and shareholders of Amgen, Inc.
↵6 Drs. Ponikowski and Anker contributed equally to this work.
This study was funded by Amgen, Inc.
- Received June 14, 2006.
- Revision received August 30, 2006.
- Accepted September 11, 2006.
- American College of Cardiology Foundation