European Journal of Heart Failure Advance Access originally published online on October 8, 2009
European Journal of Heart Failure 2009 11(11):1071-1077; doi:10.1093/eurjhf/hfp130
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The safety and tolerability of darbepoetin alfa in patients with anaemia and symptomatic heart failure
1 Department of Cardiology, New Jersey Medical School, Newark, NJ, USA
2 Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH, USA
3 Detroit Medical Center, Cardiovascular Institute, Detroit, MI, USA
4 Faculty of Public Health, Cardiac Department, Medical University, Wroclaw, Poland
5 Cardiac Department, Military Hospital, Wroclaw, Poland
6 Division of Applied Cachexia Research, Department of Cardiology, Charité Campus Virchow-Klinikum, Berlin, Germany
7 Centre for Clinical and Basic Research, IRCCS San Raffaele, Rome, Italy
8 Amgen, Inc., Thousand Oaks, CA, USA
9 Department of Cardiology, University Medical Centre Groningen, Groningen, The Netherlands
* Corresponding author. Tel: +1 973 972 4731, Fax: +1 973 972 1592, Email: klapholz{at}umdnj.edu
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Abstract |
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Aims: To assess the safety and tolerability of darbepoetin alfa (DA) in the treatment of anaemia in heart failure (HF).
Methods and results: In this pooled analysis of three randomized, double-blind, placebo-controlled studies of anaemic [haemoglobin (Hb) 
12.0 g/dL or 12.5 g/dL] symptomatic HF subjects, DA was administered subcutaneously once every 2 weeks and titrated to achieve and maintain a target Hb of 14.0 ± 1.0 g/dL. In total, 516 subjects were randomized; 231 (44.8%) to placebo, 285 (55.2%) to DA. Darbepoetin alfa was well tolerated, with an adverse event (AE) profile similar to placebo. Most subjects (placebo, 85%; DA, 87%) experienced at least one AE. There was a lower incidence of serious AEs in the DA group (placebo, 43%; DA, 37%) with the most frequent being worsening HF (placebo, 19%; DA, 11%). Treatment-related AEs were reported for 9% and 12% in placebo and DA subjects, respectively. Fewer deaths were reported in DA group (6%) vs. placebo (8%).
Conclusion: Darbepoetin alfa was well tolerated with an AE profile similar to placebo in HF subjects treated to a target Hb of 14.0 ± 1.0 g/dL. Contrary to recent data in other patient populations, there was no evidence of increased risk of mortality or cardiovascular events.
Key Words: Heart failure • Anaemia • Kidney • Haemoglobin • Mortality
Received June 3, 2009; Revised August 4, 2009; Accepted September 3, 2009
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