The safety and tolerability of darbepoetin alfa in patients with anaemia and symptomatic heart failure

Marc Klapholz, William T. Abraham, Jalal K. Ghali, Piotr Ponikowski, Stefan D. Anker, Beat Knusel, Yan Sun, Scott M. Wasserman, Dirk J. Van Veldhuisen

Research output: Contribution to journalArticlepeer-review

Abstract

Aims To assess the safety and tolerability of darbepoetin alfa (DA) in the treatment of anaemia in heart failure (HF).Methods and resultsIn 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).ConclusionDarbepoetin 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.

Original languageEnglish
Pages (from-to)1071-1077
Number of pages7
JournalEuropean Journal of Heart Failure
Volume11
Issue number11
DOIs
Publication statusPublished - Nov 2009

Keywords

  • Anaemia
  • Haemoglobin
  • Heart failure
  • Kidney
  • Mortality

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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