| Title | The safety and tolerability of darbepoetin alfa in patients with anaemia and symptomatic heart failure. | | Author(s) | Klapholz M, Abraham WT, Ghali JK, Ponikowski P, Anker SD, Knusel B, Sun Y, Wasserman SM, van Veldhuisen DJ | | Institution | Department of Cardiology, New Jersey Medical School, Newark, NJ, USA. | | Source | Eur J Heart Fail 2009 Oct 8. | | Abstract | 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. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 19815661 |
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