The safety and tolerability of darbepoetin alfa in patients with anaemia and symptomatic heart failure
- Klapholz, Marc
- Abraham, William T.
- Ghali, Jalal K.
- Ponikowski, Piotr
- Anker, Stefan D.
- Knusel, Beat
- Sun, Yan
- Wasserman, Scott M.
- van Veldhuisen, Dirk J.
DOIAbstract
To assess the safety and tolerability of darbepoetin alfa (DA) in the treatment of anaemia in heart failure (HF). 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 freque...
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