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 language | English |
|---|---|
| Pages (from-to) | 1071-1077 |
| Number of pages | 7 |
| Journal | European Journal of Heart Failure |
| Volume | 11 |
| Issue number | 11 |
| DOIs | |
| Publication status | Published - Nov 2009 |
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Keywords
- Anaemia
- Haemoglobin
- Heart failure
- Kidney
- Mortality
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
Cite this
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.
In: European Journal of Heart Failure, Vol. 11, No. 11, 11.2009, p. 1071-1077.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - The safety and tolerability of darbepoetin alfa in patients with anaemia and symptomatic heart failure
AU - Klapholz, Marc
AU - Abraham, William T.
AU - Ghali, Jalal K.
AU - Ponikowski, Piotr
AU - Anker, Stefan D.
AU - Knusel, Beat
AU - Sun, Yan
AU - Wasserman, Scott M.
AU - Van Veldhuisen, Dirk J.
PY - 2009/11
Y1 - 2009/11
N2 - 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.
AB - 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.
KW - Anaemia
KW - Haemoglobin
KW - Heart failure
KW - Kidney
KW - Mortality
UR - http://www.scopus.com/inward/record.url?scp=71049164279&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=71049164279&partnerID=8YFLogxK
U2 - 10.1093/eurjhf/hfp130
DO - 10.1093/eurjhf/hfp130
M3 - Article
C2 - 19815661
AN - SCOPUS:71049164279
VL - 11
SP - 1071
EP - 1077
JO - European Journal of Heart Failure
JF - European Journal of Heart Failure
SN - 1388-9842
IS - 11
ER -