The safety and tolerability of darbepoetin alfa in patients with anaemia and symptomatic heart failure.
OBJECTIVE
To assess the safety and tolerability of darbepoetin alfa (DA) in the treatment of anaemia in heart failure (HF).


RESULTS
In this pooled analysis of three randomized, double-blind, placebo-controlled studies of anaemic [haemoglobin (Hb) < or =12.0 g/dL or < 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%).


CONCLUSIONS
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.
Klapholz
Marc
M
Department of Cardiology, New Jersey Medical School, Newark, NJ, USA. klapholz@umdnj.edu
Abraham
William T
WT
Ghali
Jalal K
JK
Ponikowski
Piotr
P
Anker
Stefan D
SD
Knusel
Beat
B
Sun
Yan
Y
Wasserman
Scott M
SM
van Veldhuisen
Dirk J
DJ
D000368:Aged; D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D000068256:Darbepoetin alfa; D004921:Erythropoietin / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006333:Heart Failure / Q000150:complications* / Q000188:drug therapy; D006397:Hematinics / Q000009:adverse effects*; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D008297:Male; D016032:Randomized Controlled Trials as Topic; D016019:Survival Analysis
D006397:Hematinics; D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa