Randomized, double-blind, placebo-controlled study to evaluate the effect of two dosing regimens of darbepoetin alfa in patients with heart failure and anaemia

Veldhuisen, Dirk J. van; Dickstein, Kenneth; Cohen‐Solal, Alain; Lok, Dirk J.; Wasserman, Scott M.; Baker, Nigel; Rosser, Dylan; Cleland, John G.F.; Ponikowski, Piotr

doi:10.1093/eurheartj/ehm328

Cited by 185 publications

(168 citation statements)

References 25 publications

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“…Several studies have focused on the effect of anemia correction, usually by iron and erythropoietin or darbopoietin, on exercise performance, measured either by peak _ VO 2 , exercise tolerance or by distance walked at the 6 min walking test, in both HF and non-HF patients [21][22][23][24][25][26][27][28][29]. However, only four [21][22][23] reports all based on small studies, showed the effect of anemia correction on peak exercise _ VO 2 in HF patients, with discordant findings.…”

Section: Discussionmentioning

confidence: 99%

Relationship of resting hemoglobin concentration to peak oxygen uptake in heart failure patients

et al. 2010

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Anemia is frequent in chronic heart failure (HF). To calculate what change in peak oxygen uptake ( _ VO 2 ) should be expected in the event of changes in hemoglobin concentration, we studied the correlation between peak _ VO 2 and hemoglobin concentration in a large HF population. We carried out retrospective analysis of all cardiopulmonary exercise tests (CPET) performed in our HF Clinic between June 2001 and March 2009 in HF patients who had a resting hemoglobin concentration measurement taken within 7 days of the CPET. We collected 967 CPETs, 704 tests were considered maximal and analyzed. We identified 181 patients (26%) as anemic. Peak _ VO 2 was lower (P < 0.001) in anemic patients (971 ± 23 ml/min) compared with nonanemic (1243 ± 18 ml/min). The slope of the _ VO 2 vs. hemoglobin ratio was 109 ml/min/g/dl at peak exercise. This correlation remained significant also when several confounding variables were analyzed by multivariate analysis. As an average, each gram of hemoglobin accounts, at peak exercise, for 109 ml/min change in _ VO 2 which is equivalent to 0.97 ml/min/kg. Therefore, in HF patients anemia treatment should increase _ VO 2 by 109 ml/min for each g/dl of hemoglobin increase. Am. J. Hematol. 85:414-417, 2010. V

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Section: Discussionmentioning

confidence: 99%

Relationship of resting hemoglobin concentration to peak oxygen uptake in heart failure patients

et al. 2010

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“…A pooled analysis of 473 patients included in the Study of Anemia in Heart Failure-Heart Failure Trial [67] and another controlled trial of darbepoetin [68] showed a significantly lower risk for the combined endpoint of all-cause mortality or first heart failure-related hospitalization (HR, 0.67; confidence interval, 0.44 -1.03; p ϭ .06) in patients treated with the ESA rather than placebo [67,68]. In a recent meta-analysis of seven of these randomized trials of erythropoietic agents in CHF patients, including 363 treated patients and 287 controls, there was a significantly lower risk for CHF hospitalization (RR, 0.59; p ϭ .006) [69].…”

Section: The Effect Of Treating Anemia On Chfmentioning

confidence: 99%

Iron Metabolism, Iron Deficiency, Thrombocytosis, and the Cardiorenal Anemia Syndrome

2009

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In treating moderate to severe anemia of chronic kidney disease (CKD), oral iron is effective only in a minority of nondialysis patients. Intravenous iron is more effective and can raise levels of hemoglobin even without the use of erythropoiesis-stimulating agents (ESAs). Unfortunately, the current assays of iron status that are presently widely available are not especially helpful in predicting response. In patients on dialysis, i.v. iron is effective over a wide range of serum ferritin from <100 ng/ml to 800 ng/ml. None of the three available randomized controlled trials comparing oral with i.v. iron showed evidence of nephrotoxicity caused by i.v. iron.Iron deficiency is a risk factor for thrombocytosis and should, wherever possible, be avoided. Optimal coadministration of iron may reduce the risk for ESA-driven cardiovascular events. Increased total body iron stores (imperfectly reflected by serum ferritin levels in CKD) do not appear to be related to such events or hospitalization in CKD; it is unclear what other risk factors and mechanisms need to be considered.In the appreciable proportion of patients with both renal and cardiac dysfunction, management is further complicated by a vicious circle (which can be characterized as cardiorenal anemia syndrome) in which CKD, heart failure, and anemia exacerbate each other. In such patients, correction of anemia appears to improve cardiac function and quality of life without a greater risk for adverse events. The Oncologist 2009;14(suppl 1):22-33

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“…In 2007, van Veldhuisen and colleagues reported a multi-centre, double-blind placebo-controlled trial in patients with NYHA class II-III CHF, a LVEF B40% and haemoglobin 9.0-12.5 g/dl using darbepoetin alfa as the active treatment [39]. Placebo (n = 55) or darbepoetin alfa was given subcutaneously every 2 weeks for 26 weeks at a starting weight adjusted dose of 0.75 mcg/kg (n = 56) or a fixed dose of 50 mcg (n = 54), to gradually achieve and maintain a target haemoglobin of 14.0 g/dl.…”

Section: Darbepoetin Alfa As a Treatment For Chfmentioning

confidence: 99%

Approaches to the treatment of anaemia in patients with chronic heart failure

Murphy

McMurray

2008

Heart Fail Rev

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Randomized, double-blind, placebo-controlled study to evaluate the effect of two dosing regimens of darbepoetin alfa in patients with heart failure and anaemia

Cited by 185 publications

References 25 publications

Relationship of resting hemoglobin concentration to peak oxygen uptake in heart failure patients

Relationship of resting hemoglobin concentration to peak oxygen uptake in heart failure patients

Iron Metabolism, Iron Deficiency, Thrombocytosis, and the Cardiorenal Anemia Syndrome

Approaches to the treatment of anaemia in patients with chronic heart failure

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