TY - JOUR
T1 - Randomized double-blind trial of darbepoetin alfa in patients with symptomatic heart failure and anemia
AU - Ghali, Jalal K.
AU - Anand, Inder S.
AU - Abraham, William T.
AU - Fonarow, Gregg C.
AU - Greenberg, Barry
AU - Krum, Henry
AU - Massie, Barry M.
AU - Wasserman, Scott M.
AU - Trotman, Marie Louise
AU - Sun, Yan
AU - Knusel, Beat
AU - Armstrong, Paul
PY - 2008/1/29
Y1 - 2008/1/29
N2 - Background-Substantial evidence suggests that anemia is an independent risk factor for worse outcomes in patients with heart failure (HF). The Study of Anemia in Heart Failure Trial (STAMINA-HeFT) is the largest multicenter, randomized, double-blind, placebo-controlled trial to date evaluating the effect of treating anemia in HF. Methods and Results-Patients (N=319) with symptomatic HF, left ventricular ejection fraction ≤40%, and hemoglobin ≥9.0 g/dL and ≤12.5 g/dL were randomized (double-blind) to placebo (N=157) or darbepoetin alfa (N=162) subcutaneously every 2 weeks for 1 year (target hemoglobin, 14.±1.0 g/dL). The primary end point was change from baseline to week 27 in treadmill exercise time. Secondary end points were change from baseline in New York Heart Association class and quality of life at week 27. An additional prespecified efficacy analysis included the time to death by any cause or first HF-related hospitalization by 1 year. At baseline, the median (interquartile range) hemoglobin was 11.4 (10.9, 12.0) g/dL. At week 27, darbepoetin alfa treatment increased median (interquartile range) hemoglobin by 1.8 (1.1, 2.5) g/dL (placebo, 0.3 [-0.2, 1.0] g/dL; P<0.001). Of the patients treated with darbepoetin alfa, 85% achieved 2 consecutive hemoglobin levels of 14.0±1.0 g/dL during the study and experienced a hemoglobin increase of ≥1.0 g/dL from baseline. By intent-to-treat analysis, darbepoetin alfa treatment did not significantly improve exercise duration, New York Heart Association class, or quality of life score compared with placebo. A nonsignificant trend was observed toward a lower risk of all-cause mortality or first HF hospitalization in darbepoetin alfa-treated patients compared with placebo (hazard ratio, 0.68; 95% CI, 0.43, 1.08; P=0.10). Occurrences of adverse events were similar in both treatment groups. Conclusions-In this study of patients with symptomatic HF and anemia, treatment with darbepoetin alfa was not associated with significant clinical benefits. Darbepoetin alfa treatment was well tolerated and effectively raised hemoglobin. A trend of lower risk of morbidity and mortality was observed. (Circulation. 2008;117:526-535.). copy; 2008 American Heart Association, Inc.
AB - Background-Substantial evidence suggests that anemia is an independent risk factor for worse outcomes in patients with heart failure (HF). The Study of Anemia in Heart Failure Trial (STAMINA-HeFT) is the largest multicenter, randomized, double-blind, placebo-controlled trial to date evaluating the effect of treating anemia in HF. Methods and Results-Patients (N=319) with symptomatic HF, left ventricular ejection fraction ≤40%, and hemoglobin ≥9.0 g/dL and ≤12.5 g/dL were randomized (double-blind) to placebo (N=157) or darbepoetin alfa (N=162) subcutaneously every 2 weeks for 1 year (target hemoglobin, 14.±1.0 g/dL). The primary end point was change from baseline to week 27 in treadmill exercise time. Secondary end points were change from baseline in New York Heart Association class and quality of life at week 27. An additional prespecified efficacy analysis included the time to death by any cause or first HF-related hospitalization by 1 year. At baseline, the median (interquartile range) hemoglobin was 11.4 (10.9, 12.0) g/dL. At week 27, darbepoetin alfa treatment increased median (interquartile range) hemoglobin by 1.8 (1.1, 2.5) g/dL (placebo, 0.3 [-0.2, 1.0] g/dL; P<0.001). Of the patients treated with darbepoetin alfa, 85% achieved 2 consecutive hemoglobin levels of 14.0±1.0 g/dL during the study and experienced a hemoglobin increase of ≥1.0 g/dL from baseline. By intent-to-treat analysis, darbepoetin alfa treatment did not significantly improve exercise duration, New York Heart Association class, or quality of life score compared with placebo. A nonsignificant trend was observed toward a lower risk of all-cause mortality or first HF hospitalization in darbepoetin alfa-treated patients compared with placebo (hazard ratio, 0.68; 95% CI, 0.43, 1.08; P=0.10). Occurrences of adverse events were similar in both treatment groups. Conclusions-In this study of patients with symptomatic HF and anemia, treatment with darbepoetin alfa was not associated with significant clinical benefits. Darbepoetin alfa treatment was well tolerated and effectively raised hemoglobin. A trend of lower risk of morbidity and mortality was observed. (Circulation. 2008;117:526-535.). copy; 2008 American Heart Association, Inc.
KW - Anemia
KW - Exercise
KW - Heart failure
KW - Hemoglobin
KW - Trials
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UR - http://www.scopus.com/inward/citedby.url?scp=41049115024&partnerID=8YFLogxK
U2 - 10.1161/CIRCULATIONAHA.107.698514
DO - 10.1161/CIRCULATIONAHA.107.698514
M3 - Article
C2 - 18195176
AN - SCOPUS:41049115024
SN - 0009-7322
VL - 117
SP - 526
EP - 535
JO - Circulation
JF - Circulation
IS - 4
ER -