title: Randomized double-blind trial of darbepoetin alfa in patients with symptomatic heart failure and anemia.
abstract: 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.
  
  
  RESULTS
  Patients (N=319) with symptomatic HF, left ventricular ejection fraction < or = 40%, and hemoglobin > or = 9.0 g/dL and < or = 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, 14.0+/-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 > or = 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.
authors.affiliation: Wayne State University, Detroit, Mich, USA. jghali@med.wayne.edu
authors.forename: Jalal K
authors.initials: JK
authors.lastname: Ghali
authors.forename: Inder S
authors.initials: IS
authors.lastname: Anand
authors.forename: William T
authors.initials: WT
authors.lastname: Abraham
authors.forename: Gregg C
authors.initials: GC
authors.lastname: Fonarow
authors.forename: Barry
authors.initials: B
authors.lastname: Greenberg
authors.forename: Henry
authors.initials: H
authors.lastname: Krum
authors.forename: Barry M
authors.initials: BM
authors.lastname: Massie
authors.forename: Scott M
authors.initials: SM
authors.lastname: Wasserman
authors.forename: Marie-Louise
authors.initials: ML
authors.lastname: Trotman
authors.forename: Yan
authors.initials: Y
authors.lastname: Sun
authors.forename: Beat
authors.initials: B
authors.lastname: Knusel
authors.forename: Paul
authors.initials: P
authors.lastname: Armstrong
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000188:drug therapy*; D000068256:Darbepoetin alfa; D004311:Double-Blind Method; D004921:Erythropoietin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D017079:Exercise Tolerance; D005260:Female; D006333:Heart Failure / Q000150:complications* / Q000188:drug therapy* / Q000401:mortality; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D013318:Stroke Volume; D015996:Survival Rate
chemical_list: D006454:Hemoglobins; D004921:Erythropoietin; D000068256:Darbepoetin alfa