OBJECTIVE: Anemia is a frequent comorbidity in chronic heart failure (CHF) adversely affecting patients' prognosis. Erythropoietin seems to improve exercise capacity in CHF patients. This study investigates the effects of recombinant human erythropoietin analog darbepoetin-alpha on quality of life and emotional stress, evaluated by relevant questionnaires in patients with CHF and anemia. METHODS:Forty-one CHF patients [New York Heart Association class: II-III; left ventricular (LV) ejection fraction (EF)<40%; hemoglobin<12.5 g/dl; serum creatinine<2.5 mg/dl] were randomized (1:1) to receive either 3-month darbepoietin-alpha at 1.5 microg/Kg every 20 days plus iron orally (n=21) or placebo plus iron orally (n=20). Echocardiographic LVEF, questionnaires addressing quality of life (Kansas City Cardiomyopathy Questionnaire, functional and overall, Duke's Activity Status Index) and emotional stress [Zung self-rating depression scale (SDS), Beck Depression Inventory], as well as plasma b-type natriuretic peptide and 6-min walking distance (6MWT as a marker of exercise capacity) were assessed at baseline and posttreatment. RESULTS: A significant improvement in LVEF (32+/-6 from 26+/-6%, P<0.001), 6MWT (274+/-97 from 201+/-113 m, P<0.01), hemoglobin (12.8+/-1.4 from 10.9+/-1.0 g/dl, P<0.001) and plasma b-type natriuretic peptide (517+/-579 from 829+/-858 pg/ml, P=0.002) was observed posttreatment only in darbepoetin-treated group. Kansas CityCardiomyopathy Questionnaire functional (78+/-14 from 57+/-24%, P<0.01) and overall (68+/-20 from 47+/-22, P<0.001), Duke's Activity Status Index (19+/-11 from 14+/-9, P<0.05), Zung SDS (38+/-10 from 47+/-11, P<0.05) and Beck Depression Inventory (11+/-9 from 16+/-10, P<0.05) scores also improved in darbepoetin-treated patients, whereas they remain unchanged in the placebo group except for the Zung SDS which worsened (P<0.05). A significant correlation between drug-induced percent changes in 6MWT and Zung SDS (r=-0.627, P<0.05) was also observed. CONCLUSIONS:Darbepoetin-alpha improves quality of life and emotional stress in CHF patients with anemia, with a parallel increase in exercise capacity.
RCT Entities:
OBJECTIVE:Anemia is a frequent comorbidity in chronic heart failure (CHF) adversely affecting patients' prognosis. Erythropoietin seems to improve exercise capacity in CHFpatients. This study investigates the effects of recombinant humanerythropoietin analog darbepoetin-alpha on quality of life and emotional stress, evaluated by relevant questionnaires in patients with CHF and anemia. METHODS: Forty-one CHFpatients [New York Heart Association class: II-III; left ventricular (LV) ejection fraction (EF)<40%; hemoglobin<12.5 g/dl; serum creatinine<2.5 mg/dl] were randomized (1:1) to receive either 3-month darbepoietin-alpha at 1.5 microg/Kg every 20 days plus iron orally (n=21) or placebo plus iron orally (n=20). Echocardiographic LVEF, questionnaires addressing quality of life (Kansas City Cardiomyopathy Questionnaire, functional and overall, Duke's Activity Status Index) and emotional stress [Zung self-rating depression scale (SDS), Beck Depression Inventory], as well as plasma b-type natriuretic peptide and 6-min walking distance (6MWT as a marker of exercise capacity) were assessed at baseline and posttreatment. RESULTS: A significant improvement in LVEF (32+/-6 from 26+/-6%, P<0.001), 6MWT (274+/-97 from 201+/-113 m, P<0.01), hemoglobin (12.8+/-1.4 from 10.9+/-1.0 g/dl, P<0.001) and plasma b-type natriuretic peptide (517+/-579 from 829+/-858 pg/ml, P=0.002) was observed posttreatment only in darbepoetin-treated group. Kansas City Cardiomyopathy Questionnaire functional (78+/-14 from 57+/-24%, P<0.01) and overall (68+/-20 from 47+/-22, P<0.001), Duke's Activity Status Index (19+/-11 from 14+/-9, P<0.05), Zung SDS (38+/-10 from 47+/-11, P<0.05) and Beck Depression Inventory (11+/-9 from 16+/-10, P<0.05) scores also improved in darbepoetin-treated patients, whereas they remain unchanged in the placebo group except for the Zung SDS which worsened (P<0.05). A significant correlation between drug-induced percent changes in 6MWT and Zung SDS (r=-0.627, P<0.05) was also observed. CONCLUSIONS: Darbepoetin-alpha improves quality of life and emotional stress in CHFpatients with anemia, with a parallel increase in exercise capacity.
Authors: Alberto Palazzuoli; Ilaria Quatrini; Anna Calabrò; Giovanni Antonelli; Maria Caputo; Maria S Campagna; Beatrice Franci; Ranuccio Nuti Journal: Clin Exp Med Date: 2010-05-29 Impact factor: 3.984