Chronic anemia and fatigue in elderly patients: results of a randomized, double-blind, placebo-controlled, crossover exploratory study with epoetin alfa.
OBJECTIVE
To evaluate the effect of epoetin alfa treatment on hemoglobin (Hb), fatigue, quality of life (QOL), and mobility in elderly patients with chronic anemia.


METHODS
An exploratory, 32 week, randomized, double-blind, crossover treatment trial.


METHODS
Sixty-two community-dwelling individuals aged 65 and older with chronic anemia (Hb < or =11.5 g/dL).


METHODS
Subcutaneous epoetin alfa or placebo weekly for 16 weeks (Phase I) with crossover to the opposite treatment (Phase II).


METHODS
Hb and QOL scores from the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system. Mobility was assessed as a secondary outcome using the Timed Up and Go (TUG) test.


RESULTS
Of the 62 subjects enrolled, complete data were analyzed for 58 in Phase I and 54 participants in Phase II. Of those enrolled, most were African American (95%) and female (85%) and had multiple comorbidities and a mean age+/-standard deviation of 76.1+/-7.2. Mean baseline Hb was 10.5+/-0.9 g/dL (7.3-11.5). In Phase I, 67% of those taking epoetin alfa, and in Phase II, 69% of those taking epoetin alfa had an increase in Hb of more than 2 g/dL, significantly more than those taking placebo (P<.001). Similarly, elderly participants significantly improved on the fatigue and anemia subscales of the FACIT across phases (all P<.05). No significant differences were found between treatment and placebo on TUG scores. Epoetin alfa was well tolerated.


CONCLUSIONS
In this trial involving predominantly older African-American women with anemia, a direct relationship existed between increases in Hb during epoetin alfa therapy and improvements in fatigue and QOL.
Agnihotri
Parag
P
Division of Geriatrics, Department of Medicine, Mercy Medical Group, Sacramento, California 95816, USA. parag.agnihotri@chw.edu
Telfer
Margaret
M
Butt
Zeeshan
Z
Jella
Abhay
A
Cella
David
D
Kozma
Chris M
CM
Ahuja
Mukesh
M
Riaz
Shahbaz
S
Akamah
Joseph
J
D000368:Aged; D000740:Anemia / Q000188:drug therapy*; D002641:Chicago; D015897:Comorbidity; D018592:Cross-Over Studies; D004311:Double-Blind Method; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000627:therapeutic use*; D005221:Fatigue / Q000188:drug therapy*; D005260:Female; D006397:Hematinics / Q000627:therapeutic use*; D006454:Hemoglobins / Q000187:drug effects*; D006801:Humans; D008297:Male; D051346:Mobility Limitation; D011788:Quality of Life; D011994:Recombinant Proteins; D016896:Treatment Outcome
D006397:Hematinics; D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D000068817:Epoetin Alfa