Chronic Anemia and Fatigue in Elderly Patients: Results of a Randomized, Double-blind, Placebo-controlled, Crossover Exploratory Study with Epoetin Alfa

Objectives: To evaluate the effect of epoetin alfa treatment on hemoglobin (Hb), fatigue, quality of life (QOL), and mobility in elderly patients with chronic anemia.

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

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

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

Measurements: 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.

Conclusion: 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.