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Chronic Anemia and Fatigue in Elderly Patients: Results of a Randomized, Double‐Blind, Placebo‐Controlled, Crossover Exploratory Study with Epoetin Alfa

2007; Wiley; Volume: 55; Issue: 10 Linguagem: Inglês

10.1111/j.1532-5415.2007.01357.x

1532-5415

Parag Agnihotri, Margaret Telfer, Zeeshan Butt, Abhay Jella, David Cella, Chris M Kozma, Mukesh Ahuja, Shahbaz Riaz, Joseph Akamah,

Dialysis and Renal Disease Management

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 ≤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.